Charlotte Jacobsen

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…

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…

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…

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…

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…

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…

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…

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…

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…