By Lori Valigra (Mass High Tech, Feb 15, 2012)--The U.S. Food and Drug Administration’s recently issued guidance for development of biosimilars, which could take a bite out of both escalating drug prices and drug company profits, has upped the stakes for intellectual property protection at biotech and pharmaceutical companies, causing them to assess their patent positions and look at other safety devices such as trade secrets, a Boston-based patent lawyer said.

“Companies are starting to think about what to patent and what to keep as a trade secret, and how to protect a trade secret,” Konstantin Linnik, an intellectual property (IP) attorney at Nutter McClennen & Fish in Boston, told Mass High Tech. Linnik was formerly a senior corporate counsel at Pfizer.

With 2014 looming as a year when a lot of drugs will come off patent, Linnik said the ensuing litigation will be very different than earlier lawsuits due to the new law. This will be both in terms of which patents will be asserted and how IP will be protected. This is especially true as companies try to get more mileage out of their blockbuster drugs by creating “biobetter” products, which are improvements the companies themselves make to existing drugs as they try to essentially extend IP protection.

“For biobetter products, the improvements they make are often incremental in nature. The patent office typically rejects this, so they have to look at how get a patent on a biobetter and how broad it will be,” he said.

This has brought a long-established practice, trade secrets, front and center. Most pharmaceutical companies haven’t focused on trade secrets, although biotechs have used them, particularly for manufacturing processes, which often are crucial to a new drug’s success. Manufacturing processes are patent eligible, but require disclosure of all information about how the invention is enabled. But that opens the door for competitors to look at the details and design around them, Linnik said.