Actonel Patent Validity Affirmed: Nonobviousness of Positional Isomer

Obviousness, Patent, Patent Cases 2009

Procter & Gamble (P&G) v. Teva Pharmaceuticals (Fed. Cir. 2009)

P&G’s osteoporosis drug Actonel reportedly has $1.5 billion in annual sales. Hoping to manufacture a generic version, Teva challenged P&G’s patent – arguing obviousness in light of a prior P&G patent (the ‘406 patent) and obviousness-type double patenting. The district court rejected those challenges, and on appeal the Federal Circuit affirmed the patent’s validity. The patent is set to expire in 2013.

New Compound is Nonobvious: The claimed active compound – risedronate – is a bisphosphonate. In arguing obviousness, Teva pointed to P&G’s ‘406 patent which listed “central problems” in using bisphosphonates to treat osteoporosis. Although the prior art patent does not list risedronate, it does suggest the use of thirty-six similar molecules in the same class including one a positional isomer of the claimed risedronate. The positional isomer (2-pyr EHDP) includes the same atoms as risedronate, but those atoms are arranged in a somewhat different order.

In risedronate, the hydroxy-ethane-diphosphonate group is connected to the #3 carbon of a pyridine ring, while in 2-pyr EHDP, the hydroxy-ethane-diphosphonate group is connected to the #2 carbon. Because the nitrogen atom is in a different position in the two molecules, they differ in three dimensional shape, charge distribution and hydrogen bonding properties.

In addition to these structural differences, P&G pointed to “contemporaneous writings from Herbert Fleisch, the preeminent authority on bisphosphonates during the relevant time period.” Fleisch wrote that “every … bisphosphonate, exhibits its own physical-chemical, biological and therapeutic characteristics, so that each bisphosphonate has to be considered on its own. To infer from one compound the effects in another is dangerous and can be misleading.”

On appeal, the Federal Circuit agreed that these differences were sufficient to push development of the new compound beyond the obvious – additionally noting that Teva had not shown that a PHOSITA would have had a “‘reasonable expectation of success’ in synthesizing and testing risedronate.” Here, the court quoted its 1988 O’Farrell decision: “Patents are not barred just because it was obvious ‘to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.'”

This holding further supports the conventional wisdom that the KSR case will have much less impact in the area of pharmaceutical research.

Secondary Factors: In arguing secondary considerations of nonobviousness, TEVA argued that the element of long-felt but unmet need could not be proven because another drug (aledronate) was available prior to risedronate. The Federal Circuit rejected that argument – holding that the need may still have existed because the P&G patent application was filed before the other drug was on the market. “Under Monarch, we look to the filing date of the challenged invention to assess the presence of a long-felt and unmet need.”

Swearing Behind Not Allowed: P&G’s researcher had evidence that it had invented risedronate prior to the filing of the ‘406 patent. In particular, the inventor submitted a lab notebook with detailing the structure of risedronate and the procedure for its synthesis. However, the Federal Circuit rejected the evidence because the entry “was unwitnessed and was not corroborated by any other evidence.”

Double Patenting: “Having concluded that risedronate was not obvious under 35 U.S.C. § 103, we similarly conclude that the [risedronate] patent is not invalid for obviousness-type double patenting … [because] the claims of the [risedronate] patent are distinct from the claims of the ‘406 patent.”

Further Discussion:

BPAI Precedential Opinion: The Nexus for Obviousness and Nonobviousness

BPAI, Obviousness, Patent, Patent Cases 2009,

Ex parte Jellá (BPAI Precedential Opinion) fd081619-1.pdfpic-30.jpg

Most modern metal garage doors have four or five panel sections. The older wooden doors often had only one panel. Jella’s invention is simple — have three panels each “substantially twenty-eight inches” in hight. The prior art taught “any number” of panels including one, four, five, or six. Following the examiner’s lead, the Board of Patent Appeals and Interferences (BPAI) found the invention obvious.

The BPAI issued a precedential opinion focusing on obviousness. The prima facie case of obviousness is easy under KSR even without any evidence that anyone had previously considered a twenty-eight inch door.

The Court in KSR noted that “[wlhen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, Section 103 likely bars its patentability.” Changing a conventional seven foot high overhead garage door from a four panel section door to a three panel section door is nothing more than a predictable variation sparked by design incentives in the hope that a new look to the door would result in increased sales.

What it looks like here is that the driver for the innovation really was a need for a new ornamental design – motivating PHOSITA to create the obvious variation.

In our minds, this is an example of market demand driving a design trend, and the Supreme Court in KSR warned against granting patent protection to advances such as this that would occur in the ordinary course without real innovation . . . .

We further find that market pressure existed in the garage door industry to create a new design trend by updating the look of garage doors to spur additional sales in the industry.

In addition to allowing ornamental design needs to serve as the motivator to try a new design, the Board did not require any tight nexus between the design motivation and the new design (other than the need for a new design).

I highlight the lax approach on obviousness to contrast the Board’s strict approach when considering objective or secondary factors of nonobviousness.

Nexus: The bulk of the Jellá opinion is spent repeatedly shooting down the applicant’s arguments on secondary considerations of non-obviousness and the accompanying declarations. The most often repeated point was that any objective evidence must have a clear nexus with the invention as claimed.

“To be given substantial weight in the determination of obviousness or non-obviousness, evidence of secondary considerations must be relevant to the subject matter as claimed, and therefore the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations.”

The nexus requirement include being “commensurate in scope with the claims.”

Ornamental Features in Utility Patents: Additionally, the ornamentality or striking good looks of a design cannot be used as evidence of nonobviousness. Here, the BPAI rejected a declaration discussing the “unique” look of the garage door based on a desire to avoid overlap with design patent law: “Were we to allow secondary considerations of non-obviousness to be based on the industry’s reaction to the ornamental appearance of the claimed invention, we would be blurring the distinction between design and utility patent protection. Objective evidence of secondary considerations of non-obviousness should be tied to the functional aspects of the claimed invention for a utility patent application.” Oddly enough, the BPAI did allow the PTO to use the ornamental features to prove a “market pressure” — finding that “market pressure existed in the garage door industry to create a new design trend by updating the look [and appearance] of garage doors to spur additional sales in the industry. …  In our minds, this is an example of market demand driving a design trend, and the Supreme Court in KSR warned against granting patent protection to advances such as this that would occur in the ordinary course without real innovation.”

Rejection Affirmed.

Obviousness-Type Double Patenting and Splitting Ownership (CAFC Says Don’t Do It)

Obviousness, Patent, Patent Cases 2009,

In re Fallaux pic-29.jpg (Fed. Cir. 2009) 08-1545.pdf

The Fallaux family of patents began with a PCT filing in June 1995. The first US patent issued in November 1999. Three more patents issued from continuation applications in 2001, 2003, and and 2006. The application at issue here was filed in 2003.

The PTO’s appellate board – the BPAI – rejected the most recent application under the judge-made doctrine of obviousness-type double patenting. Obviousness-type double patenting is equitable in nature and operates as a mechanism to prevent “unjust extension of patent exclusivity beyond the term of a patent.” Thus, an obviousness-type double patenting rejection requires a link between the two applications – either in terms of inventorship or ownership. The doctrine is only relevant when a prior patent cannot be considered prior art as defined by Sections 102 and 103(a) of the Patent Act. (If it is prior art, then the reference is applied under those statutory provisions.)

The change in the patent term and publication of pending applications eliminated most of the need for this judge-made regime. Because patent term is calculated from the filing date, it is now difficult to extend the term while claiming priority. Likewise, published applications ordinarily create a statutory bar that operates to prevent an applicant from extending the term by not claiming priority to an earlier filing. Here, the Federal Circuit recognized the significance of the change in the law, but was not prepared at this juncture to eliminate the doctrine.

It is true that the unjustified patent term extension justification for obviousness-type double patenting has limited force in this case. Indeed, this is surely true of many double patenting rejections today, in no small part because of the change in the Patent Act from a patent term of seventeen years from issuance to a term of twenty years from filing. … Nonetheless, we do not think that we may disregard all of our cases relying on this justification for obviousness-type double patenting. In some cases there may still be the possibility of an unjust time-wise extension of a patent arising from patent term adjustment under § 154 or patent term extension under § 156.   

Furthermore, there is a second justification for obviousness-type double patenting—harassment by multiple assignees. … The harassment justification for obviousness-type double patenting is particularly pertinent here because the Fallaux application and the Vogels patents are not commonly owned.

Of course, careful Patently-O readers will realize that the Court’s use of mismatched patent term extensions as a justification for a double patenting rejection does not sit well with the law. In 2007, the Federal Circuit in Merck v. HI-TECH held that the patent term extension should apply to further extend the patent term despite a terminal disclaimer. Id. (Holding that a patent term extension under the Hatch-Waxman Act, 35 U.S.C. § 156, may be applied to a patent subject to a terminal disclaimer under 35 U.S.C. § 253, filed to overcome an obviousness-type double-patenting rejection.) The dicta of this Fallaux decision will tend to confuse the issue.

Common Inventorship: As the court notes, in this case, the double patenting rejection is based on second patent family. Both families list multiple inventors, and the link between the families is a single common inventor. Originally, the families were commonly owned by IntroGene, but some of the patents were assigned to Crucell and others to Galapagos Genomics.

No Common Ownership: The division of ownership rights here puts the applicant in a bind. Notably, it could not file a terminal disclaimer because the prior patent and the pending application were not commonly owned.

One Way versus Two Way Test: In most obviousness determinations, the examiner applies a “one way test” – asking “whether the application claims are obvious” over the prior art. This same approach is used in obviousness-type double patenting except that the prior patent is generally not considered “prior art.” More particularly, because the focus is on extending patent term, the question is whether the pending claims are only obvious variations of the already patented claims. Occasionally, courts have required a more stringent two-way test where the examiner additionally considers “whether the patent claims are obvious over the application claims.”

The two way test can be required if the PTO “is at fault” for a delay that causes an improvement patent to issue prior to the basic patent. Here, the court agreed with the PTO that

Dr. Fallaux was entirely responsible for the delay that caused the Vogels patents to issue prior to the filing of the Fallaux application. . . . there [is no] evidence to suggest—that the PTO shared any responsibility for the delay. . . . Dr. Fallaux elected to prosecute other applications and delay filing the Fallaux application [for] six years after the [original US] application was filed. During this six year period, the Vogels patents were filed for and issued. In view of the Board’s fact findings, we hold that the PTO was not responsible for the delay.

Because the PTO had not caused the delay in prosecution, it could apply the less stringent one-way test of obviousness. And, as a consequence, the Federal Circuit affirmed the rejection.

Notes:

  • The Fallaux panel of Judges Schall, Archer, and Moore* have no overlapping authors with the Merck v. HI-TECH panel of Judges Linn*, Friedman, and Plager. The direct contradiction of this case and the dramatic shift in the statutory law opens it to en banc rehearing.
  • Patent term adjustments (due to PTO delay) are definitely limited by terminal disclaimers. Meck (“Section 154(b)(2)(B) expressly excludes patents in which a terminal disclaimer was filed from the benefit of a term adjustment for PTO delays.”).

Supreme Court Reverses: Finding that the Federal Circuit has Appellate Jurisdiction to Review Remand to State Court

Patent, Patent Cases 2009

Carlsbad Tech v. HIF Bio (Supreme Court 2009) 07-1437-1.pdf

This involves the power of a federal appellate court to review a district court order to remand a case back to state court. In its opinion, the Federal Circuit held that it lacked such power. The Supreme Court has now reversed that decision and instead followed lead of the Third, Fourth, Fifth, Sixth, Seventh, Eighth, Ninth, Tenth, and Eleventh Circuits.

HIF first sued Carlsbad in California state court seeking a declaratory judgment of ownership and inventorship of various anti-angiogenesis drugs under California state law. The complaint also alleged various issues of slander, conversion, fraud, etc. The case was removed to federal court based on one federal RICO allegation. However, once that claim was dismissed, the district court refused to continue to exercise its supplemental jurisdiction to hear the remaining state claims — thus remanding the case back to state court. The Federal Circuit refused to review the remand for an abuse of discretion – instead finding that it lacked subject matter jurisdiction to hear the appeal.

The Federal Circuit’s outcome makes sense if you look at the statute. 28 U.S.C. §1447(d) says: ‘An order remanding a case to the State court from which it was removed is not reviewable on appeal or otherwise . . . .’ However, the Supreme Court has clearly moved beyond the words of the statute in this situation. Here, the Supreme Court reversed — finding that the remand may be appealed in federal court.

When a district court remands claims to a state court after declining to exercise supplemental jurisdiction, the remand order is not based on a lack of subject-matter jurisdiction for purposes of §§1447(c) and (d). The judgment of the Court of Appeals for the Federal Circuit is reversed, and the case is remanded for further proceedings consistent with this opinion.

On remand, the Federal Circuit will need to determine whether the remand was properly within the discretion of the lower court.

Although the decision was unanimous, the decision is accompanied by three concurring opinions by Justices Stevens, Scalia, and Breyer. Justice Stevens was honest about the court’s failure to follow the text of the statute: “If we were writing on a clean slate, I would adhere to the statute’s text.”

When the Federal Circuit’s decision was issued in 2007, I noted that “[t]his case would have a good shot of being granted certiorari. Its impact on patent law, however, is nil.” [Link]

Pointing Out the Problem to be Solved or Objects of the Invention

Enablement, Patent, Patent Cases 2009

Revolution Eyewear v. Aspex Eyewear (Fed. Cir. 2009) 08-1267.pdf [UPDATED 5/7/09 – To correct a mix-up of parties]

The patents at issue in this litigation focus on eyeglasses configured to be fitted with a second set of sunglass lenses using magnets. Magnetic auxiliary frames were already in the prior art, but the apparent advance is that the magnets are located in projections rather than embedded in the frames — thus allowing for a stronger magnetic bond. The patent also identified a second deficiency in the prior art: insufficient “stability support.”

The district court held that Revolution infringes claim 22 of Patent No. RE37,545.

On appeal, Revolution argued that that the claim was invalid — raising three separate arguments: (1) failure of written description under Section 112 ¶ 1 because the apparatus as claimed does not address both deficiencies in the prior art; (2) failure to claim the “original” invention in the reissued patent under Section 251; and (3) improper expansion of claim scope in the reissue application under the recapture rule. The Federal Circuit rejected each of these invalidity arguments.

Written Description: The written description requirement is often raised when the issued claims are different than those originally filed. New claims must find support in the original specification in a way that “convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, [the inventor] was in possession of the [claimed] invention.”

Revolution admits that all of the claimed elements are found in the original drawings. Of course, that is not conclusive for written description. Rather, in cases such as LizardTech and Liebel-Flarsheim, the Federal Circuit found claims invalid even though all the explicitly claimed limitations and arrangements were originally disclosed. The problem with the claims in those cases was that they did not include enough limits.

The invalidity argument in this case is actually more akin to Gentry Gallery. Here, Revolution argues that the patent is invalid because the claimed apparatus does not address both of the stated functions of the invention. The Federal Circuit found that argument lacked legal grounding: “when the specification sets out two different problems present in the prior art, it is unnecessary for each and every claim in the patent to address both problems.” Of course, the negative implication of the court’s statement is that the claim must address at least one of the stated problems. “Inventors can frame their claims to address one problem or several, and the written description requirement will be satisfied as to each claim as long as the description conveys that the inventor was in possession of the invention recited in that claim.” In this case, the claim addressed the magnetic strength problem – and thus satisfied the written description requirement.

Claiming the Same Invention: 35 USC Section 251 focuses on requirements of reissue applications. Under the statute, a reissued patent must be for the same “invention disclosed in the original patent.” Here, the Federal CIrcuit found that this requirement is “analogous to the written description requirement.” “Because we have held that the written description requirement is satisfied, we similarly hold that claim 22 complies with § 251.”

Recapture Rule in Reissue Patents: Reissue patents are intended to correct errors in the originally issued patents. Courts have created the recapture doctrine which would exclude certain intentional acts from the list of correctable ‘errors.’ In particular, under the recapture rule, an intentional and deliberate act of narrowing claims or disclaimer of claim scope in order move the patent application toward issuance will not be considered an “error” under Section 251. Akin to prosecution history estoppel, “the recapture rule is aimed at ensuring that the public can rely on a patentee’s admission during prosecution of an original patent.” On appeal, the Federal Circuit could find no admission or disclaimer being recaptured.

Affirmed.

Notes:

  • Pointing out deficiencies in the prior art: Most patent attorneys no longer discuss the prior art in the patent application because of the potential problems raised by this and other cases. Almost as an aside, this case also notes that by “pointing out the two deficiencies in the prior art, [the inventor] disclaimed an auxiliary frame that is not stably supported in top-mounting configuration and a primary frame that has embedded magnetic members.”

Federal Circuit Applies Phillips to Limit Gift Card Claim Construction

Claim Construction, Patent, Patent Cases 2009,

Every Penny Counts, Inc. v. American Express, Visa, Green Dot, MasterCard, First Data, etc. (Federal Circuit 2009)

Dr. Burke is a psychoanalyst who never liked change. I’m not talking Obama style change. No, Burke patented a method for donating leftover change (“excess cash”) to charities (or to store it in a separate savings account.)

Burke’s company (EPC) sued a host of defendants. who sell gift cards — alleging that the retail sale of gift cards along with merchandise infringe upon his patents because the gift card sales “loading value onto accounts at a point-of-sale terminal.” EPC’s argument was that the purchaser was using “excess cash” to buy the gift card.

On appeal, the Federal Circuit rejected the patentee’s argument for a broad claim construction – instead holding that the claimed “excess cash” was an “amount selected by the payor beyond the total amount due at the point of sale.”

Looking at the specification as “the primary basis for construing the claims,” the appellate panel noted that the specification repeatedly described the method’s purpose as allowing someone to conveniently donate to charities or to painlessly save money. From the specification:

In current shopping situations a clerk inputs the price of all items in a cash register and the latter totals the price. The consumer offers either the exact amount of cash or a sum exceeding the price, and the clerk enters that amount. The cash register then subtracts the price from the cash.

The excess cash offers the customers an opportunity to save small amounts of money painlessly. It also affords the consumer to donate [sic] small amounts of money to charity.

Interpreting this, the Federal Circuit determined that the claimed “excess cash” must be only what is left over after all items (including gift cards) are paid for. “Where the consumer does not offer a sum in excess of the total displayed on the cash register, then there is no excess cash.”

Non-infringement affirmed.

Notes:

  • Read the Opinion: 08-1434.pdf.
  • The Federal Circuit remarked that EPC wasted its appellate time arguing process – that it didn’t get a fair chance to argue claim-construction below. Claim construction is reviewed de novo, and the appellant needs to focus on why it should win on the merits, not on whether the district court was listening. “EPC has surprisingly little to say about what it alleges is substantively wrong with the district court’s construction, or why its proposed construction would be better on the merits. Instead, it attempts to assign error to the district court’s construction on a number of procedural grounds. Principally, it argues that the court erred by (1) spending a portion of the claim construction hearing considering the meaning of the phrase “sales price,” which was not a disputed claim term; and (2) using the accused products to tailor a construction of the patent claims that would make it impossible for EPC to prove infringement. Neither of these arguments has merit.”
  • As a rule, the Federal Circuit is respectful to both parties as well as their arguments and positions. Here, Senior Judge Cudahy went about as far as the Court ever does by describing Burke’s invention only within quotation marks (Burke’s “invention”) and once referring to the “‘invention’, such as it is.” The court more explicitly showed its disdain by awarding costs to the defendants.
  • Some of you may have heard of Bank of America’s “Keep the Change” program. According to the company brochure: “Each time you buy something with your Bank of America Check Card, we’ll round your purchase to the nearest dollar amount and transfer the difference from your checking account to your savings account. You get to keep the change and grow your savings. What could be easier?” EPC’s litigation against BOA continues.

Federal Circuit Revises: Amgen v. ITC

Patent, Patent Cases 2009

Amgen v. ITC and Roche Diagnostics (Fed. Cir. 2009).

Issues: FDA Safe Harbor; Joint Interpretation of Patent and Tariff Act; ITC Jurisdiction

Section 271(e)(1) of the Patent Act excuses would-be infringing uses of a patented invention that “reasonably relate to the development and submission of information under a Federal Rule which regulates the manufacture, use, or sale of drugs or veterinary biological products.” The language of the provision is that those activities will not be considered “act[s] of infringement.” In its 2005 Merck decision, the Supreme Court indicated a policy preference for broadly interpreting the exception in order to encourage drug development and FDA approval. Patent cases at the International Trade Commission (ITC) do not derive their authority from the Patent Act. Rather Section 337 of the Tariff Act (19 USC § 1337) authorizes the ITC to halt imports of articles that either (i) “infringe a valid and enforceable US patent” … or (ii) are made … by means of, a process covered by the claims of a valid and enforceable US patent.”

The distinction came to light in Kinik (Fed. Cir. 2004). In that case, the Federal Circuit distinguished between the Patent Act and the Tariff Act with regard to importation of a product made by a patented process. Section 271(g) of the patent act includes the caveat such importation is not infringement if the product is “materially changed by subsequent processes.” The court held that caveat did not apply to ITC cases based on the differences in the statutes and the explicit limitation in the Patent Act that the 271(g)(1) caveat applied “for the purposes of this title.”

In Amgen, Roche hoped to claim immunity under Section 271(e)(1) for its research use of imported EPO. Thus, when the Amgen case arose, the Federal Circuit was forced to decide between the statutory distinctions highlighted in Kinik and the Supreme Court’s broad reading of the 271(e)(1) defense. In their 2008 decision, the appellate panel (led by Judge Newman) held that the 271(e)(1) safeharbor applies to the ITC action.

Following the 2008 decision, Amgen petitioned for a rehearing en banc. After some apparent inter-chamber negotiations, the court sitting en banc has vacated the 2008 decision and the original panel has issued a revised opinion. The new opinion again confirms that the 271(e)(1) defense applies to ITC actions. Instead, the new opinion removes all discussion of whether the ITC has jurisdiction over non-sales based “imminent importations” except to note that resolution of that dispute was “not necessary … to decide this case.” (Here, Amgen’s allegations that Roche had imported IPO was sufficient to create subject matter jurisdiction.)

“In this case, the Commission had jurisdiction as a result of Amgen’s allegation that Roche imported an article made by a process covered by the claims of a valid and enforceable United States patent. See 19 U.S.C. § 1337(a)(1)(B)(ii). The Commission therefore was correct to reach the merits of Amgen’s claim. We need not and do not address whether the Commission would have had jurisdiction if Amgen had not asserted actual importation and relied instead entirely on its “imminent importation” theory.”

The ITC previously held that it did not have jurisdiction without an “importation, sale for importation, or sale within the US after importation.”

On remand, the ITC must determine “whether all of the EPO that Roche imported was entitled to the protection of the safe harbor.”

Judge Linn’s dissent remains unchanged. He argues that the plain language of 271(e)(1) cannot be read to extend to excuse imports of products made by patented process since that activity is not defined as “infringe[ment]” under Section 337.

Federal Circuit Remands Patent Pool Misuse Case: Issue of Improperly Sequestering Alternative Technology

ITC, Patent, Patent Cases 2009,

Princo v. ITC200904211316.jpg (Fed. Cir. 2009) Read the Decision

The ITC found that the CD-R and CD-RW disks imported by Princo violate a handful of Philips patents that cover industry standard compact disk technology. On appeal, the adjudged infringer argued that the patents should be unenforceable under the equitable doctrine of patent misuse. Giving some credence to the argument, the Federal Circuit vacated-in-part and remanded for further proceedings to determine whether Philip’s misused its patents by allegedly agreeing with a competitor not to license-out would-be competing technology.

Misuse is an antitrust theory that attempts to restrain a patentee from over-extending the anticompetitive strength of the patent rights in ways “contrary to public policy.” In some situations the antitrust authorities allow multi-company patent pooling as a way to promote foundational development and convergence. See Herbert Hovenkamp, Mark. D. Janis & Mark A. Lemley, IP and Antitrust § 34.4, at 34-20.1 (2009) (“Typical procompetitive benefits [of patent pools] include the clearing of blocking positions, the advantages flowing from integration of complementary technologies, and the cost savings from avoiding litigation.”). These agreements may be reviewed under the rule of reason for pro-competitive benefits.

In the early 1990’s Philips, Sony, and others formed a patent pool to cover CD-R and CD-RW technology and – in the process – defined the industry standard. Philips licenses the pools (but not individual patents) — charging a per disk royalty and requiring that the licenses be used only to make CD’s that comply with the defined “Orange Book compliant” standards. When Princo refused to pay the royalty, Philips sued for infringement in the ITC.

This appeal focuses on one particular patent in the pool – Sony’s U.S. Patent No. 4,942,565 (“Lagadec”). Lagadec claims a digital process for identifying the laser position. The patent pool also includes a patent covering a similar analog process for identifying the laser position developed by Philips. And, in fact, the defined standard requires that the analog process (not the digital process) be used.

Tying Non-Essential or Non-Used Patent: Princo argued that Lagadec is a non-essential patent and that Philips “improperly used its market power to force manufacturers seeking patents essential to the production of Orange Book compliant discs to also take a license to Lagadec, an allegedly-nonessential and Non-used Sony patent.” The Supreme Court saw this type of tying as problematic in Zenith v. Hazeltine, 395 US 100 (1968). In Zenith, the court held that “conditioning the grant of a patent license upon payment of royalties on products which do not use the teaching of the patent [is] misuse.”

Reasonable Claim Construction: Although the final claim scope was not clear, Philips argued under a reasonable broad claim construction, the standard analog process would infringe one of the claims in the Lagadec patent — thus making that patent “essential” to the pool and immunizing the pool from the tying challenge. Without determining the specific claim construction, the Federal Circuit agreed that misuse may be avoided if at the time of the licensing “it would have been reasonable for a manufacturer to believe a license … was necessary.”

We thus think that perfect certainty is not required to avoid a charge of misuse through unlawful tying. Rather, in this context a blocking patent is one that at the time of the license an objective manufacturer would believe reasonably might be necessary to practice the technology at issue.

The Federal Circuit’s “reasonable” approach meshes with the Hovenkamp Antitrust-IP treatise which states:

Indeed, even if the patents are only arguably conflicting, there are strong reasons to permit the settlement of patent disputes by means of a cross-licensing agreement. Not only will judicial economy be served and litigation costs reduced by settling such disputes, but the delay and uncertainty associated with blocking patent disputes may prevent either party from going forward with a commercial product for years while litigation is pending. Where two or more patents are arguably blocking, therefore, settling the dispute by means of cross-licensing is likely to be procompetitive.   

Here, for instance, by licensing Lagadec, a manufacturer has more certainty that licensing the pool will avoid later allegations of infringement — a major goal of the standard setting operation.

Cutting-off Alternatives: By including Sony’s Lagadec patent in the pool but then preventing manufacturers from using the digital process, Princo argued that Philips improperly colluded to sequester the work-around technology from competitive development. In Princo’s words “Philips bribed Sony not to use . . . Lagadec to compete against the [Philips dominated standard].” On appeal, the Federal Circuit agreed with Princo that such collusion could be misuse even if the patent included “essential” claims.

It is one thing to offer a pooled license to competing technologies; it is quite another to refuse to license the competing technologies on any other basis. In contrast to tying arrangements, there are no [pro competitive] benefits to be obtained from an agreement between patent holders to forego separate licensing of competing technologies, as counsel for Philips conceded at oral argument. . . . Agreements between competitors not to compete are classic antitrust violations. . . . Agreements preventing patent licensing of competing technologies also can constitute such violations.

On remand, the ITC must determine whether Princo has provided sufficient evidence to show that Sony and Philips agreed not to separately license Lagadec as competing technology and that the digital technology could have been a viable alternative.

Dissent in Part: Dissenting in part, Judge Bryson would have fully affirmed the ITC’s findings.

Prior Discussion of the Case:

Narrowing Amendment and Prosecution History Estoppel

Doctrine of Equivalents, Patent, Patent Cases 2009, Vitiation

Felix v. American Honda (Fed. Cir. 2009)

Mr. Felix sued Honda for infringement of his patent covering a truck bed with a storage compartment underneath the bed. The Honda Ridgeline advertises a “lockable In-Bed Trunk®” that appears to serve the same overall purpose. The problem is that Felix’s asserted claim is rather narrow and the district court found no literal infringement and no infringement under the doctrine of equivalents. Asserted claim 6 reads as follows:

6. In combination with a vehicle including a vehicle bed, the improvement of a storage system which includes: a) an opening formed in the vehicle bed and including an opening rim; b) a compartment with an interior; c) said compartment being mounted on said bed with said compartment interior accessible through said opening; d) a lid assembly including lid mounting means for mounting said lid in covering relation with respect to said opening; e) a channel formed at the rim of said bed opening and including an inner flange; f) a weathertight gasket mounted on said flange and engaging said lid in its closed position; and g) a plurality of drain holes formed in said channel.

In particular, the accused Honda truck bed has a “weathertight gasket” mounted on the lid rather than to the flange as claimed in the Felix patent.

On appeal, the Federal Circuit affirmed the lower court’s judgment of non-infringement – finding Honda did not literally infringe and that Felix’s claim under the doctrine of equivalents (DOE) was foreclosed by prosecution history estoppel. Here, I will discuss the DOE dispute.

Doctrine of Equivalents: The patent claims spell out the boundaries of an inventor’s claimed invention. However, courts may extend the scope of exclusionary rights beyond the literal claim language to capture equivalent products. In recent years, the doctrine of equivalents has been limited. This case, the doctrine of prosecution history estoppel came into play because Felix had narrowed his claims prosecution. (Actually, the applicant cancelled the broad independent claims and re-wrote the dependent claims into independent form. Under Honeywell, that process has the same estoppel effect as narrowing the independent claim.)

Tangential: The presumption of estoppel can be overcome with evidence that the reason for the narrowing amendment is no more than tangentially related to the equivalent in question. The evidentiary standard for proving the “no more than tangential relationship” is quite high. Here, Felix offered a credible alternative explanation, but the Federal Circuit rejected his argument because (1) he did not prove that his alternative was “the only reason” for the amendment and (2) he did not “explain the entire amendment.”

“Because we conclude that Felix is barred by the doctrine of prosecution history estoppel from relying on the doctrine of equivalents to prove that the accused In-Bed Trunk meets the gasket limitation, we also affirm the district court’s summary judgment of no infringement by equivalents.”

Drafting Strategies: One interesting aspect of this case is that Felix had to go through a couple of rounds of amendments. After first amending to add the gasket, Felix then had to amend again to secure allowance. Although the first amendment did not directly lead to allowance, the narrowing amendment still created a presumption of estoppel:

“The fact that the first amendment did not succeed and that a further amendment was required to place the claim in allowable form, however, is of no consequence as to the estoppel. It is the patentee’s response to a rejection—not the examiner’s ultimate allowance of a claim—that gives rise to prosecution history estoppel.

We therefore hold that the presumption of prosecution history estoppel attaches when a patentee cancels an independent claim and rewrites a dependent claim in independent form for reasons related to patentability, even if the amendment alone does not succeed in placing the claim in condition for allowance.”

Judge Linn also pointed to an “open question” in footnote 4:

“We leave open the question of whether the presumption of surrender would have attached as to the gasket limitation if, in response to the first office action, Felix had cancelled both claim 1 and claim 7, and had rewritten claim 8 in independent form, instead of attempting to secure the broader coverage of rewritten claim 7 as an intermediate step.”

[Corrected 3:40 CST]

     

Double Patenting: Proving Distinctiveness Based on Later Developed Evidence

Patent, Patent Cases 2009

Takeda Pharma. v. Doll (Fed. Cir. 2009)

For several decades, Hal Wegner has been the shepherd of Takeda’s family of Cepham patents claiming priority back to 1974. The question on appeal in this case involves double patenting and whether post-filing developments in the art can be used to inform the question of whether two claims are “patentably distinct.” Takeda’s evidence that its claims were distinct was generated in this decade, but the PTO argued that double patenting must be determined based on evidence pre-dating the priority application. Takeda could file a terminal disclaimer, but that would destroy the valuable pre-GATT patent term.

Obviousness Type Double Patenting is also known as non-statutory double patenting because … the theory is not based on any statute. Rather the doctrine is a judicially created mechanism designed to prevent a patentee from unfairly extending the term of patent rights through consecutive patents. To the extent this problem existed, much of it was eliminated in the 1995 changes that linked the patent term with the filing date rather than the issue date. Under the doctrine, separate claims with different patent terms will not both be patentable unless their subject matter is “patentably distinct.” Today the double patenting issues may arise most frequently when family-member patent terms differ due to patent term adjustments based on PTO delay during prosecution.

Product and Process: Takeda’s case involves a change in claim form. The PTO argued that the company’s latter manufacturing process claims are not patentably distinct from its earlier product claims. Generally, a product and its manufacturing process are deemed patentably distinct when “the product as claimed can be made by another materially different process.” MPEP § 806.05. Here, the “materially different process” was not known until well-after the applications were filed.

Holding: In its holding, the Federal Circuit compromised: Evidence of distinctiveness can be post-filing, but must be prior to the filing of the secondary application because that filing “actually triggers the potential of an unjustified extension of patent term.”   The case is then remanded for a determination of whether Takeda can prove distinctiveness using evidence that predates the second application (which was filed in 1990).

Judge Schall concurred in the judgment of remand, but disagreed with the rule of law that post-filing information should be available to prove distinctiveness. “I believe that tying the inquiry to the invention date is most commensurate with patent law as a whole and the policy goals relating to obviousness-type double patenting.” Judge Schall noted that the double patenting doctrine is one of patentability – and thus should be judged based on the date of invention.

Comments: I do not pretend to know the correct rule. However, Judge Rader’s decision looks to be incorrect. His judgment was based on the filing date of the second application as being the triggering date for the potential of an unjustified extension of patent term. Of course, the potential having double patenting problems was at least implicitly created in the original filing. If you are looking for an explicit trigger, that might not even be found in the second application as filed since claims are usually amended during prosecution. If selecting a triggering date – I would have chosen the date that the second patent issues. Until that point, there is no double patenting.

Note:

  • Judge Moore joined Judge Rader’s majority opinion.

In re Ferguson (Answers to Frequently Asked Questions FAQ)

Articles and Publications, Patent, Patent Cases 2009,

Scott Harris is the attorney who prosecuted, briefed, and argued in re Ferguson at the Federal Circuit. Harris is a former Fish & Richardson partner and is now in solo practice. He is also listed as a co-inventor on the patent application in dispute here as well as 40 other patents and 100+ pending applications. I asked him to provide his perspective on the case. In response, Harris provided the following FAQ.

What is Ferguson’s holding?

In order for a claim to be patentable under 35 USC 101, that claim must recite either a machine, or recite something that is tied to a machine; or the claim must transform some physical thing. The machine or the physical thing being transformed cannot be a paradigm, cannot be a corporation, and cannot be a legal obligation. 35 USC 101 requires that you must be able to “touch” the machine or the thing being transformed.

How does Ferguson differ from Bilski?

The patent application of In re Bilski, 545, F.3d 943 (Fed Cir 2008) related to an improved mathematical way in which hedged commodities were analyzed and managed. Like many of the previous “preemption” cases that had been decided by the Supreme Court and by the Federal Circuit, Bilski’s claims recited a mathematical algorithm. The Federal Circuit holding announced a new test – requiring the claim combination to be either tied to a “machine” (e.g. a computer) , or claiming a transformation of an object. Since there was no “machine” or “transformation”, the court concluded that Bilski’s claims would “preempt” one specific mathematical form of hedging, effectively stopping anyone else from using these mathematical formulas in the same way. The machine/transformation cannot be peripheral to the claim – which means that the machine or transformation cannot be related to data gathering or “mere” post solution activity.

Unlike the “preemption” cases relied on by the Bilski court, Ferguson had no mathematical calculation at all. The Federal Circuit chose to extend the Bilski test beyond the confines of “preemption” to defeat patentability of Ferguson’s pure business method. Ferguson holds that Bilski’s “machine or transformation” test is the sole and exclusive test for determining patentable subject matter, with or without a mathematical calculation.

Ferguson also held

– that the machine prong of the Bilski test must be a physical thing that one must be able to touch, and

– that the “article” to be changed into a different state or thing cannot be a legal obligation – and presumably likewise must be something that can be touched.

What was the Ferguson patent application about?

In a nutshell – software written by the little guy that was marketed and supported as though it had been written by the big guy. We believed that institutions would simply refuse to adopt or purchase any software unless it was supported by a credible company. Someone in their basement could write the best word processor or drawing program ever – but no one would ever know, because few would ever adopt it.

The patent application claimed a way to support a very small software developer or writer – who had the skills to write the software, but did not have the skills or resources to market and support the software. Ferguson claimed a shared marketing force that took a share of the income or profit from the software in return for doing this marketing and support.   

Why did you write claims to a “paradigm”?

In 1999, new forms of patents and claims were erupting. The patent office had decided to accept as statutory Beauregard claims, which recited a sequence of instructions on a readable computer media. I was excited by the prospect of writing a whole new claim form for the business method genre.

I had originally filed Ferguson’s patent application with many claims reciting a “paradigm”, a way in which a business organization would carry out a specific business task. Other claims defined a process of doing that business task. Ferguson was about selling computer software, and that was not something that would normally be carried out on a computer.   

Based on everything I knew at that time, business methods should be patentable. I wanted to see if we could get the patent office to accept a wholly new form of claim adapted to the business method. I called this a paradigm, which Kuhn, in The Structure of Scientific Revolutions defined as “an accepted model or pattern, . . . Paradigms gain their status because they are more successful than their competitors in solving a few problems that the group of practitioners has come to recognize as acute.” A paradigm in this sense, therefore, referred to the successful way in which a problem is solved.

Why did you think you get claims like this?

I believed the Supreme Court when they said that 35 USC §101 allows you to patent “anything under the sun that is made by man”. Diamond v Chakrabarty, 447 US 303, 308 (1980).

I believed the Federal Circuit, when they said that “business methods” were patentable. State Street Bank and Trust v Signature Financial Group Inc., 149 F.3d 1368 (Fed Cir 1998).

I did not believe there was any prior art defeating patentability, and indeed, the patent office never found any.

Are Business Methods still patentable after Bilski/Ferguson?

Bilski expressly did not overrule the part of State Street Bank and Trust v Signature Financial Group Inc., 149 F.3d 1368 (Fed Cir 1998), which held that business methods were NOT per se unpatentable.

However, I define a business method as a novel and unobvious way that a business carries out a new business function.

The holdings in Bilski and Ferguson make any such business method unpatentable, unless tied to a machine, or operated to transform a physical object. Therefore, some ways of carrying out the business method may be patentable under Bilski / Ferguson. I do not believe any pure business method could be patented under the holdings of Bilski/Ferguson.

What’s your take away from Ferguson?

Disclose (and claim) interaction with a computer in every patent application that is not a pure mechanical device.

Don’t get your hopes up about the patent office accepting an innovative claim form.

No Stay of District Court Proceedings Pending Appeal of Preliminary Injunction

Injunctions, License, Patent, Patent Cases 2009, Transnational

Fairchild Semiconductor v. Third Dimension (3D) Semiconductor 200903292047.jpg (Fed. Cir. 2009) (nonprecedential order)

Fairchild originally licensed 3D's US and Chinese patents – agreeing to a royalty for all Fairchild products "covered by" a 3D patent. However, after analyzing the patents, Fairchild decided that it need not pay any royalties and then sued for a declaratory judgment that it owed no royalties and that none of its products are covered by 3D's patents.

Restraining License Termination: In a preliminary ruling, the district court granted Fairchild's request for a preliminary injunction prohibiting 3D from terminating the license agreement. The ongoing license serves as a defense to charges of patent infringement by 3D. As the district court held, "termination of the agreement does create irreparable harm in depriving Fairchild of its primary defense to 3D patent infringement litigation.

The threat of such litigation is not speculative: 3D has already filed a complaint in the United States District Court for the Eastern District of Texas and has promised to file an infringement case in China based on the Chinese patents otherwise licensed by the Agreement. Without the Agreement as an affirmative defense to those suits, Fairchild could be forced to endure years of litigation in those other forums despite this Court eventually ruling that Fairchild did not breach the Agreement.

The preliminary injunction is now on appeal to the Federal Circuit. In a recent order, the appellate panel rejected 3D's motion to stay the district court proceedings pending outcome of the appeal. 3D argued that the appeal divested the district court with jurisdiction over the matter. That argument was regarded "without merit."

A preliminary injunction, i.e., an injunction pendente lite, is an injunction issued pending the ongoing litigation. Although a district court may not proceed with matters involved with the injunction itself, e.g., it may not amend the injunction, or make findings to support its injunction while the injunction is on appeal, the district court may proceed with the litigation and permit discovery, enter rulings on summary judgment, or hold a trial on the merits. (internal citations omitted)

Briefing in the appeal will begin in April.

Notes & Docs:

Federal Circuit Awards Sanctions for Frivolous Appeal

Attorney Fees, CAFC, Patent, Patent Cases 2009, Software

E-Pass v. 3Com, Palm, Visa, et al. (Fed. Cir. 2009)

This litigation began in 2000 when E-Pass sued for infringement of its electronic credit card patent. Patent No. 5,276,311. The district court granted summary judgment of non-infringement, which was affirmed on appeal. The district court then found the case exceptional under 35 U.S.C. § 285 and awarded attorneys’ fees to the defendants. E-Pass appealed that judgment. In a counter-motion, PalmSource also asked for attorneys fees for the appeal – arguing that the appeal was frivolous as well. The Federal Circuit affirmed the trial court without opinion, but wrote an extensive opinion finding a frivolous appeal.

Frivolous Appeal: An appeal is frivolous if the appellant fails “to present cogent or clear arguments for reversal.” In addition, the court may award sanctions based on misconduct or misrepresentations to the appellate court.

Here, the court found that E-Pass did not present any specific argument relating to the attorney fees for one of the defendants – PalmSource. Instead, the plaintiff-appellant focused on its case against the other defendants. E-Pass did not “challenge any finding of the district court relating to litigation misconduct in the case against PalmSource.” Furthermore, E-Pass did not change its strategy even after being notified of PalmSource’s frivolous appeal argument. Adding to E-Pass’s problems are “multiple misrepresentations” to the Federal Circuit – primarily in referring to the defendants collectively when each stood in different situations. Perhaps the straw-that-broke-the-camel’s-back was E-Pass’s use of the quote that “a trial court may only sanction the patentee if both the litigation is brought in subjective bad faith and the litigation is objectively baseless.” With the help of PalmSource and the CAFC clerks, the court easily found that a critical exception to the sanctions rule had been left off. Notably, the full quote reads: “Absent misconduct in the litigation or in securing the patent, a trial court may only sanction the patentee if both the litigation is brought in subjective bad faith and the litigation is objectively baseless.”

Sanctions and attorney fees granted against E-Past and its counsel, jointly and severally.

In dissent, Judge Bryson saw serious misconduct, but would not have imposed sanctions.

Accepting that in those regards E-Pass’s briefs on appeal fell short of the standards we expect of counsel in this court, I nonetheless conclude that the shortfall is not so egregious as to call for the imposition of sanctions.

Inequitable Conduct Based on Failure to Submit Rejection in Co-Pending Case

Inequitable Conduct, Patent, Patent Cases 2009

Larson Mfg. Co. v. Aluminart Products Ltd. (Fed. Cir. 2009)pic-15.jpg

In an earlier post, I discussed the concurring opinion in this case where Judge Linn argued for a restatement of the law of inequitable conduct that makes it more difficult to allege inequitable conduct absent evidence of fraud. This post covers the majority opinion.

Larson sued Aluminart for infringement of two claims of its patent covering a storm door with a moving glass panel. Without reaching the merits of the infringement argument, the district court found the patent unenforceable due to inequitable conduct during prosecution. The district court found that the patentee had improperly withheld documents from the examiners during reexamination of the patent. (The reexamination had been requested by Aluminart). The Federal Circuit provided the following description of the lower court holding:

The [district] court found that Larson failed to disclose to the Reexamination Panel three items of prior art and two office actions issued in the prosecution of a continuation application that grew out of the application that resulted in the ’998 patent [the patent being reexamined]. The court rejected Larson’s argument that the three items of prior art were cumulative of prior art which already was before the Reexamination Panel and therefore were not material, as well as its argument that the office actions were not material because all of the critical references noted in them already had been disclosed to the Reexamination Panel. After finding that Larson intended to deceive the Reexamination Panel, the court balanced its findings of materiality and intent and found inequitable conduct.

On appeal, the Federal Circuit vacated the holding and remanded for a potential new trial on inequitable conduct.

The inequitable conduct charges stem from the PTO's parallel examination of both the reexam of the patent in suit and a continuation application. During the reexam, Larson's patent attorney submitted hundreds of references, district court proceedings, and disclosed the co-pending continuation. However, the patent attorney did not cross-cite two office action rejections from the continuation or one of the prior art references from the continuation (although every other reference from the continuation was cited). In addition, the attorney did not cite two marketing configuration sheets that were later uncovered during discovery.

Law of Inequitable Conduct: Inequitable Conduct requires clear and convincing evidence of at least a threshold level of evidence that the applicant both (1) "made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information" and (2) by that act "intended to deceive the PTO." The materiality of the action is determined based on a reasonable examiner standard – what would a reasonable examiner "consider important in deciding whether to allow the application to issue as a patent?" If an unsubmitted reference is cumulative to information already on hand, then it will not be seen as material. Proof of intent to withhold a reference is not sufficient. Rather, the evidence must show intent to deceive the PTO. That said, intent may be proven by circumstantial evidence. After finding both threshold materiality and intent, the court must determine if the proof is sufficient to find inequitable conduct and consequently hold the patent unenforceable.

What is Cumulative?: After reviewing the submitted and unsubmitted prior art references in detail, the Federal Circuit found that the lower court had clearly erred in finding the art non-cumulative. Notably, the only features found in the non-submitted art that were not in the submitted art were "irrelevant to the claim limitations at issue and therefore could not support a finding of materiality and non-cumulativeness." Although the unsubmitted prior art included a different embodiment than the submitted reference, that difference was not important because the claims were broadly drafted in a way that cover both embodiments.

Disclosure of Office Actions in Related Cases: The examiner of the co-pending continuation filed four office action rejections. The first was used as the basis for the reexamination request. The second was used as a basis for an initial rejection in the reexamination. However, the patentee did not submit the third or fourth office action for consideration. The Federal Circuit agreed with the lower court that the office actions should have been submitted because the rejections contained "adverse decisions about substantially similar claims" that were "not cumulative" to materials already submitted to the examiner.

Because the Third and Fourth Office Actions contained another examiner’s adverse decisions about substantially similar claims, and because the Third and Fourth Office Actions are not cumulative to the First and Second Office Actions, the district court correctly found the withheld Office Actions material.

In its analysis, the Federal Circuit reviewed Dayco Products where it found the patentee had wrongly withheld rejections from co-pending applications.

In Dayco Products, the patentee failed to disclose rejections in a copending application of claims “that were substantially similar in content and scope to claims pending in the applications that issued as the patents-in-suit.” 329 F.3d at 1367. We held “that a contrary decision of another examiner reviewing a substantially similar claim” was material. Id. at 1368. We further explained that, because a “rejection of a substantially similar claim refutes, or is inconsistent with the position that those claims are patentable, [the] adverse decision by another examiner . . . meets the materiality standard.” Id.   

Thus, on remand, the district court must determine whether the patentee failure to submit the two office actions was done with sufficient intent to deceive the PTO. Although seemingly dicta, the Federal Circuit provided four points of explicit guidance to the lower court. First, the district court need not accept any additional evidence; Second, the court should remember that "material does not presume intent, and nondisclosure, by itself, cannot satisfy the deceptive intent element." Rather, if intent is inferred, it must be "the single most reasonable inference able to be drawn from the evidence." Further, intent cannot be inferred based on a decision to withhold if the patentee has plausible legitimate reasons for withholding. Third, good faith on behalf of the applicant must be considered as it "militates against a finding of deceptive intent." One element of good faith here, may be that the patentee notified the examiners of the co-pending application. Finally, although the Federal Circuit agreed that the office actions were material, the court did not opine on how material. Thus, if the lower court does find clear and convincing evidence of a threshold intent to deceive, the court must again determine whether the combined intent and materiality are sufficient to warrant a holding of inequitable conduct.

Notes:

  • This case is rather silly because the defendant Aluminart was closely following the reexamination. I can almost guarantee that Aluminart realized that the documents had not been submitted even before the reexamination certificate was issued. Certainly, the company could have brought the omission Larson's attention if it truly was material.

Judge Linn Calls for En Banc Restatement of the Law of Inequitable Conduct

En Banc, Inequitable Conduct, Patent, Patent Cases 2009, ,

Larson Mfg. Co. v. Aluminart Products Ltd. (Fed. Cir. 2008)

Larson's patent covers a specially designed outside. The appeal focuses on inequitable conduct and the Federal Circuit vacated a district court judgment that the asserted patent was unenforceable. I will return to the decision in a later post, but wanted to focus attention on the concurring opinion by Judge Linn and his call for an en banc review of inequitable conduct jurisprudence. Linn's concerns could be addressed by the Supreme Court in Aventis Pharma v. Amphastar Pharmaceuticals, which is pending certiorari.

I write separately … to express my view that this precedent has significantly diverged from the Supreme Court's treatment of inequitable conduct and perpetuates what was once referred to as a "plague" that our en banc court sought to cure in Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc). …

Symptoms of this plague are apparent from the facts of this case. The patent-in-suit has undergone examination twice in the PTO, and the patentee has been accused of inequitable conduct on each occasion for allegedly withholding material information. During original prosecution, the PTO considered 143 references, 135 of which the submitted two more IDSs in the reexamination, each within approximately one month of the application's Office Actions. The IDSs contained all references relied on in those rejections but did not include the Office Actions themselves. With full knowledge of the co-pending application, the PTO confirmed the patent, which survived reexamination without substantive change to the litigated claims. When the litigation resumed, the accused infringer again charged the patentee with inequitable conduct, this time based on conduct in the reexamination. This second inequitable conduct allegation was the sole issue at trial. Following remand today, the litigation will continue to focus on inequitable conduct, to the exclusion of the patentee's infringement contentions.

The ease with which inequitable conduct can be pled, but not dismissed, is a problem of our own making. The Supreme Court's three inequitable conduct cases involved overt fraud, not equivocal acts of omission. Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 809, 819 (1945) ("patent claims infected with fraud and perjury" where assignee knew that its employee "gave false dates as to the conception, disclosure, drawing, description and reduction to practice" during interference proceeding and then "secured the perjured . . . application and exacted promises from the other parties never to question the validity of any patent that might be issued on that application"); Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240, 243 (1933) (false affidavits and deposition testimonies obtained "for valuable considerations" averring that the prior art use "was an abandoned experiment" and "to keep secret the details of the prior use"); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 240, 243 (1944) (false trade article procured from "an ostensibly disinterested expert" in exchange for $8,000 to gain patent issuance in spite of previously "insurmountable Patent Office opposition"), overruled on other grounds by Standard Oil Co. v. United States, 429 U.S. 17 (1976).

We clarified en banc that the "two elements, materiality and intent, must be proven by clear and convincing evidence," and that "'gross negligence' does not of itself justify an inference of intent to deceive." Kingsdown. But in seeming contradiction with Kingsdown, a standard even lower than "gross negligence" has propagated through our case law. This standard permits an inference of deceptive intent when "(1) highly material information is withheld; (2) 'the applicant knew of the information [and] . . . knew or should have known of the materiality of the information; and (3) the applicant has not provided a credible explanation for the withholding.'" Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1313-14 (Fed. Cir. 2008).

This test is problematic. First, the "high materiality" prong of the intent element simply repeats the materiality element. Conflating materiality and intent in this manner is inconsistent with the principle that "materiality does not presume intent, which is a separate and essential component of inequitable conduct." Manville Sales Corp. The second, "should have known" prong sets forth a simple negligence standard, lower even than the "gross negligence" standard that was expressly rejected in Kingsdown. I also question whether a fact-finder who has deemed information to be "highly material" would not also be compelled to conclude that a reasonable patentee "should have known of the materiality," at least when the patentee "knew of the information," as prong two requires. Third, the "credible explanation" prong effectively shifts the burden to the patentee to prove a negative: that it did not intend to deceive the PTO. But it is the "accused infringer"—not the patentee—who "must prove by clear and convincing evidence that the material information was withheld with the specific intent to deceive the PTO." Star Scientific, Inc. As to this third prong, we have also explained that "[t]he patentee need not offer any good faith explanation unless the accused infringer first carried his burden to prove a threshold level of intent to deceive by clear and convincing evidence." Id. As explained above, however, the first two prongs are not evidence of deceptive intent. The first is evidence of materiality; the second is evidence of negligence. These two prongs are therefore insufficient as a matter of law to establish a clear and convincing "threshold level" of deceptive intent before the third prong can ever properly come into play.

As it now stands, the test generally permits an inference of deceptive intent to be drawn whenever the three prongs are satisfied. This is in tension with the rule in Star Scientific that "the inference must not only be based on sufficient evidence and be reasonable in light of that evidence, but it must also be the single most reasonable inference able to be drawn from the evidence." Id. It cannot be said that deceptive intent is the "single most reasonable inference" when all that prong two shows is that the patentee "should have known" that the information was material. An equally reasonable inference under this test is that the patentee incorrectly believed that the information was not material, or that the patentee was negligent, or even grossly negligent. None of these gives rise to deceptive intent under Kingsdown, nor is deceptive intent the "single most reasonable inference" under Star Scientific.

For the foregoing reasons, I respectfully submit that the test for inferring deceptive intent, as it currently exists, falls short of the standard "need[ed] to strictly enforce the burden of proof and elevated standard of proof in the inequitable conduct context." Star Scientific. The facts of this case suggest that the time has come for the court to review the issue en banc.

Improper Summary Judgment on Doctrine of Equivalents; Marking Products that Perform Method Claims

Damages, Doctrine of Equivalents, Method Claims, Patent, Patent Cases 2009, Summary Judgment, , ,

Crown Packaging v. Rexam Beverage Can (Fed. Cir. 2009)

On summary judgment, the district court held that Rexam did not infringe Crown’s patent beverage can-top patent. The lower court also found that that Crown did not infringe Rexam’s beverage can “necking” patent. On appeal, the Federal Circuit reversed both rulings.

The Doctrine of Equivalents: Over the past two decades, the doctrine of equivalents been pushed out of the usual infringement discussion. Part of the doctrine’s downgrade is due to restricted application due to prosecution history estoppel (Festo) and tighter doctrine (Warner-Jenkinson). Perhaps equally important in the decline of the DOE has been the rise of claim construction as the primary variable of patent litigation. Rather than arguing for infringement as an equivalent, applicants are instead arguing for broad construction of the claim terms. Finally, patent drafters are – on average – better today than they were twenty years ago and spend more energy on considering how to draft claims that capture literal infringement. In a 2007 paper, Professors Lemley and Allison found something similar – that since the late 1990’s (even before Festo), that “equivalents claims usually failed, most often on summary judgment.” Their paper title – “Demise of the Doctrine of Equivalents” – overstates its case. The DOE is sometimes valuable.

Function-Way-Result Test: There are at least two alternate tests for infringement under the doctrine of equivalents. The function-way-result test considers “on a limitation by limitation basis” whether “the accused product performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented product.”

Summary Judgment on DOE: Here, the issue was not so much the law of the DOE, but rather the requirement for summary judgment that there be no remaining material issue of fact. Crown’s patent claims an “annular reinforcing bead,” while Rexam’s product uses a reinforcing fold. The lower court found those different enough to avoid infringement under the DOE. On appeal, however, the Federal Circuit reversed – finding at least one unresolved material issue of fact that precluded summary judgment. DOE requires expert testimony to step through the function-way-result test. And, here, the patentee’s expert stepped through each element and his testimony had not been completely indicted or even refuted.

Because Crown provided evidence in support of its position that the annular reinforcing bead of claim 14 of the ‘826 patent had only one function, and because we must resolve any reasonable factual inferences in favor of the nonmoving party, we conclude that there is a material issue of fact regarding the function of the claimed bead. Accordingly, we reverse and remand the district court’s grant of summary judgment of noninfringement.

This decision by Judge Moore is in line with the court’s 2008 Voda case which was affirmed after parsing expert testimony to ensure that the elements had been properly proven. (In Voda, the court used the alternative “insubstantial difference” test.)

Unmarked Sales by Licensee: In a scenario reminiscent of the recent Quanta v. LG case, Rexam licensed its patents to Belvac to make “neckers” used to stretch out the top of the can bodies. Under the license, Belvac was required “to notify its customers that they would require a separate license from Rexam to perform the smooth die necking method” that is claimed in Rexam’s patents. The license did not require Belvac to mark the machines that it sold. And, in fact, Belvac did not mark them with the Rexam patent number. Crown then used the machine to make over one hundred billion cans.

Marking under 35 U.S.C. § 287(a): The district court found that this past infringement was not actionable because Crown was not on notice of the patent. That decision seemingly follows from 35 U.S.C. § 287(a). Under that provision, a patentee who does not properly mark a patented article “is not entitled to damages for infringement prior to actual notice.” (quoting CAFC decision).

Marking of Method Claims: Rexam’s trick here was to assert only method claims. On its face, Section 287 applies to “any patented article,” and Federal Circuit precedent has clearly stated that the marking requirement does not apply when only method claims are asserted. With palpable regret, Judge Moore writes:

“The law is clear that the notice provisions of § 287 do not apply where the patent is directed to a process or method. Bandag, Inc. v. Gerrard Tire Co., 704 F.2d 1578, 1581 (Fed. Cir. 1983). In Hanson, 718 F.2d 1075 (Fed. Cir. 1983)—we held that 35 U.S.C. § 287(a) did not apply where the patentee only asserted the method claims of a patent which included both method and apparatus claims. Hanson is factually identical to this case, and we are therefore bound by the rule of Hanson.”

Thus the patentee is free to claim damages back six years under Section 286 even without marking or providing actual notice. This decision thus provides an additional reason to include method claims in a patent application. Now, it would be improper to conclude that there is no reason to mark products that perform method claims. In the 1993 American Medical Systems case, the Federal Circuit ruled that marking would be required if “both apparatus and method claims” were asserted and there is a “tangible item to mark.” In this case, the patent claimed both a method and apparatus, but Rexam sued only on the method claims.

The Essential Element Test and ICU Medical

Enablement, Patent, Patent Cases 2009

In discussing the recent ICU Medical case, I noted that Judge Moore’s decision did not rely on the “essential element” test or even cite Gentry Gallery. In Gentry Gallery, the patent covered a sectional recliner. During prosecution, the patentee had amended its claims to drop any reference to the location of the recliner controls. The Federal Circuit held those later-drafted claims invalid because the location of the controls was an “essential element” of the invention that must be included in the claims – otherwise, the claim scope would be unduly broad. Following Gentry Gallery, however, the Federal Circuit stepped-back from the essential element language– instead narrowing the case holding to the well trod notion that claims should be limited to the supporting disclosure. In both Johnson Worldwide, and Cooper Cameron, for instance, the Federal Circuit explicitly denied that Gentry Gallery created any new requirement.

“[W]e did not announce a new ‘essential element’ test mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements.” Cooper Cameron, 291 F.3d 1317 (Fed. Cir. 2002)

In parallel fashion to Gentry Gallery, ICU had included a “spike” in every embodiment and each original claim. During prosecution, and apparently after seeing competing products, ICU amended its claims to drop the “spike” limitation. This was important because the market had moved to a spikeless version of IV valves. This district court in ICU discussed Gentry Gallery and the essential element test, but found no need to base its ruling on that “disfavored” theory. Rather, the court based its analysis on the traditional notion that claims must be described in the specification.

“[T]he Court’s analysis employs the accepted rule that the claims may be no broader than the supporting disclosure, or, conversely, that claims are invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope. By focusing on the language of the Common Specification in a manner that highlights the function of the “spike” element, and the frequency and ubiquity with which it is referenced, the Court is only attempting to discern the breadth and substance of the invention ICU actually disclosed in the original 1992 Application.”

Although the district court denied its application of any “essential element” test, it went on to hold that any valid claims must include a spike:

“The pervasiveness of the “spike” element in the invention description clearly informs the Court, and would inform any reasonable juror, that what was disclosed and claimed as the invention in the 1992 Application was a needleless medical valve with at a minimum, a “body,” a “seal” and a “spike.””

Likewise, the Federal Circuit’s version denies an omitted element test, but held that any valid claim must include a spike limitation because “a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”

Notes:

  • ICU Medical Part I
  • ICU Medical Part II
  • ICU Medical Part III
  • The essential element and omitted element test are largely interchangeable, although some logical distinction could perhaps be made.

Written Description: Federal Circuit Again Invalidates Broadened Claims

Enablement, Patent, Patent Cases 2009, , , ,

ICU Medical v. Alaris Medical System (Fed. Cir. 2009)

This is the second post on the ICU case. Part I discusses the $4.6 million award of attorney fees to the accused infringer based on the patentee’s litigation misconduct.

The district court found several of ICU’s claims invalid for lack of written description under 35 U.S.C. § 112, ¶ 1. On appeal, the Federal Circuit affirmed. (Judges Michel (CJ), Prost, and Moore; Opinion by Moore). Although similar to enablement, the written description requirement pushes an applicant to “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” Most often, written description arises in cases where new matter is added to the claims during prosecution. That is also the case here – during prosecution ICU amended its claims to include “spikeless” claims — directed to a valve mechanism for adding drugs to an IV without using needles.

To be clear – the original claims included the “spike.” That element was removed during prosecution – seemingly broadening the claims. As the court stated “we refer to these claims as spikeless not because they exclude the preferred embodiment of a valve with a spike but rather because these claims do not include a spike limitation—i.e., they do not require a spike.” It is that failure to include any discussion of a spike in the claim that lead to the claim being held invalid for lack of written description.

The Federal Circuit does not cite Gentry Gallery or the infamous “omitted element” or “essential element” theories. However, the court does rely heavily on LizardTech. In that case, the court did not point to any claim limitation that was not sufficiently described. Rather, the court found the claim invalid because an embodiment arguably covered by the claim was not sufficiently disclosed.

We addressed a similar issue in LizardTech . . . We explained that “the specification provides only one method for creating a seamless DWT, which is to ‘maintain updated sums’ of DWT coefficients. That is the procedure recited by claim 1. Yet claim 21 is broader than claim 1 because it lacks the ‘maintain updated sums’ limitation.” We determined, however, that “[a]fter reading the patent, a person of skill in the art would not understand how to make a seamless DWT generically and would not understand LizardTech to have invented a method for making a seamless DWT, except by ‘maintaining updat[ed] sums of DWT coefficients.'” We therefore concluded that claim 21 was invalid under the written description requirement of § 112, ¶ 1.

In LizardTech, the court explicitly rejected the argument that the written description requirement “requires only that each individual step in a claimed process be described adequately.”

In this case, ICU’s original disclosure focused on spiked embodiments, but the more generic claims are not so limited.

ICU’s asserted spikeless claims are broader than its asserted spike claims because they do not include a spike limitation; these spikeless claims thus refer to medical valves generically—covering those valves that operate with a spike and those that operate without a spike. But the specification describes only medical valves with spikes.

Since all the embodiments included the “spike,” the court concluded that “Based on this disclosure, a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”

Invalidity affirmed

Notes:

  • This case also includes an important discussion of claim differentiation that will be dissected in a later post.  
  • Of course, this case suggests the best patent drafting practice of providing multiple embodiments of each claim element, and considering whether each and every limitation in the broadest original claims are necessary.
  • ICU broadened its claim by dropping a limitation — did ICU introduce new matter?
  • In a powerful rhetorical approach, Judge Moore chose to refer to the broad claims as “spikeless claims.” As mentioned, those claims do not include a “spikeless” limitation. Rather, they simply omit a “spike” element. As it turns out more than 99.9% all patent claims issued in 2008 are silent about “spikes,” and under the traditional interpretation of the “comprising” transition – all those claims would literally cover embodiments without spikes. The holding here cannot be that all those claims are invalid. I believe that the holding here is largely a result of the fact that the accused device was in-fact spikeless. Unfortunately, this decision does not provide helpful guidance as to when it will apply. Rather, it appears to simply be an additional vague tool available to defense attorneys.
  • The court did not mention enablement – since it was easy to remove the needle from a syringe and the disclosure includes a preslit seal that could arguably work with a spikeless syringe. That modification would have been enabled based on the original disclosure.

Federal Circuit Affirms $4.6 million award for litigation misconduct

Attorney Fees, Damages, Patent, Patent Cases 2009

ICU Medical v. Alaris Medical System pic-14.jpg (Fed. Cir. 2009)

ICU’s patents covers technology for using syringes to add drugs to an IV. The district court granted summary judgment of invalidity and also awarded attorney fees and found a violation of Rule 11 of the Federal Rules of Civil Procedure. Alaris was awarded $4.6 million in attorney fees and sanctions. On appeal, the Federal Circuit affirmed.

Section 285 of the Patent Act provides for the award of attorney fees to the winning party in “exceptional cases.” In Brooks Furniture, the Federal Circuit discussed a two-part test for whether attorneys fees may be awarded due to litigation conduct. The test requires that “both (1) the litigation is brought in subjective bad faith, and (2) the litigation is objectively baseless.” A district court fee award will be affirmed absent clear error.

The problem – ICU argued that the claim term “spike” could be a non-pointed structure such as a tube even though the specification “repeatedly and uniformly describes the spike as a pointed instrument.” The claim construction was not ICU’s only problem:

For example, the district court found that ICU made “multiple, repeated misrepresentations . . . to the Court regarding its own patents in an effort to conceal what are now characterized as errors in order to rescue the TRO/PI from denial.” These misrepresentations related to (1) ICU’s assertion of claims in the ’509 patent that were identical to claims in the ’592 patent (i.e., assertion of double-patented claims); (2) ICU’s assertion of more double-patented claims from the ’509 patent even after Alaris and the district court warned ICU of the double-patenting issue; (3) ICU’s misrepresentation of Federal Circuit authority; (4) ICU’s representation that figures 13 and 20–22 of the common specification “clearly” disclosed a spikeless embodiment, only to later acknowledge that these figures do not disclose such an embodiment and state that its representation was an “honest mistake.”

Although the Brooks Furniture rule discusses objectively baseless “litigation,” that rule is not construed to focus on the litigation as a whole. Rather, attorney fees may be assessed if any portion of the litigation is brought in bad faith and in an objectively baseless manner. Here, the Federal Circuit found that the lower court had “appropriately exercised its discretion in awarding attorney fees only for [a] portion of the litigation.”

Notes:

  • Federal Circuit Decision 08-1077.pdf
  • District Court award of Fees: 232495.pdf. Bottom line: “The Court finds that Alaris is due $4,587,622.44 in attorney fees and $164,721.19 in costs for the reasons set forth below. . . . This represents a reasonable lodestar calculation for Alaris’ work . . . , and it constitutes a reasonable pro rata amount of Alaris’ total expenditure of $11,000,000 in attorney fees and $2,000,000 in costs overall in this case.”
  • District Court decision to find a Section 285 exceptional case and Rule 11 sanctions. 232494.pdf. Money Quote: “[The submitted declarations] do not substantively justify or excuse ICU’s litigation tactics or show its good faith. These declarations were prepared by ICU’s litigation counsel for the purpose ofopposing the Rule 11 and Fees Motions, and comprise mostly self-serving assertions of good faith by interested witnesses, such as ICU’s CEO (Dr. George Lopez), trial counsel (Fulwider, Patton, Lee & Utecht; Paul Hastings; or Pooley & Oliver), patent counsel (Knobbe Martens) and its paid experts (Dr. Maureen Reitman and Bob Rogers). These materials lack the indicia of credibility provided by declarations or opinions from outside, independent counsel or experts, particularly outside patent, as opposed to litigation, counsel. Most of the materials appear to have been “memorialized” in retrospect, providing marginal support compared to, for example, an ex ante documented and vetted analysis that preceded the litigation or that, al minimum, preceded the TRO/PI request and the inclusion of the “spike” claims in the amended complaint.”
  • Although the district court decision appears to identify the Fulwider firm as “trial counsel,” that appears to have been a mistake made by the court. A Fulwider attorney has indicated that their firm “was never one of ICU’s trial counsel in that matter, and thus made no representations to the court on ICU’s behalf.” In fact, ICU appears to be somewhat of a toxic client. According to the court documents, Fulwider represented ICU in the 1990’s. At some point ICU dropped the firm as a client and sued for malpractice based on Fulwider’s representation of alleged ICU competitors. Fulwider did not admit wrongdoing, but a 2007 press release by ICU claims that ICU “will be paid $8 million in settlement of its claims against Fulwider.”

Federal Circuit Affirms $4.6 million award for litigation misconduct

Attorney Fees, Damages, Patent, Patent Cases 2009

ICU Medical v. Alaris Medical System pic-14.jpg (Fed. Cir. 2009)

ICU’s patents covers technology for using syringes to add drugs to an IV. The district court granted summary judgment of invalidity and also awarded attorney fees and found a violation of Rule 11 of the Federal Rules of Civil Procedure. Alaris was awarded $4.6 million in attorney fees and sanctions. On appeal, the Federal Circuit affirmed.

Section 285 of the Patent Act provides for the award of attorney fees to the winning party in “exceptional cases.” In Brooks Furniture, the Federal Circuit discussed a two-part test for whether attorneys fees may be awarded due to litigation conduct. The test requires that “both (1) the litigation is brought in subjective bad faith, and (2) the litigation is objectively baseless.” A district court fee award will be affirmed absent clear error.

The problem – ICU argued that the claim term “spike” could be a non-pointed structure such as a tube even though the specification “repeatedly and uniformly describes the spike as a pointed instrument.” The claim construction was not ICU’s only problem:

For example, the district court found that ICU made “multiple, repeated misrepresentations . . . to the Court regarding its own patents in an effort to conceal what are now characterized as errors in order to rescue the TRO/PI from denial.” These misrepresentations related to (1) ICU’s assertion of claims in the ’509 patent that were identical to claims in the ’592 patent (i.e., assertion of double-patented claims); (2) ICU’s assertion of more double-patented claims from the ’509 patent even after Alaris and the district court warned ICU of the double-patenting issue; (3) ICU’s misrepresentation of Federal Circuit authority; (4) ICU’s representation that figures 13 and 20–22 of the common specification “clearly” disclosed a spikeless embodiment, only to later acknowledge that these figures do not disclose such an embodiment and state that its representation was an “honest mistake.”

Although the Brooks Furniture rule discusses objectively baseless “litigation,” that rule is not construed to focus on the litigation as a whole. Rather, attorney fees may be assessed if any portion of the litigation is brought in bad faith and in an objectively baseless manner. Here, the Federal Circuit found that the lower court had “appropriately exercised its discretion in awarding attorney fees only for [a] portion of the litigation.”

Notes:

  • Federal Circuit Decision 08-1077.pdf
  • District Court award of Fees: 232495.pdf. Bottom line: “The Court finds that Alaris is due $4,587,622.44 in attorney fees and $164,721.19 in costs for the reasons set forth below. . . . This represents a reasonable lodestar calculation for Alaris’ work . . . , and it constitutes a reasonable pro rata amount of Alaris’ total expenditure of $11,000,000 in attorney fees and $2,000,000 in costs overall in this case.”
  • District Court decision to find a Section 285 exceptional case and Rule 11 sanctions. 232494.pdf. Money Quote: “[The submitted declarations] do not substantively justify or excuse ICU’s litigation tactics or show its good faith. These declarations were prepared by ICU’s litigation counsel for the purpose ofopposing the Rule 11 and Fees Motions, and comprise mostly self-serving assertions of good faith by interested witnesses, such as ICU’s CEO (Dr. George Lopez), trial counsel (Fulwider, Patton, Lee & Utecht; Paul Hastings; or Pooley & Oliver), patent counsel (Knobbe Martens) and its paid experts (Dr. Maureen Reitman and Bob Rogers). These materials lack the indicia of credibility provided by declarations or opinions from outside, independent counsel or experts, particularly outside patent, as opposed to litigation, counsel. Most of the materials appear to have been “memorialized” in retrospect, providing marginal support compared to, for example, an ex ante documented and vetted analysis that preceded the litigation or that, al minimum, preceded the TRO/PI request and the inclusion of the “spike” claims in the amended complaint.”
  • Although the district court decision appears to identify the Fulwider firm as “trial counsel,” that appears to have been a mistake made by the court. A Fulwider attorney has indicated that their firm “was never one of ICU’s trial counsel in that matter, and thus made no representations to the court on ICU’s behalf.” In fact, ICU appears to be somewhat of a toxic client. According to the court documents, Fulwider represented ICU in the 1990’s. At some point ICU dropped the firm as a client and sued for malpractice based on Fulwider’s representation of alleged ICU competitors. Fulwider did not admit wrongdoing, but a 2007 press release by ICU claims that ICU “will be paid $8 million in settlement of its claims against Fulwider.”