Do you speak genomics? Patenting biotechnology 'Translation' inventions and other macromolecules

In addition to the development of impressive products, the advent of biotechnology has triggered an important patent activity. Due to the unprecedented nature of the products and processes involved, patent law problems have inevitably arisen. This work examines the various patentability requirements in the context of biotechnology, with a special focus on non obviousness. Along with a review of the relevant case law, it offers a thorough analysis of the requirement for non obviousness as applied to biotechnology molecular products. It first establishes a typology of recombinant inventions, useful in determining ultimate non obviousness and patentability. Three categories of recombinant products are distinguished. "Translation" inventions are products obtained by entering a known molecular information into a known process. "Molecular modification" products are obtained by modifying prior art molecules. "Combination" inventions are products composed by combining several known functional molecular units. Although the statutory requirement for non obviousness ultimately applies to all these categories, the focus of the analysis varies for each. The author then extends the concept of "translation" inventions beyond recombinant technology. Besides receptor ligands retrieved by library screening are also considered "translation" inventions. An in-depth analysis of non obviousness concludes that many "translation" inventions will be considered obvious upon maturation of the underlying technology. Recognizing the importance of intellectual property protection in such products, the author examines possible alternatives for protection. The avenue consisting in lowering the non obviousness standard, chosen by the Federal Circuit in In re Deuel, is rejected in a detailed critic of the case. Several current examples of sui generis intellectual property rights are then described. Among them, a regulatory solution along the lines of the Orphan Drug Act appears as best suited for "translation" inventions. A "no action" scenario is also examined, emphasizing that the rapid changes occurring in biotechnology might ultimately make the current problem obsolete. Finally, broader issues such as the growing secrecy in basic science are acknowledged, and linked to the disappearance of a clear distinction between basic and applied research.