In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
Federal Circuit
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By Benjamin R. Holt Comments are off
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for...
Tagged with: Amgen, FDA, Federal Circuit, Praluent®, Regeneron, Repatha®, Sanofi, Supreme Court
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By Monica Chin Kitts Comments are off
Prior to 1994, the term of a U.S. patent was 17 years from the date of issuance. When the Uruguay Round Agreements Act (“URAA”)...
Tagged with: AbbVie, Breckenridge Pharmaceutical, Federal Circuit, Gilead Sciences, Natco Pharma, Novartis AG
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Litigation Spotlight Update: Epogen® Litigation Status in Face of Retacrit Regulatory Approval
By Spencer Johnson Comments are off
As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
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By Monica Chin Kitts Comments are off
Lately, it has been very difficult to get diagnostic claims allowed without limiting the method steps to very specific components (e.g....
Tagged with: 35 USC §101, Alice, Federal Circuit, Nonprecedential, Patent eligible
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By Aydin Harston Comments are off
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...
Tagged with: Amgen, Apotex, BLA, FDA, Federal Circuit, filgrastim, IPR, Neulasta®, Neupogen®, pegfilgrastim, PTAB
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By Andrew Storaska Comments are off
Last week, the Federal Circuit affirmed a lower court’s dismissal of AbbVie’s complaint seeking declaratory judgment of invalidity of...
Tagged with: AbbVie, adalimumab, AstraZeneca, Federal Circuit, Humira®, Legal, MedImmune
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By Nicole DeAbrantes Comments are off
On December 20, 2017, Bristol Myers Squibb Company, Bavarian Nordic, and Enzo Biochem, Inc. filed an amicus brief in support of Amgen’s...
Tagged with: Amgen, Amicus Brief, Bavarian Nordic, Bristol-Myers Squibb, District Court, En banc, Enzo Biochem, Federal Circuit, Inc., Praluent®, Regeneron, Sanofi
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Standing Questioned Before the Federal Circuit in Momenta Pharms. v. Bristol-Myers Squibb Co.
By Nicole DeAbrantes Comments are off
On December 5, 2017, the Federal Circuit held oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 17-1694. The...
Tagged with: abatacept, Bristol-Myers Squibb, Federal Circuit, IPR, Momenta Pharmaceuticals, Orencia®, PTAB
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