Patents

Federal Court of Appeal Rules on Double Patenting

David Katz, JD
Published December 7th, 2010

Bayer Schering Pharma Aktiengesellschaft v. Canada (Attorney General), 2010 FCA 275
Evans J.A. (Dawson J.A., Stratas J.A. concurring)

Bayer appealed an Order affirming the decision of the Commissioner of Patents refusing to grant its patent claiming a medicinal compound. Bayer had previously been granted a product-by-process patent (which had then expired) claiming the same compound made by a particular process.1 The Commissioner found that the later application could not issue to a patent because it would offend the “obviousness” branch of the rule against double patenting.

Double patenting occurs when a later patent claims the same subject matter as the claims of an earlier patent by the same patentee. There are two distinct branches of double patenting: “same invention” double patenting; and “obviousness” double patenting.

Under the “same invention” branch, a patent will be invalid where the claims are identical to the claims in the earlier patent. This is a very strict test to meet, as even small differences in the wording of the claims will overcome the restriction.

The second branch, “obviousness” double patenting, is “more flexible and less literal”.2 A patent will be invalid if the claims are “not patentably distinct” from the claims of the earlier patent.

The Commissioner found there was no “same invention” double patenting because the earlier patent claimed a product-by-process while the later application claimed only the product. However there was “obviousness” double patenting because the claims in the later application did not exhibit novelty or inventive ingenuity over the claims of the first patent. The Federal Court upheld the Commissioner’s refusal.

On appeal, the Federal Court of Appeal agreed with the lower court that a patent claiming a compound alone will not exhibit inventive ingenuity over a patent claiming the compound made by a particular process. In reaching their conclusion, the Court stated it would be inconsistent with the fundamental premise of patent law as a bargain to allow a patentee to “evergreen” its monopoly by first patenting the product by a particular process and subsequently patenting the product regardless of the process used to make it. The Court dismissed the appeal.3

The Court also suggested that had the order been reversed and the first patent issued for the product alone, a later product-by-process patent might properly issue. However this statement appears to be at odds with Hoffmann-La Roche & Co. Ltd. v. Commissioner of Patents, [1955] S.C.R. 414, where the Supreme Court of Canada stated that no product-by-process claims can issue for a known compound, even if the process is new. Hoffman was recently applied by the Federal Court of Appeal in Abbott Laboratories v. Canada (Minister of Health), 2007 FCA 153.

Should Bayer have donated the earlier patent to the public?

There has been a recent trend by brand-name pharmaceutical manufacturers to dedicate patents to the public shortly before NOC proceedings in which they anticipate having to defend a later patent from a double patenting attack. The theory is that there can be no double patenting if the brand-name manufacturer no longer owns the earlier patent. See for example Abbott v. Sandoz, 2010 FCA 168, and Merck v. Apotex, 2010 FC 1043. In Abbott, the Federal Court of Appeal upheld the later patent and said there can be no double patenting because of the earlier dedication. In Merck, the Federal Court came to the opposite conclusion, finding that to give effect to the dedication would improperly extend the patentee’s monopoly. The Court in Merck distinguishes Abbott on the basis that the two patents in Abbott were set to expire at the same time, thus there was no improper extension of the monopoly in that case.

All of this begs the question: Could Bayer have avoided the double patenting problem if it had dedicated the earlier patent to the public before its expiry and before the later patent was examined. Can Bayer rely on those cases4 that seem to imply that legal effect of dedicating a patent to the public is that it is “as if it never issued”? If the law is as Abbott suggests then the effect of the dedication may well immunize the later application from a double patenting objection. On the other hand, if the law is as Merck suggests and the facts in Abbott are distinguishable, then no dedication will be effective to extend a patentee’s monopoly and Bayer’s later patent will be invalid. The policy behind the Bayer decision is aligned with Merck which, as Merck did not appeal the finding, remains good law for now.

                                                    
1 The Patent Act as it existed while the earlier patent was being prosecuted did not permit claims to the medicine itself independent of the process used to make it.
2 Bayer citing Whirlpool Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067 (Whirlpool) at para. 66.
3 However they overruled the Federal Court’s finding as to the standard of review of a decision by the Commissioner to grant or refuse a patent. Below, the Federal Court held the standard of review is reasonableness. The Federal Court of Appeal has now confirmed the standard of review is correctness.
4 See, for example comments made in G.D. Searle & Co. v. Merck & Co., 2002 FCT 540, and later considered in Abbott without deciding their merit. Note however, the Court in G.D. Searle made this statement in a context other than double patenting, an observation recognized by Merck but ignored in Abbott.

Publication Archives
Contact us

Telephone: 416-595-1155
Fax: 416-595-1163

Email: mailroom@simip.com

100 Simcoe Street
Suite 200
Toronto, Ontario, Canada
M5H 3G2