Posts Tagged: "enablement"

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.

McRO Patent Upheld Again at Federal Circuit, But Not Infringed

The U.S. Court of Appeals for the Federal Circuit, in a precedential decision authored by Judge Taranto, today affirmed-in-part, vacated-in-part and remanded a decision of the U.S. District Court for the Central District of California in McRO, Inc. v. Bandai Namco Games America Inc. et. al. The case derives from the 2016 Federal Circuit decision determining that McRO’s challenged patent claims were directed to the display of lip synchronization and facial expressions of animated characters, which the court said were not directed to an abstract idea and were therefore patent eligible subject matter under 35 U.S.C. 101. In today’s ruling, the Court considered whether the district court’s decision on remand, which held that the Developer defendants and defendant-appellees “were entitled to summary judgment of noninfringement because the accused products do not practice the claimed methods and to summary judgment of invalidity because the specification fails to enable the full scope of the claims,” was correct.

Federal Circuit Invalidity Determination for Idenix Underscores Continuing Intra-Circuit Split

One day before the now-famous Arthrex decision was issued, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided an appeal by Idenix Pharmaceuticals LLC and Universita Degli Studi Di Cagliari (collectively “Idenix”) against Gilead Sciences, Inc. (Gilead) that reiterates the extent to which the Court is split in its approach to so many issues. The precedential opinion was authored by Chief Judge Prost, with Judge Newman dissenting. In 2013, Idenix sued Gilead for infringement of U.S. Pat. No. 7,608,597 (the ‘597 patent), which claims a drug directed to the treatment of the hepatitis C virus (HCV). In response, Gilead argued that the ‘597 patent was invalid for failure to meet the written description and enablement requirements. At trial, the jury found for Idenix and upheld the validity of the patent. Gilead filed a renewed motion for Judgment as a Matter of Law (JMOL) on the written description and enablement requirements, and the court granted the motion only on enablement grounds, thus holding the patent invalid. The decision overturned the jury’s award to Idenix of $2.5 billion.

The PPH Program at the USPTO: Favorable Stats Don’t Alleviate Big Risks

Since 2006, the U.S. Patent and Trademark Office (USPTO) has participated in the Patent Prosecution Highway Pilot Program (the PPH Program). Generally, the program is designed to accelerate examination of a given patent application as a result of examination of a corresponding application at another PPH-participating patent office having reached a positive ruling more quickly. If an application is eligible for and accepted into the PPH Program, the USPTO expedites processing of the application. Examiners also have the benefit of drawing from another examiner’s assessment of corresponding claims. Generally, existing data on the PPH Program has indicated that it is associated with increased allowance prospects and decreased examination times relative to non-PPH applications. However, the vast majority of this data is years old (e.g., from 2014). This article will briefly summarize the eligibility requirements for the program and present new data showing favorable allowance and pendency times. However, it will end with a warning: request entry to the PPH program in the United States at your own risk.

Pinning False Blame of Lack of Enablement In Issued Patents On the USPTO

Last week, the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, held an oversight hearing on the U.S. Patent and Trademark Office (USPTO) with Director Andre Iancu as the sole witness. A particular inquiry from Rep. Zoe Lofgren (D-CA) regarding the USPTO’s allegedly lax examination quality under 35 U.S.C. § 112 caught my attention. She remarked [at 1:33:30]:  “Theranos, the blood testing company whose founder is being investigated for fraud, was granted nearly 100 patents based on an invention that didn’t work; and it concerns me that a patent application for an invention that doesn’t work gets approved.”  She generally questioned examiners’ attention to Section 112 requirements. Rep. Lofgren’s statement was no doubt primed by information from the Electronic Frontier Foundation (EFF) in the Ars Technica blog post titled “Theranos: How a broken patent system sustained its decade-long deception.” In this article, the author, who was introduced as holding the “Mark Cuban Chair to Eliminate Stupid Patents” at EFF, declares with no evidence or proof, that the “USPTO generally does a terrible job of ensuring that applications meet the utility and enablement standards.” The article cited no study, identified no patent, nor any claim to any “invention that didn’t work.” This outrageous, baseless allegation is outright reckless and irresponsible.

Anatomy of a Valuable Patent: Building on the Structural Uniqueness of an Invention

From a conceptual standpoint, it would seem logical to assume that writing text to describe a particular invention ought to be easy for the inventor of that invention. Unfortunately, it isn’t that simple. While inventors are very good at inventing, they tend to be less good at many of the adjacent and necessary tasks along the road from invention to market success. Indeed, while an inventor undoubtedly knows the invention better than anyone else, it can be enormously difficult for inventors to describe their own inventions. The inventor of a new and useful invention is always in the best position to describe the invention. The problem lies with the reality that most inventors simply don’t understand what needs to be described in order to satisfy the U.S. patentability requirements. And, sadly, when inventors forgo professional assistance, they all too often wind up focusing their entire description of their inventions on how their new device or gadget will be used at the expense of describing the parts and pieces that make up the invention. This is an enormous mistake, and one from which there is often no recovery.