United States Patent 9,907,756: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,907,756, titled "Pharmaceutical Compositions and Methods of Use," is a significant patent in the pharmaceutical industry, particularly related to the drug nintedanib. This patent is held by Boehringer Ingelheim Pharmaceuticals, Inc., and it plays a crucial role in the protection and commercialization of nintedanib, a kinase inhibitor used in the treatment of various diseases, including idiopathic pulmonary fibrosis (IPF) and non-small cell lung cancer (NSCLC).
Background of Nintedanib
Nintedanib is a small molecule tyrosine kinase inhibitor that targets multiple receptor kinases involved in the regulation of angiogenesis, metastasis, and the proliferation of cancer cells. It is marketed under the brand name Ofev for the treatment of IPF and under the brand name Vargatef for the treatment of NSCLC.
Scope of the Patent
Pharmaceutical Compositions
The patent 9,907,756 covers specific pharmaceutical compositions of nintedanib, including its salts, solvates, and hydrates. These compositions are designed to enhance the bioavailability, stability, and efficacy of the drug. The patent describes various formulations, such as capsules, tablets, and oral solutions, which are optimized for patient compliance and therapeutic effectiveness[2].
Methods of Use
The patent also includes methods of using nintedanib for the treatment of various diseases. This encompasses the administration of nintedanib for conditions like IPF, NSCLC, and other fibrotic diseases. The methods detail the dosing regimens, administration routes, and combination therapies that can be used to maximize the therapeutic benefits of nintedanib[2].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of protection. These claims cover:
- Specific pharmaceutical compositions containing nintedanib or its pharmaceutically acceptable salts.
- Methods of treating diseases such as IPF and NSCLC using these compositions.
- Dosage forms and their respective formulations.
Dependent Claims
Dependent claims further specify the details of the independent claims, including:
- Particular solvates and hydrates of nintedanib.
- Specific excipients and their proportions in the formulations.
- Methods of manufacturing the pharmaceutical compositions[2].
Patent Landscape
Competitors and Litigation
The patent landscape surrounding nintedanib is complex, with several generic manufacturers attempting to challenge the patent. For instance, in the case of Cipla Ltd. v. Boehringer Ingelheim Pharms. Inc., Cipla sought to invalidate the patent, but the litigation resulted in a settlement where Cipla was enjoined from infringing the patents-in-suit until permitted under the settlement agreement[2].
Related Patents
Several related patents cover different aspects of nintedanib, including its synthesis, other pharmaceutical compositions, and additional methods of use. These patents collectively form a robust intellectual property portfolio that protects Boehringer Ingelheim's interests in nintedanib.
International Patent Filings
Nintedanib-related patents have been filed in various jurisdictions, ensuring global protection for the drug. For example, international patent filings such as the one disclosed in the Australian patent application AU2019363244A1, highlight the global strategy to protect nintedanib formulations[4].
Impact on the Pharmaceutical Industry
Market Protection
The patent 9,907,756 provides significant market protection for Boehringer Ingelheim, allowing the company to maintain exclusivity over nintedanib formulations and methods of use. This protection is crucial for recouping investment in research and development.
Innovation and Research
The patent encourages innovation by protecting the intellectual property of Boehringer Ingelheim, thereby incentivizing further research and development in the field of kinase inhibitors. This can lead to the discovery of new therapeutic targets and improved treatments.
Challenges and Future Directions
Generic Challenges
Generic manufacturers continue to challenge the validity of the patent, which can lead to litigation and potential settlements. These challenges can impact the exclusivity period and the market share of the branded drug.
Drug Repurposing
The patent landscape also highlights opportunities for drug repurposing. As seen in other areas of drug discovery, patents can reveal potential new therapeutic targets and applications for existing drugs, including nintedanib[3].
Key Takeaways
- Patent Scope: The patent covers specific pharmaceutical compositions and methods of use for nintedanib.
- Claims: Independent and dependent claims define the scope of protection, including formulations and methods of treatment.
- Patent Landscape: The patent is part of a complex landscape with ongoing litigation and global filings.
- Impact: The patent provides market protection, encourages innovation, and opens avenues for drug repurposing.
FAQs
Q: What is the primary use of nintedanib as described in the patent 9,907,756?
A: The primary use of nintedanib as described in the patent is for the treatment of idiopathic pulmonary fibrosis (IPF) and non-small cell lung cancer (NSCLC).
Q: Who is the assignee of the patent 9,907,756?
A: The assignee of the patent is Boehringer Ingelheim Pharmaceuticals, Inc.
Q: What types of formulations are covered under the patent?
A: The patent covers various formulations including capsules, tablets, and oral solutions.
Q: Have there been any significant legal challenges to this patent?
A: Yes, there have been legal challenges from generic manufacturers, such as Cipla Ltd., which resulted in settlement agreements.
Q: How does the patent impact the pharmaceutical industry?
A: The patent provides market protection, incentivizes innovation, and opens opportunities for drug repurposing.
Cited Sources
- United States Patent and Trademark Office - US Patent 9,907,756.
- Robins Kaplan - ANDA Litigation Settlements | Hatch-Waxman[2].
- BioRxiv - A novel approach to understand patents from the drug discovery perspective[3].
- Google Patents - AU2019363244A1[4].
