The patent law requires that a patent contains a written description of the claimed invention. The central objective is to describe the invention clearly enough so that it allows a skilled artisan to recognize that the inventor invented what is claimed. The written-description requirement presents an intricate issue to pharmacogenomics patenting.
One frequent pitfall is where the description provides inadequate representative species to support broad genus claims. In the highly competitive field of pharmacogenomics, one often needs to decide whether to file early with less than ideal support or to file later when more is established but risk losing out to competitor’s patent filing or public disclosure. It is important for the patent specification to support the full scope of the claimed invention with adequate representative species and embodiments.
Another common misstep is having insufficient support for a method of use claim in terms of exemplary compositions that possess the claimed functionality. In Ariad v. Eli Lilly, the asserted patents involve gene regulation and the NF-kB transcription factor. A critical issue is whether the patent provides adequate written description on how reduction of NF-kB activity can be achieved. The patent disclosed no examples of molecules that possess the claimed activity. In the end, the Federal Circuit found the patent invalid.
Patent drafters should bear in mind that the key consideration with regard to the written-description requirement is to know what the desired protection is and to sufficiently support it. During patent drafting and prosecution, patent counsel should be abreast of the scope of the available written support when crafting claims and presenting arguments before the patent office. Sufficient examples of representative species should be included to support the desired genus claim. Back-up claims, typically dependent claims that are directed to preferred species or embodiments, should be included in the event that the broader genus claim fails to gain allowance or is later held invalid in patent reexamination or litigation.