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Doctoring The Lilly Doctrine

September 01, 2009

Michael Shuster, Ph.D., partner in the Intellectual Property Group and Co-Chair of the Life Sciences Group at Fenwick & West LLP, was recently quoted in the BioCentury article, "Doctoring The Lilly Doctrine."

For more than a decade confusion has plagued the Biotech industry regarding the written description requirement for patents. The CAFC now has the opportunity to clear the air by rehearing Ariad v. Lilly, which may determine how much space early-stage researchers will be able to claim.

Prior to 1997, the CAFC considered "written description" wording of section 112 as a modifier of the "enablement" requirement, and not as a separate requirement. That changed with Regents of the University of California v. Eli Lilly and Co., which introduced what is know as the "Lilly Doctrine."

The suit accused Lilly of infringing two patents related to recombinant human insulin. The ruling effectively separated the enablement and written description requirements.

"They had clearly achieved enablement because they described exactly what to do, but they did not have the recombinant human insulin in their possession," Shuster, partner with Fenwick & West told BioCentury. Furthermore, Shuster added, "since Lilly, biotech patents have been held to a de facto reduction to practice standard. Lilly was the first time the Federal Circuit said the written description has to match what you've actually done."

The next landmark case was University of Rochester v. G.D. Searle & Co., Inc., which involved the University's patent (no. 6,048,850) that covered a method of treating pain and inflammation. Shuster stated, "Rochester reiterated Lilly in holding that describing the needed compound by its desired function or activity is not adequate written description because it does not show possession of the compound."

After Rochester, Ariad had little hope of prevailing against Lilly's appeal due to the similarity between the two cases, which both revolved around method-of-treatment claims. The CAFC is divided on the issue of whether the written description requirement should be separate from the enablement requirement, and now the Ariad case puts the dichotomy before the full court.

"It has been my view for a long time that the way the law has shaken out since Lilly means it will be very difficult for Universities that do pioneering work to get full protection that is commensurate with their contributions to the art," said Shuster.

According to Shuster, very broad claims could impede a downstream developer's freedom to operate or stymie the developer's ability to protect its own claims. If the patent holder wants too much, then a would-be-developer could decide to abandon the space altogether rather than pursue the work and let the courts decide whether the claims are too broad, a la Rochester.