Merck Sharp & Dohme Corp. et al v. Wyeth LLC, 2021 FC 317 (Pneumococcal*)

Justice Gagné - 2021-04-30

Read full decision. Automatically generated summary:

Merck, seek to impeach three Canadian patents, one composition patent and two formulation patents, property of Wyeth, pertaining to a 13-valent pneumococcal polysaccharide protein conjugate vaccine commercialized under the name Prevnar® 13. ... For these reasons, I find that Claim 1 of the 363 Patent is limited to 13 serotypes and does not disclose any “platform” for making a vaccine with greater coverage. ... The evidence shows that conjugating is a complex endeavour; it also shows that the increasing reports on immune interference could have deterred the skilled person to pursue a 13-valent PCV all conjugated with CRM197. ... Merck successfully argued that Claim 1 of the 363 Patent is limited to 13 serotypes and that no particular level of immunogenicity should be read into Claim 1 of the 363 Patent. However, I find that Claims 1-6, 13-14, 17-19, 22-30, and 36-38 of the 363 Patent are valid, though limited to 13 serotypes. ... I agree with Merck that the term “stabilizes” is not limited in the claims. The inventors could have limited the claims to physical stability but they chose otherwise. I believe, however, that this is a case where recourse to the disclosure portion of the specification does assist in understanding the term “stabilizes” as used in the claims. ... In my view, Merck has met its burden to prove that the Formulation Patents are invalid for obviousness, with the exception of the serotype selection claims that are, in my view, invalid for double patenting and which I will discuss in the next section. ... In my view, the claims of the Formulation Patents are all obvious variants of the invention claimed in the 363 Patent that claims a composition of 13 specific pneumococcal polysaccharides conjugated to the carrier protein CRM197 in a buffer with aluminum phosphate.

Decision relates to:

  • A-145-21 - which is an appeal from this decision


Canadian Intellectual Property