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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?
As we move into the second half of the year, we are alerting you to 11 patent cases that you should look out for during the second half of 2024. This judicial mix touches on a range of industries and interests, such as...more
On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more
On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...more
Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more
On December 4, 2023, the Federal Court issued its public judgment and reasons in two patent infringement actions pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and two patent...more
Artificial intelligence is transforming drug design — but it could also disrupt intellectual property law. To realize AI’s full promise, the US may have to reconsider its approach to issuing patents....more
On Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more
The Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s long-standing requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions...more
On May 18, 2023, the Supreme Court unanimously affirmed the Federal Circuit's decision, Amgen Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021), that the claims of two of Amgen's patents were invalid for lack enablement. The...more
On May 18, 2023, the Supreme Court affirmed the Federal Circuit’s (CAFC) decision on enablement in Amgen Inc. v. Sanofi, 987 F.3d 1080 (CA Fed. 2021). The Court thus left in place a significant decision making it more...more
In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more
On May 18, 2023, the Supreme Court of the United States issued a unanimous decision in the case of Amgen Inc. et al. v. Sanofi, et al., No. 21-757. After a nine-year saga, beginning when Amgen sued Sanofi for allegedly...more
On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more
On November 4, the U.S. Supreme Court granted Amgen’s petition to review the “enablement requirement” of Section 112 of the Patent Act. See generally Amgen Inc., v. Sanofi, No. 21-757 (U.S. 2022). The Court’s decision will...more
The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. In July 2021, President Biden issued an Executive Order...more
2021 saw changes in Canadian patent legislation, and a variety of court decisions addressing rarely interpreted provisions of the Patent Act, early consideration of recently enacted provisions, and new takes on central tenets...more
Update: On September 29, 2021, Canada applied to the Supreme Court of Canada for leave to appeal (Docket No. 39858). In September 2017, the Patented Medicine Prices Review Board (PMPRB or Board) decided (see article here)...more
On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more
Patenting antibodies has long been challenging. Although most inventions can be patented based on their functionality, assuming the functionality is new and non-obvious, for antibodies and other biomolecules there is a higher...more
Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more
In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....more
Update: Apotex has appealed. On March 8, 2021, the Ontario Superior Court of Justice granted Eli Lilly’s (Lilly) motion for summary judgment and dismissed Apotex’s claims under the Statutes of Monopolies, Trademarks Act, and...more
On December 24, 2020, the Federal Court issued a decision in a patent infringement action pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin (Allergan’s RAPAFLO): Allergan...more
On November 23, 2020, Innovative Medicines Canada (IMC) and a number of research-based pharmaceutical companies commenced an application for judicial review (T-1419-20) of the final Patented Medicine Prices Review Board...more
In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more