Pharma, Biotech IP Counsel Expect a Litigious Year

Lisa Shuchman

Corporate Counsel

03-14-2013

Nearly half of the chief IP counsel working in the pharmaceutical and biotech industries who participated in a new survey indicated that their companies are currently involved in patent infringement litigation—and 43 percent said there was a “very high” likelihood that they would file a claim for patent infringement in the year ahead.

“That’s a pretty significant number,” said Paul Mandell, founder and chief executive of global consultants Consero Group. “It speaks to the importance of patent protection in the pharma and biotech space.”

An additional 10 percent of counsel surveyed said the likelihood they would file a claim for patent infringement in the next 12 months is “high.”

The results of the survey, “2013 Chief Intellectual Property Counsel Data Survey for the Pharmaceuticals and Biotechnology Industry” [PDF], are based on responses given by 38 chief IP counsel from pharmaceutical and biotechnology firms.

While the sample is small, the response calls attention to some of the challenges faced by the pharmaceutical and biotechnology industries. Big Pharma stands on the edge of a patent cliff, with patents on many major drugs that treat such varied conditions as asthma, high cholesterol, and depression scheduled to go off patent by 2016. The industry, like every other sector, will also have to contend with global prior art and prepare to fight in new PTO proceedings during and after the patent examination process under the new first-inventor-to-file system that goes into effect this week under the America Invents Act. In addition, the courts—including the U.S. Supreme Court—have been scrutinizing the patentability of subject matter related to biotechnology, raising uncertainty in the industry.

These factors are forcing IP counsel in the pharmaceutical and biotechnology companies to more rigorously protect their intellectual property—both offensively and defensively.

“Few would dispute that litigation is an increasingly common strategic business tactic, or that patent infringement has never been a greater challenge for global companies—particularly in the pharmaceuticals and biotechnology industries,” the report said.

Mandell said the IP counsel participating in the survey, who were attendees at a pharmaceutical and biotechnology IP forum hosted by Consero in December, described a “ferocity of competition” in their industry that has led to increased claims of patent infringement.

“If the surveyed participants are a reasonable representation of chief IP counsel at Fortune 1000 companies in the pharmaceuticals and biotechnology industries, the next 12 months for this category of in-house counsel should be quite busy,” the report said.

The survey also found that the IP counsel had access to substantial resources, with the median in-house legal budget of surveyed participants between $2.5 million and $5 million. Staff size remained stable in 2012 compared to 2011, with 45 percent reporting no change in their staff size, the report said.

“With most of the respondents expecting to file litigation of their own, the trend of generally increasing budgets and steady or increasing departmental staff size to accommodate swelling IP demand seems all but certain to continue,” Mandell said.