Forest Laboratories, Inc. (NYSE:FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced the filing of patent infringement lawsuits in the U.S. District Court for the District of Delaware against Apotex Corp.; Hetero USA Inc.; Lupin Ltd.; Mylan Pharmaceuticals, Inc.; Par Pharmaceuticals, Inc.; Ranbaxy Laboratories Ltd.; and related companies and subsidiaries. The complaint alleges the aforementioned companies are infringing U.S. Patent No. 6,602,911 (“the ‘911 patent”), U.S. Patent No. 7,888,342 (“the ‘342 patent”), and U.S. Patent No. 7,994,220 (“the ‘220 patent”), which relate to Forest’s SAVELLA^® product. Forest licenses the ‘911 patent, the ‘342 patent, and the ‘220 patent from Royalty Pharma.

Forest and Royalty Pharma received notification from these companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications seeking approval to market generic versions of SAVELLA before the expiration of the ‘911 patent, the ‘342 patent, and the ‘220 patent. The lawsuits were commenced before the expiration of 45 days from the date of receipt of each notification letter.

On September 25, 2013, Mylan Inc. (NASDAQ: MYL) confirmed that the company has been sued by Forest Laboratories Inc. based on the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Milnacipran HCl Tablets 12.5 mg, 25 mg, 50 mg and 100 mg, which is the generic version of SAVELLA^®, and indicated for the management of fibromyalgia.

Mylan says that it believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval. A “paragraph IV certification,” 21 U.S.C. § 355(j)(2)(A)(vii)(IV), is where an entity that seeks to market a generic counterpart of a patented drug product or method of use, before the patent has expired, challenges the patent before actually marketing the drug.

It may seem odd that a claim of infringement can be made when there has yet to be a product enter the marketplace. This, however, is by design. The whole purpose of the Hatch-Waxman Act was to make it easier for a generic drug manufacturer to piggyback on the studies previously submitted by the original inventor of a new drug. Thus, in the U.S., in order for a new drug to receive market approval, a New Drug Application, known as an NDA, must be submitted to the FDA.  To lessen the burden on generics, Hatch-Waxman allows generic manufacturers to submit ANDAs.  In the event that the generic manufacturer can establish that the drug mentioned in the ANDA is the bioequivalent of a drug approved in a NDA, the generic manufacturer can sail through approval by relying on the costly and time-consuming studies previously submitted as a part of the NDA.

The patent wrinkle associated with Hatch-Waxman comes because ANDA filers must make one of four different assertions or statements: either (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be infringed by the drug covered in the ANDA.  It is the paragraph IV certifications that are the most interesting.

Thanks to Hatch-Waxman, the patent owner is allowed to treat the paragraph IV certificate as an act of infringement despite no truly infringing activities in the marketplace. In other words, the mere filing of a Paragraph IV certification is an act of technical infringement as defined by the statute. As with all Paragraph IV-related patent infringement cases, the parties can be expected to litigate the issues of infringement, validity, and enforceability of the underlying patents. For more on paragraph IV certifications, see A Primer on Paragraph IV Certifications.

For the 12 months ending June 30, 2013, SAVELLA had U.S. sales of approximately $123 million, according to IMS Health. The ‘911 patent expires in January 2023, the ‘342 patent expires in November 2021, and the ‘220 patent expires in September 2029.

Tags: Abbreviated New Drug Application, ANDA, FDA, Forest Laboratories, Hatch-Waxman Litigation, NDA, New Drug Application, patent, patents, SAVELLA

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