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- Moderna Settles Patent Litigation with Arbutus et al.
- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
- Why AI Will Not Take Over the World
- BioNTech Sues Moderna over mRNA Vaccine Technology
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Category: Hatch-Waxman
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners…
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By Kevin E. Noonan — The Supreme Court granted certiorari Friday in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment settlement agreements in ANDA litigation under the Hatch Waxman Act. (The petition in the other case, In re K-Dur Antitrust Litigation, was…
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By Kevin E. Noonan — The Federal Trade Commission, in an attempt to extend the scope of its signal (and sole) victory in its crusade against reverse payment settlement agreements in ANDA cases, In re K-Dur Antitrust Litigation, has moved for leave to file an amicus brief in another case in a district court in the…
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By Kevin E. Noonan — Reinvigorated by its triumph in convincing a three-judge panel of the Third Circuit to adopt its view that reverse payment settlement agreements in ANDA cases are presumptively illegal (in the K-Dur case, In re K-Dur Antitrust Litigation, which was a relaxation of the Commission's former position that such agreements were…
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By Andrew Williams — Last week, in Hoffmann-La Roche Inc. v. Apotex Inc., the Federal Circuit affirmed the denial of a request for a preliminary injunction from the U.S. District Court for the District of New Jersey related to the sale of Roche's osteoporosis drug Boniva®. The lower court had found that Roche failed to…
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By Kevin E. Noonan — Joining the parties and amici with clear interests in resolving the circuit split created by the Third Circuit opinion in the K-Dur case (In re K-Dur Antitrust Litigation), the Washington Legal Foundation, self-described as having the aim of "promot[ing] economic liberty, free enterprise, and a limited and accountable government," filed…
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By Kevin E. Noonan — Joining the parties and amici with clear interests in resolving the circuit split created by the Third Circuit opinion in the K-Dur case (In re K-Dur Antitrust Litigation), two "public interest" groups have also filed amicus briefs urging the Supreme Court to grant certiorari. These groups, the New York Intellectual…
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By Kevin E. Noonan — The Generic Pharmaceutical Association (GPhA) filed an amicus brief in support of a grant of certiorari by the Supreme Court in the K-Dur case (In re K-Dur Antitrust Litigation). Characterizing the issue as being "profoundly important to the pharmaceutical market and pharmaceutical companies," GPhA argues that "[t]he decision of the…
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By Kevin E. Noonan — Bayer Corp. and Bayer AG have filed an amicus brief in support of a grant of certiorari by the Supreme Court in the K-Dur case (In re K-Dur Antitrust Litigation). Being a branded drug maker, it is no surprise that Bayer argues in its brief that the Third Circuit's decision…
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By Kevin E. Noonan — The Pharmaceutical Research and Manufacturer's of America (PhRMA) have filed an amicus brief in support of a grant of certiorari by the Supreme Court in the K-Dur case (In re K-Dur Antitrust Litigation). Not surprisingly, like the branded and generic drug makers, PhRMA argues that the Third Circuit's decision created…
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