Philip W. Grubb

Imperfect Solutions: Innovation and Intellectual Property Protection in the Life Sciences
A 1997 article in the San Francisco Business Times about the pioneering Boyer-Cohen recombinant DNA patents declared that many researchers in academic settings “have only a vague notion of what a patent is and how it can be commercialized”. A decade later, it was reported that biotechnology-linked patent filings from academia have outpaced the number of patent filings by biotechnology companies by over fifty per cent. This singular shift in patent-filing productivity can be attributed in part to the increasing propensity of universities to commercialize scientific research output, given the complexities and difficulties in securing government research support and the need to buttress university treasuries; having witnessed the power of patents in generating considerable royalty income, universities are now actively involved in the commercial exploitation of scientific research, and have even considerably modified their policies on intellectual property generation to accommodate increasing faculty involvement in non-academic, external business matters.

As universities have belatedly started to realize, patents often play a fundamental role in extracting economic returns from innovation. And patent portfolios can also be construed as an indicator of an enterprise’s value to investors. Nowhere are these verities more apparent than in the pharmaceutical sector, where the loss of patent protection for a key revenue-generating chemical entity could impair future profitability and thus translate into significant market value erosion. Ownership of potentially lucrative patents is indubitably acquiring untold strategic importance in the pharmaceutical industry, with major pharmaceutical companies presently being plagued with low research and development productivity and with many of their best-selling drugs going off patent. Patent expirations are already taking a heavy toll on industry revenues; according to one estimate, the pharmaceutical sector is projected to lose more than US$50 billion in revenues between 2008 and 2012 due to the loss of patent protection on various chemical entities. It therefore becomes readily apparent that, in an innovation-intensive business area such as the biomedical industry, extensive portfolios of intellectual property rights as represented by patents are highly effective instruments for entry deterrence and monopoly control of proprietary technologies.

Patents, as Grubb, a European patent attorney, reminds us in this book, are nothing more than instruments issued by a state to an inventor conferring the right to exclude others from economically exploiting a particular innovation for a limited duration. Patents, which traditionally encompassed machines, industrial processes, compositions of matter, and articles of manufacture, have of late evolved to include hitherto unpatentable items such as biological matter, software, and business methods. “There can be no doubt”, according to Grubb, “that patents are of greater commercial importance in the fields of chemistry, and particularly pharmaceuticals and biotechnology, than in other fields such as engineering or electronics” because of the relative ease of replicating a known molecule or chemical compound and the mounting expense of development and commercialization. With the number of therapeutically-relevant patents filed yearly growing at an exponential rate, and with biotechnology emerging as the pharmaceutical industry’s primary driver of innovation, the protection of intellectual property has never been more paramount to the momentum of pharmaceutical innovation.

An invention, to be deemed patentable, must be novel—it must not constitute part of the presently disclosed state of the art. Additionally, a patentable innovation must involve an inventive step, i.e., the invention must be non-obvious to a person with ordinary skills in the invention’s area of use. Finally, the invention must be demonstrably capable of industrial application. Patents, however, are not immutable assertions of possession over a certain item of intellectual property. Grubb reminds us that the existence of a patent provides no absolute assurance that the patent in question will be valid or even enforceable; the inherent fluidity of the nature of protection afforded to a patent holder can be attributed to a patent office’s exactitude in examining patent applications, among other factors.

Covering an extensive range of patent cases and doctrinal sources, Grubb’s opus explores the deepest intricacies of the global patent system, including a discussion of patent regulation in the developing world, and provides a first-rate overview on the strategic facets of pharmaceutical and biotechnology patenting. The author’s ability to proffer perceptive insights into the workings of the global patent registration system without losing sight of the diverse commercial aspects of intellectual property in general provides the book’s central strength. This book is arguably one of the most useful and readable references on intellectual property management.… (altro)