October 2008

Federal Circuit Finds No Antitrust Liability for Hatch-Waxman Reverse Payment Settlements

In re Ciprofloxacin Hydrochloride Antitrust Litigation (Fed. Cir. 2008)

Bayer’s patent on Cipro was challenged by Barr. However, the parties settled on the eve of trial. In all, Bayer paid $398 million to Barr to ensure that it didn’t receive a judgment of invalidity or unenforceability. Subsequently, Bayer filed for reexam to ensure that there would not be a later inequitable conduct problem. When other companies later challenged the patent, it was repeatedly found valid.

To many, the Barr settlement looked like a way to prop-up the drug price at the expense of consumers, health insurance companies. Various groups filed suit – arguing violations of Sections 1 and 2 of the Sherman Act and violations of state antitrust and consumer protection laws.

On summary judgment, the Federal District Court in New York applied a rule of reason to find no antitrust violations as follows:

  1. The relevant market is CIPRO and Bayer had market power in that market.
  2. However, any “adverse effects on competition” due to the settlement could not create antitrust violations because the settlement was “within the exclusionary zone of the ‘444 patent.”

In its holding, the district court rejected the notion that the “exclusionary zone” would be narrowed or altered by the potential invalidity of the patent. Furthermore, the district court held that unenforceability due to prosecution misconduct cannot be the subject to a Walker-Process antitrust violation – rather, the misconduct must be market-based misconduct. And, the Walker-Process argument failed because Bayer later successful litigation showed that its approach with Barr was not a ‘sham.’

On appeal, the Federal Circuit affirmed the summary judgment in favor of the pharmaceutical companies.

Per Se vs Rule of Reason: Some activities are considered so pernicious that they will be considered per se violations of the Sherman Act. Most actions, however, are judged under the rule of reason to determine if the particular activities had a potentially pro competitive impact. Here, the federal circuit could find no basis for “confidently predict[ing]” that such reverse-payment settlement agreements were unlawful – and consequently should be judged under the rule of reason.

Patents and Antitrust: Patents lead to anticompetitive behavior – that is the nature of the right to exclude. A patentee will not have antitrust liability for activity within the “zone of exclusion” of its patent. On appeal, the Federal Circuit agreed that the reverse payment was within the zone of exclusion.

Reverse Payments: In patents, a reverse payment is a payment by a patentee to an accused infringer to end litigation and perhaps to keep the infringer off the market. Remember, typically, it is the patentee who is looking for damages, not seeking to pay. The plaintiffs argued that such a reverse payment could not be considered within the ordinary scope of patentee behavior. The appellate court disagreed, finding that through the payment, Bayer was protecting its market share in its patented product and thus was well within its rights.

Pursuant to the Agreements, the generic defendants agreed not to market a generic version of Cipro until the ‘444 patent expired and not to challenge the validity of the ‘444 patent, and Bayer agreed to make payments and optionally supply Cipro for resale. Thus, the essence of the Agreements was to exclude the defendants from profiting from the patented invention. This is well within Bayer’s rights as the patentee. . . .

A settlement is not unlawful if it serves to protect that to which the patent holder is legally entitled—a monopoly over the manufacture and distribution of the patented invention.

In addition, the court found that settlements are favored even when anti-competitive.

Furthermore, there is a long-standing policy in the law in favor of settlements, and this policy extends to patent infringement litigation. Settlement of patent claims by agreement between the parties—including exchange of consideration—rather than by litigation is not precluded by the Sherman Act even though it may have some adverse effects on competition.

And, settlements normally include a promise not to challenge validity – something allowed under antitrust laws:

Settlements in patent cases, however, frequently provide that the alleged infringer will not challenge the validity of the patent. Thus, the mere fact that the Agreements insulated Bayer from patent validity challenges by the generic defendants was not in itself an antitrust violation.

Affirmed

Notes

  • On the panel were Circuit Judges Schall and Prost and Judge Ward from the Eastern District of Texas sitting by designation. The opinion was written by Judge Prost.
  • Expect petitions for en banc hearing and certiorari. The reverse payment issue has been brewing for some time.
  • During the post-9/11 anthrax scares, the Federal Government threatened to break the patent and begin manufacturing a generic version if sufficient supplies were not available. [Link]

Rethinking the Scope of Prior Art in Obviousness Cases

In Cohesive Technologies, the Federal Circuit issued a reminder that the novelty analysis of 35 U.S.C. §102 is separate and distinct from the nonobviousness analysis of 35 U.S.C. §103(a). The court notes that some prior art evidence – such as inherent elements of a disclosure – used for anticipation argument may not be used in obviousness analyses. That result is in tension with the traditional understanding that § 102 material may be used for §103(a) analysis.

In a recent e-mail, Professor Isaacs (NKU) saw that tension as a reason to for courts to take a fresh look at the text of §103(a). This is especially timely in light of the recent cases such as eBay, KSR, and MedImmune where the Supreme Court had no trouble altering longstanding precedent.

The most glaring problem with the current interpretation of § 103(a) involves post-invention art and secret prior art that are available as §102(b)/§103(a) and §102(e)/ §103(a) references respectively. These two allowances are contrary to the plain language of §103(a) because the statute focuses on what “would have been obvious at the time the invention was made.”

35 U.S.C. 103(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in §102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. …

Under a plain reading of §103(a), post-invention references cannot negate patentability because they were not available “at the time the invention was made.” Similarly, secret prior art – almost by definition – could not be known by one of ordinary skill in the art – especially under the Supreme Court’s new “common sense” approach to obviousness.

Of course, these arguments have been tried before – and failed.

  • In re Foster, 343 F.2d 980 (C.C.P.A. 1965) (cert denied) (creating §102(b)/§103(a) prior art)
  • Hazeltine Research, Inc. v. Brenner, 382 U.S. 252 (1965) (creating §102(e)/ §103(a) prior art)

Perhaps the time is right for a challenge.

Patently-O Bits and Bytes

Researchers at the IP Research Institute of Australia (IPRIA) have a recent paper on pendency at the various patent offices. Professors Jensen, Palangkaraya and Webster looked at almost 10,000 international patent application families filed in the early 1990’s and studied how they fared in the USPTO, EPO, JPO and APO. When examining the same applications, the USPTO had the shortest pendency. The study also shows that many applicants would take advantage of deferred examination if allowed in the US. [Read the Paper]

    

Top 25 referrals to Patently-O in the past month (excluding search-engines). Thanks for the links!

Tafas v. Dudas: Amicus Briefs at the Federal Circuit

In support of Tafas:

In support of the PTO:

Federal Circuit Vacates ITC’s Broadcom Order

Kyocera v. ITC (Fed. Cir. 2008) (Broadcom v. Qualcomm)

The ITC found that Qualcomm infringed Broadcom’s ‘983 patents and issued a limited exclusion order against imports by Qualcomm and its customers.

On appeal, the Federal Circuit vacated and remanded — finding that the ITC (1) did not properly find inducement of infringement and (2) lacked authority to issue a limited exclusion order against non-respondents.

Inducement Requires Specific Intent: On their own, Qualcomm’s MSM chipsets do not infringe. However, the ITC found direct infringement in handsets that use the Qualcomm chipset in conjunction with “system determination software.”  The ITC found Qualcomm liable for inducing infringement because it provided the chipsets and the system determination software along with training and customer support.

Inducement requires underlying direct infringement and that the accused infringer “knowingly induced infringement and possessed specific intent to encourage another’s infringement.” This includes an “affirmative intent to cause direct infringement.”

On appeal, the Federal Circuit found that the ITC had based its decision on a lower level of “general” intent without requiring evidence of Qualcomm’s “culpable conduct” of “encouraging another’s infringement.”

In particular, the ITC’s statement that “Qualcomm intends to induce infringement because it provides its customers with the system determination code” is insufficient.  On remand, the ITC must find specific intent.

ITC Exclusion Orders: The ITC may issue either limited exclusion orders directed toward the actions of specific companies or general exclusion orders directed broadly to an industry. In this case, the ITC issued a limited order that excluded, inter alia, downstream manufacturers who were not named parties in the litigation.

On appeal, the Federal Circuit found that limited exclusion orders may not go beyond the named parties.  A general exclusion order may be appropriate. However, additional proof of necessity are required for general orders.

Notes:

  • This case involves different patents than the District Court Broadcom case [Part I][Part II]
  • This case is also involves different patents from the earlier Broadcom v. ITC. In that case, the Federal Circuit also vacated an ITC holding this time in Broadcom’s favor — vacating the ITC’s non-infringement finding. [LINK]

 

Shifting Burden of Production Does Not Shift Burden of Proof; PTO Deference

Technology Licensing Corp v. Videotek (Fed. Cir. 2008)

The independent inventor J. Carl Cooper invented and patented technology separating a sync signal from a video signal to better ensure vertical and horizontal hold on a video screen. Cooper assigned his rights to TLC which sued Videotek for infringement. Videotek pulled-in its supplier Gennum for indemnification. Gennum now remains as the only defendant.

Priority Date: Cooper’s asserted patent claims priority to an earlier application filed in 1992. The district court found specifically that claim 33 could not claim priority all the way back because the claim included a limitation to an “other circuit” which was only disclosed in the subsequent continuation.

Burdens of Proof and Production: Although a defendant ultimately bears the burden of proving invalidity, the burden of producing evidence may shift back and forth during litigation. For instance, once a defendant provides evidence of anticipation, the patentee then has the “burden of going forward with evidence either that the prior art does not actually anticipate, or … that it is not prior art because the asserted claim is entitled to the benefit of a filing date prior to the alleged prior art.” Proving priority requires evidence of the priority claim and also evidence showing that “the written description in the earlier application supports the claim.” Here, the court required cooper to produce “sufficient evidence and argument to show that [the priority document] contains a written description that supports all the limitations of claim 33, the claim being asserted.” Once the evidence is on the table, the claim will only be invalid if the defendant’s proof remains is clear and convincing.

[B]ecause an issued patent is by statute presumed valid, a challenger has the burden of persuasion to show by clear and convincing evidence that the contrary is true. That ultimate burden never shifts, however much the burden of going forward may jump from one party to another as the issues in the case are raised and developed.

Here, the Federal Circuit agreed that the defendants had clearly proven that the original written description was insufficient – and thus that the patentee could not claim priority all the way back.

Deference To and Waiting For the PTO: The PTO issued Cooper’s patent and then, through a reissue, again allowed the challenged claim to issue even after considering the same prior art (the reissue issued while the appeal was pending). On appeal, the Federal Circuit distinguished Ralston v. Far-Mar-Co (Fed. Cir. 1985). In Ralston, the court deferred to the PTO’s determination of priority date. Here, however, there was no evidence that the PTO specifically considered the priority dates. However, the Federal Circuit refused to “add an additional deference-thumb to the scale, or, even more disruptive, our asking the trial court to reopen the entire invalidity question to reweigh the intangible worth of additional deference.”

This is not to say that the determinations made by the corps of examiners are not important, or should not be worthy of appropriate deference to their expertise in these technical matters, especially when we have the benefit of well-reasoned explications. It is to say that when dealing with the intangible worth to be accorded an administrative agency’s decision making, the judicial process cannot be held hostage to the timing of either the agency or the litigants who have invoked the agency’s further review. In some circumstances a party may be able to obtain a stay from the trial court while awaiting the sought-for agency action; absent that, and absent extenuating circumstances not here present, the case must be decided on the record the litigants present for appeal.

Inequitable Conduct:

There has never been an exception [requiring submission of] anticipatory cumulative references, and we are not inclined to create one now.

Definiteness of Means Plus Function Claim: A MPF claim must be supported by structural disclosure found in the patent specification – this requirement is akin to the written description requirement and focuses on actual disclosure rather than enablement.

The question is not whether one of skill in the art would be capable of implementing a structure to perform the function, but whether that person would understand the written description itself to disclose such a structure.

In electronic circuit cases the actual circuit disclosures are not necessarily required. Rather, generic “core logic” may be sufficient. Here, the defendants were unable to provide clear and convincing evidence of a lack of structure.

Federal Circuit Agrees to Hear Interlocutory Appeal on Standing

Sky Tech v. SAP (Fed. Cir. 2008 ) (nonprecedential order)

Sky sued SAP in the Eastern District of Texas. SAP argued that Sky lacked standing because a prior assignment of patent rights had not been properly obtained. The district court found standing but gave its approval for an interlocutory appeal – noting that the issue was a close question. At the Federal Circuit, the three-judge panel agreed to hear the case and eventually to determine whether Sky has standing. The Sky patents were purchased by XACP in a foreclosure sale of Ozro’s assets – the question will be whether the foreclosure sale was proper even without a written assignment agreement.

Stay pending appeal: SAP had requested a stay pending appeal. The appellate panel refused to rule on that motion – instead noting that “the better course is for the Texas district court to consider that issue in the first instance.”

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CAFC allows Venue Transfer to Texas

In re Volkswagen (Fed. Cir. 2008) (nonprecedential denial of mandamus)

In July 2007, MHL filed a patent infringement suit against VW in the Eastern District of Texas. Hoping to avoid that venue, the automobile company countersued in the Eastern District of Michigan. Although primarily a declaratory judgment action, VW included Michigan state law claims of unfair competition, defamation, trade disparagement, and abuse of process. In a preliminary hearing, the Michigan court declined its powers of supplemental jurisdiction over the state law claims and ordered the case be transferred to Texas. Because the transfer was not a final action, VW had no right to an appeal. Instead, it filed a writ of mandamus.

The Federal Circuit considered the writ, but ultimately declined to exercise authority over the case – finding that VW had not shown the importance of immediately deciding the issue. “A party seeking a writ bears the burden of proving that it has no other means of attaining the relief desired.”

In Texas, the 5th Circuit Court of Appeals just released its en banc opinion in another In re VW case. In that case, the 5th Circuit held that the E.D. Texas (Marshall) court had unreasonably refused to transfer VW’s case to a Northern District court in Dallas. The AIPLA filed a brief in that case, noting that the Eastern District of Texas rarely allows an out-transfer. From the AIPLA brief: “The routine filing of patent infringement complaints in the Eastern District of Texas that have essentially no connection to that district has been encouraged by the seeming reluctance of courts in that district to transfer cases under § 1404(a).” [Link]

In another venue case, Judge Patel of the Northern District of California noted that venue games are “perfectly legitimate”

“It is clear that both parties are attempting to achieve tactical advantage in the choice of a forum (which is a perfectly legitimate goal in an adversarial system of justice).” 

In Sorensen v. Phillips, Judge Patel transferred the case to the Southern District of California where a parallel proceeding was already underway (and stayed pending reexamination).

Notes:

 

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Paul Cole, Patentability of Computer Software As Such

In Symbian Limited v. Comptroller General of Patents [2008] EWCA Civ 1066, the UK Court of Appeal recently took a broader approach to patentability of software. UK patent attorney and author Paul Cole has written a short article for the Patently-O Patent Law Journal discussing the case and its impact. [Paul Cole Article]. The opinion cites John Duffy’s recent “Death of Google’s Patents” article also published on Patently-O.

Anticipated yet Nonobvious

Patent.Law159Cohesive Tech v. Water Corp (Fed. Cir. 2008)

Perhaps the most important portion of this case relates to the notion that novelty and nonobviousness are separate and distinct inquiries. And, that a patent may be found anticipated yet nonobvious.

On summary judgment, the district court Cohesive’s HPLC patent might be obvious, but certainly was not anticipated.  Water appealed — arguing that the judgment was logically incorrect if anticipation truly is the “epitome of obviousness.”  On appeal, however, the Federal Circuit confirmed that novelty and obviousness are separate and distinct — one does not necessarily follow the other.

While it is commonly understood that prior art references that anticipate a claim will usually render that claim obvious, it is not necessarily true that a verdict of nonobviousness forecloses anticipation. The tests for anticipation and obviousness are different.

The court suggested two circumstances where an anticipated claim might still be nonobvious.  First, secondary considerations of nonobviousness may exist that are not relevant in an anticipation claim. Second, although inherent elements apply in an anticipation, inherency is generally not applicable to nonobviousness. 

“[O]bviousness requires analysis of secondary considerations of nonobviousness, while secondary considerations are not an element of a claim of anticipation. And although anticipation can be proven inherently, proof of inherent anticipation is not the same as proof of obviousness.”

The court also gives an example —

“Consider, for example, a claim directed toward a particular alloy of metal. The claimed metal alloy may have all the hallmarks of a nonobvious invention—there was a long felt but resolved need for an alloy with the properties of the claimed alloy, others may have tried and failed to produce such an alloy, and, once disclosed, the claimed alloy may have received high praise and seen commercial success. Nevertheless, there may be a centuries-old alchemy textbook that, while not describing any metal alloys, describes a method that, if practiced precisely, actually produces the claimed alloy. While the prior art alchemy textbook inherently anticipates the claim under § 102, the claim may not be said to be obvious under § 103.”

Patent.Law160Judge Mayer dissented — arguing that anticipation is a subset of nonobviousness. “Although a claimed invention can be obvious but not anticipated, it ‘cannot have been anticipated and not have been obvious.’ In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982).”

“The majority’s assertion that a claim can be anticipated but not obvious, flies in the face of a long line of precedent to the contrary. Not surprisingly, it is unable to cite a case remanding to the district court for consideration of anticipation, while at the same time sustaining a determination that claims at issue are not obvious.”

The practical impact of this case:

  1. Anticipation still gets to a jury even when the defense has a credible obviousness argument.
  2. The Majority’s example might be seen to narrow the scope of documents available for obviousness arguments along a temporal axis. (References from a long time ago shouldn’t be combined with more recent references.)
  3. In some ways, the ‘common sense’ approach of KSR encourages this decision. While anticipation may still be a formal construct, obviousness should focus on what really would have been obvious at the time of the invention.
  4. Professor Ochoa (Santa Clara) reminded me about the European rule that does not allow “secret” prior art to be used in obviousness (inventive step) analysis.  If the US so modified its rules, perhaps the distinction between obviousness and anticipation would begin to ring true.

ABC is Looking for a “Superstar Family of Inventors”

The casting producer at “Wife Swap” thought some of our readers may know some great inventors:

WIFE SWAP, ABC’S HIT PRIMETIME SHOW, SEEKS A SUPERSTAR FAMILY OF INVENTORS!

The premise of Wife Swap is that one parent from each household swaps places for a week to experience how another family lives. It is an incredible family experience and opportunity to both learn and teach different family values.

Wife Swap is a fascinating story of what happens when two couples see themselves and their partners in a whole new light. The New York Post says, “It should be called ‘Life Swap’ because it’s not just the wives who learn something here. It’s the families.”

Potential families can live anywhere in the United States, but we ask that families applying for the show consist of two parents and have at least one child, age 7 or older, living at home. Specifically, I’m looking for families who are always looking for the next big invention! To submit for the show please email a family photo and description to: gaby.wifeswap@gmail.com.

Families featured on the show will receive a $20,000 honorarium. If you refer a family that is selected you receive $1,000.

If you are a family unit (two parents and children between the ages of 7 and 17) who love an adventure, I would love to hear from you today! Also, please feel free to send this casting along to any families you feel would be appropriate!

More information is available at: http://abc.go.com/primetime/wifeswap.

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Federal Circuit Affirms $46m Default Judgment Against Bodog

1st Technology v. Rational Ent. and Bodog (Fed. Cir. 2008)

1st Technology won a default patent infringement judgment against the online gambling company Bodog and the Nevada district court awarded $46 million in damages plus interest. The patentee has been enforcing the judgment by attaching Bodog’s US assets – including its domain names and trademark registrations. Without opinion, the Federal Circuit has affirmed that judgment.

On appeal, Bodog argued that it was not properly served notice of the litigation and that the Nevada court lacked personal jurisdiction over the company. 1st argues that the service (to a Bodog’s Costa Rica office) was proper and that by not arriving in court Bodog had waived its personal jurisdiction argument. In addition, plaintiffs cite to a 2005 Forbes article noting how “in 2005, the Bodog entities handled $7.3 billion in online wagers, 95% of which came from the United States, with sales increasing every year. [Bodog’s founder] Mr. Ayre pays no United States income tax, and prides himself on the fact that he and the Bodog entities routinely evade United States law.”

Links:

Laches and Equitable Estoppel

Troxler Electronic Labs v. Pine Instrument (E.D.N.C. October 6, 2008).

In 2001, Troxler filed a patent infringement action against Pine – alleging infringement of its patent covering equipment for testing the quality of asphalt. In 2002, Pine counterclaimed with its own infringement allegations against Troxler. The two companies were direct competitors in this market and together held most of the market share.

The dates are important here:

  • 1996: In a letter, Pine accused Troxler of infringement (pre-issuance).
  • 1997: Pine’s patent Issues; In a letter, Troxler opined that Pine’s patent was invalid.
  • 2001: Troxler sues Pine on another patent
  • 2002: Pine counterclaims alleging infringement

In the 1996-2002 interim, it was clear that “Pine had first-hand knowledge that Troxler continued to sell its gyratory compactors. . . Despite this knowledge of Troxler’s allegedly infringing activities, Pine did not takeany action against Troxler to defend its patent until February 19, 2002, when it asserted its counterclaim. Nearly five years of allegedly infringing activity occurred before Pine took any legal action to defend its patent.” According to deposition testimony, Pine’s president explained the delay because he “didn’t feel motivated to pursue [the claim].”

Laches & Equitable Estoppel: Looking at these facts, Magistrate Judge Webb found that Pine may well be barred from pursuing its infringement allegations under the doctrines of equitable estoppels and laches.

Under the defense of equitable estoppel, the accused must have relied on the patentee’s assurances or non-enforcement activity in choosing to continue infringing. On summary judgment, the Magistrate recommended that the case go to trial to determine reliance:

[T]here is a material issue of fact as to whether Troxler was in fact lulled by Pine into a sense of security. Because of this material issue of fact, neither party is entitled to summary judgment on this prong Troxler’s equitable estoppel defense.

Enforcement Laches does not require detrimental reliance. However, the patentee must be shown to have “unreasonably and inexcusably” delayed bringing suit and that the alleged infringer subsequently suffered material prejudice. A six year delay creates a presumption of laches. Here, the delay was only five years – calculated from the 1997 patent issuance to the 2002 counterclaims. Although no presumption exists in this case, the magistrate judge noted that Pine’s excuse – lack of motivation – is insufficient.

[A] laches defense exists precisely to prevent patentees from delaying in filing suit simply because they do not feel “motivated to do so.” Accordingly, the undersigned hereby finds that Pine’s unjustified five year delay was unreasonable and that Troxler is entitled to summary judgment on the unreasonable delay prong of its laches defense

The harm of the delay can be shown in a variety of ways. Here, the magistrate judge focused on evidentiary harms and economic harms.

  • Evidence Lost: Troxler founder and CEO died during the interim. He had directed the development of the accused product.
  • Evidence Lost: Time delay has probably faded the memory of the Pine inventors.
  • Evidence Lost: Many documents have been destroyed. (Troxler is a family business – “When the drawer gets full, you toss something.”)
  • Economic: In the interim, Troxler has invested millions of dollars in manufacturing facilities and producing the alleged product.

Based on the potential validity of some of these arguments, the magistrate judge recommended they be explored at trial.

Unclean Hands: Because laches and equitable estoppel are both judged in equity, Pine argued that Troxler’s “unclean hands” should bar the company from relying upon those defenses. Particularly, Pine noted discovery shenanigans and filing suit without a good faith basis. The magistrate judge agreed that allegations of “egregious behavior” must be included in any equitable decision.

The district court will now decide whether to convert the magistrate judge’s recommendations into an order.

Patently-O Bits and Bytes: Prior Art Citations

Over the past 33 years, the sheer number of prior art citations have steadily risen. In the mid 1970’s less than one percent of issued patents cited more than twenty prior art references. Today, more than thirty percent of recently issued patents reach that benchmark. Although the examiner is considering more prior art, the average amount of time an examiner spends reviewing an application is about the same as it was back then.

Inventor Remuneration Around the World

Article 35 of the Japanese Patent laws provide for “reasonable remuneration” from the employer when the employer takes assignment of patent rights. In my first reading, the Japanese law does not appear to include a limit to only Japanese employers. In fact, such a limitation could arguably be a violation of the country’s obligation of national treatment. Is there a definitive answer to whether the Japanese law applies to all patents filed in Japan or only those originating in Japan? Do other country inventor remuneration laws apply to US companies filing US initiated inventions in that country?

IGT Petitions for En Banc Rehearing: Asking Court to Allow Invalidity Defense for “Improper Revival”

Aristocrat v. IGT (Fed Cir. 2008 – on rehearing) ITG PETITION

IGT has petitioned the Federal Circuit for a rehearing en banc. IGT asks the court to consider which violations of the Patent Act would be sufficient to render a patent invalid during litigation.

In this case, Aristocrat filed its US national-stage application one day late. The PTO allowed the applicant to revive the application as unintentionally abandoned. In litigation, IGT argued that the patent should be held invalid as improperly revived because the statute only allows for revival of unavoidably abandoned applications in this situation.

Without reaching the merits of IGTs validity argument, the Federal Circuit summarily dismissed IGT’s claim – finding that ‘improper revival’ is not a ‘cognizable defense’ because it does not fit within any of the four defenses listed in 35 U.S.C. §282 and it is not otherwise justified in equity.

This unanimous decision – signed by Judges Newman, Bryson, and Linn – has broader implications. It calls into question whether traditional invalidity defenses such as nonstatutory double patenting and improper inventorship remain. IGT provides its own list of challenges that will be barred even after PTO error. Notably the gaming company argues that under the new rule, improper revivals of any type could not be challenged nor could failure to pay the maintenance fees.

In its brief, IGT seeks to overturn the panel’s narrow interpretation of a “condition for patentability.” Section 282(2) allows for an invalidity defense based on failure to meet a condition for patentability. However, the appellate panel limited that section only to issues of novelty, utility, and nonobviousness.

‘Section 131 supports [a] common sense reading of the statute. It states that the PTO “shall issue a patent” only if “the applicant is entitled to a patent under the law.” 35 U.S.C. § 131. The plain meaning of that provision is that lawful entitlement to a patent is a condition of patentability. An applicant who abandoned its application without reviving it under the statutory mandated standard is not lawfully entitled to a patent and should have no right to enforce it. The panel’s decision overthrows these common-sense principles as set forth in the Patent Act.’ IGT rehearing motion.

IGT also argues that improper revival was “made a defense” by Congress when it created the law of abandonment that allows only revival for unavoidable delay in cases like these. IGT argue essentially that failure to comply with any patent statute is sufficient to render the patent invalid in litigation.

Notes:

  • DDC Comment: The Case Should be Heard. The Patent Office serves as a threshold check to establish presumptive property rights. However, both the technology and the law are complicated enough to warrant a ‘second look’ to ensure that each legal requirement is met. It is clear that a significant number of issued patents would be found invalid if challenged. The second look could be through litigation challenges, reexamination proceedings, or some other ex post proceeding. This opinion, however, concludes that no challenge is available in a variety of potential cases. That result is wrong from a policy perspective and It appears that IGT has a strong statutory construction argument as well.
  • Hat Tip: Thanks to Chico Gholz and Mark Lemley for suggesting specific implications of the panel holding.

Inventorship and Claim Scope Decisions

< ?xml:namespace prefix ="" w />By Ronald A. Krasnow.

Do you fully use an inventorship determination for the benefit of your company or client?  Do you decide on claim scope in view of inventorship?

Consider the Federal Circuit’s decision in Lucent v. Gateway, Dell & Microsoft (decided Sept. 25, 2008 – Fed. Cir. 2007-1546, -1580).  While this case undoubtedly demonstrates that patent legislation should not be outcome driven, it contained an interesting proposed use of inventorship determinations.  In Lucent, the Court decided that claims 1 and 3 were solely owned by Lucent (because they were invented by Lucent’s employees), but that claims 2 and 4 was jointly owned by Lucent and a joint development partner under a joint development agreement.  The Court reasoned that Lucent, who was in control of prosecution, could have split up the claims into separate patents so that it solely owned the invention claimed in claims 1 and 3. (The Court unfortunately did not deal with the reality facing an attorney trying to balance patentable subject matter with inventorship and obviousness under 35 UCS 103(c).)

The Court’s reasoning, created in hindsight, raises a number of practical issues.

The first is, really, how do you make an inventorship decision in view of a joint development agreement?  For example, do you draft the patent application as broadly as the prior art will allow?  Or do you draft the claims only as broad as your company’s inventors contributions?  Can you realistically split up the claims along inventorship lines and still get past Section 103 on parallel applications?

Once the inventorship decision has been made, have you made full use of that decision to the benefit of your company or client.  Most patent attorneys focus on making sure that the patent application names the correct inventors or complying with the laws of the countries where the inventors reside.  But, the Lucent decision suggests that enforcement should also be considered at the time inventorship and claim scope decisions are made.

One other consideration is drafting the joint development agreement. The Lucent decision suggests that large companies with negotiating power might require joint development partners to not license others inside the field of joint research and development program.

On the policy side, the Federal Circuit’s reasoning logically leads to other considerations:

  1. If you draft broader claims, should there be an equitable remedy available so that the added inventor (read as joint development partner) does not gain a windfall by access to the broader claims, when it is only the narrow and more subservient claims to which it contributed? 
  2. Should reissue be afforded to allow case to be divided, to shelter the contribution of the dominant technology owner?
  3. Does the party prosecuting the patent applications have any “duty” to an omitted inventor?  For example, if claims to which the omitted inventor contributed are cancelled, or are disclaimed during post-issuance proceedings, does the omitted inventor have any claim for “waste”?

Note: Mr. Krasnow’s new book Intellectual Property Culture (Oxford University Press) was just released [Link]

Sample Responses to Office Actions

Attorneys have always learned by following the example of their elders and peers. With that in-mind, I would like to post several exemplary responses to patent office rejections and objections. Please forward to dcrouch@patentlyo.com with a very brief explanation of the topic/technology. If you like, you may scrub the response for anonymity. Likewise, feel free to submit good ones you have found that were written by others. Potential topics:

  • Arguing that combination is nonobvious (under KSR);
  • Arguing secondary factors of nonobviousness;
  • Swearing behind prior art;
  • Arguing that prior art is not enabled;
  • Disputing date of prior art;
  • Arguing that prior art is not inherently anticipatory;
  • Responding to obviousness type double patenting;
  • Arguing utility;
  • Responding to restriction;
  • Arguing against indefiniteness;
  • Arguing amendment is not new matter;
  • Etc.

Prior Art Must Enable a Skilled Artisan to Make the Invention without Undue Experimentation

Impax Labs v. Aventis Pharmaceuticals (Fed. Cir. 2008)

This appeal focuses on the question of when a prior art disclosure is sufficiently enabled.

An Aventis patent covers the use of RILUTEK (riluzole) to treat ALS. Impax filed an ANDA with the FDA (seeking to market a generic version of the drug). In subsequent litigation, Impax also alleged, inter alia, that the listed patent should be held invalid. In particular, Impax argued that an earlier Aventis patent (the ‘940 patent) anticipates the asserted Aventis patent (the ‘814 patent) by suggesting a class of compounds may be used to treat ALS. The district court, however found that the ‘940 patent “does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ‘814 patent.”

Burden particularly heavy: A defendant who hopes to use previously considered art to invalidate a patent has a “particularly heavy” burden.

Thus, a party challenging patent validity has the burden to prove its case with clear and convincing evidence. When the examiner considered the asserted prior art and basis for the validity challenge during patent prosecution, that burden becomes particularly heavy. See Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990).

In this case, the ‘940 patent had been considered by the examiner during prosecution of the asserted patent.

Enabled Prior Art: To anticipate, the prior art must be enabling – i.e., it must “enable one of ordinary skill in the art to make the invention without undue experimentation.”  This enablement standard is different from the applicant’s 112 enablement requirement which requires enablement of both making and using the invention.  That distinction becomes lost in cases like this, however, where the patent covers a method of treatment.  Here, the Federal Circuit appears to require anticipatory prior art to enable practicing the claimed method.

Enablement of prior art is a question of law, but is based on underlying factual findings. In close cases, the important factual finding is the amount of experimentation that would have been necessary. Applying Wands factors, the Federal Circuit agreed that the prior reference was not enabling.

As shown by the trial court, the [prior art] ‘940 patent’s dosage guidelines are broad and general without sufficient direction or guidance to prescribe a treatment regimen. The alleged prior art also contains no working examples. Finally, nothing in the ‘940 patent would have led one of skill in the art to identify riluzole as a treatment for ALS. In sum, each component of the claimed invention—identifying riluzole as a treatment for ALS and devising dosage parameters—would require undue experimentation based on the teachings of the ‘940 patent.

Burden of Proving Enabled Prior Art: In judging anticipation, courts generally presume that prior art is enabled. That presumption may be overcome by a patentee by providing “persuasive evidence” of nonenablement. At that point, the ultimate burden of proof (with clear and convincing evidence) lies with the accused infringer. In this case, the district court did not explicitly follow this burden shifting framework. On appeal, the Federal Circuit held that articulation of the rule was not necessary. The burden was properly shifted because Aventis presented “sufficient evidence to overcome the presumption of enablement.”

Holding: Affirmed. Validity challenge defeated because prior art was not enabled.

Notes:

  • The opinion did not focus on timing: As technology develops more and more prior art references become enabled. Thus, it is important to consider at what point in time the reference must be enabling.

Disclosure: My former colleagues at MBHB represent Aventis in this case. The district court case was ongoing while I was there.