Lakshmi Kumaran & Sridharan AttorneysAn ISO 9001 / 27001 certified law firm

Patent for process of testing – Use in ‘manufacture’

28 December, 2015

The Court of Appeals of the Federal Circuit, in respect of a process patent for testing a drug, has held that infringement only occurs under 35 U.S.C. § 271(g), as a result of “making” a product, and does not extend to testing to determine whether an already synthesized drug substance possesses existing qualities. Section 271(g) prohibits the unauthorized importation into the United States, or sale or use within the United States, of a “product which is made by a process patented in the United States”. The patentee here was of the view that “made” means “manufactured,” and that its patented method is “a crucial interim step used directly in the manufacture of defendant’s product”. The Court however in the case of Momenta Pharmaceuticals Inc. v. Teva Pharmaceuticals USA Inc has held that it is more consonant with the language of the statute to limit § 271(g) to the actual “making” of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made.

It was however held that routine quality control testing of each batch of a generic drug as part of the commercial production process, after FDA approval, is not protected by the Hatch-Waxman Safe Harbor provision of 35 U.S.C. § 271(e)(1). The said provision states that there is no infringement in use of a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs”. It was held that the routine quality control testing of each batch of generic drug as part of the post approval, commercial production process is not “reasonably related to the development and submission of information” to the FDA.
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