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.
Whoever drafted this bill may have thought it a distinction with a difference to not negate the presumption of validity attached to issued patents but, rather, in section (2), to attach a presumption that each later-filed listed patent is an obvious variant of the first-filed patent. In other words, the later-filed patents may be valid per se, but they represent an impermissible extension of patent term under the judicial doctrine of obviousness-type double patenting. Patentee must prove that there is no obvious-type double patenting over the first-filed patent, to escape the presumption of disclaimer.
Of course, patentee may well have already demonstrated to the Examiner the non-obviousness of the invention disclosed in the later-filed patent over the first-filed patent– in some cases, the PTAB or the Fed. Cir. will have also ruled for the patentee. If patentee has not done so, there will be a terminal disclaimer on file and the act will not affect such patents. In some cases, the Examiner may have failed to find obviousness-type double patenting. Now the patentee must somehow prove that the Examiner was correct.
So apart from the procedural conundrums posed by this bill, will it help generics who face a “thicket” of, say, fifteen “add-on patents”, all of which claim features of the drug, the method of its use, delivery systems, dosing regimens, purity difference, etc., etc.? Even if they are found – somehow – to all expire on the same day, the generic still has to prove that they are all obvious variants of the claims [?] of the first filed patent in order to get to the market. The statutory presumption of infringement in s. 271(e)(2) is still in place. As Keven O’Leary likes to say when he encounters a product on Shark Tank that he believes will not find a market, “Take it out behind the barn and shoot it.”