by Dennis Crouch
Although somewhat slow thus far, there is some potential that 2023 will turn out to be a major year for Supreme Court patent law jurisprudence.
Full Scope Enabling Written Description: The court has granted only one petition, Amgen Inc., v. Sanofi, No. 21-757, with merits briefs due beginning December 27, 2022. Although Amgen presented two questions in its petition, the Supreme Court indicated its interest only in hearing the second:
Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “ ‘time and effort,’ ”
Amgen Petition. Enablement rejections continue to primarily be found in chem and biotech areas. This case, for instance, focuses on a functionally claimed monoclonal antibody. Still, the Federal Circuit has been clear in recent years that the “full scope” requirement applies to all tech areas and both to enablement and written description requirements. The parallel full-scope written description issue is raised in the parallel case of Juno Therapeutics, Inc., v. Kite Pharma, Inc., No. 21-1566. Juno’s petition argues that the Federal Circuit’s test goes too far by requiring the original patent filing “demonstrate the inventor’s possession of ‘the full scope of the claimed invention,’ including all ‘known and unknown.'” Juno Petition. The Court is holding conference on January 6, 2023 to consider the fate of Juno. Although petition-stage briefing is complete in Juno, questions raised by Amgen and its amici will hopefully influence the court to simultaneously pick-up this Juno case. USPTO written description rejections most often occur based upon late-stage claim amendments, and those can happen in any area of technology. (Note here that often the result is refusal to permit a priority claim resulting in intervening prior art rather than a straight written description rejection.)
Six additional petitions remain pending. Of these, the Court has indicated at least some interest in five (three CVSGs and two additional requests for responsive briefing). The sixth petition was only recently filed and so the court has not had the opportunity to indicate interest.
Eligibility: Similar to the enablement/WD cases, the eligibility petitions all come from patent holders who argue that their claims were wrongly invalidated.
- Interactive Wearables, LLC v. Polar Electro Oy, No. 21-1281 (System for displaying media information while simultaneously experiencing the media content).
- Tropp v. Travel Sentry, Inc., No. 22-22 (method of using a luggage lock with a master key held by TSA for airport security).
Both of these cases argue that the Federal Circuit has taken Alice Corp., too literally and in a way that is limiting the patentability of traditionally eligible subject matter. Also in both, the Supreme Court has asked for views of the Solicitor General (CVSG) and will very likely await that filing before deciding whether to grant or deny certiorari. In my view, the Interactive Wearables claims are much stronger because they recite an arguably novel device. See, US9668016. It will be interesting to see whether the SG splits hairs or simply refiles a version of its American Axle brief supporting certiorari.
Skinny Label: Although it involves a fairly narrow issue, the pending case of Teva Pharms. v. GlaxoSmithKline LLC, No. 22-37, has a good chance of being heard by the Court, although it may be better for Congress to work to resolve the pending questions. The basic issue here involves a generic drug with several medical treatments. Some of the treatments are covered by method-of-use-patents while other treatments are no longer patented. Teva has been selling the drug for the non-patented uses, and the question is whether the FDA-approved drug label that purported to carve-out the patented actually encourages infringement. Question presented:
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 petition. The Federal Circuit held that the drug label could induce infringement, even though FDA approved it. In my view, the generic manufacturer here has a very strong estoppel defense because the patentee itself proposed the language used on the generic label. That defense has not yet been considered at the district court. As with the eligibility cases, the Supreme Court has asked for the views of the Biden Administration in this case as well. Although the SG’s views have often been important in guiding certiorari grant/denial, it is unclear to me what influence Solicitor General Prelogar’s statements will have on the strongly conservative court.
Estoppel and Procedure: The remaining three pending petitions all relate to some form of estoppel or procedure.
- Apple Inc., et al. v. California Institute of Technology, No. 22-203. Following an inter partes review, the petitioner is estopped from re-raising validity arguments that “reasonably could have been raised during that inter partes review.” Apple lost the IPR against CalTech’s patent and wants to raise additional defenses in the district court litigation. Apple has argued for a very narrow interpretation of the 315(e) estoppel while the Federal Circuit broadly interpreted the statute.
- Jump Rope Systems, LLC v. Coulter Ventures, LLC, dba Rogue Fitness, No. 22-298. This case focuses on the doctrine of collateral estoppel and asks whether the Federal Circuit is correct that “a determination of unpatentability by the Patent Trial and Appeal Board in an inter partes review proceeding, affirmed by the Federal Circuit, has a collateral estoppel effect on patent validity in a patent infringement lawsuit in federal district court.” In other parallel scenarios, there would be no collateral estoppel because the first decision (invalidity at PTAB) is judged with a lower preponderance-of-the-evidence standard as compared with the later district court case that requires clear-and-convincing-evidence.
- Innovation Sciences, LLC v. Amazon.com, Inc., No. 22-554. This final asks the Supreme Court to reinvigorate its old precedent requiring contemporary corroboratory evidence in order to invalidate a patent based upon prior art.
These final three cases are all in the petition briefing stage. They could still be heard and decided by June if the Court quickly grants certiorari. However, it is increasingly more likely that the briefing would extend over the summer.
Three more petitions likely coming soon:
- Thaler v. Vidal (patentability of AI-created inventions)
- Novartis v. HEC. (Written description and changed panel composition)
- Wakefield v. Blackboard (pro se; indefiniteness of means-plus-function claim for failure to disclose corresponding algorithm in the specification)