Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its investment without fear of generic competition. Even a few months of additional patent term can mean the difference between millions of dollars or several billion dollars. This short article will highlight the provisions put in place for patent owners to be compensated for up to 5 years of patent term lost while developing a product and obtaining FDA approval.
Eligible FDA-approved products
Products eligible for patent term extension (PTE) include human drugs[i], human biological products such as viruses, therapeutic sera, toxins, antitoxins, vaccines, blood/blood components or derivatives, allergenic products, or analogous products[ii], animal drugs and veterinary biologics, medical devices, and food or color additives subject to regulation under the Federal Food, Drug, and Cosmetic Act (FFDCA).[iii]
Patents eligible for PTE are those that claim a product, a method of using the product, or a method of manufacturing the product. 35 U.S.C. Section 156(a) sets forth conditions for granting PTE:
a. the term of the patent has not expired before an application is submitted;[iv]
b. the term of the patent was never extended;[v]
c. the application for extension was submitted by the owner of the patent or its agent, within the 60-day period beginning on the date the product received permission for commercial marketing or use;[vi],[vii]
d. In addition, the product has been subject to a regulatory review period before its commercial marketing or use, and
e. permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.[viii]
For combination drug products that contain more than one active ingredient, so long as at least one of the active ingredients is new to the marketplace, the patent covering the combination drug product is eligible for PTE.[ix]
Scope of Protection During the Extended Period
During the extended period, the scope of protection is limited to "any use approved for the product" if the patent claims a product, and to "any use claimed by the patent and approved for the product" if the patent claims a method of using a product.[x] In Merck & Co., Inc. v. Kessler (1996), the Federal Circuit indicated that "the restoration period of the patent does not extend to all products protected by the patent but only to the product on which the extension was based."[xi]
The effective patent term including the restoration period cannot exceed 14 years following FDA approval of the new drug.[xii] And, the relevant regulatory review period for calculating the length of the PTE is the review period that occurred after issuance of the patent.[xiii] Even though the patent owner may submit multiple patent applications to the USPTO based on the same regulatory review period, ultimately one patent must be chosen for PTE.
The Federal Food, Drug, and Cosmetic Act & the Public Health Service Act
The FFDCA and the Public Health Service Act (PHSA) contain statutory provisions under which regulatory review can occur. These provisions are:
- Section 505 of the FFDCA for human drugs
- Section 505 of the FFDCA and Section 351 of the PHSA for biologics
- Section 515 of the FFDCA for medical devices
- Section 512 of the FFDCA for animal drugs
- Section 409 or section 721 of the FFDCA for food or color additives
A product as described in 35 U.S.C. section 156 can be approved under one or more of these sections. In other words, each provision can have its own first permitted commercial marketing or use of a product. This means that a product may be eligible for PTE under one section of the FFDCA even if it was previously approved by the FDA under a different section of the FFDCA. For example, a patent covering a product may be entitled to PTE if the product received the first commercial marketing approval under section 505 of the FFDCA even if it was previously approved under section 512. For instance, the USPTO granted 5 years of PTE to U.S. Patent No. 5,985,320 covering the animal product OvuGel (active ingredient: triptorelin acetate), which was approved under section 512 of the FFDCA. The PTE was granted for OvuGel even though another salt, triptorelin pamoate, was previously approved for human use as Trelstar under a different section of the FFDCA, section 505, for U.S. Patent No. RE42072 (reissue of U.S. Patent No. 6,908,623).[xiv]
Another example is everolimus. Here, the USPTO granted 5 years of PTE to U.S. Patent No. 5,665,772 covering the human product Afinitor (active ingredient: everolimus), which was approved under section 505 of the FFDCA. Prior to that, PTE was granted for Xience V Everolimus Eluting Coronary Stent System which was approved for human use under a different section of the FFDCA, section 515, for U.S. Patent No. 5,451,233.
With the complexities associated with a PTE application, one must carefully consider the appropriate section of the relevant statute under which to apply for PTE and analyze the relevant eligible patents.[xv]