In re Kubin Decision Raises Troubling Issues for Life Sciences

April 24, 2009 – In The News
BNA, Inc., Vol. 3, No. 8

The Federal Circuit decision In re Kubin has raised many issues for life sciences patent prosecution and litigation, possibly delaying pending legislation on follow-on biologics. In the case, a Patent and Trademark Office rejected Marek Kubin and Raymond Goodwin's patent application, prompting an appeal citing the rejection conflicted with Federal Circuit precedent. Janet MacLeod was interviewed regarding the effects of the decision on the life sciences arena.

‘‘Kubin discredits the court’s repudiation of the ‘obvious to try’ doctrine it articulated in Deuel, but it does not preclude patent prosecution for nucleic acid molecules that encode a protein that was known in the prior art. Rather, in prosecution of claims directed to isolated nucleic acids, the obviousness inquiry will now follow on the predictability of a method of cloning a nucleic acid rather than the predictability of the sequence,’’ MacLeod said.

‘‘Rebuttal of a prima facie case of obviousness may consequently require evidence of unpredictability in the method of cloning or evidence of unexpected properties of the resulting nucleic acid molecule,’’ she explained.

MacLeod said that the decision will affect litigation of biotechnology patents, particularly if an abbreviated process for FDA approval of follow-on biologic (FOB) or biogeneric drugs is approved by Congress and implemented. She wondered, however, if Kubin could actually frustrate approval of pending legislation that would create the abbreviated process.

Competing bills recently introduced in Congress (3 LSLR 348, 4/10/09; 3 LSLR 291, 3/27/09; 3 LSLR 240, 3/13/09) differ significantly in the length of the data exclusivity period—the period during which a follow-on applicant is precluded from using the innovator’s data to obtain FDA approval. MacLeod said, ‘‘The length of the data exclusivity period affects the timing of and incentive for challenges to the innovator’s patents and is the most contested aspect of the proposed legislation. Perceived vulnerability of biotechnology patents to an obviousness challenge based on Kubin will make a longer data exclusivity period and a longer time for return on investment even more critical for innovator companies and a shorter exclusivity period and earlier opportunity for patent challenge far more desirable to follow-on applicants.’’

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