Strategies for Strengthening Patent Protection of Pharmaceutical Inventions in Light of Federal Court Decisions

Xavier      Pillai; William      A. Kinney

Abstract

In this article, a brief history of patent law is presented, along with recent changes in its interpretation that are relevant in securing patents in the current landscape. Specific patent examples are presented to illustrate key issues. For example, the case of KSR International Co. v. Teleflex, Inc. is an important recent decision by the United States Supreme Court, which developed a more flexible definition of the teaching-suggestion-motivation (TSM) test in determining obviousness, which negates patentability. Although KSR case involved a mechanical invention, the ruling in this case has had implications in other areas of patent law, particularly as it applied to pharmaceutical and chemical inventions. It has had a significant impact on the outcome of patent prosecution at the United States Patent and Trademark Office (USPTO), as well as in defending patents in federal courts. If an invention is obvious to try and there are a finite number of predictable solutions in the prior art, then the invention will be considered obvious by current standards. Bayer Schering Pharma AG v. Barr Laboratories, Inc is presented as a case in which the court of appeals has applied the KSR standard of obviousness in invalidating a formulation patent claim, in which a finite number of options were available to the formulator. Unlike the formulation patent example, patents covering new molecules have survived challenges more successfully. In The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., the court of appeals for the Federal Circuit determined that the invention of risedronate was unobvious, although it was a mere positional isomer of a prior bisphosphonate. However in Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., the court of appeals judged against the innovator company when there was a clearer case of predictable prior art. Finally, Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc. presents an example of a case at the Federal Circuit where topiramate was more easily defended, because the scientist had at his disposal a great number of unpredictable options and the results were clearly surprising. In light of these and other court decisions the USPTO has established new guidelines for patent examinations going forward that this article describes.

Keywords: Obviousness, drospirenone, spirorenone, steroids, contraceptive, diuretic, risedronate, bisphosphonates, proton pump inhibitor, pantoprazole, omeprazole, topiramate, anticonvulsant, antidiabetic, ANDA, Preliminary Injunction, teaching-suggestion-motivation, bisphosphonate, USPTO, United States Patent and Trademark Office, potassium carbonate, The United States Supreme Court, Patent 6,237,565, Byler patent, KSR's argument, Engelgau patent, Abbreviated New Drug Application, Barr counter-sued, micronization, U.S. Patent 5,583,122, 2-pyridyl isomer, 3, 3-Pyr EHDP, 4, 2-Pyr EHDP, pump inhibitor, bis-acetonide protected fructose, fructose bisphosphatase