All posts by Dennis Crouch

About Dennis Crouch

Law Professor at the University of Missouri School of Law.

CareDx v. Natera: A Response To Professor Holman

Guest Post by Edward Reines.  Reines Co-Chairs the nationwide Patent Litigation practice at Weil Gotshal. He represents CareDx and Stanford in the pending patent lawsuits.

Professor Holman’s recent post on the Federal Circuit’s CareDx v. Natera opinion is a thoughtful addition to Professor Crouch’s review of that decision.  Professor Holman concludes that the Stanford inventions were doomed from the start because they can be labelled as “molecular diagnostics methods” and are thus patent ineligible under Federal Circuit law.  Professor Holman’s conclusion is troubling.  It would limit the patentability of new inventions in an entire scientific discipline merely based on a label.

This labelling mode of analysis is fundamentally flawed because the Supreme Court’s Alice decision mandates a two-step test focused on the claimed advance of the patent, no matter the field of invention.  The test is designed to “distinguish between patents” that would pre-empt a field by broadly claiming “[l]aws of nature, natural phenomena, and abstract ideas” and patents that do not pose this risk because they add to these concepts with “human ingenuity.” There is thus nothing inherent about molecular diagnostics that precludes their patentability and merely labelling a method as “molecular diagnostics” should not be a kiss of death.

Take the Stanford patents.  Those patents document that the natural correlation between organ rejection and elevated levels of cell-free DNA of the organ donor was known for almost a decade before the inventions.   The patents then explain that numerous scientists motivated to measure that increase in cell-free DNA failed to come up with the patented measurement methods.   The patents cite an article published right before the Stanford patent filing that concluded that it was altogether “impractical” to measure cell-free DNA to monitor organ rejection.

The Stanford patents distinguish the failed prior art measurement efforts and describe new inventions on how to better measure cell-free DNA using advanced DNA analysis techniques.  The claimed inventions are better measurement methods that previously eluded the field – not the discovery of the natural correlation itself.  And there was no claim that they posed the pre-emption risk that animated Alice.

Federal Circuit law places at the heart of Alice step one whether the “claimed advance” is the natural law.  In CareDx, as Magistrate Judge Burke had originally concluded, the claimed advance of the Stanford patents is an improved human-devised measurement method.  The Federal Circuit’s opinion failed to properly focus on the “claimed advance” analysis and failed to squarely address that the patents describe numerous prior art failures. This prior art history is irreconcilable with the panel’s conclusion that the patented measurement methods are so conventional as applied to the natural correlation that they could not possibly qualify as patent-eligible human invention.

Instead, the Federal Circuit imported the “conventionality” analysis from step two into step one in lieu of a proper “claimed advance” analysis of Federal Circuit precedent.  As originally contemplated in Mayo, the “conventionality” analysis was akin to determining if the claims included mere trivial additions on top of discovery of a natural law.   Here, the conventionality analysis instead became a short-cut obviousness analysis.  Yet, even that fails because the decade of prior failures at measuring the cell-free DNA for a good organ rejection test proves that it was not conventional to use the patented measurement methods for this purpose – otherwise the many groups working on the problem would have arrived at that solution ultimately invented by the Stanford team.  And the supposed disclaimers in the patents never even suggest that applying the claimed measurement techniques to the tough context of cell-free DNA somehow was not an invention.  Everything about the description of the inventions is inconsistent with that conclusion.

The Federal Circuit cannot blame the Supreme Court for this latest constriction of molecular diagnostic patenting even though many Federal Circuit judges have bemoaned the stinginess of the Supreme Court’s Alice test in this area.  As explained long ago in Diamond v. Diehr, and as repeated in Bilski and Mayo, the Supreme Court recognizes that: “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”  Even if the Stanford measurement methods were known (and the prior art history calls that into serious doubt) their application to a natural law can certainly be patent eligible if it is the product of human innovation, as claimed by the patents.

Professor Holman’s conclusion that the Federal Circuit labelling method may have controlled the CareDx outcome should give real pause to the patent law community.   Such labelling might be useful to describe the inventions at issue in prior decisions, but it is not a basis to proscribe whether an invention is eligible for patenting.   The Stanford patents are plainly directed to a better measurement method that evaded many motivated prior artists.  Such human innovation is the claimed advance and is patent eligible under Alice even if it can be labelled as a molecular diagnostic method.

Waco is Waning

by Dennis Crouch

If you want a pro-patent judge, the conventional wisdom since 2018 has been to file your complaint in the Waco Courthouse of the Western District of Texas.  Judge Alan Albright is the only federal judge stationed in Waco and so he hears the case. This setup has led to substantial consternation among accused infringers who don’t really like Waco and especially don’t like Judge Albright.  With increasing political pressure, W.D.Texas Chief Judge Orlando Garcia has changed the rules.  Going forward patent cases filed in Waco go on the wheel and be randomly assigned to one of twelve judges.

 

TAMU Copyright Infringement — No Liability

by Dennis Crouch

Canada Hockey LLC (Michael Bynum) v. Texas A&M University (Supreme Court 2022)

E. King Gill started the TAMU Aggie’s “12th Man” tradition back in 1921 by coming down from the stands back ready to step-in and play after a player injury.

Michael Bynum spent over 1,500 hours preparing a book on Gill.  The book included a short biography of Gill written by Whit Canning (under a work-made-for-hire agreement).  Bynum was seeking more materials from TAMU and sent a PDF draft version of the book to TAMU athletics publicity folks. The email and PDF included several statements indicating it was copyrighted and not for redistribution.

TAMU publicity liked the 1-page biography and so retyped it; changed the byline to “by Whit Canning, special to Texas A&M Athletics”; and sent it out electronically to 100,000+ folks (all without permission or notification).

Bynum sued for copyright infringement.  But, the action was stymied by the Supreme Court’s decision in Allen v. Cooper, 140 S. Ct. 994 (2020).  That case held that sovereign immunity protected states from copyright infringement liability despite direct Congressional statements otherwise.  In his new petition for certiorari, Bynum presents two end-runs around Allen:

  1. Actual Violation of the 14th Amendment.  Even if Congress did not have the power to entirely eliminate sovereign immunity for copyright infringement, a copyright holder still has an action if the infringement itself constitutes an actual violation of the 14th Amendment under United States v. Georgia, 546 U.S. 151 (2006).
  2. Taking. Although a state might not be liable under a copyright infringement theory, it may still be liable for a Fourteenth Amendment taking.

[Petition for Certiorari]

In rejecting the actual due-process violation claim, the 5th Circuit concluded that the plaintiff’s copyright claims were
“viable [as a] takings claim against TAMU for copyright infringement under the Texas Constitution.” Canada Hockey, L.L.C. v. Texas A&M U. Athletic Dept., 20-20503, 2022 WL 445172, at *8 (5th Cir. Feb. 14, 2022).  Since the state provided an adequate potential remedy, the 5th Circuit found no due process violation by the state of Texas. The court did recognize that the Texas Supreme Court recently rejected a copyright takings claim in Jim Olive Photography v. Univ. of Hous., ––– S.W.3d ––––, 2021 WL 2483766, at *9 (Tex. June 18, 2021).  But, the 5th circuit pointed to a concurring opinion that it is possible that – in some circumstances – the state might find copyrights to have been unduly taken.

Federal Takings Claim: Likewise, the 14th Amendment due process clause also makes the 5th amendment takings clause applicable to the states.  But, states retain sovereign immunity in this context if they provide an adequate remedy under state law.  Here, the 5th Circuit court found again that Texas takings law suffices and so no due process problem.

= = =

Background Law:

  • The Eleventh Amendment states that “The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.”
  • The Copyright Remedy Clarification Act of 1990 (“CRCA”) indicates that individual states can be held liable for copyright infringement and “shall not be immune, under the Eleventh Amendment of the Constitution of the United States or under any other doctrine of sovereign immunity, from suit in Federal court by any person . . . for a violation of any of the exclusive rights of a copyright owner.”
  • In Allen v. Cooper, the Supreme Court held that congress lacked power to prophylactically abrogate sovereign immunity.
  • In United States v. Georgia, 546 U.S. 151 (2006), in the context of applying ADA to state prisons, the court held that Congress had power to apply the law to state prisons in situations where the conduct actually violates the 14th amendment on a claim-by-claim basis.  This is a distinct justification from the prophylactic approach discussed in Allen. The Allen court did not directly address the US v. Georgia arguments.

Enjoining Patent Prosecution

by Dennis Crouch

Steven Young and Carl Hewitt developed technology for monitoring infant biometrics.  Later, they began working with Sleep Number Corp. who eventually purchased their company.  The result was SleepIQ technology for Sleep Number smart beds.

Eventually Young & Hewitt decided to leave the company and start out on their own once again and founded a new venture UDP Labs–still focusing on sleep biometric data integrated into hospital/medical furniture. However, the pair had not fully exited from their Sleep Number contract.  Rather, they had both signed consulting agreements with Sleep Number that included quite a broad scope.  In particular, the agreement required disclosure and assignment of “any ideas, conceptions, inventions, or plans relating to sleep, mattresses, bedding, sleep monitoring, health or wellness as it relates to sleep (including biometric monitoring relating to sleep), or bedroom or sleep technologies.”  The agreement expressly excluded some areas: “monitoring technologies for sudden infant death syndrome” and “blood pressure.”

UDP Labs quickly filed a provisional patent application for Young and Hewitt’s new inventions. The pair tried (unsuccessfully) to get Sleep Number to agree that their UDP work wasn’t covered by the consulting agreement; and ultimately terminated the consulting agreement.  More patent applications filed rather quickly, all claiming priority back to that original application filed during the consulting agreement period. One complicating issue is that the patent applications list three other inventors who were (apparently) not subject to the agreements with Sleep Number.

Lawsuit: In 2020, Sleep Number sued Young & Hewitt along with UDP Labs seeking (1) declaration of “ownership of the inventions” as well as claims of (2) breach of contract and (3) conversion (by failing to disclose the information); (4) trade secret misappropriation; etc.

The lawsuit is ongoing, but in March 2021 Minnesota district court issued a preliminary injunction. Barring the defendants from prosecuting, amending, or abandoning any claims that claim priority to one of the early provisional applications.  The order further includes a mechanism for avoiding abandonment:

Defendants shall not respond or reply to any Office Action. . . After the fifth month but prior to the six‐month deadline to respond … Defendants shall (1) pay any and all necessary fees for a three‐month extension and (2) file a continuation … that does not remove or limit any claims of priority nor alter or abandon any claims.

Sleep No. Corp. v. Young, 532 F. Supp. 3d 793 (D. Minn. 2021), aff’d, 33 F.4th 1012 (8th Cir. 2022). On appeal, the 8th Circuit has affirmed. Sleep No. Corp. v. Young, 33 F.4th 1012 (8th Cir. May 11, 2022).  The appellate panel agreed that Sleep Number had a fair chance of prevailing since the contract “clearly and unambiguously places the inventions described in the patent applications within” its scope.

With regard to irreparable harm due to patent prosecution, the appellate panel agreed with the district court that the parties incentives are not aligned and, as such, UDP Labs “might respond to a future Office Action in a way that prejudices Sleep Number’s purported patent rights.”

The court noted that the potential for irreparable harm was demonstrated by “curiously timed” prosecution actions by UDP Labs to narrow certain claims and eliminate the priority claims.  The district court explained:

In November 2020, after this suit was filed, UDP filed several “Request[s] for Corrected Filing Receipt” with the United States Patent and Trademark Office (“USPTO”) seeking to amend the ‘087, ‘367, ‘385, and ‘848 Applications to eliminate their claims of priority to the ‘613 Application, leaving only the claims of priority to the ‘623 Application. As a result of UDP’s amendment to the applications’ claims of priority, the ‘087, ‘367, ‘385, and ‘848 Applications now only claim priority to an application filed after Young and Hewitt terminated their Consulting Agreements. Additionally, by moving the priority date forward, the applications are now subject to several additional months’ worth of potentially invalidating prior art.

Sleep No. Corp. v. Young, 532 F. Supp. 3d 793, 798 (D. Minn. 2021).

The court considered the balance-of-harms.  On UDP Labs side, it identified the only harm as “a mere delay in participation in the patent-prosecution process.”  That statement omits consideration of patent term and patent term adjustment. On February 2, 2022, the USPTO issued a non-final rejection in one of the pending actions.  The six-month date will come within the fortnight.

In May 2022, the district court also amended its preliminary injunction order to prohibit the defendants “from taking action-including selling, transferring, assigning, conveying, etc.-that would cause a change in ownership and/or interfere with Plaintiff’s asserted rights with respect to the Inventions-at-Issue.”

Preliminary Injunction and Patent License Disputes

by Dennis Crouch

Symbiont Nutrition, LLC v. BJM Feed Ingredients, LLC, 1 CA-CV 21-0218 (Ariz. App. 1st Div. May 19, 2022)

Symbiont’s US Patent No. 9,446,094 covers a method of extruding corn into a resulting “hydrophilic, low-vitreous, gelatinous feedstuff” that is fed to dairy cattle. Apparently this process leads to increased digestion of the starch content.  The inventor Mark Holt is also owner of Symbiont. Holt was part of forming two additional companies, BJM and Matrix and Symbiont licensed the technology (including the patent) to those companies.  The agreement included a number of provisions — primarily a license with royalties for feed sold using the process.

Things fell apart in 2019 with Matrix dissolving and BJM terminating its license.  BJM then began to work with another company (Garner) to manufacture feed products.  The resulting lawsuit in Arizona state court alleged: (1) breach of NDA; (2) conversion of “assets, monies, and intellectual property”; and (3) breach of fiduciary duty.

The district court issued a preliminary injunction prohibiting BJM from selling its feed product using the ‘094 patent or from soliciting other to do the same.  On appeal though, the Arizona Court of Appeals has vacated and remanded–holding that the district court erred by presuming irreparable harm due to patent infringement.  The appellate court noted the change in law under eBay, but also went on to explain that  Arizona Law “does not presume irreparable harm.”  On remand, the district court will need to decide whether the potential ongoing infringement causes any harm to the patentee that cannot be remedied by damages alone.

The appellate court also addressed the question of jurisdiction.  All cases “arising under” the U.S. patent laws are subject to exclusive jurisdiction of the Federal Court system. Here, however, the lawsuit asserts only state law claims of breach & conversion.  Applying Gunn v. Minton, 568 U.S. 251 (2013), the court concluded that the underlying patent law issues were not substantial enough to warrant Federal jurisdiction.

While issues of federal patent law may be embedded in Plaintiffs’ claims, the resolution of their claims rests ultimately on the application of Arizona law, not federal patent law. To succeed on counts one and two, Plaintiffs must prove the existence and validity of the licensing and nondisclosure agreements, that these agreements governed Defendants’ conduct, and that Defendants’ conduct violated the agreements. Similarly, Plaintiffs’ conversion claim turns on a showing of Plaintiffs’ ownership or right to possession of certain property and Defendants’ wrongful interference with that property. Finally, Plaintiffs’ fiduciary duty claim rests on Plaintiffs proving the existence of such a duty and Defendants’ breach of that duty. Arizona law, not federal patent law, is dispositive of each of these claims.

. . . Although the adjudication of Plaintiffs’ claims may require the court to determine whether Defendants used a feed-manufacturing process that infringed on Plaintiffs’ patented process, there is little to suggest that the state court’s analysis of this issue will affect uniformity in patent law.  Indeed, the embedded patent issues in this case are fact-bound and situation-specific and will have no precedential effect on federal courts or federal patent law generally. Nor do Plaintiffs’ claims raise novel patent issues. To the extent they raise patent issues, they are ones of basic infringement.

Slip Op. (internal citations eliminated).

Arthrex One More Time

by Dennis Crouch

Arthrex v. Smith & Nephew (Fed. Cir. 2022)

In this ongoing litigation IPR litigation, Arthrex has filed another petition for  rehearing — arguing that it still has not received the promised “Director Review” sufficient to cure the appointments clause problem apparent in the prior PTAB decision cancelling its patent claims.

The Supreme Court remanded this case so Arthrex could seek review of the Patent Trial and Appeal Board’s decision by a principal officer appointed by the President and confirmed by the Senate. On remand, Arthrex never received that principal officer review. Instead, Arthrex’s petition was denied by Commissioner Hirshfeld, who purported to exercise the Director’s functions during a vacancy in the office.

Arthrex’s particular argument focuses on the Federal Vacancies Reform Act providing “the exclusive means for temporarily authorizing an acting official to perform the functions and duties” of a principal office.   Hirshfeld did not qualify for that role under FVRA.  If you recall, Hirshfeld was never particularly identified as the “acting director” as a linguistic twist around the statute. Rather, Hirshfeld’s title was “performing the functions and the duties” of the Director.

The merits of the IPR turned on the Board’s decision that Arthrex’s purported priority application did not provide written description support of the challenged claims. The result was that Arthrex could not claim the benefit of that earlier filing data and intervening various prior art references rendered the claims invalid.   In its petition, Arthrex also focuses on this issue and argues that “the Board acted beyond the scope of its statutory grant of authority” when it considered the Section 112 issues.  Rather, under §311(b), review is limited only to consideration of Section 102/103.

Arthrex Petition 2022.  Jeffrey Lamkin argued the case before the Supreme Court and continues to represent Arthrex in this appeal.

 

IPR: Federal Circuit Claim Construction Did not Open Door to Revised Grounds

by Dennis Crouch

Wireless Protocol Innovations (WPI) v. TCT Mobile, Inc. (Fed. Cir. 2022) (non-precedential)

Literally Disclosed: In IPR round one, the PTAB sided with patent challenger TCT Mobile and found claims 1 & 3-5 of US8274991 unpatentable as obvious.  On appeal though the Federal Circuit partially reversed, vacated and remanded.  The appellate decision altered claim construction and told the PTAB to try its analysis again with the new construction.

Not Literally Disclosed: On remand, the patent challenger TCT successfully shifted its argument based upon the Federal Circuit’s new claim construction.  The PTAB again found the claims obvious based upon the same prior art–albeit with a slightly different explanation. In its original decision, the PTAB concluded that the prior art disclosed a particular claim element. On remand, that conclusion was no longer appropriate because of the altered claim construction.  Still, the PTAB concluded that it would have been obvious to modify the prior art achieve the invention as construed. I call this the not-literally-disclosed ground.

On appeal this time, the Federal Circuit has fully reversed–holding that TCT had waived the not-literally-disclosed ground by failing to raise it in IPR Round One–prior to the first Federal Circuit appeal.   The court suggests here that an altered argument might be appropriate if the new claim construction had suddenly arrived out of the blue sky. But in this particular case, the Federal Circuit’s preferred claim construction was the construction argued throughout the IPR by the patent owner WPI.

TCT was on notice of WPI’s claim construction position [during the IPR Round One briefing] and TCT thus forfeited the Sen-modification argument by failing to even attempt to introduce it prior to remand. Our decision in Wireless Protocol I did not set forth a new claim construction never contemplated by the parties.

Slip Op.

The original Federal Circuit decision issued in the summer of 2019.  The Board took 21 months to issue the new decision on remand.  The patentee had also argued that the delay was improper because it blew past the 6-month goal set within the Board’s Standard Operating Procedure.  On appeal, the Federal Circuit concluded that the parties had no appealable right in this situation:

We disagree with WPI that the Board violated WPI’s due process rights or any statute, regulation, or internal operating procedure by not meeting the goal to issue remand decisions within six months of this court’s mandate as set forth in the Board’s Standard Operating Procedure 9.

Slip Op. (emphasis in original).

 

Boilerplate Admissions in the Patent Document Lose Eligibility Case for Stanford

by Dennis Crouch

The Federal Circuit’s new eligibility decision in CareDx, Inc. v. Natera, Inc., — 4th — (Fed. Cir. 2022) should cause patent attorneys to pause once again as they draft patent applications and consider any characterizations of the technology as “conventional”; “well known”; or even “known in the art.” At times some characterization will be useful for satisfying disclosure requirements.  Still, the statements will also potentially haunt the patentee both on the obviousness side and, as here, with eligibility.

Stanford owns several biotech patents claiming methods of diagnosing organ transplant rejection. U.S. Patents 8,703,652, 9,845,497, and 10,329,607.  Stanford and its exclusive licensee CareDx sued Naterta and Eurofins for patent infringement.  But, Chief Judge Connolly (D.Del) dismissed the case–finding the claims ineligible under Section 101.  On appeal, the Federal Circuit has affirmed.  This is another major case that could set-up Supreme Court review.

The technology in this case is somewhat similar to the prenatal testing methods in the Illumina and Sequenom cases.  The key difference is that the prenatal technology looked for fetal DNA floating in the mother’s bloodstream while this graft technology looked for DNA of the transplanted-organ floating in the stream.  Transplant rejection is a major immune response and involves eating-away of the transplanted cells. That process releases bits of DNA into the bloodstream.  The Stanford researchers found that the amount of Donor DNA floating in the blood stream of the recipient is indicative of whether the transplant is being rejected.

The claims at issue all share a common four step approach for detecting cell free DNA (cfDNA) in the recipient:

  1. “obtaining” or “providing” a “sample” from the recipient that contains cfDNA;
  2. “genotyping” the transplant donor and/or recipient to develop “polymorphism” or “SNP” “profiles”;
  3. “sequencing” the cfDNA from the sample using “multiplex” or “high-throughput” sequencing; or performing “digital PCR” with certain error rates; and
  4. “determining” or “quantifying” the amount of donor cfDNA.

Slip Opinion.  On summary judgment, the district court concluded that these claims were all directed to a patent ineligible natural phenomena. In particular, the claims are directed to “the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection.”  Since the particular techniques used to obtain and analyze the cfDNA were all conventional, the court concluded that nothing in the claims transformed their nature into a patent-eligible invention.

On appeal, the Federal Circuit affirmed, holding that “[t]his is not a case involving a method of preparation or a new measurement technique.”

The claimed methods are indistinguishable from other diagnostic method claims the Supreme Court found ineligible in Mayo and that we found ineligible on multiple occasions. . . . Here, as in Ariosa, the claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which was inventive. The claims here are equally as ineligible as those in Ariosa.

Slip Op. If the claims in Mayo & in Ariosa are invalid, then the Federal Circuit is likely correct that–so are the claims in this case.

= = =

Alice Step Two: One important caveat on conventionality of the technology.  CareDx argued that the particular technological approach was new and different from prior efforts.  It had been theorized for years that cfDNA of the donor tissue could be used as a measure of tissue failure, prior researchers had repeatedly tried and failed.

Despite many attempts over the following decade, even accomplished researchers could not invent a satisfactory way to measure donor cf-DNA in the recipient’s bloodstream sufficient to monitor organ rejection. At best, preexisting techniques worked only in a small subset of cases. This decade of failure culminated in a discouraging announcement in 2008 by a prominent research group that using cf-DNA to monitor organ rejection was “difficult” and “impractical.” . . .

Not only had there been many reported failures and outright disbelief that a viable cf-DNA organ rejection test could be developed, but attempting to measure cf-DNA, rather than cellular DNA was foreboding. As even defendants’ expert concedes, cf-DNA was believed at the time to be “more challenging” than other analytes to measure because cf-DNA is smaller, not random, typically present in low concentrations, and because this “detection analysis is difficult with techniques prior to 2009.”

CareDx Opening Appellate Brief.  The particular approach that worked for the Stanford Researches was their application of newly created digital PCR and next-generation sequencing (“NGS”) techniques.  And, those advances are part of the claims.

The problem though was a number of boilerplate statements found within the patent document that the courts saw as admissions that the technology was wholly conventional:

The practice of the present invention employs, unless otherwise indicated, conventional techniques of immunology, biochemistry, chemistry, molecular biology, microbiology, cell biology, genomics and recombinant DNA, which are within the skill of the art.

‘607 Patent, Col 5, line 55.  The patent also discussed the availability of commercial high throughput sequencing products and stated that high-throughput genotyping is “known in the art.”  According to the Federal Circuit, these statements from the specification characterize “the claimed techniques in terms that confirm their conventionality.”  As such, the court found no reason to disturb the summary judgment finding.

Judges LOURIE, BRYSON, and HUGHES. Authored by LOURIE, Circuit Judge.  The case was argued by world class attorneys with Ed Reines (Weil Gotshal) for Stanford/CareDx; Willy Jay (Goodwin Procter) for Eurofins; and Gabriel Bell (Latham & Watkins) for Natera.

 

Inducing Infringement with the Skinny Label

Hypo: Copycat would like to copy Competitor’s product. The patent covering the product expired as have patents covering some methods-of-use, but Competitor still has one method-of-use patent in force.  The question–when you sell its product, how careful does Copycat need to be to avoid inducing infringement?

This hypothetical situation gets trickier when we are talking about FDA regulated drugs because the FDA dictates labeling content for generic (ANDA) filers.  And, for the most part, the content of the generic label is derived directly from the brand-patentee’s label.

An important drug case involving this situation is pending on petition for certiorari before the Supreme Court. Teva Pharms. USA, Inc. v. GlaxoSmithKline LLC, SCT Docket No. 22-37 (2022).  Teva has petitioned its “skinny label” induced infringement loss to the Supreme Court–seeking a ruling that the FDA-approved process creates a limited safe harbor for its label content.

Once a brand drug is no longer patented, the fact that some of the drug’s uses remain patented “will not foreclose marketing a generic drug for other unpatented [uses].” Caraco (2012). Instead, a generic manufacturer can sell its product with a “skinny label” that “carves out” any patented uses found in the brand drug’s labeling—and thereby avoid inducing infringement of the brand manufacturer’s patent rights. See 21 U.S.C. § 355(j)(2)(A)(viii). To aid in this process, brand manufacturers must provide a sworn statement to FDA identifying “the specific section(s)” of their labeling “that describes the method of use” claimed by their patents. 21 C.F.R. § 314.53(c)(2)(i)(O)(2), (c)(2)(i)(P)(2). Those are the sections that generic manufacturers then carve out of their labeling in order to obtain FDA approval despite the brand manufacturer’s remaining patents.

The question presented is:

If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?

Teva Pharms. USA, Inc. v. GlaxoSmithKline LLC, SCT Docket No. 22-37 (2022).

Background: The drug carvedilol (a beta blocker) was patented, but those patents have expired.  GSK sells the drug with FDA approved labelling for treatment of three different cardiac-related problems: (1) congestive heart failure; (2) hypertension; and (3) left ventricular disfunction following myocardial infarction.  GSK had patent rights covering all three uses, but by 2007 the patents covering uses (2) and (3) had expired.  Teva obtained FDA approval to begin selling and marketing a generic version of the drug, but with a “skinny label” that doesn’t mention the still-patented method of use for congestive heart failure.  As you might expect, folks paying the bills in American healthcare immediately realized that Teva’s much cheaper drug was therapeutically equivalent to GSK’s branded ver$ion and began substituting the generic to treat congestive heart failure as well.  GSK sued Teva for inducing infringement and won a jury verdict for $235 million, but the district court rejected the verdict on JMOL. (Judge Stark, now at the Federal Circuit). On appeal, the Federal Circuit reinstated the jury verdict–critically finding that the FDA-required label on Teva’s generic drugs encouraged doctors to prescribe the drug.  The basic problem was that a medical professional could examine the label information about how the drug works for the non-patented uses and gain an understanding that it also works for congestive heart failure.  The majority opinion from Chief Judge Moore and Judge Newman was per curium.  Judge Prost filed a strong dissent in the case:

GSK’s sworn FDA filings identified just one use as patented. So Teva carved out that use and came to market with its “skinny” label. It played by the rules, exactly as Congress intended.

Prost in dissent. Beyond the label itself, GSK also presented evidence of a limited amount of Teva advertising that its version was “indicated for treatment of heart failure and hypertension” and was a “generic equivalent” of GSK’s branded drug.  That evidence helped the Federal Circuit reinstate the jury verdict.  But, the majority still relied upon language from the label itself in finding inducement.  The majority in the case also noted that on remand the district court might still decide the case in Teva’s favor on the theory of equitable estoppel based upon GSK’s statements to the FDA that were relied upon by Teva (to its detriment).

The petition provides two reasons for granting the writ:”

The divided panel’s controversial opinion upends the legal rules facing the modern prescription-drug marketplace, wreaking doctrinal havoc in two equally troubling ways. Such a radical transformation warrants this Court’s intervention now.

First, the decision below eviscerates the key element of inducement liability: the requirement that a plaintiff prove “active steps taken to encourage direct infringement.” Grokster. Actively encouraging or instructing an infringing use has always been required to support inducement, and merely “mentioning” or “describing” an infringing use has always been legally insufficient. Now, however, that difference has disappeared, leaving would-be defendants who sell off-patent products labeled for unpatented uses in the dark about whether and when they will face massive infringement verdicts.

Second, the decision below effectively nullifies a Congressional enactment created specifically to encourage precisely what Teva did here: bring a low-cost generic drug to market labeled for unpatented uses. For decades, the skinny-label statute has worked as intended by providing generic manufacturers with the predictability they need to bring low-cost generic drugs to market labeled for unpatented uses. If they carved out the portions of the labeling that brandname manufacturers themselves identified as covered by method-of-treatment patents, they could launch without risk of infringement liability. But now, every skinny-label launch is an at-risk launch—and patients, FDA, and the healthcare system will suffer the consequences.

Petition. The petition was filed by highly regarded Supreme Court litigator William Jay (Goodwin) on July 11, 2022.  This is a case that I would ordinary expect to see a CVSG from the Supreme Court. We’ll see.

Intellectual Property and the Historic Kinship Between Patents and Copyrights

by Dennis Crouch

In a recently published article, Homayoon Rafatijo and I take-on sovereign immunity in copyright cases.  We argue that the Supreme Court got it wrong in Allen v. Cooper. Our abstract:

The FBI Anti-Piracy Warning provides that “unauthorized reproduction or distribution of a copyrighted work is illegal.” In Allen v. Cooper, the Supreme Court effectively qualified this warning by adding an exception in favor of “sovereign” pirates. In allowing the states to usurp citizens’ intellectual property rights, the justices of the Allen Court prioritized either a dogmatic form of stare decisis or the New Federalist ideology over the Constitution and its structure and history. The Allen Court largely based its decision upon a perceived historic kinship between patents and copyrights, concluding that if not patent, then not copyright. This article walks through the historical record, especially in the period following the Federal Convention, and reports key differences between the patent and copyright systems that that tilt toward a conclusion that the States agreed “to be subordinate to the government of the United States” in the copyright space. In the end, Allen creates serious practical problems for copyright holders. The decision emboldens copyright infringement by state actors by cutting-off the possibility of any recovery of damages for the infringement.

Read it here: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4163206.

O Prior Art, Prior Art, Wherefore Art thou Prior Art? 

by Dennis Crouch

In a new opinion the court asked and answerd an interesting question: What if most on-point prior art was accidentally created due to a typographical error? In LG Electronics, Inc. v. ImmerVision, Inc., — F.4th — (Fed. Cir. 2022), the Court sided with the patentee in holding that a person of skill in the art would have “disregarded or corrected” the  error rather than relying on the error as the foundation of an inventive project.  A key to the analysis was a finding that the error would have been apparent to someone of skill in the art.  See In re Yale, 434 F.2d 666 (CCPA 1970).

ImmerVision’s patent claims an improved method for panoramic images.  The basic idea is to use a non-linear objective lens that captured and then digitally mapped onto a linear pixel grid. The claims require that the lens compress the image at its center and edges and expands intermediate zones.  You can compare the prior art linear objective lens results (Fig. 4A) with those of the proposed panorama lens (Fig 7A).

Because of lens curvature, the center and edges of a super-wide-angle-lens are typically produce lower image quality. The approach here improves the quality of those areas but at the same time creates odd distortions in the image that then need to be corrected using digital image processing.   There are other solutions that would work as well. One example would be higher sensor density in these particular areas.

Lots of smartphones now have multiple lenses, including panorama lenses.  ImmerVision sued LG (and others) for patent infringement and LG responded with two IPR petitions. The PTAB instituted the IPR here, but eventually concluded that LG had failed to prove that the claims should be cancelled. On appeal, the Federal Circuit has affirmed.  Judge Stoll penned the majority opinion joined by Judge Cunningham.  Judge Newman wrote in partial dissent — arguing that the error in the prior art was not an obvious-enough error.

Typo in the Prior Art: The key prior art (Tada) included one table of aspherical data that appeared to show a non-linear lens similar to ImmerVision’s.  The problem — those figures do not match-up with other descriptions of the embodiment in the Tada specification and there is no discussion in Tada of having such a non-linear lens.  Tada is a U.S. patent, and the clincher for the court was that the original Japanese priority document included different numbers that actually matched the other portions of the specification.  Finally, LG did not dispute that “the aspheric coefficients in Tada’s Table 5 were erroneous.”

Of course patent lawyers usually don’t get a balcony scene asking: O Prior Art, Prior Art, wherefore art thou Prior Art?  Rather, we take the printed publication as it is and compare the published words and figures to the patent document.  But for obviousness we do ask an additional WWPD question: What would POSITA do? And here, we have some precedent with the court announcing that a Person of Skill in the Art (POSITA) would disregard an obvious typographical in the prior art and instead fix the typo before trying to modify the reference. In re Yale, 434 F.2d 666 (C.C.P.A. 1970).

In Yale, a patentee was seeking protection for a specific compound of inhalation  the anesthetic—CF3CF2CHClBr.  The USPTO rejected Yale’s claims as obvious based upon a prior art publication that listed that same compound (CF3CF2CHClBr) as an known important analgesic compound.  At the time though the compound was not actually known and it was clear from context that the author of that prior art publication meant CF3CHClBr which was actually well known at the time. In correspondence, the author of the prior art admitted that was “of course, an error.” Still, the PTO rejected the claims as obvious since the compound was actually disclosed in the prior art.  On appeal, the CCPA reversed — holding that such an POSITA would “mentally disregard” such an “obvious error” in the prior art.

Certainly he would not be led by the typographical error to use the erroneous compound as an anesthetic even if as a chemist of ordinary skill in the art he would know how to prepare the compound. He simply would not get so far in the thought process as to determine if he knew how to make CF(3) CF(2) CHClBr, as it would have long since been discarded by him as an obvious typographical error.

Yale. One aside about YaleYale was decided by the Federal Circuit’s predecessor court, the Court of Customs and Patent Appeals (CCPA) and remains good law and binding precedent on the Federal Circuit.  In its first decision back in 1982, the Federal Circuit adopted all prior CCPA holdings as binding precedent. South Corp. v. U.S., 690 F.2d 1368 (Fed. Cir. 1982):

In LG, the Board concluded that the Tada error was an obvious error in line with the holding of Yale. On appeal, the Federal Circuit affirmed — holding that substantial evidence supported the Board’s findings.

This is where Judge Newman dissent comes into play.  She notes that the error was not discovered “until an expert witness conducted a dozen hours of experimentation and calculation.”  Further, Tada’s owners had filed a certificate of correction to fix some aspects of the patent — but did not correct the table.  Judge Newman also notes that the only way that the expert witness firmly concluded that the error existed was by translating the Japanese priority document–something even optics experts are unlikely to do.

I agree with the panel majority that Yale establishes the correct standard to determine if an error would be obvious to a person of ordinary skill in the field. However, I do not agree with the majority’s application of this standard to the facts herein. An “obvious error” should be apparent on its face and should not require the conduct of experiments or a search for possibly conflicting information to determine whether error exists. When a reference contains an erroneous teaching, its value as prior art must be determined.

The error in the Tada reference is plainly not a “typographical or similar error,” for the error is not apparent on its face, and the correct information is not readily evident. It should not be necessary to search for a foreign document in a foreign language to determine whether there is an inconsistency in a United States patent. The foundation of the “typographical or similar” standard is that the error is readily recognized as an error. I am concerned that we are unsettling long-standing law, and thus I respectfully dissent in part.

Slip Op. (Newman, J. in dissent).  The majority disregarded Judge Newman’s arguments: “The distinction between the typographical error in Yale and the copy-and-paste error here is a distinction without a difference.”  Id. (majority opinion).

LG had asked the court to shift its standard — only disregard typographic errors that are “immediately” obvious.  The court rejected this temporal urgency as not required by Yale.

Law Prohibits All Federal Employees from Representing Private Clients before the USPTO

by Dennis Crouch

The Federal Circuit has agreed that Kevin Correll’s 5-year suspension from patent law practice should move forward. Correll v. Vidal (Fed. Cir. 2022) (non-precedential).  Unfortunately, the per curiam decision appears poorly reasoned and seems to lack sufficient legal grounding.  The panel included Chief Judge Moore, and Judges Prost and Hughes.

Kevin Correll worked for the US Navy as an engineer, but also moonlighted for years as a solo patent attorney (prosecuting 211 patent applications). In 2016, the Navy notified the USPTO that Correll may have violated federal rules of ethics.

The key rule:

18 U.S.C. § 205: [Federal employees may not] act as agent or attorney for anyone before any department, agency, court, court martial, officer, or civil, military, or naval commission in connection with any covered matter in which the United States is a party or has a direct and substantial interest.”

The USPTO’s Office of Enrollment & Discipline (OED) conducted an investigation and then filed a disciplinary complaint against Correll.  That complaint was then decided against Correll an Administrative Law Judge and  issued a 5-year suspension from practice. Drew Hirshfeld in his role as agency head affirmed the ALJ finding.  Correll then moved to district court and again lost when the E.D.Va. judge denied his motion for a preliminary injunction against enforcement of the suspension.  On appeal here, the Federal Circuit has affirmed.

The USPTO has long taken the position that these statutory rules prohibit any federal employee from representing private clients at the USPTO.  On appeal here, the Federal Circuit agreed with the USPTO interpretation, although the court appears to limit this broad holding to cases where the attorney is compensated for the work.  Slip Op. (distinguishing Van Ee v. EPA, 202 F.3d 296 (D.C. Cir. 2000) based upon receipt of compensation).  I would suggest compensation as a distinguishing mark applies for the parallel statute 18 U.S.C. § 203, but doesn’t seem to apply directly to Section 205.

The DC Circuit’s Van Ee decision includes dicta stating that an employee representing a private party in an “application for a … patent” could create a conflict of interest. On appeal here, the Federal Circuit latched-onto that language in its conclusion that Section 205 applies to Correll’s behavior.  But, a major difference between Van Ee and this case is that the DC Circuit was considering a situation involving an EPA employee who was advising a private group regarding EPA actions.  Here, Correll is an outsider to the USPTO.  That distinction is relevant because the courts have interpreted Section 205 in light of its primary goal of preventing situations “in which a federal employee, acting as a private party’s agent or attorney, could be perceived as having divided loyalty and as using his or her office or inside information to corrupt the government’s decisionmaking process.”  Slip Op. (quoting Van Ee).  An outsider to the agency is seemingly much less likely to create a conflict.

Here, the district court also concluded that “[t]he government has a direct and substantial interest in patent applications.” Correll v. Under Sec. of Com. of Intell. Prop. (“Director” ), 121CV898AJTIDD, 2022 WL 298125, at *2 (E.D. Va. Jan. 13, 2022).  That conclusion stuck on appeal.

Correll’s biggest argument appears to be that First Amendment freedoms of speech and association should apply to limit the reach of the statute.  Courts use a balancing test to decide when a gov’t employer can permissibly limit its employees speech. Pickering v. Board of Education, 391 U.S. 563 (1968).  Here, the Federal Circuit agreed with the district court that “the government’s interest in avoiding even the appearance of impropriety outweighs the burden that Mr. Correll’s suspension has on his rights.”  The courts particularly noted that the prohibition on representing clients was only a “minimal” burden while the government interest is “direct and substantial.”  I’m not sure about the basis for that conclusion in this situation.

The court also found waiver by Mr. Correll.  In particular by signing-up as a patent attorney Mr. Correll expressly agreed to be bound by the laws and as such cannot now complain about those laws.

Even without Pickering balancing, however, it is apparent that Mr. Correll’s suspension does not violate his First Amendment rights. Mr. Correll agreed to comply with the conflict-of-interest statutes when he registered to practice before the PTO by signing an “Oath or Affirmation” in which he promised to “observe the laws and rules of practice of the [PTO].” Among those rules was a prohibition on federal employees representing private clients.

Slip Op.  I’ll note that the “rules” prohibiting federal employees from representing private clients is simply 18 U.S.C. §§ 203, 205 cited above.  This conclusion seems obviously overreaching. If the prohibition on practice is a violation of 1st Amendment rights, then any waiver requirement is also likely an unconstitutional condition in violation.

If you remember, this appeal is from a denial of a preliminary injunction. On remand the district court will still need to decide the case on the merits.   It will be a bit of a process to tease out which aspects of the decision here were definitive legal conclusions creating the law of the case and which were more deferential conclusions allowing for reconsideration on remand.

Safe Skies Eligibility Petition

David Tropp sued Travel Sentry for patent infringement back in 2006. That was the same year that I first taught a patent law class.  Back then, eligibility was almost an unknown concept in patent litigation.  The rule of thumb was “anything under the sun, made by man,” and I mean ANYTHING. But as we crawled into the 2010s, eligibility emerged as a powerful tool to invalidate issued patent claims–including Tropp’s covering covering a TSA-approved luggage lock.  The basic idea here is to give TSA a master key, or as the district court suggested: “using and marketing a dual-access lock for luggage inspection.”

Tropp recently petitioned the Supreme Court seeking a writ of certiorari on the following question:

Inventor David Tropp owns and practices two patents that disclose a solution to the problem of screening all passenger luggage for flights originating in the United States, following the September 11 attacks. Through a series of specific claimed steps, his patents describe a method of providing consumers with special dual-access luggage locks that a screening entity would access in accordance with a special procedure and corresponding key controlled by the luggage screening entity, all while allowing the luggage to remain locked following screening.

The question presented is: Whether the claims at issue in Tropp’s patents reciting physical rather than computer-processing steps are patent eligible under 35 U.S.C. § 101, as interpreted in Alice Corp Pty v. CLS Bank Int’l, 573 U.S. 208 (2014).

Tropp Petition.  The parties agreed that the following claim is representative:

1. A method of improving airline luggage inspection by a luggage screening entity, comprising:

making available to consumers a special lock having a combination lock portion and a master key lock portion, the master key lock portion for receiving a master key that can open the master key lock portion of this special lock, the special lock designed to be applied to an individual piece of airline luggage, the special lock also having an identification structure associated therewith that matches an identification structure previously provided to the luggage screening entity, which special lock the luggage screening entity has agreed to process in accordance with a special procedure,

marketing the special lock to the consumers in a manner that conveys to the consumers that the special lock will be subjected by the luggage screening entity to the special procedure,

the identification structure signaling to a luggage screener of the luggage screening entity who is screening luggage that the luggage screening entity has agreed to subject the special lock associated with the identification structure to the special procedure and that the luggage screening entity has a master key that opens the special lock, and

the luggage screening entity acting pursuant to a prior agreement to look for the identification structure while screening luggage and, upon finding said identification structure on an individual piece of luggage, to use the master key previously provided to the luggage screening entity to, if necessary, open the individual piece of luggage.

US7021537.

Reasonable Expectation of Success as the Post-KSR Nonobviousness Hook

Tris Pharma v. Actavis Labs (Fed. Cir. 2022) (non-precedential opinion)

One quirk of the Patent Act is Section 271(e), which creates infringement liability for simply seeking FDA approval to market a generic version of an already approved drug. 35 USC 271(e).  Here, Actavis filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a “liquid methylphenidate (MPH) oral suspension.”  This is the same drug found in Ritalin and used to treat ADHD and other neurological concerns.  This particular formulation is in liquid form and the active ingredient is designed for slow release. (Tris sells under the brand “Quillivant XR”).  Tris responded to the Actavis ANDA by suing under 271(e) and asserting three separate patents.

271(e) actions are seen as a form of declaratory action similar to those taken by courts of equity prior to the merger of law and equity.  As such, there is no Constitutional right to a jury trial in these cases and instead all issues of fact and law are typically determined by a federal district court judge.

The usual jury verdict just requires the ticking of an [X] invalidity box. Likewise, the Federal Circuit regularly decides its cases with by ticking the [X] affirmed without opinion box.  The trick with bench trials though, is that the judge is required to explain its factual and legal conclusions.  Fed. R. Civ. Pro. 52(a).

In an action tried on the facts without a jury or with an advisory jury, the court must find the facts specially and state its conclusions of law separately.

Id.  Here, Judge Connolly (D.Del.) held a bench trial and original sided with the generic manufacturer–finding the asserted claims obvious.  That original decision though was vacated by the Federal Circuit back in 2018 (the also panel slightly amended its decision in a 2019 rehearing order). In its decision, the Federal Circuit found that the district court had failed to explicitly and specifically consider a number of factual disputes and thus remanded for further findings:

[T]he district court failed to make the necessary factual findings and provide sufficient analysis of the parties’ arguments to permit effective appellate review. Specifically, the district court’s opinion merely recites the parties’ arguments but fails to explain or identify which arguments it credits or rejects. We thus cannot reach the merits of whether the Quillivant XR® formulation would have been obvious over the prior art. Rather, we identify gaps in the district court’s opinion and remand for the district court to conduct further factfindings and detailed analysis consistent with this opinion.

Tris Pharma, Inc. v. Actavis Lab’ys FL, Inc., 755 F. App’x 983 (Fed. Cir. 2018) (Tris I).

On remand, the district court accepted further briefing on the merits and then flipped the outcome–this time siding with the patentee.  In particular, the district court held that “Actavis failed to prove by clear and convincing evidence that a person of ordinary skill in the art would have been motivated to combine the prior art references with a reasonable expectation of success.”  On appeal here, the Federal Circuit has affirmed.

Claim 1 of Tris Pharma’s U.S. Patent Nos. 8,465,765 reads as follows:

1. A methylphenidate aqueous extended release oral suspension comprising (1) an immediate release methylphenidate component, (2) a sustained release methylphenidate component, and (3) water, said suspension having a pH of about 3.5 to about 5,

wherein said suspension provides a single mean average plasma concentration peak and a therapeutically effective plasma profile for about 12 hours for methylphenidate, and

wherein the suspension has a pharmacokinetic profile in which the single mean plasma concentration peak for methylphenidate has

  • an area under the curve (AUC)0->∞ of about 114 to about 180 ng-hr/mL,
  • Cmax of about 11 to about 17 ng/mL,
  • Tmax of about 4 to about 5.25 hours, and
  • T1/2 of about 5 to about 7 hours

following a single oral administration of said suspension at a dose equivalent to 60 mg racemic methylphenidate HCl in adults.

By the time Tris filed its patent application, several other methylphenidate oral formulations & extended release versions were already on the market, including Concerta, Daytrana, Focalin XR, Metadate CD, and Ritalin LA. As with most obviousness cases, the prior art taught all the claim limitations in various subsets, but no single reference disclosed an embodiment with all the limitations.  And, the Federal Circuit agreed with the district court that the patent challenger had failed to show that PHOSITA would have a reasonable expectation of success when attempting to make any of the proffered combinations.

Without delving into the merits here, I only want to note the court’s focus on motivation-to-combine that is now regularly coupled with the requirement that the combination be based upon a “reasonable expectation of success.”   The Federal Circuit (as well as lower courts and the USPTO) have increasingly used the “reasonable expectation of success” as a prong in the obviousness analysis.   The chart below shows the number of Precedential Federal Circuit decisions that discuss a the Reasonable Expectation of Success test as part in the context of an Obviousness determination. As you can see, there was a substantial rise in its use beginning in 2006 during the lead-up to KSR (2007).

I’ll note also that this appears to be a case where forcing the tribunal to fully explain its decision ended up shifting the ultimate result.

Atextual Conditions for Patentability and Stare Decisis

by Dennis Crouch

The new petition in SawStop v. USPTO (Supreme Court 2022) focuses the question of whether COURTS have power to create non-statutory patentability doctrines.

Does the judiciary have the authority to require a patent applicant to meet a condition for patentability not required by the Patent Act?

SawStop Petition for Certiorari.  You might imagine this argument being raised as tied to any number of patent doctrines: atextual eligibility limitations; assignor estoppel; doctrine of equivalents, etc.  This particular case focuses on obviousness-type double patenting (OTDP).  Question 2 of the petition focuses the question further: “Is the judicially created doctrine of nonstatutory double patenting ultra vires?”

Section 103 of the Patent Act generally defines the doctrine of obviousness and instructs tribunals to look to the prior art and consider whether the claimed invention is sufficiently beyond the prior art. But, even if a claims are found patentable under Section 103, the USPTO still considers obviousness-type double patenting.  Even if there is no prior art, the USPTO still bars a patentee from obtaining a separate patent claiming an obvious variation of already-issued claims held by the patentee/inventor. Thus, although 102(b)(2) explains that certain prior-filed patents are not prior art when attributed to the applicant/inventor, OTDP steps in on the back-side to effectively assert those excused documents as prior art.  Pause here to note that one big difference between obviousness and OTDP is that applicants can skirt OTDP rejections by filing a terminal disclaimer that effectively links the two similar patents together along two axes: same term and same owners.

My middle school shop teacher was missing fingers courtesy of a table saw. Yours? Steve Gass has a PhD in physics and also a patent attorney.  He was doing some amateurs woodworking when he conceived of his SawStop technology.  The basic idea: if the spinning blade ever touching human skin, the electrical connection triggers an emergency brake that stops/retracts the blade within 5 milliseconds.  “Fast enough to turn a life changing event into a minor cut.”  Gass has over 100 patents and runs the innovative product company SafeSaw.

Gass’s U.S. Pat No. 9,927,796 was filed back in 2002 — claiming priority to a 2001 provisional application. That patent finally issued in 2018–only after SawSafe filed a civil action and received a court-judgment in its favor.  A 1974 patent had disclosed use of a safety circuit and a braking-means. However, the district court concluded  that the prior art was not enabling — i.e., a person of skilled in the art would not be able to construct (or even design) the claimed invention without undue experimentation. [2016 Decision].

Another 16 issued patents also claim priority back to this 2002 application.  One application is still pending, Application 15/935,432, that claims an obvious variant of what has already been patenting.   The USPTO rejected the ‘432 application based upon the judicially created non-statutory doctrine of obviousness-type double patenting.  SawStop did not want to file a terminal disclaimer on this valuable patent and instead appealed.  On appeal, the Federal Circuit affirmed without opinion in a R.36 Judgment.  Now, SawStop has petitioned the Supreme Court asking that the doctrine be eliminated.

= = =

Although the petition does not cite the Supreme Court’s recent abortion decision, it certainly picks-up upon some of the same themes:

  • A right to abortion “is nowhere mentioned in the Constitution.”  Similarly, obviousness type double patenting has no grounding in the Patent Act.
  • The fact that a precedent is old does not convert that precedent to a sacred text.

The Supreme Court in Bilski addressed this issue to some degree in the context of the non-statutory categorical bars of abstract ideas; laws of nature and natural phenomenon.

While these exceptions are not required by the statutory text, they are consistent with the notion that a patentable process must be “new and useful.” And, in any case, these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years.

Bilski v. Kappos, 561 U.S. 593 (2010).  The Bilski court found a small textual hook, but also identified the doctrine as built upon longstanding precedent.

The longstanding nature of precedent is important in the patent context.  But unlike in the Constitutional abortion context, we have always had direct statutes guiding patent issuance and enforcement, beginning with the First Congress in 1790. In the area of obviousness, the doctrine was developed by courts and then implemented by statute in 1952.  In Graham though, the Supreme Court indicated that, with minor exceptions, the 1952 Act maintained all the old precedent.

Double Patenting in the Statute.  In its 2014 Abbvie decision, the Federal Circuit wrote that Obviousness Type Double Patenting is “grounded in the text of the Patent Act.”   In particular, the court honed-in on Section 101’s use of the singular article “a” in describing what is granted to an inventor: “a patent.”

While often described as a court-created doctrine, obviousness-type double patenting is grounded in the text of the Patent Act. . . . Section 101 reads: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, … may obtain a patent therefor.” 35 U.S.C. § 101 (emphasis added). Thus, § 101 forbids an individual from obtaining more than one patent on the same invention, i.e., double patenting.

Abbvie Inc. v. Mathilda and Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1372 (Fed. Cir. 2014).  But Judge Dyk’s conclusions in Abbvie are not well grounded themselves as there are several ways this provision could be interpreted. It also proves too much, since there are ways for a patentee to obtain multiple patents covering patentably indistinct inventions: (1) via terminal disclaimer; (2) via restriction.  If the patentee files a terminal disclaimer then the patent office will allow multiple patents to issue.  If the patentee files a divisional application (following a restriction) then the patent office will allow multiple patents to issue even without a terminal disclaimer.

 

Supreme Court – Looking Forward to 2022-2023

By Dennis Crouch

The Supreme Court has closed-out its 2021-2022 term without deciding or granting certiorari in any patent cases.  Overall, the court denied certiorari in 40+ patent cases, including the biggest case of American Axle.  I’ll post a review of those denied cases later this month. Meanwhile we can start a preview for the 2022-2023 term.

Eight patent cases are now pending before the Supreme Court. Several focus on the written description and enablement requirements of 35 USC 112(a).

The current most-likely big case is Amgen Inc., et al. v. Sanofi, No. 21-757.  Amgen asks fundamental questions of how the enablement doctrine should operate and whether enablement is a question-of-fact or a question-of-law. These are important issues fundamental to patentability that also touch on some of the same principles as  the eligibility cases.  The Court has requested an amicus filing from the Solicitor General.  Interactive Wearables, LLC v. Polar Electro Oy, No. 21-1281, is a patent eligibility case, but it asks a related question about the extent that principles of Section 112 are applicable to the eligibility analysis.  In Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 21-1566 focuses on “full scope” written description – arguing that the Federal Circuit’s application goes too far beyond the statutory text.  Biogen International GmbH, et al. v. Mylan Pharmaceuticals Inc., No. 21-1567, also focuses on the written description requirement – asking what level of disclosure is necessary for a claim limitation requiring a therapeutic treatment to be “effective.”

The one other case that I would suggest has a good chance of certiorari is Hyatt v. USPTO.  But, that case focuses on the summary judgment standard for APA cases and so would in reality have very little impact on the patent system.

The final three cases are all well written briefs, but I expect that they have a very low chance of being heard because of intervening events:

  1. Apple Inc. v. Qualcomm Incorporated, No. 21-1327 (appellate standing – same question as the already denied parallel Apple v Qualcomm petition);
  2. CustomPlay, LLC v. Amazon.com, Inc., No. 21-1527 (can the same PTAB judges both institute and decide IPR – I believe that Arthrex implicitly solved this issue, at least from a Constitutional perspective); and
  3. Worlds Inc. v. Activision Blizzard Inc., et al., No. 21-1554 (eligibility same question as the already denied petition in American Axle).

The court takes a summer break and then returns in the fall for the October 2022 term.

Supreme Court Refuses to Reconsider its Patent Eligibility Doctrine

by Dennis Crouch

As its final act for the 2021-2022 term, the US Supreme Court has denied certiorari in the pending patent eligibility cases of American Axle v. Neapco and Spireon v. Procon.

The Patent Act expressly lists four categories of patentable inventions: “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor.”  35 U.S.C. 101. This language is almost identical to the list created for the Patent Act of 1790.  The Supreme Court added further atextual caveats — no abstract ideas; laws of nature; or natural phenomenon.

SCT: Breyer to Jackson

by Dennis Crouch

Justice Stephen Breyer is retiring today from the Supreme Court after 28 years on the bench.  Judge Ketanji Brown Jackson will be sworn-in as his replacement. Congratulations!  Justice Breyer was an administrative law and copyright scholar at Harvard before moving into the judiciary in 1980 (1st Circuit). President Bill Clinton nominated Breyer to the Supreme Court in 1994 on the retirement of Harry Blackmun.

Justice Breyer wrote the opinion for a unanimous court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).  That decision established the two step eligibility test and broadly construed the concept of a ‘law of nature.’ In Dickinson v. Zurko, 527 U.S. 150 (1999), Justice Breyer wrote the majority opinion holding that the Administrative Procedure Act’s (APA) standards applied to appellate review of USPTO factual findings.  The result is a high level of deference and thus a low chance of overturning a PTAB factual finding on appeal.

Judge Jackson was a D.C. district court judge and then later on the D.C. Circuit Court of Appeals. on the the D.C.  In those roles, she handled a number of administrative cases in the FDA/Patent space.

Trademarks, Territoriality, and Migration

Meenaxi Enterprise, Inc. v. Coca-Cola Company, 21-2209 (Fed. Cir. 2022)

Although goods are often shipped globally, many companies manufacture and sell region-specific products.  That divide allows the company to cater to local market preferences and regulations and also avoid potential arbitrage.

In the 1970’s Coca-Cola withdrew its flagship sugary cola from the Indian market at a time of heavy regulation of foreign companies. A local company then started Thums Up and it quickly became popular across the country.  Although similar to Coca-Cola, Thums Up is ‘spicier’ and you can almost taste the cardamom and cinnamon.  In the 1990s, the Indian market opened again to foreign competition. Coca-Cola purchased rights to Thums Up along with Limca lemon-lime and others and continues to sell those products in India (as well as other countries).  Coca-Cola holds the trademark rights in India, but not in the USA.  Apparently Coca-Cola abandoned its US version of the THUMS UP application back in 1987 and its US LIMCA mark expired in 1996.

About 5 million Indians and Indian-Americans live in the USA, and some of those people want to purchase Thums Up and Limca.  In 2008 Meenaxi began filling the US demand with its own version version of the drinks.  In 2012, the Meenaxi registered the two word marks with the USPTO (THUMS UP & LIMCA).  Coca-Cola stepped-in in 2016 seeking to cancel Meenaxi’s mark registrations.

The TTAB sided with Coca-Cola in ordering the marks cancelled.  On appeal, however, the Federal Circuit has reversed with Judge Dyk writing the opinion joined by Judge Stoll and Judge Reyna writing a concurring opinion.

A case like this begins with the territorial doctrine of trademark law:

Under the territoriality doctrine, a trademark is recognized as having a separate existence in each sovereign territory in which it is registered or legally recognized as a mark.

McCarthy on Trademarks § 29:1.  A simple assumption is that territorial limits align with both the laws and the people. e.g., Indians live in India and are subject to the law of India.  But here we know that Indians have migrated and brought their distinctiveness understandings with them to the USA.  Meenaxi has been free-riding off those understandings and continues to do so.  Here though, the this population centric notion of trademark law falls to the hard principle of U.S. law that trademark rights in the US require that the mark be used in the US.

Here, the court also considered whether Meenaxi’s use should actionable under the more general provisions of Section 43(a) of the Lanham Act. 15 U.S.C. § 1125(a).  However, the court found that Coca-Cola had failed to show any US injury.  (1) No lost sales; and (2) No reputational injury.  The court seemed to agree that it could be improper for Meenaxi to use Coca-Cola’s goodwill with Indian-American consumers.  But, the problem was that Coca-Cola failed to provide substantial evidence proving the existenece of free-riding. In particular, the evidence showed that the marks were well known in India, and that Meenaxi was marketing the products to Indians and Indian-Americans in the USA.  But, the missing link was evidence that the US-based Indians and Indian-Americans were aware of the branding.

There is no basis [in the evidence] to assume that an American of Indian descent is aware of brands in India. The Board did not consider what portion of Indian Americans had spent time in India, i.e., how many had visited India or lived in India. The Board’s conclusion relies at least in part on stereotyped speculation. . . .

Coca-Cola has not presented any survey evidence showing awareness of either mark in the United States. . . . This is plainly insufficient.

Slip Op.

Unlike IPRs on the patent side, trademark cancellation proceedings have a standing requirement.  The petitioner must “believe[] that he is or will be damaged . . . by the registration of a mark on the principal register[:] . . .”  15 U.S.C. § 1064.  And, although the “belief” element appears subjective, it is interpreted as quite objective.  Here, since Coca-Cola could not show any US injury then could not reasonably believe it was damaged.   REVERSED in favor of Meenaxi.

Judge Reyna argued that the case is governed by the territorial principal of trademark law. “[T]he majority’s opinion could be reasonably read to imply that CocaCola could have established statutory standing if it proved that U.S. consumers were aware of its Indian brands. But if that were the case, I would still reverse because the territoriality doctrine governs, and Coca-Cola waived reliance on the well-known mark exception thereto.”

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The case cites recent work by Professors Farley & McKenna with regard to some confusion created by Belmora LLC v. Bayer Consumer Care AG, 819 F.3d 697 (4th Cir. 2016). Christine H. Farley, No Trademark, No Problem, 23 B.U. J. Sci. & Tech. L. 304, 313 (2017) (stating the Belmora decision “failed to acknowledge that its ruling challenged fundamental principles of trademark law”); Mark P. McKenna & Shelby Niemann, 2016 Trademark Year in Review, 92 Notre Dame L. Rev. Online 112, 122 (2016) (stating the Belmora decision “is especially notable . . . [in] its failure to recognize the implications of its decision for the territoriality of trademark rights”).