Fewer challenges to patents listed in the FDA’s Orange Book of approved drug products are being launched at the U.S. Patent and Trademark Office, as generic drug companies refine their strategies against brand-name manufacturers.
Patents in the Food and Drug Administration’s Orange Book are extremely valuable because they protect brand name drug products from generic competition.
Generic drug makers have become more selective about which patents they target for challenge in the agency’s Patent Trial and Appeal Board’s inter partes review program, attorneys say. The reviews haven’t turned out to be an easy method to attack drug patents as some ...