United States Patent 4,418,068: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,418,068, issued on November 29, 1983, is a significant patent in the pharmaceutical industry, particularly in the context of raloxifene hydrochloride. This patent, assigned to Eli Lilly and Company, covers various aspects of raloxifene, including its synthesis, uses, and therapeutic applications.
Inventors and Assignees
The patent was invented by a team of researchers at Eli Lilly and Company. The assignee of the patent is Eli Lilly and Company, reflecting the company's extensive research and development efforts in pharmaceuticals[4].
Patent Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
Claim 1
Claim 1 typically describes the compound raloxifene hydrochloride itself, including its chemical structure and composition. This claim sets the foundation for the patent by defining the specific compound that is the subject of the invention.
Claim 2
Claim 2 often pertains to the methods of synthesizing raloxifene hydrochloride. This includes the chemical processes and reactions involved in producing the compound, which is crucial for manufacturing and reproducing the invention.
Claim 3 and Subsequent Claims
Subsequent claims may cover various uses of raloxifene hydrochloride, such as its application in treating or preventing specific medical conditions. For example, these claims might include the use of raloxifene in the treatment of mammary tumors, osteoporosis, and other conditions related to estrogen receptors[5].
Therapeutic Applications
Treatment of Mammary Tumors
One of the significant therapeutic applications covered by this patent is the use of raloxifene in treating mammary tumors. Raloxifene acts as a selective estrogen receptor modulator (SERM), which means it can mimic or block estrogen's effects in different parts of the body. This property makes it useful in treating conditions where estrogen plays a role, such as certain types of breast cancer[5].
Prevention and Treatment of Osteoporosis
Another important application is the prevention and treatment of osteoporosis, particularly in postmenopausal women. Raloxifene helps maintain bone density by mimicking estrogen's beneficial effects on bone tissue while avoiding some of the risks associated with estrogen therapy[1][2].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 4,418,068 includes several related patents that expand on the original invention. For example, later patents such as U.S. Patent Nos. 5,457,117, 6,458,811, and RE39,049 cover specific aspects like the oral administration of raloxifene hydrochloride, particle size formulations, and low-dose regimens. These patents collectively form a robust intellectual property portfolio for Eli Lilly and Company[1][2].
Litigation and Challenges
The patent has been involved in several legal challenges, particularly regarding generic versions of raloxifene hydrochloride. For instance, Teva Pharmaceuticals USA, Inc. filed an Abbreviated New Drug Application (ANDA) for a generic version of raloxifene, which led to litigation with Eli Lilly and Company over patent infringement. The courts have upheld some of Eli Lilly's patents while invalidating others, highlighting the complex nature of patent law and the ongoing battles to protect intellectual property[1][2].
Patent Analytics and Claim Coverage
To manage and analyze the extensive patent portfolio related to raloxifene, companies like Eli Lilly and Company use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, creating claim charts, and identifying gaps or opportunities in the patent coverage. This approach ensures that all aspects of the technology are adequately protected and that future design opportunities are explored[3].
Impact on the Pharmaceutical Industry
The issuance and subsequent enforcement of U.S. Patent 4,418,068 have had a significant impact on the pharmaceutical industry. It has enabled Eli Lilly and Company to develop and market Evista (raloxifene hydrochloride) as a branded drug, providing a treatment option for millions of patients worldwide. The patent has also driven innovation in the field of SERMs and bone health, encouraging further research and development in related areas.
Key Takeaways
- Compound and Synthesis: U.S. Patent 4,418,068 covers the compound raloxifene hydrochloride and its synthesis methods.
- Therapeutic Applications: The patent includes uses such as treating mammary tumors and preventing or treating osteoporosis.
- Related Patents: Later patents expand on the original invention, covering oral administration, particle size formulations, and low-dose regimens.
- Litigation: The patent has been involved in several legal challenges, particularly regarding generic versions.
- Patent Analytics: Tools are used to manage and analyze the patent portfolio, ensuring comprehensive protection and identifying future opportunities.
FAQs
Q: What is the primary compound covered by U.S. Patent 4,418,068?
A: The primary compound covered by U.S. Patent 4,418,068 is raloxifene hydrochloride.
Q: What are some of the therapeutic applications of raloxifene hydrochloride?
A: Raloxifene hydrochloride is used in treating mammary tumors and in the prevention and treatment of osteoporosis, particularly in postmenopausal women.
Q: How has the patent landscape evolved around U.S. Patent 4,418,068?
A: The patent landscape has evolved with the issuance of later patents covering specific aspects like oral administration, particle size formulations, and low-dose regimens.
Q: What role do patent analytics play in managing the patent portfolio related to raloxifene hydrochloride?
A: Patent analytics help in categorizing patents by claims and scope concepts, creating claim charts, and identifying gaps or opportunities in the patent coverage.
Q: What are some of the legal challenges faced by U.S. Patent 4,418,068?
A: The patent has faced legal challenges, particularly from generic drug manufacturers like Teva Pharmaceuticals USA, Inc., over patent infringement and the validity of related patents.
Sources
- Case 1:06-cv-01017-SEB-JMS Document 655 Filed 09/23/09 - GovInfo
- Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. - Casetext
- Patent Analytics - Schwegman
- Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. - Casetext
- WO 98/18325 - Google APIs
