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Find Information about a U.S. Drug Patent Extension?
TOPIC: In the United States the Drug Price Competition and Patent Term Restoration Act of 1984 permits extension of the patent or market exclusivity period to recapture those years that a drug spent under FDA review during valuation of the original NDA application. Some drugs are automatically granted market exclusivity in excess of their patent life. For actual patent life extensions, originating companies must apply to the USPTO within 60 days of NDA approval. The FDA is then asked for official authorization of the claimed review period.
The first public announcement from an official (govt.) source of a patent term extension application is publication in the Federal Register of the FDA’s validation of the product’s regulatory review period eligible for restoration to the patent term. Typically, Federal Register notices lag behind NDA approval by at least two years. The text and summary portions of records often cite the legislative authority behind documents published. In this case, the authority is searched both as a Public Law and also with keywords. The patent assignee and name of drug can also be used in the search.
In this example, using the Federal Register (File 180), you want to find information about U.S. drug patent extensions for Mivacron. The Federal Register is a daily publication of the U.S. government that serves to notify the public of official actions by Federal agencies like the Federal Drug Administration (FDA).
COMMAND SUMMARY
BEGIN 180
SELECT PUB?()(LAW OR L)()98()417
SELECT DRUG()PRICE()COMPETITION(1W)PATENT()TERM()RESTORATION
SELECT S1 OR S2
SELECT S3 AND MIVACRON
TYPE S4/9/1
HOW TO...
1. BEGIN File 180, Federal Register, to view U.S. government documents.
2. SELECT the public law which cites the legislative authority behind laws published.
3. Also use keywords for the public law and OR the two sets together.
4. Limit the set (S3) with the drug for which you are trying to find the extension. |
?BEGIN 180
File 180:Federal Register 1985-2006/Aug 21
(c) 2006 format only DIALOG
Set Items Description
--- ----- -----------
?SELECT PUB?()(LAW OR L)()98()417
658588 PUB?
412736 LAW
228548 L
80713 98
6745 417
S1 844 PUB?()(LAW OR L)()98()417
?SELECT DRUG()PRICE()COMPETITION(1W)PATENT()TERM()RESTORATION
52746 DRUG
47626 PRICE
57066 COMPETITION
18684 PATENT
94432 TERM
13708 RESTORATION
S2 891 DRUG()PRICE()COMPETITION(1W)PATENT()TERM() RESTORATION
?SELECT S1 OR S2
844 S1
891 S2
S3 900 S1 OR S2
?SELECT S3 AND MIVACRON
900 S3
5 MIVACRON
S4 1 S3 AND MIVACRON |
4. TYPE the Federal Register record to see extension information about Mivacron.
|
?TYPE S4/9/1
4/9/1
DIALOG(R)File 180:Federal Register
(c) 2006 format only DIALOG. All rts. reserv.
DIALOG Accession Number: 02243345 Supplier Number: 920600270
Determination of Regulatory Review Period for Purposes of Patent Extension; Mivacron (R)
Volume: 57 Issue: 106 Page: 23235
CITATION NUMBER: 57 FR 23235
Date: TUESDAY, JUNE 2, 1992
AGENCY: Department of Health and Human Services--(HHS); Public Health Service--(PHS); Food and Drug Administration--(FDA)
DOCUMENT TYPE: Notices
NUMBERS: No. 92E-0156
DATES: 19920803
19921130
Comment by: 19920803
CONTACT INFORMATION: John S. Ensign, 301-443-1382
ACTION: Notice
INTERNAL DATA: (FR Doc. 92-12845 Filed 6-1-92; 8:45 a.m.)
Word Count: 787
SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for MivacronR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Commissioner of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. |
Note the maximum extension period is given along with the rationale for its determination.
Note: Part of the record is omitted from this display.
|
FDA has determined that the applicable regulatory review period for MivacronR is 2,755 days. Of this time, 2,245 days occurred during the testing phase of the regulatory review period, while 510 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: July 7, 1984. FDA has verified the applicant's claim that the investigational new drug application became effective on July 7, 1984.
2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the Federal Food, Drug, and Cosmetic Act: August 30, 1990. FDA has verified the applicant's claim that the new drug application (NDA) for MivacronR (NDA 20-098) was submitted on August 30, 1990.
3. The date the application was approved: January 22, 1992. FDA has verified the applicant's claim that NDA 20-098 was approved on January 22, 1992.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 172 days of patent term extension. |
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