By Carmella L. Stephens, Ph.D.

The Court of Appeals for the District of Columbia recently held that it is not necessary that an applicant seeking to market a generic version of a drug to have "successfully defended" a patent infringement action to qualify for a 180 day marketing exclusivity. Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 46 U.S.P.Q.2d 1385 (D.C. Cir. 1998).

Before marketing a new drug, manufacturers must obtain FDA approval of the drug by filing a New Drug Application ("NDA") which includes data demonstrating the safety and efficacy of the drug. In 1984, in an effort to save time and cost, Congress enacted the Hatch-Waxman Amendments which established a procedure wherein FDA approval of a "generic drug" could be obtained through the filing of what is referred to as an "Abbreviated New Drug Application" ("ANDA"). In addition to showing proof of bioequivalence to the previously approved drug and proof of proper manufacturing procedures, the ANDA applicant must certify to the FDA that a patent covering the listed drug is either invalid or non-infringed. This ANDA Certification is provided for in 21 U.S.C.§ 355(j)(2)(A)(vii)(iv) and is referred to as a "paragraph IV certification".

Should a patent exist covering the listed drug, the ANDA applicant can also certify that marketing will not occur until after the patent expires. However, if a paragraph IV certification is filed the applicant is required to give notice to the patent holder that an ANDA has been filed. The notice must specify in detail the basis for applicant's belief that the patent is invalid or non-infringed. Once notice has been given, the patent holder has 45 days to file an infringement lawsuit against the ANDA applicant pursuant to 35 U.S.C. § 271(e)(2). Should the patent holder choose to file an infringement lawsuit, ANDA approval is automatically suspended for 30 months.

In instances where more than one ANDA has been filed on a particular drug, the first filed ANDA may be entitled to 180-days of marketing exclusivity following approval against later filed ANDAs. It is usually the case that the first generic company to market a generic drug will often acquire a larger initial market share and will retain that larger market share. Thus, an important marketing benefit is provided to the first ANDA applicant who is entitled to the 180 day marketing exclusivity.

The FDA's interpretation of §355(j)(5)(B)(iv) as it relates to the 180-day marketing exclusivity is contained in regulation 21 CFR §314.107(c)(1), which states that the 180-day marketing exclusivity is available only if "...the applicant submitting the first application has successfully defended against a suit for patent infringement brought within 45 days of the patent owner's receipt of notice...." The FDA's interpretation of §355(j)(5)(B)(iv) was recently contested in Mova.

Mova filed an ANDA with a paragraph IV certification seeking FDA approval to market a generic version of a drug used to treat diabetes. Upjohn the holder of a patent covering the drug, filed a patent infringement suit against Mova, automatically staying FDA approval of Mova's ANDA for up to 30 months. Subsequent to Mova's filing of their ANDA, Mylan Pharmaceuticals Inc. filed its own ANDA for the same drug. Upjohn did not file an infringement suit against Mylan and the FDA approved its ANDA. The FDA ruled that since Mova had not "successfully defended" the infringement suit it was not entitled to the 180-day exclusivity period.

In Mova, the D.C. Circuit stated that "...the FDA's successful defense requirement is inconsistent with the unambiguously expressed intent of Congress. The rule is gravely inconsistent with the text and structure of the statute. Nor can the FDA show that the successful defense requirement is needed to avoid a result demonstratively at odds with the intentions of the [section 355(j)(5)(B)(iv)'s] drafters." Mova, at 1392. Thus, pursuant to Mova, the first party to file an ANDA is entitled to the 180 day marketing exclusivity regardless of whether it has prevailed in litigation.

For further information please contact us.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.