Plaintiff

Roche Products, Inc.

1 case as plaintiff.

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

Company profile

Roche Products, Inc. was a U.S. affiliate/operating entity of the Roche Group, the Swiss healthcare company founded in 1896 and headquartered in Basel (Grenzacherstrasse 124). The parent, Roche Holding AG, is publicly listed on the SIX Swiss Exchange (ROG) with group sales of roughly CHF 62 billion (2024) and about 103,000 employees; it is one of the largest pharmaceutical and diagnostics companies globally (Roche.com; stockanalysis.com; Wikipedia). Roche Products, Inc. itself was the corporate vehicle in the 1980s that held and enforced U.S. rights in Roche's products; its current separate registration/operations are not independently verifiable from public sources — U.S. Roche operations today run principally through Hoffmann-La Roche Inc., Genentech (wholly owned since 2009) and Roche Diagnostics.

Products / services. The parent operates in two divisions: Pharmaceuticals (prescription medicines in oncology, immunology, neuroscience, ophthalmology, haematology and infectious disease — e.g., Ocrevus, Vabysmo) and Diagnostics (in-vitro diagnostics, molecular and pathology testing, point-of-care and diabetes care). The product at issue in the tracked case was Dalmane (flurazepam hydrochloride), Roche's prescription sleep aid.

Patent-litigation posture. This is an operating company, not an NPE: the tracked data show 1 case as plaintiff and 0 as defendant, consistent with a brand pharmaceutical company enforcing a product patent rather than a shell licensor asserting an acquired portfolio. The single tracked suit was filed in the District of New Jersey on 28 July 1983 and transferred on change of venue to the Eastern District of New York — not a plaintiff-friendly venue selection, simply a transfer.

Notable case. Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984). Roche sued generic manufacturer Bolar, which had imported flurazepam HCl to run bioequivalence testing for an FDA application before Roche's compound patent (issued 1967, expiring 17 January 1984) lapsed. The district court denied Roche's injunction, finding the testing de minimis and experimental; the Federal Circuit reversed on 23 April 1984. Congress then enacted the Hatch-Waxman Act (Sept. 1984), codifying 35 U.S.C. § 271(e)(1) and effectively superseding that ruling — the origin of the "Bolar exemption."

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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).