Court: FDA’s Role is Not to Analyze Patent Claims

Alphapharm PTY v. Tommy G. Thompson (Secretary of HHS) (D.D.C. 2004) (CA 03-2269).

 

By Mark Chael

Recently, the District Court in Washington, D.C. agreed with the Federal Circuit, the Fourth Circuit, and a District Court in Maryland by determining that the listing of patents in the Orange Book by the Food and Drug Administration (FDA) is merely “a ministerial act” and that the Hatch-Waxman Act does not require the FDA “to police the listing process by analyzing whether the patents listed by NDA (New Drug Application) applicants actually claim the subject drugs or applicable methods of using those drugs.”

 

In a case captioned, Alphapharm PTY Limited v. Tommy G. Thompson, the court reasoned that substantive patent analysis is beyond the expertise of the FDA and is a function they are not mandated to perform.  Rather, substantive patent analysis is better left with the U.S. Patent and Trademark Office. The function of the FDA, on the other hand, is to assure the safety and availability of useful pharmaceutical compounds.  The laws and regulations that govern the FDA, in particular those laws and regulations that govern the listing of patents in the Orange Book, “commit the resolution of disputes between ANDA (Abbreviated New Drug Application) applicants and patent holders regarding the validity or correctness of the listed patent information to actions between ANDA applicants and patent holders, rather than to FDA action.”

Note: This is the first post by patent attorney Mark Chael, PhD.  Mark’s prior research in biochemistry, molecular biology, and cellular biology make him well equipped to understand the intricacies involved in biotech and pharmaceutical patents. He is an associate at the intellectual property law firm McDonnell Boehnen Hulbert & Berghoff in Chicago. [Brief Biography]