CaseCobalt Pharmaceuticals Company v. Bayer Inc. et al., 2015 FCA 116

Drug: YAZ® (drospirenone/ethinylestradiol)

Nature of case: Appeal from section 6 prohibition application under thePatented Medicines (Notice of Compliance) Regulations

Successful party: Cobalt and Bayer appeals both dismissed

Date of decision: May 4, 2015

Summary

Bayer Inc. (Bayer) distributes a combination oral contraceptive tablet under the brand name YAZ® (drospirenone and ethinylestradiol). YAZ® is covered by Canadian Patent Nos. 2,382,426 (426 Patent) and 2,179,728 (728 Patent). Cobalt Pharmaceutical Company (Cobalt) applied to the Minister of Health for a Notice of Compliance (NOC) to distribute a generic version of YAZ®, alleging its tablet did not infringe either patent, or alternatively, that the patents were invalid. Bayer brought applications in the Federal Court under section 6 of thePatented Medicines (Notice of Compliance) Regulations, SOR 93/133 for an order prohibiting the Minister from issuing a NOC to Cobalt. The Federal Court granted Bayer’s application in respect of the 426 Patent but dismissed the application in respect of the 728 Patent. We previously reported on the Federal Court’s decision here.

Both parties appealed to the Federal Court of Appeal (FCA) which dismissed both appeals. In obiter, the Court called on the Supreme Court of Canada (SCC) to provide clarity on the appropriate standard of review on the issue of claims construction, and on the patentability of methods of medical treatment.

Cobalt appeal

The Federal Court granted Bayer’s prohibition application in respect of the 426 Patent and Cobalt appealed. The FCA dismissed the appeal, finding that none of Cobalt’s allegations of non-infringement or invalidity were justified. The allegations all turned on the construction of the claims of the 426 Patent, specifically, claim 31.

Cobalt argued that claim 31 should be construed to include micronized, but not sprayed, drospirenone particles. Cobalt’s product did not contain micronized particles, so on this construction, it would not infringe the 426 Patent.

The Court rejected Cobalt’s argument and affirmed the trial judge’s construction of the claims. It rejected Cobalt’s “cherry-picking” of particular portions of the patent to support the result it wished to reach. The Court held that patents are not to be construed in a “tendentious” way and that construing the claims requires consideration of the inventor’s purpose as understood by the skilled reader. It noted that some of the claims of the 426 patent referred to micronized particles and others referred to sprayed particles. By contrast, claim 31 referred to neither, suggesting that the inventor did not intend to limit himself to any particular types of particles. Cobalt’s sprayed drospirenone particles therefore fell within the scope of the claim and Cobalt’s allegation of non-infringement was not justified.

Claims construction – The standard of review

The Court commented on the standard of review an appellate court ought to apply in construing the claims. It noted that historically, appellate courts applied a standard of correctness, but suggested that greater deference ought to be given to trial judges on the issue of claims construction. Construing patent claims requires reading them through the eyes of a person skilled in the art and expert evidence is needed to assist the court. The assessment of that evidence is reviewable only for palpable and overriding errors, and in practice, that standard of review ought to apply. The Court’s comments were made in obiter as the Court felt bound to apply the standard of review of correctness. It invited the SCC to consider the standard of review in a future case.

Validity of the 426 Patent

Cobalt also alleged the 426 Patent was invalid on the basis of obviousness, sound prediction, sufficiency of disclosure, and overbreadth. The Court rejected all of Cobalt’s  allegations finding that: (1) the prior art taught away from the solution of the 426 Patent and was not obvious; (2) Cobalt strayed from its notice of allegation in respect of sound prediction and was not entitled to raise new arguments on appeal; (3) the disclosure properly described the invention and taught the skilled reader how to practice it; and (4) claim 31 was not overbroad.

Bayer appeal

The Federal Court dismissed Bayer’s prohibition application in respect of the 728 Patent on the basis that Cobalt’s product did not infringe the patent. The Federal Court also found that certain claims were directed to unpatentable methods of medical treatment. Bayer appealed and the Court dismissed the appeal, finding Cobalt’s allegation of non-infringement was justified.

Construction of the claims of the 728 Patent

Cobalt’s product contains 3 mg of drospirenone. The Federal Court construed the claims of the 728 Patent as requiring either an indeterminate amount, or at most 2 mg, of drospirenone, and therefore Cobalt’s product fell outside the scope of the claims. The FCA upheld the trial judge’s construction.

Methods of medical treatment

Based on its finding of non-infringement, the FCA held that it did not need to decide the method of medical treatment allegations. In obiter, however, the Court referenced Professor Norman Siebrasse’s, “Sufficient Description” blog, where he questions whether the prohibition against method of medical treatment claims is still applicable given that it was based on a particular provision of the Patent Act—section 41—which has since been repealed. He also offers other policy considerations questioning its justification. The FCA called on the issue to be revisited in a case where it is squarely raised on the facts.

Link to decision:

Cobalt Pharmaceuticals Company v. Bayer Inc., 2015 FCA 116