In Hatch-Waxman litigation, the filing of an ANDA seeking approval to market a pharmaceutical product before the expiration of patents covering that product is a technical act of infringement sufficient to establish jurisdiction to resolve the issues of patent infringement and validity in litigation. The ultimate question of infringement, however, is established in the litigation that follows the ANDA filing by considering whether the product that is likely to be sold would infringe the patent.
Two recent Federal Circuit cases address when a court should determine infringement by reference to the ANDA specification alone, and when it must look to the physical product that is likely to be sold.
In theory, there are four different ways an ANDA specification can relate to infringement. First, the ANDA specification could preclude the sale of an infringing product by specifying product properties outside the scope of the claims of the patent in suit. In that situation, the ANDA filer could not legally sell a product with infringing properties. Second, the ANDA specification could require the sale of an infringing product by including product specifications which could only result in a product that infringes the patent in suit. Third, the ANDA specification could permit a range of properties, some of which infringe and some of which do not infringe, which in theory would allow the ANDA applicant to sell either an infringing product or a non-infringing product. Fourth, the ANDA could be silent with respect to properties which result in infringement, which again would permit the ANDA filer to legally sell a product that infringes as well as one that does not infringe.
The first possibility is addressed in Bayer AG v. Elan Pharmaceutical Research Corp. In Bayer, the ANDA specification required product criteria that did not infringe the patent, and although a sample of the physical product submitted to the FDA was alleged to infringe, the court held that there was no infringement because the ANDA precluded the generic company from legally selling a product with infringing properties.
Logically, in the second possible case, where the ANDA specification mandates that the product fall within the patent claims, infringement should be established by reference to the ANDA alone because the ANDA filer would be legally precluded from selling a non-infringing product after ANDA approval. There would be no need to examine the physical product submitted to the FDA as a “biobatch” sample of the product.
The third scenario is represented by the case Sunovion Pharm. v. Teva Pharm. USA, Inc. InSunovion, the patent claim required less than 0.25 percent of a particular L isomer. The ANDA specification permitted a range of 0.0 to 0.6 percent of the isomer, but the ANDA applicant certified that its internal manufacturing guidelines required its generic product to contain at least 0.3 percent of the isomer which was arguably outside of the patent claim. The ANDA holder further asserted that it would not manufacture the product in the infringing range. The Federal Circuit held that the ANDA specification alone established infringement because the ANDA filer could legally change its product within the ANDA specification to one that infringed the patent. It held that when an ANDA specification defines a compound such that it meets the limitations of the asserted claims, the ANDA infringes regardless of the filer’s stated intentions.
The fourth scenario is represented by the recent case of Ferring B.V. v. Watson Laboratories, Inc.In Ferring B.V., the patent claimed certain dissolution profiles, but the ANDA specification was silent on the specific dissolution criteria claimed in the patent. In that circumstance, the ANDA filer could in theory make and legally sell a product that infringed the patents as well as one that did not infringe the patents. The Federal Circuit held that in those circumstances, like the Glaxocase, the court should determine infringement by testing the physical product the ANDA filer submits to the FDA. (The ANDA applicant, however, avoided infringement by amending its ANDA specification to require a dissolution profile that did not infringe the claims. This amendment, in accordance with the Bayer case discussed above, established noninfringement without further reference to the product.)
The Federal Circuit’s discussion on Sunovion, where the patent specification contained a range of criteria some of which would allow an infringing product and some of which would preclude an infringing product, seems inconsistent with its decision in Ferring B.V., where the ANDA specification was silent regarding the infringement criteria. In both cases the ANDA specification permitted the ANDA filer to make and sell a product which infringes as well as one which does not infringe, but the Federal Circuit reached different conclusions on infringement.
While one could question the logic of the distinction made by the Federal Circuit, the practical effect is clear: An ANDA filer can avoid needless disputes against the filer’s physical product itself by filing an ANDA, where possible, that requires product properties which are not infringing. And as Ferring B.V. demonstrates, it is possible to await the court’s claim construction and development of litigation positions before amending the ANDA in the manner that would preclude patent infringement.