U.S. Supreme Court Decision Places Onus of Patent Infringement on Challenger

A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for drugmakers to sue for patent infringement, a patent law attorney said.

The 6-2 ruling, with one abstention, in Commil USA v. Cisco Systems means plaintiffs will no longer need to prove their patents are good to bring a claim, says Jonathan Losk, a partner with Knobbe Martens. Previously, defendants could not be held liable for infringement if they had a good faith belief the patent was invalid.

The case involved allegations by Commil that Cisco infringed upon a patent for a method of implementing short-range wireless networks. The case went to trial and Cisco was held liable for direct and induced infringement, despite the defendant’s claim that it had a “good-faith belief” that the patent was invalid. The U.S. District Court for the Eastern District of Texas deemed Cisco’s supporting evidence inadmissible, and the Federal Circuit affirmed the decision.

In upholding the appeals court and lower court rulings, the Supreme Court said “a defendant’s belief regarding patent validity is not a defense to an induced infringement claim.”

While this is good news for drugmakers, there are steps that can be taken to better protect intellectual property, says Losk. For starters, companies should file separate patents on the drug, the formulation and mode of action and the manufacturing process, if applicable. Patent applications should “give breadth and length to your intellectual property protections,” Losk says. He spoke at an FDAnews webinar.

Companies should take extra care to protect critical assets — those that, if usurped by competitors, could disrupt the business, Losk warns. This normally involves identifying an asset owner, implementing primary and secondary safeguards and restricting access based on the need to know. In addition, firms should forensically capture and review every computing asset when it is replaced or when an employee leaves.

Losk also recommends correlating patents with business value models by developing a list of key clinical value features and mapping patent claims against these features.

View the decision in Commil USA v. Cisco Systems at www.fdanews.com/06-01-15-CommilvCisco.pdf. — Elizabeth Orr