Detailed Analysis of the Scope and Claims of United States Patent 7,125,879
Introduction
United States Patent 7,125,879, hereafter referred to as the '879 Patent, is a significant intellectual property asset in the pharmaceutical industry, particularly in the treatment of HIV infection. This patent, owned by Janssen Pharmaceutica N.V., covers the active ingredient rilpivirine and its hydrochloride salt.
Patent Overview
Patent Details
- Patent Number: 7,125,879
- Issue Date: October 24, 2006
- Original Expiration Date: April 14, 2023
- Extended Expiration Date: April 21, 2025[2][5].
Inventors
The '879 Patent was invented by a team of researchers including Jérôme Emile Georges Guilemont, Patrice Palandjian, Marc René de Jonge, Lucien Maria Henricus Koymans, Hendrik Maarten Vinkers, Frederik Frans Desiré Daeyaert, Jan Heeres, Koen Jeanne Alfons Van Aken, Paulus Joannes Lewi, and Paul Adriaan Jan Janssen[1].
Claims and Scope
Claims
The '879 Patent includes 19 claims, with specific claims reading on the active ingredient rilpivirine and its hydrochloride salt. Claims 1-3, 5-8, 11, and 13-18 are particularly relevant as they directly claim rilpivirine and/or the drug product of rilpivirine hydrochloride[1].
Scope
The patent scope is defined by the claims that cover the composition of matter, methods of use, and drug products related to rilpivirine. This includes the chemical structure of rilpivirine, its synthesis, and its application in treating HIV infection. The scope is narrow enough to protect the specific invention but broad enough to encompass various formulations and uses of rilpivirine[1].
Patent Landscape
Related Patents
The '879 Patent is part of a broader patent landscape related to HIV treatments. Other relevant patents include:
- Patent 7,390,791: Also related to HIV treatment, with an expiration date of April 17, 2025[5].
- Patent 8,754,065: Held by Gilead Sciences, Inc., and related to tenofovir alafenamide hemifumarate, another HIV treatment[5].
Generic Availability
As of the current date, there is no generic version of Edurant (the brand name for rilpivirine) available in the United States. The lack of generic competition is directly tied to the patent protection provided by the '879 Patent and other related patents[2].
Regulatory and Legal Aspects
Patent Term Extension
Janssen Pharmaceutica N.V. has petitioned for an extension of the patent term under 35 U.S.C. §156(d) and 37 C.F.R. §1.740. This extension is based on the regulatory review period for the new drug application (NDA) of rilpivirine. The NDA was initially submitted on July 23, 2010, and approved on May 20, 2011. The requested extension would extend the patent term to May 20, 2025[1].
Investigational New Drug (IND) and NDA
- IND Application: Filed on October 29, 2004, with the IND No. 67,699.
- NDA Submission: Initially submitted on July 23, 2010, with the NDA No. 202022.
- NDA Approval: Approved on May 20, 2011[1].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length (ICL) and independent claim count (ICC) to measure the breadth and clarity of patent claims. Narrower claims, as measured by these metrics, are associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation and Competition
Patent Quality and Innovation
The quality of patent claims, including their scope and clarity, can significantly impact innovation. Broad or unclear claims can lead to increased litigation and licensing costs, potentially diminishing incentives for innovation. In contrast, well-defined and narrow claims, like those in the '879 Patent, can provide clear boundaries for competitors and innovators[3].
Generic Entry
The expiration of the '879 Patent on April 21, 2025, will open the door for generic versions of rilpivirine to enter the market, assuming no new patent filings or extensions are granted. This could increase competition and potentially reduce drug prices, benefiting patients and the healthcare system[2][4].
Conclusion
The '879 Patent is a critical component of the intellectual property landscape for HIV treatments, particularly for rilpivirine. Its claims and scope are well-defined, protecting the invention while allowing for various formulations and uses. The patent's extension and the broader patent landscape will continue to influence the availability of generic versions and the competitive dynamics in the pharmaceutical market.
Key Takeaways
- Patent Details: The '879 Patent was issued on October 24, 2006, and has been extended to expire on April 21, 2025.
- Claims: The patent includes 19 claims, with specific claims covering rilpivirine and its hydrochloride salt.
- Scope: The patent scope is defined by claims related to the composition of matter, methods of use, and drug products of rilpivirine.
- Regulatory Aspects: The patent term extension is based on the regulatory review period for the NDA.
- Impact on Innovation: Well-defined claims can promote innovation by providing clear boundaries for competitors.
- Generic Entry: The patent's expiration will allow for generic versions of rilpivirine to enter the market.
FAQs
Q: What is the active ingredient covered by the '879 Patent?
A: The active ingredient covered by the '879 Patent is rilpivirine and its hydrochloride salt.
Q: When is the '879 Patent set to expire?
A: The '879 Patent is set to expire on April 21, 2025, following an extension.
Q: What is the significance of the IND and NDA dates for the '879 Patent?
A: The IND was filed on October 29, 2004, and the NDA was approved on May 20, 2011. These dates are crucial for determining the patent term extension.
Q: How does the '879 Patent impact generic competition?
A: The '879 Patent prevents generic versions of rilpivirine from entering the market until its expiration on April 21, 2025.
Q: What metrics are used to measure patent scope?
A: Metrics such as independent claim length (ICL) and independent claim count (ICC) are used to measure patent scope and clarity.
Sources
- U.S. Patent and Trademark Office, "APPLICATION FOR EXTENSION OF PATENT TERM (37 C.F.R. § 1.740)".
- Drugs.com, "Generic Edurant Availability".
- Hoover Institution, "Patent Claims and Patent Scope".
- Drug Patent Watch, "EDURANT Drug Patent Profile".
- Drugs.com, "Generic Odefsey Availability".
