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Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
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IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
An August 2023 decision from the Federal Circuit Court of Appeals highlighted potential new fragilities in the patent portfolios of many industry giants, especially those in the pharmaceutical industry....more
On March 16th, the Federal Circuit denied Biogen's petition for panel rehearing and rehearing en banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. Judges Cunningham and Stoll did not participate in the decision, which...more
As we reported earlier this year, Amgen filed a petition for rehearing en banc to the Federal Circuit, arguing that the panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims with...more
July 1, 2021 In a development having significant ramifications for many biopharma companies, the Federal Circuit has denied Amgen’s petition for rehearing en banc a decision invalidating a genus patent covering its antibody...more
An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more
Although argument week isn’t until next week, the Federal Circuit heard oral argument today in two cases. One was rescheduled from earlier this month for medical reasons. But the other, GlaxoSmithKline LLC v. Teva...more
The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute. As we have previously reported, that ruling upheld a jury verdict...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more
Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more
As we previously reported, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more
In October, a Federal Circuit panel vacated a permanent injunction (which the Federal Circuit had earlier stayed pending appeal) that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more
Earlier this month, the Federal Circuit vacated an injunction in the Amgen v. Sanofi litigation that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product in the United States until...more
In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene’s request for rehearing of a final written decision that had found the challenged claims invalid...more
The recent decisions of the USPTO Patent Trial and Appeal Board (PTAB) granting Celgene’s requests for rehearing in parallel Inter Partes Review proceedings brought by Kyle Bass’s Coalition for Affordable Drugs (CFAD) are...more
The Federal Circuit has denied the petition for rehearing en banc in Ariosa Diagnostics, Inc. v. Sequenom, Inc., despite the filing of twelve amicus briefs in support of the petition, including briefs filed by Biotechnology...more
The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more
We have previously posted about the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest Laboratories LLC (together, “Actavis”), including our analysis of the District Court’s opinion...more