Case Law, United States of America

, (Gibson, Dunn & Crutcher LLP)/

The U.S. Federal Rules of Civil Procedure allow parties to obtain discovery regarding any matter that is relevant to a party’s claim or defense. One important caveat to this general principle is that attorney-client communications and work product are privileged and protected from discovery. Generally speaking, when a party divulges privileged information to a third…

Case Law, Covid-19, Infringement, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

As we begin year three of the COVID-19 pandemic, the rise of the Omicron variant has caused many workers, who had returned to the office during summer and fall 2021, to revert to working from home. This trend has further increased speculation that remote working arrangements will become more widespread, even after the pandemic ends,…

Case Law, Pharma, Pharmaceutical patent, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

In recent years, the Court of Appeals for the Federal Circuit has invalidated or affirmed the invalidity of various biopharma patents under 35 U.S.C. § 112, which requires that a patent specification contain a written description of the invention and enable any person skilled in the art to make or use the invention. The court…

Case Law, Pharma, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/ /1 Comment

In the course of obtaining regulatory approval for a drug product in the United States, a pharmaceutical company will make numerous representations about its product in submissions to the Food and Drug Administration (“FDA”). If these representations contradict arguments made during prosecution of a patent at the United States Patent and Trademark Office (“USPTO”), they…

Biologics, Case Law, Infringement, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved biologic drug constitutes an “artificial act of infringement” for which the biologic’s patent owner may file suit.[1]  In the recent AbbVie Inc. v. Alvotech hf.[2] decision, the district court…

Case Law, Infringement, Scope of protection, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

The Hatch-Waxman Act allows the FDA to permit a generic version of a branded product, which is partially patent protected, to come to market if the generic manufacturer “carves out” the patent-protected indication from its label. The scope of protection from a finding of induced infringement afforded to generic manufacturers by this “skinny label” provision…

Case Law, Infringement, ownership, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

In Omni MedSci, Inc. v. Apple Inc., ___ F.4th ___, Nos. 2020-1715, -1716 (Fed. Cir. Aug. 2, 2021), the U.S. Court of Appeals for the Federal Circuit held that the University of Michigan’s technology transfer bylaws did not constitute an automatic assignment of a professor’s patent rights. This decision has important implications for the drafting…

Case Law, Infringement, Pharma, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

Biologic drugs, many of which are antibodies, represent an increasing share of the pharmaceutical market. In recent years, numerous broad functional patent claims directed at therapeutic antibodies have come under attack for failing to satisfy the written description and enablement requirements. The proper scope of these requirements has divided the biopharmaceutical industry. In its latest…

Double Patenting, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

In Immunex Corp. et al. v. Sandoz Inc. et al., the Federal Circuit found that there was no obviousness-type double patenting because there was no “common ownership” of patents under an agreement where Roche retained key rights to the patents-in-suit. Immunex Corp., v. Sandoz Inc., ___ F.3d ___, No. 2020-1037 (Fed. Cir. July 1, 2020)….

Case Law, Damages, Infringement, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/ /1 Comment

In the United States, a judge may increase the damages for patent infringement up to threefold[1] resulting in awards of millions, or even billons, of dollars.  In 2016, the Supreme Court, in Halo Electronics v. Pulse Electronics,[2] rejected the then prevailing objective standard for determining enhanced damages and replaced it with a subjective one requiring,…