The Rise of Double Patenting
Congress allows the granting of a patent to any proprietor who invents a new machine, manufacture or composition of matter, as well as any proprietor who improves an invention in a way not previously known.[1] The double patenting doctrine addresses patenting improvements by prohibiting two types of double patenting.[2]
The two types of double patenting are “same invention” type double patenting and “obviousness type” double patenting.[3] First, a double patent may be rejected under the same invention interpretation which states that one proprietor may obtain a patent for a single invention.[4] Second, a double patent may be rejected for “obviousness type” double patenting which is aimed at preventing expanding the patent term by prohibiting claims that a composition or matter found in an earlier patent is “new.”[5]
The “obviousness type” double patenting often appears and is heavily litigated within the pharmaceutical industry. Pharmaceutical companies often obtain second patents for molecular compositions covered by their earlier patents in an effort extend their exclusive rights and profits prior to generic manufacturers entering the market.[6] Pharmaceutical companies often argue that their second patent reflects a different invention than that which the first patent covers, and that the composition in the second patent was not obvious when filing for the first patent.[7]
On February 16, 2021 Judge Raymond Chen of the Federal Circuit affirmed this line of argument in a double patenting suit brought by two generic drug manufacturers against Takeda Pharmaceutical Co. (“Takeda”), stating “[w]hile motivation and reasonable expectation of success need not be expressly disclosed by the prior art itself and may instead come from the background knowledge of the skilled artisan, merely asserting that a given modification would have been obvious to a skilled artisan does not make it so.”[8]
In the lawsuit mounted against Takeda, the generic manufacturer plaintiffs argued that Takeda’s double patenting scheme harmed competition in the pharmaceutical market. [9] Specifically, the plaintiffs argued that Takeda’s second patent for the Type II diabetes treatments was merely a modified version of another patent, asserting that the patent should be rejected under the “obviousness-type” double patent theory.[10] Judge Raymond Chen denied this argument, pointing out that in the pharmaceutical industry “slight changes on the molecular level” highly impact the nature and effects of a single treatment.[11]
The Federal Circuit’s ruling in this suit reflects the trajectory that courts are on in allowing double patenting in the pharmaceutical industry. As Judge Chen points out, the pharmaceutical industry is unique in that a small molecular change may completely change the invention;[12] however, allowing double patenting of this manner increases the number of patents in the industry. Increased patents result in higher prices for the patented drugs, and have the possibility of decreasing innovation in the industry by generic manufacturers.[13]
Footnotes
