Tag Archives: Supreme Court

Mayo v. Prometheus: Medical Methods and Patentable Subject Matter at the Supreme Court

Mayo v. Prometheus Labs., (on petition for writ of certiorari 2009)

The Mayo Clinic has filed a petition asking the Supreme Court to hear its case challenging the patentable subject matter of Prometheus Labs’ patents that cover a method of optimizing the dosing of a drug. U.S. Patents 6,355,623 and 6,680,302.

The invention basically offers an iterative approach to dosing that involves three steps: (1) administer a drug to a subject; (2) then determine the level of drug in the subject; and (3) decide whether the next dose should be the same, higher, or lower. The decision on the next dose is made by comparing the the level of the drug in the subject against predetermined thresholds. Claim 1 of the ‘302 patent adds additional detail including identifying the active ingredient (6-thioguanine), the diagnosis (a GI disorder), and the predetermined thresholds (e.g., 230 pmol of drug per 8108 red blood cells). Claim 46 of the ‘623 is a broad claim in that it does not not require the administration step (step 1 from above).

Broad Functional Language: You’ll note that the claims are written in broad functional language without tying the the claimed methods to any particular technology. Thus, the “administering” step could potentially be accomplished by any effective method (that has or will be invented) of getting the drug into the subject. Likewise, the patent offers potential methods of “determining the level” of drug in the body (e.g., liquid chromatography) but the claim is broadly written to seemingly cover any mechanism that fulfills that method.

Novelty Involves the Mental Step: Of course, the general iterative process is well known, what makes the Prometheus claims novel is that they identify the particular thresholds that are important (e.g., 230 pmol). In practice, the process of comparing the thresholds to the subject’s drug level is done in the mind of a physician. As Mayo explains, this merely involves the physician’s mental recognition of a natural correlation between metabolite levels and patient condition.

With these facts in mind, Mayo presents the following question: Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations.

The Federal Circuit held the method patentable under its Bilski test by finding that the required administration of the drug transformed an article into a different state or thing — essentially creating a per se rule that a method requiring administration of a drug will be deemed patentable subject matter under Section 101. The court also held that the “determining the level” step was necessarily transformative since “those levels cannot be determined by mere inspection.”

Chances for Supreme Court Review: The fact that Bilski – another Section 101 case – is already pending before the Supreme Court does not mean that the court will reject this case. Rather, the court has often granted certiorari in tandem. The Supreme Court has regularly used case clustering in the past when considering patent issues: Nonobviousness (John Deere (1966), Adams (1966), & Anderson’s-Black Rock (1969)); Patentable subject matter (Flook (1978), Charkabarty (1980), Diehr (1980)); Prosecution history estoppel (Warner-Jenkinson (1995) & Festo (2000)).

The case also represents a growing trend of pitting patient advocates (who want cheaper access to medicine) against innovators (who create better medicine).

Notes & Documents:

Claim 1 of the ‘302 patent: A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

   (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

   (b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder,

   wherein a level of 6-thioguanine less than about 230 pmol per 8108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

   wherein a level of 6-thioguanine greater than about 400 pmol per 8108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Supreme Court Indicates Interest in International Exhaustion Case

Costco Wholesale Corp. v. Omega, S.A. (Supreme Court 2009)

The Supreme Court has asked the Solicitor General to file a brief expressing the Obama Administration’s view on this pending international copyright exhaustion case. The law of exhaustion in copyright and patents run roughly parallel, and the outcome of this case will likely alter US patent law as well.

Under the first sale doctrine (aka exhaustion), once a copyright (or patent) owner has made an authorized sale of a protected product, the owner no longer has rights in that particular copy.  This allows the authorized purchaser to re-sell the particular product. 

Omega sells its watches for a higher price in the US than it does elsewhere. The discount retailler Costco purchased genuine Omega watches from overseas (through an importer) and began to sell them in its US stores.  The question on appeal is whether Omega’s authorized foreign sale exhausted its US copyright.

Under the Copyright Act’s first-sale doctrine, 17 U.S.C. § 109(a), the owner of any particular copy “lawfully made under this title” may resell that good without the authority of the copyright holder. In Quality King Distribs., Inc. v. L’Anza Research Int’l, Inc., 523 U.S. 135, 138 (1998), this Court posed the question presented as “whether the ‘first sale’ doctrine endorsed in § 109(a) is applicable to imported copies.” In the decision below, the Ninth Circuit held that Quality King (which answered that question af-firmatively) is limited to its facts, which involved goods manufactured in the United States, sold abroad, and then re-imported. The question pre-sented here is:

Whether the Ninth Circuit correctly held that the first-sale doctrine does not apply to imported goods manufactured abroad.

In Fuji Photo Film Co. v. ITC, 474 F.3d 1281 (Fed. Cir. 2007), the Federal Circuit held that US patent rights are only exhausted “through a first sale in the United States.” In that case, the Court recognized that “a different rule applies in copyright cases.”  However, at least one district court has held that the Supreme Court’s 2008 Quanta decision is inconsistent with this Federal Circuit precedent. See LG Electronics, Inc. v. Hitachi, 2009 WL 667232 (N.D.Cal. 2009)

If it takes the case, the Supreme Court is likely to link the parallel patent and copyright doctrines.

One of my former students (Shourin Sen) has been following the case on his copyright focused site: Exclusive Rights.

Challenging PTO Decisions in District Court: Federal Circuit Affirms Exclusion of Enablement Evidence that “Should Have” Been Raised During Prosecution

Hyatt v. Doll (Fed. Cir. 2009) 07-1066.pdf

Gil Hyatt is a prolific inventor who has spent much of his time over the past thirty years challenging the bounds of USPTO practice. This August 11, 2009 opinion marks the seventeenth Federal Circuit decision focusing on Hyatt’s patent rights in addition to the 2003 Supreme Court decision Franchise Tax Bd. of California v. Hyatt.

This Case: During prosecution, the examiner rejected each of Hyatt’s 117 computer memory architecture claims based on anticipation, obviousness, enablement, double patenting, and written description. Hyatt appealed (pro se) to the BPAI who reversed the bulk of the rejections, but affirming only the written description and enablement rejections associated with 79 claims. Hyatt then took his case to Federal Court by filing a civil action in DC District Court grounded in 35 U.S.C. 145.

At the district court, Hyatt submitted a new declaration offering additional evidence of enablement and written description. However, the district court excluded that inventor-declaration from evidence based on Hyatt’s “negligence” in failing to previously submit the information to the PTO.

On appeal, the Federal Circuit affirmed the exclusion of evidence – holding that the district court may properly exclude evidence that Hyatt should have produced to the PTO. (Chief Judge Michel as author joined by Judge Dyk)

Hyatt was obligated to respond to the examiner’s written description rejection by In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996), by explaining where in the specification support for each of these limitations could be found. . . . The Board noted, “It is far easier for appellant to describe where the limitation he wrote is disclosed than for the Office to prove that the limitation is not disclosed.” . . . Hyatt, however, refused to cooperate, even though he necessarily possessed the information the examiner sought by the time he filed his application.   

On these facts, the district court’s exclusion of Hyatt’s new evidence must be affirmed. . . . [I]t is clear from the record that Hyatt willfully refused to provide evidence in his possession in response to a valid action by the examiner. Such a refusal to provide evidence which one possessed was grounds in Barrett to exclude the withheld evidence. Similarly, we hold that in light of Hyatt’s willful non-cooperation here, the district court did not abuse its discretion by excluding the Hyatt declaration.

Judge Moore penned a vigorous dissent in support of the patent applicant’s right to a full civil action including the right to submit additional evidence when challenging a PTO decision.

The majority takes away this patent applicant’s fundamental right to a “civil action to obtain [a] patent” as granted by Congress in 35 U.S.C. § 145. Today the majority decides that a patent applicant may not introduce the inventor’s declaration in a § 145 proceeding before the district court because the inventor had an “affirmative duty” or “obligation” to disclose this evidence to the PTO. His failure to fulfill his affirmative duty, by not disclosing evidence he could have disclosed to the PTO, results in such evidence being excluded from the district court § 145 proceeding. The district court made no fact findings indicating willful withholding or intentional suppression; in fact, the district court did not even conclude that Mr. Hyatt’s conduct amounted to gross negligence, but rather excluded the evidence under a negligence “could have” standard. Nor did the PTO even argue, at any stage of these proceedings, that Mr. Hyatt’s conduct in this case was willful or intentional. Nonetheless, the majority concludes that the applicant “owed,” the PTO all evidence he possesses that is responsive to a rejection and that failure to fulfill this newly created “affirmative duty” amounts to willful withholding as a matter of law. There are only two possible ways to interpret the majority’s willful withholding determination. Either the majority is engaging in appellate fact finding or it is determining that breach of its newly created affirmative duty is willful withholding as a matter of law.

. . .

Congress granted patent applicants the right to a civil action in the district court distinct from their right of appeal. It is our obligation to protect the distinction Congress codified in § 145, not to reweigh the virtues of that decision. The § 145 proceeding is a civil action and ought to be governed by the same Federal Rules of Evidence that govern other civil actions. Patent cases do not need, nor should they have, special rules of evidence.

. . .

The statute itself distinguishes the appeal that may be brought pursuant to 35 U.S.C. § 141 because a § 145 action is not an appeal; it is a “civil action.” The statute obligates the district court to adjudicate the facts in this civil action. Because the statute affords no limitations on the type of evidence that ought to be admissible in a civil action brought under § 145, the standard Federal Rules of Evidence that govern all civil actions ought to govern. The legislative histories of § 145 and its predecessor statute, section 4915 of the Revised Statutes, repeatedly and without contradiction indicate that the intent of Congress was to permit a patent applicant to bring a new suit built upon a new record. . . . Congress intended that the district court in a § 145 action have everything that a court would have in an infringement suit. Under this standard, Congress certainly intended for an inventor, such as Mr. Hyatt, to be permitted to introduce his own declaration in a § 145 action.

. . .

The majority holds that by failing to offer his testimony to the PTO, Hyatt has failed to satisfy “an affirmative and specific duty.” Maj. Op. at 2. In this way, this new affirmative duty for prosecution seems to resemble inequitable conduct, though here the applicant is penalized regardless of their intent. . . . With all due respect to the majority, I do not believe a new “affirmative duty” to disclose is warranted, nor do I believe Hyatt was “required by law” or “obligated” to provide his declaration to the PTO. While Mr. Hyatt may have failed to overcome the rejections or to convince the Board based upon his submissions to the PTO, he did not fail to fulfill an “obligation” or “affirmative duty” as the majority alleges.   

. . .

In this case, the district court found that Mr. Hyatt’s failure to proffer his

declaration to the PTO was merely negligent. . . . I find troubling the majority’s characterizations of Mr. Hyatt. See, e.g., Maj. Op. at 51 (Mr. “Hyatt purposefully kept [the Board] in the dark”); id. (his “blatant non-cooperation”); id. at 50 (Mr. “Hyatt willfully refused to provide evidence in his possession”); id. (Hyatt “refused to cooperate”); id. (“Hyatt’s willful non-cooperation”); id. at 55 (“Hyatt willfully refused”); id. at 49 (providing his declaration “should have been simple for him”); id. at 55 (that Hyatt’s failure “to perform a simple task that it was his burden to perform is inexcusable”); id. at 54 (“Hyatt’s perverse unhelpfulness”). None of this appears in the district court proceedings, the PTO proceedings, or the record— these fact findings ought to be left to the district court which is in the best position to weigh the contradictory evidence.

. . .

Contrary to the appellate finding of willful withholding, the record contains ample evidence of a lack of willful withholding. Here, the examiner rejected all of Mr. Hyatt’s 117 claims for lack of written description, failure to enable, obviousness-type double patenting (over 8 separate references), and Schneller-type double patenting (over the same 8 references). The examiner also rejected 9 claims as anticipated (Hill reference) and 7 as obvious (over a combination of three references). Technically, Mr. Hyatt was appealing 45 separate issues totaling 2546 separate rejections of his 117 claims to the Board. He wrote a 129-page appeal brief addressing all of these different rejections. And, to be clear, the Board reversed all the examiner’s rejections for obviousness, anticipation, obviousness-type double patenting, Schneller-type double patenting, and many of the written description and enablement rejections. With regard to the written description rejections in particular, the Board reversed the rejections of 38 claims and sustained the rejections of 79 claims. Mr. Hyatt prevailed on 92% of all the examiner’s rejections at the Board level. Despite Mr. Hyatt’s success, the majority declares Mr. Hyatt’s response to be “completely and wholly inadequate” and Mr. Hyatt to have been perversely unhelpful. Maj. Op. at 55, 56.

. . .

Although Mr. Hyatt may have failed to overcome all of the written description rejections based upon his submissions to the PTO, he did not fail to fulfill an “obligation” or “affirmative duty,” and he certainly was not “perversely unhelpful” as the majority alleges. . . I believe the court is wrong to hold that breach of the newly created affirmative duty, i.e., not producing evidence to the PTO, is willful withholding as a matter of law.

. . .

In hindsight, perhaps Mr. Hyatt should have submitted his declaration or that of any other expert earlier in the prosecution process. But hindsight is misleadingly acute. Declarations and expert reports are time consuming and expensive to prepare. It is hardly reasonable or even desirable to require patent applicants to put massive declarations into the record at an early stage of prosecution, weighing the cost to both the applicant and the PTO. See generally Mark A. Lemley, Rational Ignorance at the Patent Office, 95 Nw. U.L. Rev. 1495 (2003) (arguing that it would be inefficient for the PTO to overinvest in examination because so few patents are enforced). In this case, for example, the examiner rejected the claims on many different bases (double patenting on 8 different references, obviousness, anticipation, enablement, written description, etc.), totaling 2546 separate rejections. The Board overturned nearly all of them. It is easy with the benefit of hindsight to say Mr. Hyatt should have introduced more evidence on written description to the Board. But Mr. Hyatt was not facing merely a written description rejection, he was facing 2546 separate rejections on many, many different bases. The majority implausibly asserts that 2546 separate rejections is “proportional to Hyatt’s prosecution of an application containing 117 pending claims spanning 79 pages.” Maj. Op. at 56 n.35. An average of 21 rejections per claim is hardly proportional. Mr. Hyatt was forced to appeal 45 independent issues to the Board when the average is two. Dennis D. Crouch, Understanding the Role of the Board of Patent Appeals in Ex Parte Appeals, 4, available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1423922. Despite this challenge, Mr. Hyatt was largely successful on appeal. Further, the length of Mr. Hyatt’s application suggests that his efforts to pinpoint pages containing certain terms was helpful and in good faith. Mr. Hyatt’s response may have been especially valuable in the time before searchable electronic applications.

To say that Mr. Hyatt had an affirmative duty to introduce all evidence to the Board or that he “owed” (Maj. Op. at 56) all the evidence he possessed is to put an enormous and undesirable burden on the patentee, one that will foreclose patent protection for many small inventors. Congress foresaw exactly this problem and ameliorated it with § 145 by providing applicants a way to initiate a civil action and introduce new evidence after Board proceedings when the issues are much more succinct and consolidated. This is illustrated perfectly here, where the applicant was contending with 2546 rejections on many different bases before the Board. After the Board overturned nearly all of them, only a small number of rejections—based on written description/enablement—were maintained. Hence at the district court the applicant could proffer much more extensive evidence because the universe of issues was greatly narrowed. This is the sensible approach Congress enacted. The statute even places the cost of the proceeding on the party better positioned to know the value of the application—the applicant. The majority’s new exclusionary rule based upon its new affirmative duty upsets this balance.

Notes: I expect that Hyatt will ask for reconsideration and will then push for Supreme Court review.

Injunctive Relief: District Court Abused Discretion by Failing to Consider eBay Factors

Ecolab v. FMC Corp. (Fed. Cir. 2009)

Both Ecolab and FMC sell chemical mixtures used by beef and poultry factories to help protect raw meat from “pathogens, such as E. coli and salmonella.” Both parties hold patents on their mixtures, and in litigation each asserted infringement against the other. A jury awarded both parties damages for infringement. However, the district court refused to issue permanent injunctive relief. On appeal, the Federal Circuit invalidated Ecolab’s claims and then focused on whether the district court erred in refusing to grant an injunction to stop Ecolab from infringing.

Injunctive relief is awarded according to the traditional principles of equity. In eBay v. MercExchange, the Supreme Court interpreted those principles to require a patentee seeking injunctive relief to demonstrate “(1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.”

In this case, the district court did not explicitly consider any of the eBay factors. “That is an abuse of discretion.” In this instance, the Federal Circuit refused to consider whether – based on the fact at hand – an injunction would be proper. Rather, on remand the district court must consider whether relief is warranted based on a consideration of the four listed factors.

Note:

  • While construing claims, the decision distinguishes Chef America’s statement that claims are construed “as written, not as the patentees wish they had written it.” “Because the claim language at issue in Chef America was unambiguous, that case is distinguishable from the present case. In the present case, the definition of “sanitize” is ambiguous in that it does not indicate when consumption is to take place . . . and the district court did not err when it construed the term “sanitize” to mean that the treated meat has become safe for human handling and post-cooking consumption.”

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

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]

Guest Post: Ten Reasons the Supreme Court Should Take In re Bilski

Erika Arner is the co-author of the Bilski petition for certiorari challenging the Federal Circuit’s limits on the patentability of method claims. She handles patent prosecution and litigation at Finnegan Henderson in DC. I asked Ms Arner to write this post.

The Time Has Come – Nearly thirty years have passed since the Supreme Court addressed patentable subject matter.  The “BFD” casesGottschalk v. Benson (1972), Parker v. Flook (1978), and Diamond v. Diehr (1981)represent modern doctrine on the scope of patentable processes under 35 U.S.C. § 101.  Yet these cases were handed down before the Internet and personal computer fundamentally changed the way Americans live, work, and innovate.  In their struggle to apply the BFD cases to cutting-edge inventions, the PTO and courts have whittled away at the scope of section 101.  The time has come for the Court to reaffirm that the broad, flexible approach to section 101 set forth in the BFD cases applies with equal force in today’s information age. 

Third Time’s The Charm – The Supreme Court declined its last two opportunities to update its jurisprudence on section 101 and process claims.  In 1999, the Court denied cert. in State Street Bank, which applied the “useful, concrete, and tangible result” test to determine when a claim contains a patent-eligible practical application of a fundamental principle.  That same year, the Court declined to review AT&T v. Excel, but indicated that the section 101 issue had garnered at least some interest on the Court.  Justice Stevens filed a statement on the denial of cert. in AT&T v. Excel, noting that “[t]he importance of the question presented” made it appropriate to reiterate that a denial of cert. is not a ruling on the merits. 

Justice Stevens Is Not Alone – In addition to the statement filed in AT&T v. Excel, several justices have found opportunities to express interest in section 101 issues.  When the Court dismissed cert. in LabCorp v. Metabolite, Justice Breyer dissented, joined by Justices Stevens and Souter.  In the dissenting opinion, Justice Breyer called into question the “useful, concrete, and tangible result” test for patentable processes, arguing that “if taken literally” the test would conflict with Benson and Flook.  These three justices were joined by Justice Kennedy in a concurrence filed in eBay v. MercExchange(2006), criticizing the “potential vagueness and suspect validity” of business method patents.  Clearly, there is interest among at least some of the justices in the state of section 101. 

The PTO Picked Bilski – When the PTO began examining Mr. Bilski’s patent application, prosecution progressed as usual.  Prior art was searched and applied, claims were amended, new prior art was cited, and several claims were allowed.  Then suddenly, the examiner changed position, withdrawing the remaining prior art rejections and the claim allowances and instead rejecting all of the claims under the now-obsolete “technological arts” test for section 101.  An expanded panel of the PTO Board affirmed the rejection in a 70-page “informative” opinion setting forth a version of the machine-or-transformation test.  The PTO seemingly chose Bilski as the vehicle to reverse its position set forth in the prior year’s “precedential” decision in Ex parte Lundgren, which allowed business method claims with no tie to a computer or physical transformation. 

The Federal Circuit Picked Bilski – At the Federal Circuit, Mr. Bilski’s case progressed normally at first.  Briefs were filed; oral arguments were held.  But before the panel rendered its decision, the court ordered that the appeal would be heard en banc “in a long-overdue effort to resolve primal questions on the metes and bounds of statutory subject matter” according to Judge Mayer.  In its en banc Order, the court invited briefing from the parties and the public on five questions ranging from whether Bilski’s claims were patent-eligible under section 101 to what standard should govern the patent-eligibility of a process.  The court also took the extraordinary step of inviting two representatives of amicus parties to participate in the en banc oral arguments.  Clearly, the court decided that Bilski was the case to resolve the very “primal” question of when a process is patentable under section 101. 

The Patent Community Picked Bilski – When invited to file amicus curiae briefs to the en banc Federal Circuit in In re Bilski, the patent community and the public at large responded in force.  Thirty-eight briefs were filed representing wildly different points of view on the proper interpretation of section 101.  Briefs were filed by large organizations and small, by teams of academics and by individuals, by corporate patent owners and patent practitioners, and by industry groups ranging from software and biotechnology to the ACLU.  These assorted parties with their divergent points of view seem to agree on one thing: In re Bilski presents the perfect vehicle to address the proper scope of section 101. 

The En Banc Bilski Decision Is the Closest We Get to a Patent Circuit Split – Three dissents and a concurrence accompanied the 9-judge majority opinion.  Regarding the majority’s machine-or-transformation test, the dissenting opinions varied just as widely as the amicus briefs had.  Judge Mayer argued that the court should go farther to restrict section 101 and overrule State Street Bank andAT&T.  At the other extreme, Judges Newman and Rader filed separate dissents arguing for a broad, flexible application of section 101 to accommodate the innovations of today’s knowledge economy.  The divergence of opinions on the en banc court is akin to the “circuit split” that often signals the need for the Supreme Court to step in. 

The Issue in Bilski is Fundamental to the Patent System and the U.S. Economy The proper scope of patentable subject matter under § 101 is not only important to the nation’s economy, it is “one of the broadest, most sweeping issues in patent law,” according to Judge Moore in her dissent from en banc rehearing in In re Comiskey (2009).  The importance of this issue is highlighted by the filing of nine amicus curiae briefs in support of the petition for cert.  This level of amicussupport at the cert. stage is the highest in a patent case since Festo, where nine briefs were filed at the cert. stage.  For example, only three briefs were filed in support of the petition for cert. in KSR and six were filed at the cert. stage in eBay.   

The Machine-or-Transformation Test Conflicts with Supreme Court Precedent Although the Supreme Court has twice expressly declined to hold that the machine-or-transformation test is the “only test” for patentable processes under § 101, the Bilski court did just that.  Indeed, the court acknowledged some doubt about its interpretation of Supreme Court precedent and recognized that the Supreme Court “may ultimately decide to alter or perhaps even set aside this test to accommodate emerging technologies.”  In re Bilski

The Supreme Court Does Not Like Rigid Tests for Patents When the Supreme Court has set forth a flexible approach to interpreting the Patent Act, they are prone to overruling attempts to define a rigid “bright line” test.  Festo and KSR are two examples of the high Court reversing an attempt by the Federal Circuit to establish a bright line test when the flexible approach of earlier Supreme Court cases was difficult to apply.  In those cases, the Court instructed the Federal Circuit to return to the flexible, case-by-case analysis required by its precedent.  The Federal Circuit’s “definitive” machine-or-transformation test should meet the same fate.

Federal Circuit Takings Case: Set Up for Supreme Court Review

Casitas Municipal Water v. US (Fed. Cir. 2009) (en banc denial) (MAYER, SCHALL , and MOORE*)

Casitas is not a patent case, it is a takings case involving regulatory restrictions on water use imposed by US Government. The Federal Circuit has jurisdiction over this takings claim against the US Government because it is on appeal from the Court of Federal Claims (CFC). Although the Federal Circuit has denied the Federal Government’s motion for en banc rehearing, a set of diverging opinions sets this case in position for likely Supreme Court review.

History: The Ventura River Project provides water supply to Ventura County, California. In 1956, the US Government granted the local government the “perpetual right to use all water that becomes available through the construction and operation of the Project.” Then, in 1997, steelhead trout living in the Project became an endangered species under the Endangered Species Act (ESA), and the US Government required that Casitas construct a fish ladder and divert water over the fish ladder. Casitas complied, but filed suit in the CFC alleging that the Federal Government had taken its property without just compensation (and also under breach of contract). The CFC classified the Government action as “regulatory” rather than a “physical.” In takings law, compensation for regulatory takings is much more difficult to obtain, and Casitas admitted that it could not prove the required elements. This conclusion followed the Federal Government argument that “it did not seize, appropriate, divert, or impound any water, but merely required water to be left in the stream.”

Appeal: On appeal, the Federal Circuit reversed. Writing for the majority, Judge Moore concluded “that the government physically appropriated water that Casitas held a usufructuary right in.”

Here, the government admits for the purposes of summary judgment that it required Casitas to build the fish ladder facility, which is a man-made concrete structure that was not a portion of the existing … The government also admits that the operation of the fish ladder required water, which prior to the fish ladder’s construction flowed into the Casitas Reservoir … Specifically, the government admits that the operation of the fish ladder includes closing the overshot gate …and that the closure of this gate causes water that would have gone into the Casitas Reservoir via the Robles-Casitas Canal to be diverted into the fish ladder. … These admissions make clear that the government did not merely require some water to remain in stream, but instead actively caused the physical diversion of water away from the Robles-Casitas Canal … and towards the fish ladder, thus reducing Casitas’ water supply.

In dissent, Judge Mayer rejected the physical takings argument. At base, he argued, Casitas does not actually own the water. Rather, under California law, all water sources within California “belong to the public.” Even if Casitas did own the water flow, Mayer would have seen the endangered species requirements as regulatory because the requirements simply force a specific use of the water rather than take it away.

En Banc Rehearing: In what looks like a 7-5 (or 6-6) vote, the Federal Circuit denied a rehearing en banc. Judge Moore wrote a new opinion defending her original approach in the original opinion. In particular, Judge Moore focused on the “facts as presented” in the case. “[T]he government conceded (1) that Casitas had a property right in the water diverted from the Ventura River, and (2) that the government required Casitas to build and operate the fish ladder in such a way as to permanently appropriate water in which Casitas had the conceded property right.” Based on those two facts, the holding of a physical takings was easy.

Judge Gajarsa would have heard the case en banc. Gajarsa (joined by Chief Judge Michel and Judge Dyk) saw the taking as clearly regulatory in form because nothing had actually been taken by the US Government.

This denial implicates fundamental questions regarding takings law. The panel majority’s opinion suggests that a government action can be construed to be a physical taking even if no physical proprietary interest has actually been taken by the United States. This is contrary to present Supreme Court law and contrary to our case law. Accepting this analysis of the panel majority eliminates the fine distinction and balance that has been established by the Supreme Court between physical and regulatory takings. Moreover, it eliminates the ability of the legislature to provide for limited and parsimonious legislation protecting endangered species.

Notes:

  • Republican vs. Democrat: Moore’s position is clearly one of stronger property rights while Gajarsa/Mayer’s position is in favor of regulatory power of the government. It appears that this decision falls along political lines. Those thinking of the regulation as a physical taking (Moore, Schall, Rader, JJ) are all Republican appointees. Three of the five thinking of the regulation as regulatory in nature are Democratic appointees (Linn, Dyk, Gajarsa, JJ are all Clinton appointees; Michel, CJ, and Mayer, J, are Reagan appointees). At least three of the four other judges voted to deny a rehearing. Of those four, three are Republican appointees (Newman, Lourie, Prost, JJ, are all Republican appointees; Bryson, J, is a Clinton appointee). As you can see here, eight of the twelve active Federal Circuit judges are Republican appointees.
  • En Banc Denial
  • Original CAFC Opinion: Casitas Mun. Water Dist. v. United States, 543 F.3d 1276 (Fed. Cir. 2008).
  • Original CFC Opinion

Bilski at the Supreme Court

Bernard Bilski’s petition for certiorari is due within days (unless an extension is granted). I think that there is a real question of whether (and how) the patent community should react to presentation of the case. Should the patent community support this case for Supreme Court review, wait for a better situated case, or sit content with the machine-or-transformation test outlined by the Federal Circuit in the en banc Bilski decision? Each position has its merits.

The case is well developed, parties and amici have already invested time standing behind the case. Yet, the underlying invention is not compelling (a method of hedging the risk of bad weather by using commodities trading) and issues of obviousness would almost certainly cloud the issues. There are many other potential cases in the pipeline, and the Supreme Court may properly wait to see how the new Bilski rule develops before weighing-in.

Should the Supreme Court Grant Cert in Rambus?

This post was written by Professor Josh Wright. Wright is a professor at George Mason University Law School, but is visiting this semester at the University of Texas Law School in Austin. This post was originally published on the blog Truth on the Market.

As noted, the FTC has exercised its right under 15 USC 56(a)(3) to petition for a writ of certiorari to review the judgment of the D.C. Circuit in its FTC v. Rambus. The FTC press release is here. The petition is here. The questions presented, as framed by the Commission are:

1. Whether deceptive conduct that significantly contributes to a defendant’s acquisition of monopoly power violates Section 2 of the Sherman Act.

2. Whether deceptive conduct that distorts the competitive process in a market, with the effect of avoiding the imposition of pricing constraints that would otherwise exist because of that process, is anticompetitive under Section 2 of the Sherman Act.

I do not believe the FTC has presented a convincing case for granting cert. Further, I don’t think the Supreme Court should grant cert in Rambus for reasons I’ll discuss in the post. For a more detailed exposition on some of the issues touched upon by this post, see my article with Bruce Kobayashi, Federalism, Substantive Preemption and Limits on Antitrust: An Application to Patent Holdup (forthcoming in the Journal of Competition Law and Economics).

The FTC lists what I count as five separate reasons to grant the petition:

(1) the D.C. Circuit applied an overly restrictive “but-for” causation standard that would require the Commission to show that Rambus’s conduct was anticompetitive (”the court of appeals erred in supposing that a Section 2 tribunal must identify a particular anticompetitive effect in order to find liability”);

(2) the court erred in its application of NYNEX v. Discon, Inc. to Rambus to conclude that the loss of an opportunity for the SSO (JEDEC) to obtain a RAND commitment from Rambus was not an anticompetitive effect under the antitrust laws;

(3) the Supreme Court should grant the petition to clarify “the governing standards of causation in Section 2 cases”;

(4) the D.C. Circuit decision is at odds with the Third Circuit’s Broadcom decision which held that the loss of a RAND commitment due to deception is a proper basis for Section 2 liability; and

(5) the set “inconsistent set of rules” creates a conflict that “threatens confusion regarding the conduct of participants in industry-wide standard setting,” “will discourage participation in standard setting proceedings,” and “ultimately harm consumers.”

I want to examine some of those issues more closely, sketching out reasons why I do not believe that they warrant cert, and also highlight some issues the FTC did not but should have addressed in its brief to make the case more compelling. All of that below the fold. (more…)

Supreme Court Patent Update

Completed Cases: The Supreme Court has denied certiorari of two pending appeals: BPMC v. California and Rattler Tools v. Bilco. In BPMC, the patentee had challenged the Western state’s defense of sovereign immunity. In Rattler Tools, the appeal challenged a non-precedential claim construction opinion.

Upcoming Case: In a recently filed petition, 800 Adept has asked the Supreme Court to build on its 1995 Markman decision and consider “whether a district judge’s construction of a patent claim is ever entitled to deference upon appellate review, or, instead, are all such claim constructions reviewable only de novo, as the Federal Circuit has, over many dissenting opinions, held?” In this case, the Federal Circuit had reversed the lower court’s claim construction and – as a consequence – also reversed the jury verdict of infringement. [Link]. FTC v. Rambus is the most likely candidate of patent cases in the petition stage. That case involves the activities of a patentee during a standard setting process. In a related case, well respected Federal Judge Sue Robinson held that Rambus could not enforce twelve of its patents against Micron as a penalty for litigation misconduct. [Link]

Court Lacks Personal Jurisdiction over Foreign Patentee in Declaratory Judgment Action

Avocent Huntsville Corp. v. Aten Int’l (Fed. Cir. 2008)

Avocent (of Huntsville, Alabama) sued Aten (of Taiwan) for a declaratory judgment of non-infringement and invalidity. In a split appellate decision, the majority (Judges Schall and Linn) found that the district court lacked personal jurisdiction over Aten. The dissent (Judge Newman) would have allowed the Northern District of Alabama court to proceed with the declaratory judgment action.

Patent litigation follows the Supreme Court’s well trod standards for determining whether a court has personal jurisdiction over the parties. Courts speak in the language of minimum contacts, purposeful availment, and traditional notions of fair play. At base, the facts of each case is individually assessed to determine whether those notions have been satisfied. For specific jurisdiction in the declaratory judgment setting, the courts must also determine whether the DJ claim “arises out of or relates to” the DJ defendant’s contacts with the state.

The contacts here include (1) an infringement threat letter from Aten to Avocent mailed to Alabama and to Amazon.com; (2) distribution and sale of Aten products in Alabama through a subsidiary corporation; (3) Aten’s previous patent enforcement litigation in Texas and the ITC.

The Federal Circuit has repeatedly held that a threat letter alone is insufficient to create personal jurisdiction. Rather, for specific personal jurisdiction, the threat letter must accompany other activities related to the DJ action. In that vein, the majority also held that Aten’s “mere acts” of importing and selling products in the Alabama forum do not count as other activities because those sales do not “relate in any material way to the patent right that is at the center of any declaratory judgment claim.” Finally, personal jurisdiction is examined on a state-by-state bases. Thus, the Aten’s prior lawsuits in Texas and the ITC do not impact the issue of personal jurisdiction in Alabama. Open and shut.

In dissent, Judge Newman noted, inter alia, the lack of an alternative forum for the complaint and the existence of Alabama state law claims.

 

    

 

Canadian Supreme Court Confirms Plavix Patent Despite Evergreening Charges

Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 (Canada Supreme Court 2008)

The Supreme Court of Canada has upheld Sanofi’s “selection patent” (the ‘875 patent) covering the blockbuster anti-clotting drug Plavix. A broader “genus” patent (the ‘777 patent) – also held by Sanofi – discloses over 250,000 different compounds. The narrower patent does have some additional patent scope. In particular, while ‘875 patent claims a particular dextro-rotatory isomer, the prior ‘777 patent only describes a racemate of that compound that includes two different isomers.

As an apparent “evergreening” strategy, Sanofi did not claim priority to its earlier patent filing. This allows for an additional decade of patent term. Looking at the case, the Supreme Court determined that it should simply follow the law of novelty and obviousness and not create any special ‘evergreening’ exception:

[97] Evergreening is a legitimate concern and, depending on the circumstances, strategies that attempt to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act. The Act aims to promote inventiveness by conferring exclusivity for a limited period of time while providing for public disclosure of the invention to enable others to make or use it after expiry of the period of exclusivity.

[98] However, a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents for two reasons. First, a selection patent may be sought by a party other than the inventor or owner of the original genus patent. In such a case, anticipation or obviousness may be an issue, but evergreening does not arise.

On obviousness, the court found “a significant difference” between the claimed patent and the prior genus patent, and that the “difference was not obvious.”

Federal Circuit: State of the Court

On May 15, 2008, Federal Circuit Chief Judge Michel presented his “State of the Court” address at the well attended Federal Circuit Judicial Conference.  As usual with the Chief Judge, his remarks were upbeat but unsatisfied.  Several particular issues were emphasized:

  • Aging of the CAFC Judges: Within two years, eight of the twelve regular active CAFC judges will be eligible for senior status. 
  • Settlements: About half of all CAFC appeals settle prior to decision.
  • Speeding Up: “Expedition is a top priority.” Median time from docketing to disposition was nine-months for FY07. The current inventory of cases is now just over six months.
  • More Clerks: Judge Michel has requested a fourth law clerk for each judge to keep up with the complexity of the appeals.
  • En Banc and Supreme Court Review: Continue to be exceedingly rare. “Despite news reports of a surge in the last three years in the Supreme Court review of our patent cases, the data shows little change. I believe these data illustrate how well our panels do in nearly all appeals. We can all be proud of the work of the Federal Circuit.”
  • Read the remarks. Judge Michel’s charts are reproduced below. (Click to expand).

PatentLawPic293

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PatentLawPic296PatentLawPic297PatentLawPic298

 

Patently-O Bits and Bytes No. 33: Supreme Court

  • Patentable Signals at the Supreme Court: In Nuijten, the CAFC held that transitory propagating signals are not patentable subject matter because they do not fit within any of the four statutory invention categories of “process, machine, manufacture, or composition of matter.” Now, Nuijten has petitioned the Supreme Court for certiorari in a case captioned Nuijten v. Dudas. The petition focuses on the CAFC’s decision that arguably requires patentable inventions be (1) tangible; (2) non-transitory; and (3) measurable without “special equipment.” [Petition][About Nuijten]
  • Design Patents at the Supreme Court: In Calmar v. Arminak, the design patent holder is asking the Supreme Court to reverse the Federal Circuit’s narrow infringement analysis. ISDA has filed an amicus brief arguing that the CAFC’s application of the “ordinary observer” test improperly excludes the most natural ordinary observer – a retail customer. [Brief][About Calmer]
  • These two pending Supreme Court petitions are both important and well argued.  The fact that they are well presented also makes it more likely that the follow–on cases of Bilski and Egyptian Goddess will receive attention from the Supreme Court.

Patent.Law077

Challenge to BPAI Appointments Moves to Supreme Court

Translogic Tech. v. Dudas (on petition for certiorari 2008)

In 2007, Professor John Duffy wrote a Patently-O Patent Law Journal article challenging the constitutionality of the current system for appointing administrative patent judges. The Patent Act requires the Director of the PTO to appoint BPAI judges. 35 U.S.C. §6. However, under Article II of the constitution, appointment of “inferior officers” such as these may only be delegated as far as a “Head of Department.”  In this case, the head of department would be the Secretary of Commerce – not the PTO Director.

Now, Translogic has repackaged Professor Duffy’s article in its petition for certiorari to the Supreme Court — arguing that the BPAI’s rejection of the Translogic patent during reexamination should be vacated because one of the APJs was unconstitutionally appointed. (Based on the BPAI decision, the CAFC Set aside an $80 million jury verdict against Hitachi).

The question presented:

Under the Appointments Clause of the Constitution, art. II, § 2, cl. 2, Congress may vest the appointment of inferior officers in the President, in the Courts of Law, or in the Heads of Departments. In this case, one of the three members of a panel of the Board of Patent Appeals and Interferences (“Board”) of the United States Patent and Trademark Office (“PTO”) that ruled on the claims of Petitioner’s patent was appointed by the Director of the PTO, who is not the Head of a Department.

The Questions Presented are:

  1. Whether one of the members of the panel of the Board was appointed in violation of the Appointments Clause; and
  2. If so, whether there must be a vacatur of the Board’s decision.

Translogic’s brief is clean and could be an easy grant. It raises questions that the Supreme Court is designed to answer: how the Constitution limits federal law. The only knock is that this issue was not raised at the BPAI or the CAFC (until a rehearing request) – primarily because Professor Duffy’s article was not yet published. 

Notes and Documents:

Re-Litigating Gorham v. White: Design Patents at the Supreme Court

ScreenShot016Saint-Gobain Calmer, Inc. (now MeadWestvaco Calmer) v. Arminak & Associates, Inc. (on petition for certiorari 2008)

In 2007, the Federal Circuit dealt a serious blow to design patent protection by determining that an intermediate corporate purchaser is the “ordinary observer” for infringement analysis.  A professional corporate purchaser is presumably more likely to see differences between the patented design and an accused infringing device — thus making infringement more difficult to prove.

Calmer’s design patent, for instance, covers a sprayer shroud that is then combined with the trigger mechanism, bottle, etc.; filled with some liquid; and shipped to Wal-Mart for retail sale. The Federal Circuit’s holding looks to the typical buyer at the point where the allegedly infringing shroud is first sold to determine whether that individual would believe that “the patented design as a whole is substantially the same as the accused design.”   

Calmer has now petitioned the Supreme Court asking two questions:

  1. Whether the [Federal Circuit’s] use of expert viewpoints to determine design patent infringement is in direct conflict with this Court’s decision in Gorham Co. v. White, 81 U.S. 511, 529 (1871)?
  2. Whether the [Federal Circuit’s] test for design patent infringement of a component product, which considers deceptive similarities only as to the first purchaser of any product including the patented design, directly conflicts with its own precedent and with this Court’s “ordinary observer” test mandated by Gorham Co. v. White, 81 U.S. 511, 529 (1871), by excluding not only unsophisticated purchasers but also later purchasers of products including the patented design as a component?

As I write in an upcoming paper, the justification for design patent protections is more akin to traditional trademark policy than utility patent policy. With that in mind, it makes some sense allow design patents to operate at the retail level.

Notes:

Challenging Patent Validity: Microsoft Asks Supreme Court to Reduce “Clear and Convincing” Standard

Microsoft Corp. v. z4 Tech. (on petition for certiorari 2008)

After a jury verdict that z4’s patent was infringed and not invalid, the Eastern District of Texas district court ordered Microsoft to pay over $100M in damages to the patentee (a small Michigan company)  The award was affirmed by the Court of Appeals for the Federal Circuit (CAFC).

Now, Microsoft has asked the Supreme Court to hear its case. The appeal focuses on the CAFC’s hard-line stance of requiring “clear and convincing evidence” to invalidate a patent even when a defendant presents evidence of invalidity that was not considered by the PTO.  The question presented is:

When a defense of invalidity under Section 282 rests on documentary evidence that was not considered by the United States Patent and Trademark Office, whether the factual predicates of the defense must be proved by “clear and convincing evidence” or some lower burden of proof.

According to Microsoft’s brief (filed by Ted Olson), prior to the founding of the CAFC, “all twelve regional circuits” required a lower evidentiary burden when the invalidity argument “rests on evidence that the PTO never had an opportunity to consider.”  The petition also uses KSR as a hook — in that case, the Supreme Court stated in dicta that the “rationale underlying the presumption [of validity is] that the PTO, in its expertise, has approved the claim.” In KSR, the court found the rationale “seem[ed] much diminished” because the references were unavailable to the PTO during prosecution. 

In KSR, the Supreme Court truly did beg the question of whether the standard for proving invalidity should be lessened in certain cases. In its decision here, the the CAFC held the line, by quoting an old Uniroyal case: “The burden of proof is not reduced when prior art is presented to the court which was not considered by the PTO.”*

A weak point of Microsoft’s petition is that its claim for invalidity falls under 102(g). Microsoft is arguing that its own non-published prior invention should invalidate the z4 patent. (Specifically, Microsoft’s asserted prior art was included in a Brazilian version of Publisher). 102(g) cases provide additional rationales for a high evidentiary standard: 102(g) prior art is generally less trustworthy because the asserted prior art was not public but rather emerges from the accused infringer’s files at the opportune time. In addition, lowering the standard for 102(g) prior art encourages potential defendants to keep their developments in secret rather than publicly disclose them or present them to the PTO.  The same issues arise from non-documentary prior art, such as evidence of prior use.  In its question presented Microsoft attempts an end run around the issue by focusing on “documentary evidence.”

Related Notes:

Supreme Court News: Eleventh Amendment Immunity Question

Today is a Supreme Court theme day. The lawyers running SCOTUS blog have projected Biomedical Patent Management Corp. v. < ?xml:namespace prefix ="" st1 />California Dept. of Health Services as one of the more likely candidates to be granted certiorari after the Supreme Court’s April 18 conference. Hal Wegner also has the case on his updated top-ten patent cases to watch.

Information:

  • Case Name: Biomedical Patent Management Corp. v. California Dept. of Health Services
  • Docket No: 07-956
  • Questions Presented:
  • Whether a state’s waiver of Eleventh Amendment immunity in one action extends to a subsequent action involving the same parties and the same underlying transaction or occurrence; 
  • Whether a state waives its Eleventh Amendment immunity in patent actions by regularly and voluntarily invoking federal jurisdiction to enforce its own patent rights. < ?xml:namespace prefix ="" o />
  • Patently-O Discussion of Case
  • Opinion below (Federal Circuit)
  • Petition for certiorari
  • Brief in opposition
  • Petitioner’s reply
  • Amicus brief of the Chamber of Commerce (in support of the petition)
  •  

    Courts Resist Using the Term Patent Troll

    Despite being used en gross by accused defendants, courts have largely resisted using the term “patent troll” in their decisions. A Westlaw search revealed only seven examples of the pejorative term in court decisions:

    • IP Innovation v. Ecollege.com (Fed. Cir. 2005) (The CAFC noted that the term had been used in the defendant’s argument, but refused to engage in a discussion of its implication).
    • Colida v. Sanyo (Fed. Cir. 2004) (In dissent, Judge Newman argued that attorney fees should not be granted against an accused “patent troll”)
    • Hynix Semiconductor v. Rambus (N.D. Cal. 2008) (Judge Whyte granting Rambus motion in limine to prohibit use of the term “patent troll” during the trial)
    • Taurus IP v. DaimlerChrysler (W.D. Wisc. 2007) (Citing Magliocca’s article; piercing the corporate veil of the accused “nonpracticing entities”)
    • InternetAd Systems v. Opodo ( N.D. Tex. 2007)  (Defining a patent troll as a “small company that did not manufacture products or supply services based on patents in question but enforced patent rights against accused infringers in attempt to collect licensing fees”).
    • Overstock.com v. Furnace Brook (D.Utah 2005) (The court indicated a preference for finding that “patent trolls should be subject to more general jurisdiction, perhaps as a way of deterring coercive baseless litigation.” However, the court could not find a legal hook for such a holding.).
    • Black & Decker Mfg. v. Baltimore Truck Tire Service (D.Md. 1928) (Patent was issued to Mr. Fred Troll)

    In the eBay decision, the Supreme Court ruled that the status of the patent owner may not operate as a categorical exclusion from the prospect of injunctive relief.