The Scope and Claims of United States Patent 6,342,476: A Detailed Analysis
Introduction
United States Patent 6,342,476, hereafter referred to as the '476 patent, is one of the key patents associated with Copaxone®, a drug used to treat relapsing forms of multiple sclerosis. This patent, along with several others, has been at the center of significant litigation involving Teva Pharmaceutical Industries Ltd. and various generic drug manufacturers. Here, we delve into the scope, claims, and the patent landscape surrounding the '476 patent.
Background of Copaxone® and the '476 Patent
Copaxone®, or glatiramer acetate, is a synthetic polymer used in the treatment of multiple sclerosis. The '476 patent, along with other related patents, is owned by Yeda Research and Development Co., Ltd. and exclusively licensed to Teva Pharmaceutical Industries Ltd.[1][4].
Patent Ownership and Licensing
The '476 patent is part of a portfolio of patents owned by Yeda Research and Development Co., Ltd. and licensed to Teva. This licensing arrangement has been crucial in Teva's efforts to protect its intellectual property rights for Copaxone®[1][5].
Claims of the '476 Patent
The '476 patent includes several claims that define the scope of the invention. These claims are part of what is known as the Group II claims, which were deemed valid and enforceable by the Federal Circuit. Specifically, claim 1 of the '476 patent is one of the claims that were upheld as valid and not indefinite[2][4].
Litigation History
The '476 patent was involved in a series of lawsuits initiated by Teva against generic drug manufacturers such as Sandoz and Mylan. These lawsuits were filed in response to the submission of Abbreviated New Drug Applications (ANDAs) by these companies, which sought approval to market generic versions of Copaxone®.
District Court Ruling
On June 22, 2012, the U.S. District Court for the Southern District of New York ruled that all the asserted claims of Teva’s glatiramer acetate patents, including the '476 patent, were valid, enforceable, and infringed by Sandoz/Momenta and Mylan/Natco[5].
Federal Circuit Ruling
The Federal Circuit reviewed the district court's decision and upheld the validity of the Group II claims, which include claim 1 of the '476 patent. The court found that these claims were not indefinite and were infringed by the defendants. However, the court invalidated several other patents (Group I claims) for indefiniteness[2][4].
Supreme Court Involvement
Although the Supreme Court was involved in the case, it ultimately vacated the Federal Circuit’s conclusion that the Group I claims were indefinite and remanded the case for further consideration. However, this did not affect the validity of the '476 patent's claims[2].
Patent Expiration
The '476 patent, along with several other Orange Book patents, was set to expire on May 24, 2014. This expiration date marked the end of Teva's exclusive rights to market Copaxone® under these patents[1][5].
Impact on Generic Competition
The litigation surrounding the '476 patent and other related patents delayed the entry of generic versions of Copaxone® into the market. The validity and enforceability of these patents allowed Teva to maintain its market exclusivity for a longer period, impacting the availability and pricing of generic alternatives[4].
Technical Aspects and Specification
The '476 patent, like other patents in the Copaxone® portfolio, specifies the composition and method of manufacturing glatiramer acetate. The claims define the molecular characteristics and the process for producing the drug, which are critical for ensuring the efficacy and safety of the treatment[1][2].
Conclusion on Patent Scope
The '476 patent is a crucial component of Teva's intellectual property strategy for Copaxone®. Its claims define the invention in a way that was deemed valid and enforceable by the courts, despite challenges from generic manufacturers. The patent's scope has played a significant role in protecting Teva's market position and delaying generic competition.
Key Takeaways
- Patent Ownership: The '476 patent is owned by Yeda Research and Development Co., Ltd. and licensed to Teva Pharmaceutical Industries Ltd.
- Claims Validity: Claim 1 of the '476 patent was upheld as valid and not indefinite by the Federal Circuit.
- Litigation: The patent was involved in significant litigation against generic drug manufacturers.
- Expiration: The patent expired on May 24, 2014.
- Impact: The patent's validity delayed the entry of generic versions of Copaxone® into the market.
FAQs
What is the '476 patent related to?
The '476 patent is related to Copaxone®, a drug used to treat relapsing forms of multiple sclerosis.
Who owns the '476 patent?
The '476 patent is owned by Yeda Research and Development Co., Ltd. and exclusively licensed to Teva Pharmaceutical Industries Ltd.
What was the outcome of the litigation involving the '476 patent?
The Federal Circuit upheld the validity of claim 1 of the '476 patent, finding it not indefinite and infringed by the defendants.
When did the '476 patent expire?
The '476 patent expired on May 24, 2014.
How did the '476 patent impact the market for Copaxone®?
The patent's validity delayed the entry of generic versions of Copaxone® into the market, allowing Teva to maintain its market exclusivity.
Sources
- The National Law Review: "The Copaxone Story in the U.S. and India"
- Robins Kaplan: "Teva Pharms. USA, Inc., v. Sandoz, Inc."
- USPTO: "Patent Claims Research Dataset"
- IPWatchdog: "Patent News and Notes"
- Aitken Klee: "COPAXONE patents infringed, valid and enforceable – U.S. District Court"
