A bill was recently proposed to “reduce the improper issuance of patents that improperly extend the term of exclusivity afforded a new drug or biological product.” The bill would amend the patent statutes (s. 253 or title 35) for add the following language:
(c) Disclaimer of Drug Patent Term —
- In General—Except as provided in para. 2 [of this bill], in a proceeding challenging the validity of patents under section 505(c) of the [FFDCA] (21 USC 355(c)) with respect to a drug, under section 351(1) of the [PHS] (42 USC 262(1)) with respect to a biological product, or a federal district court proceeding involving patents that are the subject of an action under 271(e)(2), [Hatch-Waxman provisions], the patentee shall be presumed to have disclaimed the patent term for each of the listed patents after the date on which the term of the first [listed?] patent expires, subject to the exceptions provided for in subsection (2)… [which says that if a patentee demonstrates by a preponderance of evidence that certain patents described in para. (1) cover patentably distinct inventions from the invention claimed the first such patent to expire, [then “never mind.”].
Of course, this bill effectively puts terminal disclaimers on all of the later-filed patents listed in, e.g., the Orange Book for the drug under attack by the generic drug company. It begins with the “presumption” that all of the later patents are obvious variants of the first “blocking patent.” Even though the patentee has demonstrated that the invention is patentable during prosecution (and even after appeal in some cases), patentee will now have to prove that any patents that patentee did not terminally disclaim over the first-filed patent in the first instance were properly granted.