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Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
On March 13, 2025, the Federal Circuit decided in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254) how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act....more
The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more
Takeaways: 1. ODP in reexamination and reissue remains unpredictable despite Allergan 2. Patent Owners should carefully review ODP rejections to ensure they are proper Obviousness-type double patenting (ODP) is a legal...more
Case Name: In re Sugammadex, No. 20-CV-2576 (CCC/LDW), 2023 WL 3966146 (D.N.J. June 13, 2023) (Cecchi, J.) Drug Product and Patent(s)-in-Suit: Bridion® (sugammadex sodium); U.S. Patent No. RE44,733 (“the ’733 patent”)....more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
In an earlier post, we discussed the patent linkage system implemented in the Fourth Amendment to the Chinese Patent Law, which will come into effect on June 1, 2021. Another important change in the amendment is the...more
On 6 July 2020, China's National People’s Congress (NPC) released its latest Draft Patent Law for public comment, proposing, amongst other things, a patent linkage system, patent term extension for pharmaceutical patents,...more
Case Name: Biogen Int’l GmbH v. Banner Life Sciences LLC, No. 18-2054-LPS, 2020 U.S. Dist. LEXIS 3639 (D. Del. Jan. 7, 2020) (Stark, J.)....more
On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more
This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more
The Court of Appeals for the Federal Circuit issued two opinions on December 7 that address two unsettled questions relating to obviousness-type double patenting (OTDP). These issues are of particular interest to...more
The Federal Circuit recently issued a pair of decisions concerning the Gilead doctrine, which allowed later-issuing patents to be obviousness-type double patenting (ODP) references against earlier-issuing patents....more
The drug company Actelion Pharmaceuticals, Ltd., recently lost a bid to increase the term of its U.S. Patent No. 8,658,675 by five days, ultimately because its patent attorney failed to check a box on the application form. ...more
This is the final article in our five-part series on PTE. Obtaining a patent term extension (PTE) is extremely valuable to an innovator. By design, PTE extends the patent term to recoup time lost to the rigorous...more
This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more
This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more
This is the second article in our five-part series on PTE. Everywhere you look, patent term extension (PTE) is described using the “Rule of Ones:” one patent, one product, one PTE. However, the Rule of Ones does not...more