oa Editorial [Hot topic: Recent Intellectual Property Law Changes and their Impact on Drug Discovery (Guest Editor: William A. Kinney)]

Drug discovery scientists are required to make important intellectual property decisions every day on what novel compounds to make, which processes to produce them, and which assays to evaluate them in, often with a modest knowledge of patent and legal issues that impact their ability to execute these proposals or obtain patent protection on them. When the practitioner seeks advice from internal counsel, it is often hard to get a definitive answer, because the issues are quite complex and the legal landscape is ever changing. The last several decades have been particularly turbulent in the pharmaceutical arena. With the advent of the Hatch-Waxman Act in 1984, virtually every commercially important patent is challenged by generic companies, hoping to gain early entry into the market. Therefore, it is more important than ever for inventors to craft the strongest patents possible. Recent court decisions have changed the determination of what is obvious and what is patentable, and have influenced the United States Patent and Trademark Office (USPTO) in issuing new guidelines. The purpose of this review is to lay out some basic principles of patent law and how it has evolved over time, to facilitate the dialog between practicing medicinal chemists and their legal colleagues. Specific examples of cases before the courts will be presented to help understand these complex issues. In the first manuscript by Xavier Pillai and myself, 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. In the case of KSR International Co. v. Teleflex, Inc, the United States Supreme Court developed a more flexible definition of the teaching-suggestion-motivation (TSM) test in determining obviousness. 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, and therefore unpatentable, by current standards. In Bayer Schering Pharma AG v. Barr Laboratories, the court of appeals applied the KSR standard of obviousness in invalidating a formulation patent claim, in which only a finite number of predictable options were available to the formulator. Unlike the formulation patent example, patents covering new molecular entities have survived challenges more successfully. 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, the Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc. case involves a patent that was successfully defended, because the scientists had at their 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 and possibly stricter guidelines for patent examinations going forward. Allen M. Sokal and Bart A. Gerstenblith describe the details of the Hatch-Waxman Act, which was enacted to spur new pharmaceutical development and to encourage greater public access to generic drugs. The Act contains important provisions favorable to either branded drug or generic drug manufacturers. The Hatch-Waxman Act also provides a means of vetting patent rights, while enhancing the public notice of such rights. With its enactment there has been a large increase in patent litigation as a means of resolving patent disputes. While the Hatch-Waxman Act has certainly benefitted generic manufacturers, the public, and the legal profession, the pharmaceutical industry has suffered in an increasingly hostile landscape. At some point congress may need to readdress whether the provisions of the Hatch-Waxman Act are properly balanced. Christopher M. Holman addresses the Bilski decision of the U. S. Supreme Court and delves into its “machine or transformation” test in determining process claim eligibility. Historically, patents were granted primarily on inventions arising out of the mechanical and chemical arts. With the growth of the diagnostics, biotechnology, and software industries, the U. S. patent system embarked upon an expansion in its definition of patent-eligible subject matter, which encouraged investments in these technologies. However in recent years, the threshold for patent-eligibility has been raised, particularly related to business method patents. This was done to ensure that patents fulfill their constitutional objective of encouraging innovation, rather than impeding it. For example, in recent years the courts and USPTO have tried to limit process claims to particular applications of a fundamental principle, rather than claims that preempt the principle itself. This shift in patent eligible subject matter is likely to have an impact on the pharmaceutical and biotechnology industries in the near future.