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For more than four decades, Fenwick & West LLP has helped some of the world’s most recognized companies become, and remain, market leaders. From emerging enterprises to large public corporations, our clients are leaders in the technology, life sciences and cleantech sectors and are fundamentally changing the world through rapid innovation.  MORE >

Fenwick & West was founded in 1972 in the heart of Silicon Valley—before “Silicon Valley” existed—by four visionary lawyers who left a top-tier New York law firm to pursue their shared belief that technology would revolutionize the business world and to pioneer the legal work for those technological innovations. In order to be most effective, they decided they needed to move to a location close to primary research and technology development. These four attorneys opened their first office in downtown Palo Alto, and Fenwick became one of the first technology law firms in the world.  MORE >

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Year after year, Fenwick & West is honored for excellence in the legal profession. Many of our attorneys are recognized as leaders in their respective fields, and our Corporate, Tax, Litigation and Intellectual Property Practice Groups consistently receive top national and international rankings, including:

  • Named Technology Group of the Year by Law360
  • Ranked #1 in the Americas for number of technology deals in 2015 by Mergermarket
  • Nearly 20 percent of Fenwick partners are ranked by Chambers
  • Consistently ranked among the top 10 law firms in the U.S. for diversity
  • Recognized as having top mentoring and pro bono programs by Euromoney

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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.

Read the complete article on the BioCentury website (subscription required).