High Court’s Venue Ruling Could Produce Protracted Drug Patent Litigation


The Supreme Court’s ruling about where a patent case can be heard could benefit generic drug makers and hurt the makers of the original brand, attorneys say.

When I covered the BIO IP Counsels Committee Conference in March, discussion about the potential impact of the then-undecided case spanned several sessions. The Biotechnology Innovation Organization (BIO), which sponsored the conference, urged the court in an amicus brief to affirm the flexible approach to where a lawsuit can be tried, also known as venue, that has been the practice for the last 30 years as a result of decisions by the U.S. Court of Appeals for the Federal Circuit.

The generic drug companies asked the high court to reaffirm its decision from 60 years ago, which held that patent suits can be filed only in the state where the defendant is incorporated or where the defendant has a regular place of business. They gave as one of their concerns that the Federal Circuit’s more flexible approach had resulted in forum shopping—looking for the court that will more likely rule in your favor. A reported 40 percent of patent cases have been tried in the U.S. District Court for the Eastern District of Texas.

On May 22, the Supreme Court upheld its prior decision. In an article on the Supreme Court decision written by Dana Elfin and me, we quoted Guillermo C. Artiles, an associate with McCarter & English in Washington, who told us, “Generic companies sued by biopharmas claiming the generic drug infringes the biopharma’s patent will benefit because, of course, they could be able to stay in their home court and not be dragged into district courts that have rules and procedures that are foreign to them.”

Hans Sauer, BIO’s deputy general counsel for intellectual property, told us that the number of patent cases being tried in the Eastern District isn’t good for the development of the law but that he didn’t think the Supreme Court’s decision would solve the forum shopping issue. He said the decision will force brand biopharmas to file patent infringement litigation against multiple generic defendants in different district courts, which will increase costs and could produce different outcomes.

Artiles noted that generic companies have also benefited from the streamlined procedures of courts like the Eastern District of Texas and an unexpected outcome of the ruling would be that, with protracted litigation, the brand side will have a longer time to sell their products exclusively and at the same time there will be more of a delay in bringing generics to market.

Others said it is too early to assess how the high court’s ruling will affect the drug patent litigation landscape. Bloomberg BNA will be reporting on the aftermath of the decision.

You can read our full article here.

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