International Patent Law at the Supreme Court
U.S. cases rarely delve into international patent law issues. Rather, US courts have largely refused to allow parallel proceedings or filings in foreign jurisdictions to impact their decision-making at home. IBSA Institut Biochimique, v. Teva Pharmaceuticals offers an interesting perspective on this. The patent at issue was ISBA’s U.S. Patent No. 7,723,390 that claimed priority back to an Italian patent application (MI2001A1401). The patent here is directed to a “soft gel capsule formulation containing the active ingredient levothyroxine sodium…
Federal Court of Appeal upholds one of the last prohibition orders under the old PM(NOC) Regulations
The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the same patent was invalid. ZYTIGA® (abiraterone acetate or AA) is a drug marketed in Canada by Janssen Inc., Janssen Oncology, Inc., and BTG International Ltd. (collectively, Janssen) for the treatment of prostate cancer. Canadian Patent No. 2,662,422 (the 422 Patent)…
Eurasian Union: Pharmaceutical Register launched
On 1 March 2021, the Eurasian Patent Office launched the Pharmaceutical Register , covering 8 jurisdictions, including Russia, Belarus, Kazakhstan. A demo-version is available on the official website of EAPO. The new Register contains information on Eurasian patents protecting active substances of drugs. The EAPO specifically indicates that the Pharmaceutical Register shall relate to the patents protecting pharmacologically active products (chemical compounds, including those described by the same structural formula, biotechnological products, compositions, combinations), production methods and medical use of the products….
Second medical use dosage regimen claim successfully traverses both insufficiency and “obvious-to-try” attacks (T 0799/16)
The decision in T 0799/16 is a rare example of dose claim found both sufficient and inventive by the EPO Boards of Appeal. The claim was found to be sufficiently disclosed over the entire scope of the claim, despite the claimed treatment being shown as non effective in almost two thirds of patients. The Board of Appeal (3.3.01) further found the claim inventive in view of prior art disclosing clinical trial information, information that included the claimed dose itself. The key factor in persuading the Board of Appeal on both counts was the particularly challenging nature of the target indication. The case related to Acorda’s patent (EP 2377536) relating to a 4-aminopyridine (branded as Fampridine) dosage regime for the treatment of multiple sclerosis (MS). The granted claims specified 4-aminopyridine for use in a method of increasing walking speed of a patient with MS, wherein the 4-aminopyridine was administered as a 10 mg twice daily dose (Bid)…
Australian top court rules cancer gene patent invalid
SYDNEY: An Australian cancer survivor Wednesday triumphed in a landmark challenge against biotech companies, with the country’s top court ruling they could not patent a gene linked to breast cancer. Yvonne D’Arcy took her case to the High Court of Australia, arguing that the so-called breast cancer gene BRCA1 — the mutation famously carried by Hollywood star Angelina Jolie — was a naturally occurring substance. Breast cancer is the leading cancer killer of women aged 20-59 worldwide, and supporters of the case had argued that patenting a gene could stymie medical research and testing…
Knowledge of Patent, Evidence of Infringement Are Necessary, but Not Sufficient, to Establish Willfulness
Addressing claim construction, enablement, damages and willfulness, the US Court of Appeals for the Federal Circuit found that evidence of a defendant’s knowledge of the asserted patent and proof of infringement were, by themselves, legally insufficient to support a finding of willfulness. Bayer Healthcare LLC v. Baxalta Inc., Case No. 19-2418 (Fed. Cir. Mar. 1, 2021) (Stoll, J.). Bayer owns a patent on certain recombinant forms of human factor VII (FVIII), a protein that is critical for blood coagulation. Recombinant FVIII is useful as a treatment for coagulation disorders, primarily Hemophilia A. Natural FVIII has a short half-life, making therapeutic administration expensive and inconvenient.…
Sanofi Settles Patent Suit Over Copies of Gaucher-Treatment Drug
Sanofi’s Genzyme unit and The Regents of the University of Michigan, co-owners of a patent on the Gaucher-treatment drug Cerdelga, agreed to settle a lawsuit with closely held generic-drug makers Apotex and Aizant, the only remaining defendants in a consolidated case that was set for trial on Monday. All patent-related claims and counterclaims were dismissed with prejudice, but no details of the settlement were included in the dismissal orders issued Thursday in federal court in Wilmington, Delaware. Patent covers eliglustat, Cerdelga’s active ingredient, and expires in June 2026..