Drug Patent Extension Information Online: Monitoring Post-Approval Regulatory Developments

Article excerpt

There's no doubt about it. Proposed healthcare reforms have spurred many new types of information requests and have required medical searchers to expand their horizons well beyond MEDLINE and other clinical databases.

For example, demands for drug cost containment and third-party-induced price sensitivity have focused renewed attention on the flow of less expensive generic drugs onto the market. What governs that flow? It's the timetable of brandname drug patent expirations and subsequent approval of generic alternatives. At the same time, medical crises such as the AIDS epidemic or the acknowledged rise in antibiotic-resistant viruses demand a constant flow of new chemical entities into the research and development (R&D) pipeline to meet new disease challenges. What helps ensure a steady stream of therapeutic advances? Patent protection. Companies are more likely to continue investing in long-term, high-risk projects if they are guaranteed market exclusivity sufficient to exploit commercially, the products of their proprietary R&D. Thus, queries which were once the exclusive purview of law firms or intellectual property departments are now "out of the closet" and on the medical searcher's desk, along with clinical information requests.

BACKGROUND ON THE LAW: RESTORATION APPLICATIONS & FDA NOTICES

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) authorized extension of U.S. pharmaceutical, medical device or food additive patents beyond the statutory 17-year limit. This was to allow the recapture of at least a portion of the time a product spends under FDA review during evaluation for safety and efficacy. The first step in obtaining extended market exclusivity is an application by the originating company submitted to the U.S. Patent and Trademark Office (PTO) within 60 days of their product approval date. The next step is a letter from the PTO to the Food and Drug Administration (FDA) requesting confirmation that the product underwent regulatory review. Once the FDA responds affirmatively, the PTO submits a second formal request for FDA authorization of the company's claimed review period, the basis for patent term extension.

Results of these FDA determinations are published in the Federal Register. Monitoring Federal Register online citations to Public Law 98-417 is one way to identify proposed drug patent life extensions. The following example illustrates search techniques on DIALOG:

? begin 669
File 669:Fed.Register 1988-1994/Mar 25
     (c) format only 1994 Dialog Info. Svcs.
       Set    Items   Description
? select pub? (w)(law or l)(w)98(w)417
       S1        158   PUB? (W)(LAW OR L)(W)98(W)417
? s drug()price()competition(1w)patent()term()restoration
       S2        177
DRUG()PRICE()COMPETITION(1W)PATENT()TERM()RESTORATION
? s s1 or s2
       S3       181    S1 OR S2
? t s3/k
3/K/1
TEXT:

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98 - 417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100 - 670) generally provide that a patent may be extended for a period...

The Text and Summary portions of File 669 records often cite the legislative authority behind documents published. In this case, the authority is searched both as a Public Law number and as keywords. This approach will not, however, guarantee retrieval of all references to FDA recommendations concerning extension period entitlements under the 1984 law. A more comprehensive strategy would be to search for the keywords, Patent Extension, in Federal Register record titles.

? s patent()extension?/ti
       S4       181    PATENT()EXTENSION?/TI
? t s4/6
4/6/1
00500709
Determination of Regulatory Review Period for Purposes of Patent
Extension; Sporanox (registered)

Recall now (a) includes additional citations correcting previous FDA definitions of review periods, and (b) eliminates references to the law beyond specific patent life extension recommendations. …