Understanding the Scope and Claims of United States Patent 10,555,939
Introduction
United States Patent 10,555,939 is a significant patent in the pharmaceutical industry, particularly related to the drug POMALYST (pomalidomide). This patent is part of a larger patent family and has been involved in several legal proceedings. Here, we will delve into the details of its scope, claims, and the broader patent landscape.
Patent Overview
The patent in question, United States Patent 10,555,939, is one of the formulation patents held by Celgene Corporation, now part of Bristol Myers Squibb. This patent is specifically related to the formulation of pomalidomide, a drug used in the treatment of multiple myeloma and other conditions[5].
Patent Family and Related Patents
This patent is part of a larger family of patents that include method of treatment (MOT) patents and formulation patents. The MOT patents include United States Patent No. 8,198,262, 8,673,939, and 8,735,428, while the formulation patents include 8,828,427, 9,993,467, and the '5,939 Patent itself[1].
Claims and Scope
The scope of a patent is determined by its claims, which define the boundaries of what is protected. For United States Patent 10,555,939, the claims are focused on specific formulations of pomalidomide. Here are some key points regarding the claims:
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Formulation Patents: These patents cover the specific formulations of the drug, including the composition and preparation methods. The '5,939 Patent is virtually identical in its claims to another patent in the same family, the '467 Patent, which suggests that the scope of protection is closely aligned with these other patents[1].
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Claim Construction: The construction of patent claims is crucial and involves interpreting the language of the claims in light of the specification, prosecution history, and sometimes extrinsic evidence. The court relies heavily on the written description for guidance on the meaning of the claims but must avoid reading limitations from the specification into the claims unless explicitly stated by the inventor[1].
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Intrinsic vs. Extrinsic Evidence: In claim construction, intrinsic evidence (the patent specification and prosecution history) is given more weight than extrinsic evidence (such as expert testimony or dictionaries). However, extrinsic evidence can be considered if it aligns with the intrinsic evidence[1].
Legal Proceedings and Settlements
United States Patent 10,555,939 has been involved in several Hatch-Waxman Act patent infringement actions. Here are some key points from these proceedings:
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Celgene Corp. v. Hetero Labs Ltd.: This case involved multiple patents, including the '5,939 Patent. The parties agreed to consolidate several cases and stipulated that no additional claim construction proceedings were necessary for this patent due to its similarity to other patents in the same family[1].
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Settlement Terms: In cases involving Celgene and generic manufacturers, settlements often include terms that enjoin the generic manufacturer from infringing the patents-in-suit until their expiration. For example, in cases against Aurobindo and Mylan, the generic manufacturers were enjoined from infringing the patents related to Revlimid (lenalidomide), another drug by Celgene, until the patents' expiration[2].
Designing Around Patents
One of the challenges in patent law is the ability of competitors to "design around" existing patents. A wider scope of patent claims can make it more difficult for competitors to do so:
- Wider Scope: Patentees often seek a scope that is wider than the specific product to prevent competitors from making minor changes that would avoid infringement. This is particularly relevant in the pharmaceutical industry where small changes in formulation can result in a new product that is not covered by the original patent claims[3].
Expiration and Market Impact
The expiration of a patent can significantly impact the market:
- Patent Expiration: The '5,939 Patent, like other patents, has a limited lifespan. Once it expires, generic versions of the drug can enter the market, potentially reducing the market share of the original drug. This is a critical consideration for pharmaceutical companies as they plan their product lifecycle and intellectual property strategies[5].
Key Takeaways
- Patent Scope: The scope of United States Patent 10,555,939 is defined by its claims, which are closely aligned with other patents in the same family.
- Claim Construction: The interpretation of patent claims involves a careful analysis of the specification, prosecution history, and sometimes extrinsic evidence.
- Legal Proceedings: The patent has been involved in several Hatch-Waxman Act cases, with settlements typically enjoining generic manufacturers from infringement until patent expiration.
- Design Around: A wider scope of patent claims can prevent competitors from designing around the patent.
- Expiration: The expiration of the patent will allow generic versions of the drug to enter the market.
FAQs
Q: What drug is protected by United States Patent 10,555,939?
A: The drug protected by this patent is POMALYST (pomalidomide)[5].
Q: What is the significance of claim construction in patent law?
A: Claim construction is crucial as it defines the boundaries of what is protected by the patent. It involves interpreting the claims in light of the specification, prosecution history, and sometimes extrinsic evidence[1].
Q: How do settlements in Hatch-Waxman Act cases typically affect generic manufacturers?
A: Settlements often enjoin generic manufacturers from infringing the patents-in-suit until their expiration, allowing the original patent holder to maintain market exclusivity[2].
Q: Why do patentees seek a wider scope for their patent claims?
A: A wider scope makes it more difficult for competitors to design around the patent by making minor changes that would avoid infringement[3].
Q: What happens when a pharmaceutical patent expires?
A: When a pharmaceutical patent expires, generic versions of the drug can enter the market, potentially reducing the market share of the original drug[5].
Sources
- Celgene Corp. v. Hetero Labs Ltd. - Casetext
- ANDA Litigation Settlements - Robins Kaplan LLP Law Firm
- Patent claims' scope – is bigger always better? Trends in the pharmaceuticals industry - Pearl Cohen
- Stable gabapentin compositions - Google Patents
- Pharmaceutical drugs covered by patent 10,555,939 - Drug Patent Watch
