FDA requires that pharmaceutical companies create and maintain pre-approval batch records for both generic and brand drugs.
In general, a company can do so without risking infringing any patents covering manufacture of a drug. Congress enacted the
so-called "safe harbor" provision of the Hatch–Waxman Act in 1984 specifically allowing pharmaceutical companies to test their
products prior to obtaining regulatory approval to market them (1). Under that provision:
(DORLING KINDERSLEY/GETTY IMAGES)
It shall not be an act of infringement to make, use, offer to sell, or sell . . . 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 or veterinary biologic products (2).
But what happens if the company is sued for infringement after it obtains approval from FDA? Until recently, most in the legal
industry would have said that postapproval batch testing is not protected by Hatch–Waxman. As recent as 2011, in Classen Immunotherapies, Inc. v. Biogen IDEC, the Federal Circuit Court of Appeals—the final authority on most patent matters—decided that the safe harbor does not apply
to "information that may be routinely reported to the FDA, long after marketing approval has been obtained" (2). Classen had
accused Biogen and GlaxoSmithKline (GSK) of infringing Classen's patent relating to an immunization method (3). The patented
method involved screening immunization schedules and selecting and administering the schedule that presented the lowest risk
of developing certain immune-mediated chronic disorders later in life (4). As part of an FDA study, Biogen and GSK used the
patented methods to provide vaccines, advise on immunization schedules, and report adverse vaccine effects to FDA (5). Biogen
and GSK contended that their activity fell within the safe harbor (6). But the Federal Circuit disagreed, concluding that
the provision only provides a safe harbor to expedite the development of information for regulatory approval of generic counterparts
of patented products. GSK and Biogen were held not immune from Classen's suit.
But in August 2012, the same court decided in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., (7) that the safe harbor provision indeed might immunize postapproval activities. The patent at issue in Momenta covered a method for analyzing batches of enoxaparin, a synthetic version of the blood-thinning agent heparin (8). Because
of enoxaparin's unique chemical makeup, FDA requires batch analysis as a condition for the post-FDA approval sale of the drug
(9). Momenta claimed that Amphastar's quality control testing of its enoxoparin batches infringed Momenta's patent; Amphastar
argued that its testing fell within Hatch–Waxman's safe harbor because FDA required the testing (10). The Federal Circuit
determined that § 271(e)(1) unambiguously covers any activity reasonably related to developing and submitting information
under a federal law that regulates the manufacture, use, or sale of drugs regardless of whether the activity occurs pre- or
The decision has major consequences for the industry. If the Hatch–Waxman Act protects postapproval batch testing, the value
of patents on analytical methods, particularly covering biosimilars, may significantly decrease.
Chief Judge Rader, who authored the majority opinion in Classen, issued a lengthy and sharply worded dissent in Momenta, criticizing his fellow judges for failing to follow Classen (12). Judge Moore, who authored the majority opinion in Momenta and a dissent in Classen, saw it differently. She squared the Classen and Momenta decisions noting that, in Classen, there was no requirement that Biogen or GSK submit any data to FDA. By contrast in Momenta, FDA required analytical records for each batch of enoxoparin produced in order to maintain regulatory approval (13).