[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 2154 Introduced in Senate (IS)]







104th CONGRESS
  2d Session
                                S. 2154

 To provide equitable treatment for pharmaceutical patents on certain 
   pipeline drugs in order to encourage continued development of new 
                     drugs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 28, 1996

 Mr. Specter (for himself, Mr. Johnston, Mr. Heflin, and Mr. Santorum) 
introduced the following bill; which was read twice and referred to the 
                       Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
 To provide equitable treatment for pharmaceutical patents on certain 
   pipeline drugs in order to encourage continued development of new 
                     drugs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Equity Act of 1996''.

SEC. 2. EXTENSION OF PATENTS RELATING TO CERTAIN PIPELINE DRUGS.

    (a) In General.--The term of any patent in force on September 24, 
1984, and on the effective date of this Act, that claims a drug 
product, a method of using a drug product, or a method of manufacturing 
a drug product, shall be extended pursuant to subsection (b) from the 
expiration date determined pursuant to section 154 of title 35, United 
States Code, if:
            (1) an exemption described in section 156(g)(1)(B)(i) or 
        section 156(g)(4)(B)(i) of title 35, United States Code, became 
        effective for the drug product before September 24, 1984;
            (2) the regulatory review period set forth in section 
        156(g)(1)(B) or section 156(g)(4)(B) of title 35, United States 
        Code, for the drug product, exceeded 120 months; and
            (3) the regulatory review period described in section 
        156(g)(1)(B)(ii) or section 156(g)(4)(B)(ii) of title 35, 
        United States Code, for the drug product, exceeded 60 months.
    (b) Term.--The term of any patent described in subsection (a) shall 
be extended by a period of two years.
    (c) Infringement.--During any extension granted pursuant to 
subsection (b), the rights in the patent so extended shall be 
determined in accordance with section 156(b) of title 35, United States 
Code.
    (d) Definition.--For the purpose of the Act, the term ``drug 
product'' shall be defined in accordance with section 156(f)(2) of 
title 35, United States Code.
    (e) Notification.--No later than 90 days after the date of 
enactment of this Act, the patentee of a patent extended pursuant to 
subsection (b) shall notify the Commissioner of Patents and Trademarks 
of the number of any patent extended pursuant to subsection (b). On 
receipt of this notice, the Commissioner shall confirm the patent 
extension by placing a notice thereof in the official file of the 
patent, and publishing an appropriate notice of this extension in the 
Official Gazette of the Patent and Trademark Office.
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