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
On August 13, 2024, a three-judge panel of the Court of Appeals for the Federal Circuit issued a decision, authored by Judge Lourie, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the...more
The Federal Circuit recently clarified the interplay between obvious-type double patenting (ODP) and patent term adjustments (PTA) granted pursuant to 35 U.S.C. § 154(b). In In re Cellect, the Federal Circuit explained that...more
Over the last seven years there has been commotion in Obviousness-type Double Patenting (“ODP”) practice. One of the latest cases to spur a considerable amount of interest is Mitsubishi Tanabe Corp. v. Sandoz, Inc., which is...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more
In the first half of 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review the following top developments...more
On May 22, 2020, the Federal Court held that an action under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to saxagliptin (ONGLYZA) would not be rendered moot by the relevant...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
By: Urszula Wojtyra On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237...more
A Post-URAA Patent that Issues After but Expires Before a Related Pre-URAA Patent Is Not a Double-Patenting Reference Against the Pre-URAA Patent - In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.,...more
Federal Circuit Summary - Before Moore, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: Obviousness-type double patenting does not invalidate an otherwise validly...more
The Federal Circuit recently decided two appeals, Novartis AG v. Ezra Ventures LLC (“Ezra”) and Novartis Pharms. Corp. v. Breckenridge Pharm. Inc. (“Breckenridge”) that both relate to the effect of obviousness-type double...more
Federal Circuit Summary - Before Prost, Wallach, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: A post-URAA patent that issues after but expires before a related pre-URAA...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
September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more
On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of...more
In a November 9, 2017 decision, Justice Phelan of the Federal Court found that the Patented Medicine Prices Review Board Panel (Board) was unreasonable in its assessment that a patent ‘pertained’ to Galderma Canada’s DIFFERIN...more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more
As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA for its pegfilgrastim product...more