Dedicating a patent can block a double patenting argument
Justice McVeigh has added new considerations when considering a double patenting argument in AbbVie v JAMP Pharma, 2023 FC 1520.
The double-patenting discussion was made in the context of patent infringement and impeachment actions where AbbVie asserted JAMP’s SIMLANDI product (a biosimilar of AbbVie’s HUMIRA product) would infringe Canadian Patent Nos. 2,504,868 (the “868 Patent”) 2,801,917 (the “917 Patent”) and 2,904,458 (the “458 Patent”). See discussion of the anticipation arguments here. One validity issue for the 458 Patent was whether Canadian Patent No. 2,815,689 (the “689 Patent”) rendered the 458 Patent invalid for double patenting.
The 689 Patent is owned by AbbVie and was filed at a later date than the 458 Patent. The 689 Patent was on the Patent Register for HUMIRA until September 9, 2022, two months before the start of the trial, when AbbVie dedicated the Patent to the public.
JAMP argued that the 458 Patent and 689 Patent share the same inventive concept and essential elements, rendering the 458 Patent invalid for double patenting. AbbVie disagreed, arguing that a later filed patent cannot invalidate an earlier filed patent, and even if it could, the argument had no application when the later-expiring patent has been dedicated to the public.
Justice McVeigh explained that the two kinds of double patenting, same invention double patenting and obviousness double patenting, are a “means of preventing patentees from securing more advantage than they are entitled to from their inventions.” The most often discussed improper advantage is the time extension, and invalidity on the basis of double patenting seeks “to prevent a patentee from effectively extending the life of the previous patent” (Hospira), also referred to as the “evergreen” problem (Whirlpool; Les Laboratoires Servier v Apotex Inc).
Justice McVeigh held that, had the 689 Patent not been dedicated to the public by AbbVie, it would have expired after the 458 Patent. Because it was dedicated to the public, there was no improper extension on the subject matter disclosed in the 689 Patent and no “evergreen problem.”
JAMP also argued that improper patent term extension was not the only consideration under a double patenting analysis, and that the presence of the 689 Patent on the Register was an improper attempt “to require biosimilars to address both patents under the PM(NOC) Regulations.” Justice McVeigh was open to the possibility that there was merit to such an argument, but held that a “clearer description of the actual unfair advantage conferred by the double patenting” was needed.
The full decision can be read here.
