"Statutory" Obviousness-Type Double Patenting for Pharma Patents?
As all patent practitioners know, obviousness-type double patenting is a judicially created doctrine to prevent the unjust extension of patent term of follow on patents that are simply obvious variants of earlier patents. The doctrine is applied during prosecution with the USPTO and can be used to challenge the validity of issued patents in contested matters. 35 USC 121 also speaks to this issue in certain circumstances.
On June 12, 2019, Representatives Hakeen Jeffreies and Doug Collins issued a press release touting their new proposed bill “Terminating the Extension of Rights Misappropriated” (TERM) Act of 2019. The bill purports to “address the rising cost of prescription drugs by significantly limiting the process known as “evergreening”, whereby pharmaceutical companies make minor changes to a drug and file for a new patent on those trivial changes in order to extend their exclusivity and maintain high prices.” See, https://jeffries.house.gov/media-center/press-releases/reps-jeffries-collins-introduce-bipartisan-legislation-to-lower.
The core text of the bill is:
‘‘(c) DISCLAIMERS OF DRUG PATENT TERM.—
‘‘(1) IN GENERAL.—Except as provided in paragraph (2), in a proceeding challenging the validity of patents under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) with respect to a drug, under section 351(l) of the Public Health Service Act (42 U.S.C. 262(l)) with respect to a biological product, or a Federal district court proceeding involving patents that are the subject of an action under section 271(e)(2), 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 patent expires, subject to the exceptions provided for in subsection (2).
‘‘(2) DEMONSTRATION OF DISTINCT INVENTIONS.—If a patentee demonstrates by a preponderance of the evidence that certain patents described in paragraph (1) cover patentably distinct inventions from the invention claimed in the first such patent to expire, no part of the term of any such patent shall be presumed to have been disclaimed, and all patent term extensions granted by the United States Patent and Trademark Office shall be respected, unless and to the extent the patentee expressly disclaims, in writing, the patent term for each such patent.’’.
In short, the bill presumes obviousness-type double patenting of any subsequent orange book listed patent and shifts the burden to the patentee to demonstrate otherwise. I guess the sponsors and co-sponsors of this bill do not have high confidence in the USPTO in finding and applying such rejections during prosecution and despite the statutory “safe harbor” provisions in 35 USC 121. Nor do they think generic manufacturers challenging the validity of an orange book listed patent would have considered obviousness type double patenting.
The broader goal of lowering costs for prescription drugs would seem to me to be largely unaffected by this proposed bill. It will be interesting to see if this bill gets off the ground.