Sunday, April 01, 2007

On pregabalin (Lyrica) and government support

A 2004 posting at Northwestern University notes: Richard B. Silverman, 57, created the compound for pregabalin in 1989 after working on the general project since 1980. The world's largest drug maker, Pfizer Inc., submitted pregabalin to the Food and Drug Administration in October. The drug could hit the market in the fall of 2004 if the FDA approves the drug in the summer.

In 2006, Lyrica earned mored than $1 billion for Pfizer.

US 5,563,175 (issued Oct. 8, 1996) is entitled GABA and L-glutamic acid analogs for antiseizure treatment [inventors Silverman; Richard B. (Morton Grove, IL), Andruszkiewicz; Ryszard (Sopot, PL), Yuen; Po-Wai (Ann Arbor, MI), Sobieray; Denis M. (Holland, MI), Franklin; Lloyd C. (Hamilton, MI), Schwindt; Mark A. (Holland, MI)] has but one claim:

A method of treating a patient having seizure disorders which comprises administering to said patient an effective amount of a substantially pure compound of the formula S-(+)-4-amino-3-(2-methylpropyl)butanoic acid.

In terms of priority: This is a divisional of application Ser. No. 08/064,285 filed on May 18, 1993 (Abandoned); which is a CIP of Ser. No. 07/886,080, filed May 20, 1992 (Abandoned); which is a CIP of Ser. No. 07/618,692, filed Nov. 27, 1990 (Abandoned).

The '175 patent cites Andruszkiewicz, Synthesis, pp. 953-955. The full reference for this paper (not given in the '175 patent) is Andruszkiewicz, R.S., Silverman, R.B., 1989. A convenient synthesis of 3-alkyl-4-aminobutanoic acids. Synthesis 953–955.

The '175 patent is assigned in part to Warner-Lambert Company and makes no mention of government support.

See also
http://www.freshpatents.com/Pregabalin-composition-dt20050804ptan20050171203.php

***
Prior to the 175 patent, Andruszkiewicz was a named inventor on US 4,923,965.

In a different patent, US 5,684,189, entitled GABA and L-glutamic acid analogs for antiseizure treatment, one has the following priority chain:

This is a divisional of application Ser. No. 08/064,285 filed on May 18, 1993 (Abandoned); which is a CIP of 07/886,080, filed May 20, 1992 (Abandoned); which is a CIP of 07/618,692, filed Nov. 27,1990 (Abandoned). [IPBiz: same applications as in '175 patent priority chain.]

HOWEVER, one has the following in the '189 patent:

This invention was made with Government support under Grant No. NS1570 awarded by the National Institute of Health. The Government has certain rights in the invention.

AND

the reference to the 1989 paper in the '189 patent states: Andruszkiewicz, Synthesis, pp. 953-603 (received by PTO Jan. 18, 1990), 1989.

IPBiz finds it intriguing to have a notation received by PTO Jan. 18, 1990 on a patent which claims priority only as far back as Nov. 27,1990.

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