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As in past years, chemical, pharmaceutical and biotechnology patent cases in 2013 offered a combination of the predictable and the unpredictable. On the predictable end of the spectrum, the US Supreme Court offered no surprises. As virtually everyone had predicted, in its Myriad decision the Supreme Court unanimously repudiated 30 years of Patent Office practice and Federal Circuit jurisprudence by holding that an isolated naturally-occurring DNA is not statutory subject matter under Section 101, while upholding the patentability of cDNA provided it bridges at least one intron. Also, as expected, in its Monsanto decision, the Court affirmed that the doctrine of patent exhaustion does not apply to the purchase of self-replicating technologies such as recombinant seeds, thereby leaving intact the ability of seed suppliers to restrict a purchaser’s use of seeds harvested from a crop.

At the Federal Circuit level, however, there were some surprises, most of which were decidedly anti-patent. For example, in several cases, the court has displayed a markedly more jaundiced view towards an applicant’s reliance on unexpected results, both by making it more difficult to establish an unexpected result over the prior art and by carving out situations where even if an applicant demonstrates unexpected results, they nonetheless may be insufficient to establish non-obviousness. As in past years, we also saw yet another expansion of the doctrine of obviousness-type double patenting, this time to cases that were never commonly owned but nonetheless have a common inventor. We likewise saw an expansion in the area of written description, where the court found that even where a claim finds literal support for all the elements, it may nonetheless not satisfy the written description requirement. Finally, the court was particularly active in 2013 in the area of claim construction, an area that had been relatively dormant for the past several years. In particular, the court seems to be significantly lowering the bar regarding just how definitive a “disavowal” during prosecution needs to be in order to restrict a claim term to a construction narrower than its ordinary and customary meaning.


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Pharmaceutical, Chemical and Biotech Year In Review