Following all of the latest IP developments in life sciences.

(Co-authored by Alexandra Kim)

Introduction

In February of 2022, the Federal Circuit affirmed a New Jersey District Court’s determination that four patents claiming methods of treating opioid overdose by intranasal administration of a naloxone formulation, as well as devices for intranasal administration, were invalid as obvious over two, three-reference, sets of prior art. A panel majority found that all of the individual components of the claimed methods were taught in the prior art and that a person of ordinary skill in the art (POSA) would have been motivated to combine such teachings because there was a strong desire in the prior art to improve upon existing but deficient methods for treating overdose.

In a 15-page dissent, Judge Newman criticized the majority’s logic, asserting that there was no evidence of “teaching or suggestion in the prior art” to make the claimed combination of ingredients for use in the claimed method so as to achieve the described beneficial results. She faulted the majority for relying on “the need for a better product” to provide motivation since “the artisan’s knowledge that the available products are deficient does not render the remedy obvious when it is eventually discovered.”

While the challenger here prevailed, this opinion—both the majority and the dissent—provides valuable guidance (and caution) for assembling multi-reference obviousness challenges.

While issue preclusion means one strike and you are out, a court might need to call a few balls before calling the strike that ends the case.

In Horizon Medicines LLC, et al. v. Dr. Reddy’s Laboratories, Inc. et al., No. 15-cv-3324, D.I. 468, 17 (D.NJ Feb. 24, 2022), Judge Stanley Chesler of the District of New Jersey held that two Orange Book (OB)-listed patents covering Vimovo® (esomeprazole magnesium; naproxen) were invalid for lack of written description. The holding was based on issue preclusion from an earlier Federal Circuit decision addressing to two related OB-listed patents having different claims. But it took defendant Dr. Reddy’s Laboratories (“DRL”) two unsuccessful summary judgment motions before getting it right on the third try.

The lessons from this saga are threefold: (1) persistence pays off, (2) factual analyses win the day, and (3) differences in claim language should be made meaningful, not illusory.

In Juno Therapeutics v. Kite Pharma, the Court of Appeals for the Federal Circuit (CAFC) reversed a $1.2 billion dollar judgment to Juno, finding that Juno’s asserted claims, which they alleged were infringed by Kite’s CAR-T therapy YESCARTA® (axicabtagene ciloleucel), lacked written description. The decision follows a line of cases involving antibodies and written description, extending recent antibody-related jurisprudence into the realm of cell-based immunotherapies, such as chimeric antigen receptor (CAR) T cells. The court determined that while the binding element of CARs (in this case, an scFv) and methods of making them were generally known in the art, the scope of the claimed CARs was too vast to be sufficiently supported by the limited number of exemplary binding elements in the specification, as well as the absence of common structural features defining the claimed genus. The decision means that those seeking claims that aim to broadly protect CARs with functional definitions will face significant challenges based on written description.

(Co-authored by Anne Weeks)

In Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., the District Court for the District of New Jersey considered whether a patent receiving patent term adjustment (PTA) may be invalidated for obviousness-type double patenting by a later-issuing, earlier-expiring patent in the same family.

Overview

In a recent case analyzing enablement and the weight of remarks made at trial about a technology’s relevance to COVID-19, the Federal Circuit affirmed a United States District Court for the District of Delaware jury’s determination that claims asserted by Pacific Biosciences of California, Inc. (PacBio) against Oxford Nanopore Technologies, Ltd. (Oxford) were invalid for lack of enablement. PacBio had sued Oxford in district court, accusing Oxford of infringing several DNA sequencing methodology patents, including U.S. Patent Nos. 9,546,400 (‘400 patent) and 9,772,323 (‘323 patent). The jury found that all claims were infringed, but the claims were invalid for lack of enablement. PacBio moved for judgment as a matter of law and for a new trial, arguing that the jury erred in finding lack of enablement, and that the jury was prejudiced by remarks made regarding COVID-19 treatments during Oxford’s opening statement. The district court denied PacBio’s motion, and the Federal Circuit affirmed.

Mylan v. Janssen considers a topic IPR petitioners may be concerned about when institution of their petition is denied by the PTAB – is there any way to appeal the decision? The Federal Circuit held that while there is an avenue for relief, it is reserved for “extraordinary circumstances.”

(as published in the May 2021 issue of the American Chemical Society's Northeast Section publication of The Nucleus)

Olaplex v. L’Oréal involves a particular problem that can arise when claiming pharmaceutical and consumer product formulations. In particular, a chemical compound, such as maleic acid as recited in the asserted claims, may be converted to different forms (e.g., salts, such as maleate or hydrogen maleate) once added to a formulation. Claim limitations that aim to specify the amounts or concentrations of such compounds in claimed formulations can be problematic when it is unclear how they are to be calculated.

(Co-authored by Gabe McCool)

On February 11, 2021 the Federal Circuit upheld a United States District Court for the District of Delaware decision finding that Amgen’s function-only anti-PCSK9 monoclonal antibody claims were not enabled under 35 U.S.C. § 112. This highly anticipated decision involved a suit between the makers of the LDL-cholesterol-lowering drugs, Repatha® (Amgen) and Praluent® (Sanofi/Regeneron), filed nearly seven years ago by Amgen. Amgen had argued that patents for its cholesterol drug, RepathaⓇ, which cover a genus of antibodies that bind to a protein known as PCSK9, were sufficiently specific to allow one “skilled in the art” to “make and use” the patented invention without “undue experimentation” under the Wands factors.

Authors: Jason Balich, K. Blake Chancellor, Sam Estabrooks, Eric Greenwald, Chelsea Loughran, Gabe McCool, Marie McKiernan, Kevin Mosier, Jonathan Roses, Claire Schuster, Charlie Steenburg, Patrick Waller, Andrew Williams

Editors: Sam Estabrooks, Gabe McCool, Patrick Waller

In the midst of many significant challenges in 2020, the year managed to see the first increase in the total annual number of patent cases in some time. In particular, the federal judiciary produced a string of biotech-related patent decisions impacting a range of issues, including enablement, written description, indefiniteness, novelty, obviousness, patent eligibility, safe harbor, and doctrine of equivalents.

Overview

On December 11, 2020, the PTAB issued a Final Written Decision in Illumina, Inc. v. Natera, Inc., IPR2019-01201, upholding the validity of Natera Inc.’s patent for determining genetic data from fragmentary DNA. Illumina, Inc. (“Illumina”) filed its petition, challenging claims 1-27 of Natera Inc.’s (“Natera” or “Patent Owner”) U.S. Patent No. 8,682,592 B2 (“’592”). The PTAB instituted inter partes review of all the challenged claims on obviousness grounds. While Illumina carried its burden at the institution stage, it failed to prove the unpatentability of the challenged claims by a preponderance of the evidence as required by 35 U.S.C. § 316(e). The PTAB determined that the challenged claims were not unpatentable, and also denied Illumina’s Motion to Exclude Evidence. Central to the PTAB’s decision were the expert declarations submitted by the parties, and the noted failure by Illumina to include all of its expert’s declarations in its petition.