WASHINGTON _ The FDA has determined that patent protectionmust be extended for up to three years as part of terms outlined in aninternational trade agreement.

The policy announcement, made Thursday in response to a citizen'spetition filed in behalf of Glaxo Inc., of London, was issued by FDADeputy Commissioner for Policy William Schultz.

FDA's decision implements one of the most technical issues of theUruguay Round Agreements Act (URAA) of the General Agreementon Tariffs and Trade (GATT). It is an obvious setback for genericdrug makers, but a boost for the biotech sector.

URAA harmonizes worldwide patent laws by extending the life of apatent to 20 years from the date an application was filed regardless ofthe date of issue. URAA also specifies that patents in force on June 8,1995 shall be the greater of 17 years from the granting of the patentor 20 years from the date on which the application for the patent wasfiled.

URAA, signed into law in December 1994, includes specialprovisions sought by the biotech industry that would allow patentterms to be extended for up to five years to account for certain delaysbeyond an inventor's control, such as interference in the patentproceedings or successful appeals for rejected patents. (SeeBioWorld Today, Feb. 17, 1995, p. 1.)

The FDA said it expects each manufacturer to submit information onthe URAA-extended patent expiration dates from the holder of thenew drug application on or after June 8, 1995. The agency will notapprove any application that does not contain a correct certificationwith respect to an URAA-extended patient expiration date that wassubmitted in a timely manner to the agency, according to Schultz'sstatement.

A House subcommittee earlier this month cleared for full committeeconsideration a bill that would make it easier for biotech firms to winpatent for novel process. (See BioWorld Today, May, 19, 1995, p.3.)

[Editor's note: Monday's issue of BioWorld Today will report on theimplications this patent extension will have on the industry]. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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