Posts Tagged: "enablement"

Juno Asks Supreme Court to Reconsider Denial of Petition on Section 112 Question in Light of Amgen Review

Following the denial of Juno Therapeutics’ petition to the U.S. Supreme Court earlier this month, Juno last week petitioned the High Court for rehearing, arguing that the grant of certiorari in Amgen v. Sanofi warrants reconsideration. Juno explained that the issues presented in the Amgen case “are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case.” Juno is asking that the Court grant the petition for rehearing, vacate the denial of certiorari, and hold the case pending the outcome in Amgen.

SCOTUS Takes on Scope of Enablement Inquiry in Amgen v. Sanofi: Implications for Pharma/ Biotech and Beyond

On November 4, the U.S. Supreme Court granted Amgen’s petition for certiorari against the advice of the U.S. government – taking up Amgen’s challenge to the Federal Circuit’s enablement review of its PCSK9 antibody patents covering evolocumab (Repatha®). In its petition, Amgen asserts that the Federal Circuit has gone too far in invalidating its PCSK9 antibody patents by imposing a disclosure burden beyond the requirements of 35 U.S.C. § 112. Notably, the Supreme Court, albeit with a different composition, recently declined to hear several other similar cases raising issues with the Federal Circuit’s enablement precedent.

Amgen Says Solicitor General’s ‘Disagreement With Everyone’ Further Supports SCOTUS Review of Legal Standard for Enablement

On October 5, American biopharmaceutical firm Amgen filed a supplemental brief at the U.S. Supreme Court, which comes about two weeks after the U.S. Solicitor General’s office filed a brief urging the Court to deny certiorari on Amgen’s petition for writ. Amgen’s petition seeks Supreme Court review of rulings in the lower courts invalidating Amgen’s patent claims for lack of enablement. Amgen’s latest brief argues that Solicitor General’s own arguments further support Supreme Court review to clarify the proper standard for reviewing questions of enablement under 35 U.S.C. § 112.

Review Not Warranted: SG Tells SCOTUS to Scrap Amgen’s Case on Enablement Test for Biotech Patents

The United States Solicitor General (SG) on Wednesday accepted the U.S. Supreme Court’s invitation to file an amicus brief regarding Amgen’s petition for certiorari in its case against Sanofi. Amgen is seeking review of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision invalidating antibody patent claims based on a lack of enablement for genus claims. The High Court invited the SG to file a brief in April and, on September 21, the SG recommended that the Court deny the petition and said Amgen’s argument that the CAFC “erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled…. lack merit.”

Petitioner Distances Eligibility Case from American Axle, Imploring SCOTUS to Weigh in on ‘Quasi-Enablement’ Analysis

Interactive Wearables, the petitioner in yet another patent eligibility case that the U.S. Supreme Court is being asked to review, filed a reply brief on July 11 distancing its petition from that of American Axle & Manufacturing, Inc.’s, which was denied certiorari on June 30, 2022. The brief characterizes U.S. patent eligibility doctrine as being “perilously fractured” and narrows its arguments to focus on the third question presented in its petition, since the first two were addressed, and have now been rejected by the Court, in the American Axle case.

Biotechnology at the Supreme Court—Will the U.S. Government Back Amgen’s Petition?

Earlier this year, we discussed Amgen’s petition for Supreme Court review of the Federal Circuit’s affirmance invalidating several antibody patent claims based on a lack of enablement for genus claims. At that time, we believed Amgen had a slim chance of its petition being granted—mainly because the Supreme Court denied a similar petition from Idenix in 2021 (No. 20-380, January 19, 2021).
However, on April 18, the Supreme Court invited the Solicitor General to file a brief expressing the views of the U.S. government on the questions presented. The Supreme Court’s likelihood of granting cert. in any particular case increases by about 10-fold when a Solicitor General’s brief is requested, but more importantly, the Supreme Court follows the Solicitor General’s recommendation about 75% of the time.

IPWatchdog LIVE ‘Jurassic Patents’ Panel Explores Patenting Challenges for Life Sciences Innovation

On the final day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,” moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, examined the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included patent litigator and partner at Akin Gump, Dr. Rachel Elsby, patent prosecutor and shareholder with Volpe Koenig, Dr. Douglas Bucklin, and food and drug lawyer and counsel at McGuire Woods, Kae Gruner.

CAFC Denies Amgen Petition to Reconsider Enablement Test for Biotech Patents

On June 21, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing and rehearing en banc filed by Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (Amgen) in their case against Sanofi, Aventisub LLC, FKA Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S. LLC (Sanofi). Judge Lourie was joined by Judges Prost and Hughes in a separate opinion on the denial of the petition for panel rehearing. A group of intellectual property professors; GlaxoSmithKline plc; and Biogen Inc., Bristol-Myers Squibb Company, Corning Incorporated, and Merck Sharp & Dohme Corp. filed amicus briefs.

CAFC Clarifies Section 103 Prior Art Enablement Requirement, Reverses PTAB Obviousness Finding

Last week, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed an inter partes review (IPR) decision from the U.S. Patent and Trademark Office’s (USPTO’s) Patent Trial and Appeal Board (PTAB) in Raytheon Technologies Corporation (Raytheon) v. General Electric Company (GE). The PTAB found claims 3 and 16 of U.S. Patent No. (the ‘751 patent) unpatentable under Section103 as obvious in view of a 1987 NASA technical memorandum (the “Knip” reference). Raytheon submitted evidence that the Knip reference relied on the use of nonexistent composite materials, and thus failed to enable one of ordinary skill in the art to make and use the claimed invention. The PTAB sided with GE, even though GE made no attempt to rebut the evidence presented by Raytheon. The CAFC disagreed.

Federal Circuit Says Amgen’s Repatha® Patent Claims Require ‘Undue Experimentation’ to Practice

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday upheld the District of Delaware’s grant of judgment as a matter of law (JMOL) that Amgen’s patent claims covering its Repatha cholesterol treatment were invalid for lack of enablement. The court found that Amgen’s composition claims were defined by meeting functional limitations, rather than by structure, and that the patent specifications didn’t enable the preparation of the full scope of the claims without undue experimentation. Judge Lourie authored the opinion.  Amgen v. Sanofi (CAFC, Feb. 11, 2020)

Implications of Filing Subsequent Patent Applications in the United States (Part III)

In Part I, the authors reviewed the law behind subsequent patent applications. In Part II, we reviewed the different types of subsequent applications. Part III will discuss some of the implications of these. When an applicant seeks to add new claims pursuant to a continuation or divisional application, U.S. Patent Law explicitly requires that the original specification provide adequate support for the new claims by the original specification satisfying the Section 112(a) written description and enablement requirements for the new claims. 35 U.S.C. § 120. The same is also true for continuation-in-part (CIP) applications claiming overlapping subject matter but not for claims comprising “new matter” because the new matter claimed must find support in additional disclosure, i.e., in material added to the CIP application itself.

AAM v. Neapco Misreads Federal Circuit Precedent to Create a New Section 101 Enablement-like Legal Requirement – Part II

As detailed in Part I of this article, the recent opinion in AAM, Inc. v. Neapco Holdings, LLC, No. 18-1763 (Fed. Cir. July 31, 2020) misreads and misinterprets Supreme Court precedent as having long imposed the enablement-like requirements set forth in the AAM ruling. Similarly, the Federal Circuit cases cited by AAM do not reflect some longstanding Section 101 eligibility rule that the claim alone must show, with “specificity,” the “way” or “how to” “achieve” such an invention, beyond a mere “result.”

New Enablement-Like Requirements for 101 Eligibility: AAM v. Neapco Takes the Case Law Out of Context, and Too Far – Part I

With its recent opinion in AAM, Inc. v. Neapco Holdings, LLC, No. 18-1763 (Fed. Cir. July 31, 2020), and a 6-6 stalemate by the court’s active judges on whether to take the case en banc, the Federal Circuit has now adopted—under the rubric of 35 U.S.C. §101—a formalized set of enablement-like requirements for patent claims. For a simple “threshold” eligibility test, section 101 has grown remarkably complex. Indeed, since the Supreme Court’s 2012 Mayo and 2014 Alice decisions re-cast patent eligibility into a “two-step framework,” the Section 101 test adjudges not just subject-matter eligibility and the three “limited” exceptions thereto, but also patentability or “inventive-concept” challenges predicated on comparisons to the prior art, see 35 U.S.C. §§ 102-103. And now the enablement-type requirements imposed by AAM v. Neapco.

An Emerging Section 101 Expansion to Section 112(a) Enablement? The Federal Circuit Should Stop It Now

The most dominant, divisive issue in patent law over the last decade—Section101-eligibility and the Supreme Court’s Mayo-Alice framework—appears to have just become more divisive. Indeed, at least part of the reason for the controversy is that, with Mayo-Alice as the governing test, courts as a preliminary matter can decide Section101-eligibility based on considerations of an “inventive concept” and patentability—issues the Court once declared were “not relevant” to the separate eligibility provision of the Patent Act. Be that as it may, the Federal Circuit has recently issued certain decisions indicating that Section 101 now incorporates another vast area of invalidity; viz., the requirements for “enablement” under 35 U.S.C. §112(a). See, e.g., Customedia Technologies, LLC v. Dish Network Corp., 951 F.3d 1359, 1365-66 (Fed. Cir. March 6, 2020). In this article, we examine how this new requirement for Section 101 has emerged, the recent precedent on the issue, and the Patent Act’s requirements that undermine such Section 112(a) considerations for a Section 101-eligibilty test.

UK Supreme Court Refuses to ‘Water Down’ Sufficiency Requirement

Regeneron has lost a significant battle in its fight with Kymab over patents for transgenic mice. In a 4-1 split decision today, the UK Supreme Court found the patents invalid for insufficiency, reversing the decision of the Court of Appeal. (Regeneron Pharmaceuticals Inc v Kymab Ltd. [2020] UKSC 27.) Regeneron had sued Cambridge, UK-based Kymab, alleging that the latter’s Kymouse transgenic mouse platform infringed two patents (EP 1,360,287 and EP 2,264,163) also known as the Murphy patents). The two patents at issue cover Regeneron’s VelocImmune platform, which is used to produce antibodies for treating diseases, including COVID-19. In February 2016, following a trial in the High Court, Mr Justice Henry Carr revoked the patents for insufficiency. However, in March 2018 the Court of Appeal reversed that finding and found the patents to be infringed in a judgment written by Lord Justice Kitchin.