Lisa A. Haile

Haile worked as a bench scientist before law school and before she became co-chair of DLA Piper’s global life sciences sector. She has a Ph.D. in microbiology. “I spent years and years in the lab, and it gives you a different perspective on cases,” she said.

She has technical experience in molecular biology, immunology, cell biology, regenerative medicine, diagnostics, therapeutics, drug delivery systems, host-vector systems, high throughput screening and bioinformatics.

Haile advises leading research institutions. Clients include six Nobel Prize winners and International Stem Cell Corp., SteadyMed Therapeutics Ltd., Synthetic Genomics Inc. and Nexvet Biopharma PLC. She is a board member and general counsel of Biocom, the industry group representing life sciences throughout Southern California.

“I love working with amazing, brilliant scientists,” she said.

For SteadyMed, a San Ramon-based specialty pharmaceutical company, she obtained a favorable ruling after an inter partes review at the Patent Trial and Appeal Board in April. The patent her client successfully sought to invalidate protected United Therapeutics Corp.’s key drug Remodulin, which had 2016 sales of more than $600 million.

SteadyMed plans to introduce a new drug this year called Trevyent. It is designed to replace Remodulin, a vasodilator that is used for the treatment of pulmonary arterial hypertension.

United Therapeutics sought to use the review process to block SteadyMed’s introduction of Trevyent. The trial was heavily attended by so many analysts and investors they could not all fit in the courtroom and had to watch by video, Haile said.

“There were reps from large pharma companies who viewed this case with great interest,” she added. The PTAB found all of United Therapeutics’ 22 claims unpatentable and canceled them. United Therapeutics has appealed the outcome to the U.S. Court of Appeals for the Federal Circuit. SteadyMed Ltd. v. United Therapeutics Corp., IPR2016-00006 (U.S. PTO, filed Oct. 2, 2015).

“We avoided millions of dollars in litigation costs by getting that PTAB ruling,” Haile said.

Haile also represents Synthetic Genomics, founded by J. Craig Venter and Hamilton Smith. The company is developing viable products across a broad industry spectrum, and Haile and colleagues have obtained numerous patents worldwide for the client.

The patents include methods for in vitro joining of single-stranded and double-stranded nucleic acid molecules permitting the one-step assembly of multiple nucleic acid molecules with overlapping terminal sequences and recombinant microorganisms that produce compounds such as biofuels from renewable feed stocks.

“If I’d stayed in the lab, I’d never have been able to have such a great range of work,” Haile said.

— John Roemer