Understanding the Scope and Claims of United States Patent 10,702,508
Introduction
The United States Patent 10,702,508, hereafter referred to as the '508 patent, is a crucial patent in the pharmaceutical industry, particularly in the treatment of non-metastatic castration-resistant prostate cancer. This patent is owned by Aragon Pharmaceuticals, Inc. and Janssen Biotech, Inc. and is central to the drug Erleada®. Here, we delve into the details of the patent's scope, claims, and the surrounding patent landscape.
Patent Overview
The '508 patent, titled "Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer," describes methods for treating non-metastatic castration-resistant prostate cancer using an approved drug product comprising apalutamide, often in combination with androgen deprivation therapy[4].
Claim Construction
The core of any patent analysis lies in the construction of its claims. The '508 patent's claims, particularly claims 1 and 3, have been subject to dispute in recent litigation.
Disputed Term: "In Combination With"
The phrase "in combination with" in claims 1 and 3 is pivotal. The claims read:
- Claim 1: A method of improving metastasis free survival in a male human with nonmetastatic castration-resistant prostate cancer, said method comprising administering to said male human an approved drug product comprising apalutamide in combination with androgen deprivation therapy.
- Claim 3: A method of improving metastasis free survival in a male human with nonmetastatic castration-resistant prostate cancer, said method comprising providing to said male human an approved drug product comprising apalutamide in combination with androgen deprivation therapy, wherein the androgen deprivation therapy consists of orchiectomy or gonadotropin-releasing hormone agonists or antagonists[1].
The dispute centers on whether the term "in combination with" refers to the administration of a drug product and a deprivation therapy as separate entities or as a combined drug product.
Role of the Specification
The specification of the patent acts as a dictionary for understanding the claim language. It defines key terms, such as "approved drug product" and "pharmaceutical combination." The specification clarifies that a "pharmaceutical combination" is a product resulting from the mixing or combining of more than one active ingredient, which does not include methods combining administration of an active ingredient with surgical castration[1].
Patent Scope
The scope of the '508 patent is defined by its claims and the intrinsic evidence provided by the patent specification and prosecution history.
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can provide insights into the breadth of a patent. Narrower claims, as seen in the '508 patent, are often associated with a higher probability of grant and a shorter examination process[3].
Extrinsic vs. Intrinsic Evidence
In claim construction, intrinsic evidence (the patent claims, specifications, and prosecution history) is more significant than extrinsic evidence (such as FDA materials or other external sources). The Federal Circuit has emphasized that extrinsic evidence, while useful, is less significant in determining the legally operative meaning of claim language[1].
Patent Landscape
The '508 patent is part of a broader patent landscape related to Erleada® and its generic equivalents.
Hatch-Waxman Litigation
The '508 patent is involved in Hatch-Waxman litigation, where generic pharmaceutical companies have filed Abbreviated New Drug Applications (ANDAs) to produce generic versions of Erleada®. Defendants in these cases include companies like Eugia Pharma Specialties Limited, Aurobindo Pharma USA, Inc., and Hetero Labs Limited Unit V, among others[1][2].
Patent Expiration Dates
The patents related to Erleada®, including the '508 patent, have expiration dates that are crucial for understanding the timeline for generic entry. For example, the patent 8,445,507, which is also related to Erleada®, expires on September 15, 2030[5].
Generic Availability
As of the current date, there is no therapeutically equivalent generic version of Erleada® available in the United States. The ongoing litigation and patent disputes are significant factors in this delay[5].
Litigation and Infringement
The '508 patent has been at the center of several litigation cases involving generic pharmaceutical companies.
Notice Letters and ANDA Filings
Defendants have submitted ANDA applications to the FDA, which include Paragraph IV certifications alleging invalidity, unenforceability, or non-infringement of the patents-in-suit. Plaintiffs argue that these filings constitute infringement under 35 U.S.C. § 271(e)(2)(A)[2].
Claim Infringement
The litigation involves claims of direct and indirect infringement. Plaintiffs assert that the proposed generic products, if approved and marketed, would infringe the claims of the '508 patent and other related patents[2].
Industry Impact
The '508 patent and related litigation have significant implications for the pharmaceutical industry.
Innovation and Licensing
The breadth and clarity of patent claims can influence innovation and licensing costs. Narrower, clearer claims, as seen in the '508 patent, can reduce litigation costs and encourage innovation[3].
Market Competition
The delay in generic entry due to patent disputes affects market competition. The absence of generic alternatives keeps the market dominated by the branded product, Erleada®, until the patents expire[5].
Key Takeaways
- Claim Construction: The '508 patent's claims, particularly the phrase "in combination with," are crucial and must be interpreted based on the intrinsic evidence from the patent specification and prosecution history.
- Patent Scope: The patent's scope is defined by its claims and intrinsic evidence, with narrower claims associated with higher grant probabilities and shorter examination processes.
- Litigation: The patent is involved in Hatch-Waxman litigation, with generic companies challenging the validity and enforceability of the patent.
- Generic Availability: No generic version of Erleada® is currently available due to ongoing patent disputes.
- Industry Impact: The patent disputes affect innovation, licensing costs, and market competition in the pharmaceutical industry.
FAQs
Q: What is the main subject matter of the '508 patent?
A: The '508 patent describes methods for treating non-metastatic castration-resistant prostate cancer using an approved drug product comprising apalutamide, often in combination with androgen deprivation therapy.
Q: What is the disputed term in the '508 patent claims?
A: The disputed term is "in combination with," which is interpreted to determine whether it refers to the administration of a drug product and a deprivation therapy as separate entities or as a combined drug product.
Q: Why is intrinsic evidence more significant than extrinsic evidence in claim construction?
A: Intrinsic evidence (the patent claims, specifications, and prosecution history) is more significant because it directly reflects the patentee's chosen language and intent, as opposed to extrinsic evidence which may provide less relevant context.
Q: What is the current status of generic Erleada® availability?
A: As of the current date, there is no therapeutically equivalent generic version of Erleada® available in the United States.
Q: What are the implications of the '508 patent litigation for the pharmaceutical industry?
A: The litigation affects innovation, licensing costs, and market competition by delaying generic entry and maintaining the dominance of the branded product, Erleada®, until the patents expire.
Sources
- Aragon Pharm. v. Eugia Pharma. Specialities - Casetext
- in the united states district court - RPX Insight
- Patent Claims and Patent Scope - SSRN
- US10702508B2 - Anti-androgens for the treatment of non-metastatic ... - Google Patents
- Generic Erleada Availability - Drugs.com
