Patentability criteria

Valeant Pharmaceuticals Int’l Inc. et al. v. Mylan Pharm. Inc. (U.S. Court of Appeals for the Federal Circuit, 2018)

The case concerns the analysis of obviousness, when the prior art teaches structurally and functionally similar chemical compounds, proving a definite range and variables for a solution of stability.  The Appeal Court held that prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range can establish a prima facie case of obviousness. If one of the predictable solutions leads to an anticipated success, the outcome was obvious to try.

Actavis Group PTC EHF and others v ICOS Corporation and another (United Kingdom Supreme Court, 2019)

This judgment deals with an appeal submitted to the Supreme Court of the United Kingdom (hereinafter “the Supreme Court”) that concerns an application of a test of obviousness on a dosage patent under section 3 of the Patents Act 1977. The Court held that the inventiveness of dosage patent claims needs to be determined on a case by case basis and that the routine nature of the research that resulted in the discovery of a lower efficient dose undermines the inventiveness of the claims.

Teva Canada Ltd. V. Pfizer Canada Inc., 2012 SCC 60 (2012) Supreme Court of Canada

In this case Teva Pharmaceutical Industries Ltd challenged the validity of Pfizer Pharmaceuticals Inc’s patent for the drug Viagra. Teva stated that Pfizer had not met the disclosure requirements set out in the Canadian Patent Act. The main issue on appeal was whether Pfizer had failed to properly disclose its invention when it obtained the patent for Viagra.

Spectra-Physics, Inc. v. Coherent, Inc., 827 F. 2d 1524 (Fed. Circ. 1987) US Court of Appeals for the Federal Circuit

This case addresses the distinction between the requirements to disclose an invention to the public in general terms (enablement) and the separate requirement to disclose the best mode of carrying out the invention. The district court found the patents at issue invalid due to lack of enablement. The United States Court of Appeals affirmed the judgment of the district court, but on different legal grounds, i.e.

Dewey & Almy Chemical Co. v. Mimex Co., Inc., 124 F 2d 986 (1942) (U.S. Court of Appeals for the Second Circuit)

The United States Court of Appeals for the Second Circuit held that a prior art to be an anticipation must bear within its four corners adequate directions for the practice of the patent. If the earlier disclosure offers no more than a starting point for further experiments, if its teaching will sometimes succeed and sometimes fail, if it does not inform the art without more how to practice the new invention, it has not correspondingly enriched the store of common knowledge, and it is not an anticipation.

Amgen Inc., v. Chugai Pharmaceutical Co., Ltd., and Genetics Institute, Inc. (U.S. Court of Appeals - 927 F.2d 1200, Fed. Cir. 1991)

The the Court of Appeals for the Federal Circuit held that for the patenting of microorganisms the best mode disclosure requirement does not necessarily entail an obligation by the patent applicant to deposit a sample of the claimed microorganism.

Copolymers/Dupont, T124/87, OJ 1989 (1988) (European Patent Office Boards of Appeal)

In this case, the European Patent Office Boards of Appeal decided on the patentability of a class of compounds defined by parameters within numerical ranges. It denied the grant of a patent, finding that the invention lacked novelty and an inventive step.

KSR International Co. v. Teleflex Inc. et al., 550 U.S. 398 (2007)

This case concerned the condition of non-obviousness as a prerequisite for patentability. The Supreme Court of the United States (hereinafter: the Court) reinforced the objective analysis approach for applying 35 U.S.C. §103 (i.e. the domestic provision on non-obviousness) as it was established with the three determining factors in Graham v. John Deere.

Graham v. John Deere Co. of Kansas City (United States Supreme Court383 U.S. 1, February 21, 1966)

In this case, the U.S. Supreme Court established that the element of non-obviousness must be assessed with the help of the following factors: (1) the scope and content of prior art, (2) the differences between the prior art and the claims at issue and (3) the level of ordinary skill in the concerned art.  Furthermore, secondary considerations may be commercial success, long felt but unresolved needs or the failure of others to find a solution.