Orange Book Blog

In a case of first impression, the U.S. District Court for the Southern District of New York held, on cross motions for summary judgment regarding available remedies, that an Orange Book listing of patents protecting an approved drug was not effective public notice under the patent marking statute, 35 U.S.C. 287(a).  Merck & Co. v. Mediplan Health Consulting, No. 05 Civ. 3650 (S.D.N.Y. June 14, 2006).  As a result, the damages available to Merck were limited to those accruing after the date on which the lawsuit was filed, rather than those accruing after the date on which Merck listed the patent in suit in the Orange Book.

The case involves Mediplan's operation of an on-line Canadian pharmacy that offered a generic version of Zocor (simvastatin) for sale to U.S. customers, prior to expiration of Merck's simvastatin patents.  Mediplan apparently did not file an ANDA, as is required for FDA approval of generic drugs in the U.S.  Merck sued Mediplan for infringement of U.S. Patent No. 4,444,784, which included both composition and method claims to simvastatin.  As required under the Hatch-Waxman Act, Merck listed the '784 patent in the Orange Book.

It was undisputed at trial that Merck failed to "mark" its Zocor product, as called for by 35 U.S.C. 287(a).  Merck asserted only the method of use claims against Mediplan, and argued that it was not required to comply with the marking requirement, which does not apply to patents for only a method or process, since no physical item exists to be marked.  The court held that marking is required where the patent includes both composition and method claims, even if only the method claims are asserted.

The court then turned to Merck's argument that its Orange Book listing served as effective public notice under the marking statute.  The court noted the lack of precedent in the case, and proceeded to focus its analysis on the judicial interpretation of the marking statute as requiring a specific infringement charge against a specific product, and that general statements to the industry about the patent's existence do not meet this standard.  The court, finding that the Orange Book "is merely a catalog that informs the public of the patent's existence," held as a matter of law that Orange Book listing of the simvastatin patents was not adequate notice under the marking statute.

In rebutting Merck's arguments that the Orange Book is not just a generalized warning, the court noted that Merck did not send a copy of the relevant listing to Mediplan, or reference Mediplan or their products.  The court rebuffed Merck's policy arguments, as beyond the appropriate inquiry of the court.

The court's ruling is sure to raise eyebrows.  Orange Book listing of patents covering an FDA-approved drug is required under federal law.  The listing regulations make clear that the drug maker can list only those patents on which it could reasonably sue a third party for patent infringement for making or using the drug without the drug maker's approval.  Generic drug manufacturers seeking to gain FDA approval to market a generic version of an FDA-approved drug are required to make a certification with respect to patents listed in the Orange Book for the relevant FDA-approved drug.

Thus, any generic manufacturer operating within federal law is required to consult the Orange Book prior to filing its ANDA to determine whether its manufacture of a specific drug is likely to result in patent infringement, and will identify the relevant listed patents.  This certainly would appear to provide notice of the existence of patents covering the drug, as required under the patent marking statute.  It is not clear why a generic manufacturer operating outside the federal scheme for generic drug approval, like Mediplan in this case, should benefit by avoiding review of the Orange Book listings for drugs they intend to market in the United States.