Defendant

Bolar Pharmaceutical Co., Inc.

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
—
Top venue
E.D. New York
1 case

Company profile

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Bolar Pharmaceutical Co., Inc.

Company overview. Bolar Pharmaceutical Co., Inc. was a U.S. generic-drug manufacturer headquartered in Copiague, Long Island, New York, founded in 1959 by Robert Shulman and Lawrence S. Raisfeld (the name combines their nicknames, "Bob" and "Larry"). It was publicly traded on the American Stock Exchange and was described in contemporaneous press coverage as the largest publicly held generic drug company in the United States. The name no longer exists: Bolar renamed itself Circa Pharmaceuticals, Inc. in 1993 and was acquired by Watson Pharmaceuticals in 1995 for roughly $600 million, operating afterward as a Watson subsidiary (Watson later became part of Actavis and, ultimately, Teva).

Products / operations. Bolar was an operating company that developed and sold off-patent prescription generics under Abbreviated New Drug Applications, plus some OTC products. Reported activities included a generic version of SmithKline's Dyazide (triamterene/hydrochlorothiazide), a transdermal nitroglycerin patch licensed from Hercon, generic injectables via the 1985 Marsam Pharmaceuticals venture, a 50% interest in Somerset Pharmaceuticals (Eldepryl, for Parkinson's disease, with Mylan), and royalties on Dilacor XR. It was not an NPE or shell licensor.

Patent-litigation posture. The case data show 1 tracked case with Bolar as defendant and 0 as plaintiff — the classic profile of an operating company sued by an innovator, not an assertion entity. The single suit was filed by Roche Products in the District of New Jersey in 1983 and moved to the Eastern District of New York; this was not an Eastern District of Texas filing.

Notable case. Roche Products, Inc. v. Bolar Pharmaceutical Co. Roche alleged that Bolar's pre-expiration testing of generic flurazepam (a copy of Roche's Dalmane) infringed its patent. The district court found no infringement; the Federal Circuit reversed in 1984 (733 F.2d 858), rejecting the experimental-use defense for testing done to obtain FDA approval. Congress responded with the 1984 Hatch-Waxman Act, whose 35 U.S.C. § 271(e)(1) safe harbor is still called the "Bolar exemption." Separately, Bolar pleaded guilty in 1991 to 20 federal fraud counts over falsified generic drug data and paid a $10 million fine.

Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc.

reversed and remanded
Docket:
CV 83-4312
Patents:3299053

Roche sued Bolar for patent infringement of U.S. Patent No. 3,299,053, covering flurazepam hydrochloride (DALMANE), after Bolar conducted pre-expiration testing to obtain FDA approval. The district court held Bolar's testing was de minimis/experimental and not infringement, but the Federal Circuit reversed and remanded, holding that the testing infringed under 35 U.S.C. § 271(a). The decision led to the Bolar exemption and 35 U.S.C. § 271(e)(1).