Vernon M. Winters

Sidley Austin LLP

San Francisco

Patent litigation

Winters found himself in patent law partly by "serendipity." Early in his career, he said, he was fortunate to be trained by some of the best patent trial lawyers in the country.

Today, Winters is a nationally recognized patent litigator and counselor for the life sciences and technology industries.

Last August, he scored a victory for Amgen Inc. and its subsidiary Immunex in a precedent-setting biologics patent dispute regarding their rheumatoid arthritis drug Enbrel.

Novartis International AG's Sandoz unit sought to invalidate patents that protect Enbrel, so it could sell a biosimilar version of the drug.

The stakes were high as Enbrel accounts for more than 20% of Amgen's annual sales. Immunex Corp. et al. v. Sandoz Inc. et al. 16-CV01118 (D. N.J., filed Feb. 26, 2016).

Sandoz argued that the patents covering Enbrel's active ingredient should not have been granted because those concepts were already contained in previous patents.

During the trial, Amgen's attorneys "stayed true to the science," Winters said.

"Patent cases exist on multiple levels, so you need to have a narrative that is factually true but also resonates with a fact finder, whether that's a jury or a judge. We had one," he said.

"Enbrel was and is a tremendously innovative drug that has brought life-changing relief to thousands of patients," Winters added.

The judge ruled in Amgen's favor.

"Defendants have failed to show by clear and convincing evidence that the Patents-in-Suit are invalid," wrote U. S. District Judge Claire C. Cecchi in her decision.

The court's decision means Amgen will have market exclusivity until 2029. Amgen shares closed up nearly 6 percent after the ruling.

The case could serve as a precedent for future decisions on biologics patent issues. Of note is Cecchi's finding that creating a biosimilar does not demonstrate the obviousness of the patent on a referenced biologic.

While the case has some speculating whether the decision will discourage biosimilar competition, the implications, Winters said, have yet to be determined.

Sandoz is appealing the verdict.

Winters gave credit for the win to his legal team, along with Amgen's in-house lawyers.

"We had a lot of people on the case throughout, but especially at the trial site," he said, "and these are people that make real material contributions."

"Trials are team efforts."

-- Jennifer Chung Klam