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.