Opinion ID: 212098
Heading Depth: 3
Heading Rank: 2

Heading: The 2003 Medicare Amendments

Text: 10 Congress recently enacted the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub.L. No. 108-173, 117 Stat.2066. The Act was signed into law on December 8, 2003. Title XI of the Act, entitled Access to Affordable Pharmaceuticals, makes numerous changes in the Hatch-Waxman Amendments (Medicare Amendments). Among the changes is a provision for a civil action to obtain patent certainty. 21 U.S.C. § 355(j)(5)(C) (Supp.2004). Pursuant to that provision, if the patentee or NDA-holder does not bring an infringement action within forty-five days after receiving notice of a paragraph IV certification, the ANDA applicant may bring a civil action for a declaratory judgment that the patent at issue is invalid or will not be infringed by the drug for which the applicant seeks approval. Id. In exchange, the ANDA applicant must make an offer of confidential access to its ANDA application so that the patentee or the NDA-holder can evaluate possible infringement. Id. The Medicare Amendments also provide that when the above circumstances are met, courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought ... under section 2201 of title 28 for a declaratory judgment that such patent is invalid or not infringed. 35 U.S.C. § 271(e)(5) (Supp.2004). 11 Congress also addressed the statutory scheme surrounding the 180-day market exclusivity period. Congress replaced the traditional court decision trigger with a more complex set of 180-day provisions. See 21 U.S.C. § 355(j)(5)(D) (Supp.2004). However, the Medicare Amendments provide that these new forfeiture provisions are effective only with respect to those applications filed after December 8, 2003, for which no paragraph IV certification was made before December 8, 2003. Medicare Prescription Drug, Improvement and Modernization Act of 2003, § 1102(b), 117 Stat. at 2460. Thus, the new forfeiture provisions do not apply in this case.