On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. However, the Court refused to issue an injunction removing the infringing product from the Canadian market, finding that it was not in the public interest to force patients to switch to another biosimilar product. The Court also found that two other patents, which cover dosage regimens and new uses of adalimumab, are invalid for obviousness. 

Background

In January 2022, JAMP Pharma Corporation (JAMP) was approved to market SIMLANDI, a biosimilar of HUMIRA (adalimumab). JAMP’s product was the eighth adalimumab biosimilar to come to market in Canada.  HUMIRA is an AbbVie Corporation and AbbVie Biotechnology Ltd. (collectively, AbbVie) product.

As we previously reported here, the Minister of Health (Minister) permitted JAMP to market SIMLANDI even though JAMP had not addressed the patents listed against HUMIRA on the Patent Register. According to the Minister, JAMP’s new drug submission for SIMLANDI did not engage the Patented Medicines (Notice of Compliance) Regulations (Regulations). The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No. A-203-22). 

As a consequence, the Court’s recent decision of December 4, 2023 does not concern the Regulations, but rather parallel actions brought under the Patent Act. In these actions, JAMP sought declarations of invalidity and non-infringement with respect to three AbbVie patents: Canadian Patent Nos. 2,504,868 (868 Patent); 2,801,917 (917 Patent); and 2,904,458 (the 458 Patent).  AbbVie counterclaimed for infringement of all three patents.

Formulation patent valid

The Court dismissed JAMP’s attacks on the 458 Patent. The claims at issue are directed to aqueous pharmaceutical formulations comprising a high concentration (i.e., 100 mg/mL) of adalimumab, at pH 5.2, with either no pH-buffering system or a low ionic strength (i.e., conductivity of less than 2.5 mS/cm).  The Court found:

  • Anticipation: The claims at issue were not anticipated by WO 2006/138181. The Court found that this publication disclosed adalimumab and self-buffering protein formulations. However, the publication did not “plant a flag” in the claims at issue in the 458 Patent as, among other reasons, it only disclosed broad ranges of protein concentration and pH. The Court held that the disclosure of a range may, but does not necessarily, anticipate a claim to a point within the range.
  • Obviousness: The claims at issue were not obvious given the factual findings, which include: (i) the prior art only taught adalimumab formulations up to 63 mg/mL, (ii) a person of skill in the art would not have known that adalimumab could be formulated into a stable aqueous solution at 100 mg/mL, and (iii) every monoclonal antibody on the market at the relevant time contained a buffer.   
  • Overbreadth: JAMP’s evidence on overbreadth was deficient. Among other problems, JAMP’s evidence failed to identify the essential elements of the invention that were supposedly missing from the claims.
  • Double patenting: JAMP argued that the 458 Patent was invalid for double-patenting based on a patent that would have expired after the 458 Patent. As a result, the 458 Patent could not extend any monopoly conferred by the other patent and so “there would be no evergreen problem”. 

Formulation patent infringed but injunction not granted

JAMP conceded infringement of the 458 Patent. However, the Court found that it was against the public interest to remove the JAMP product from the market. The Court accepted that the JAMP product is the only adalimumab biosimilar that is higher concentration, lower volume, and citrate-free at an 80 mg/0.8 mL presentation. The Court found:

This is one of those rare cases where I will not grant a permanent injunction given the public interest factor. Forcing SIMLANDI patients to switch to another biosimilar, given it is the only 80 mg/0.8 mL formulation in Canada, is not in the public interest. AbbVie can be compensated. Even though the risk is low to those patients, it is preferable to compensate AbbVie rather than take SIMLANDI off the market. JAMP does not need to deliver up its infringing product.

The issue of any monetary damages for infringement was “left to be determined at the bifurcated trial if the parties do not reach an agreement before.”  

Other patents invalidated: dosing regimens obvious to try

The Court agreed with JAMP that the 868 and 917 Patents are invalid for obviousness.

The claims at issue in the 868 and 917 Patents are directed to the use of adalimumab in multiple-dose regimens for treating inflammatory bowel disease and hidradenitis suppurativa, respectively.  In the Court’s view, both dosing regimens were obvious to try in light of the prior art. 

  • The Court found that, by the priority dates of the 868 and 917 Patents, it was self-evident that the claimed dosing regimens would be safe and effective.
  • Of note, in reaching its conclusions on both patents, the Court did not expressly consider the second (extent, nature and amount of effort) and third (motivation) factors in the obvious-to-try analysis.

The Court rejected JAMP’s other invalidity arguments, namely that: (i) both the 868 and 917 Patents claim unpatentable methods of medical treatment, and (ii) the 917 Patent was anticipated and has an unsupported claim term that was improperly added during patent prosecution.

Appeal filed

The Federal Court’s judgment has been appealed to the Federal Court of Appeal (Court File Nos. A-347-23, A-348-23).

Links:

  • AbbVie Corporation v. Jamp Pharma Corporation, 2023 FC 1520