“1st Circuit reverses dismissal of antitrust suit vs. Sanofi“

Partner Craig Smith quoted in Massachusetts Lawyers Weekly

Craig R. Smith said the case highlights some of the issues in deciding whether to list a patent in the Orange Book.

“One of the dilemmas companies face is deciding what is considered a patent for a ‘drug’ or ‘drug product’ relating to the drug you’d gotten your initial patent on,” said Smith, an IP lawyer in Cambridge. “There’s a question of how do you comply with the regulation.”

Smith said that companies have asked the FDA for guidance on whether they should list a patent.

“They’ve never provided an answer that is clear enough for people to know for sure whether they should be filing or the approach they should take going forward,” Smith said.

Read the full article on Massachusetts Lawyers Weekly