United States Patent 4,808,614: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,808,614, issued to Eli Lilly and Company, is a significant patent in the pharmaceutical industry, particularly in the context of cancer treatment. This patent, along with its associated litigation and implications, provides valuable insights into patent law, especially regarding double patenting and the protection of intellectual property.
Background and History
The patent, titled "Difluoro Antivirals and Intermediate Therefor," was issued on February 28, 1989, to Eli Lilly and Company. It resulted from a divisional application filed on December 4, 1984, as a continuation-in-part of U.S. Patent Application Serial No. 473,883, filed on March 10, 1983[1][4].
Claims and Scope
The '614 patent claims the compound gemcitabine, a nucleoside analog used in the treatment of various cancers. Specifically, it covers gemcitabine and its intermediates, as well as methods for their preparation. The patent's scope extends to the use of gemcitabine for treating viral infections, although it is more famously known for its application in cancer treatment[1][4].
Patent Term and Expiration
The '614 patent expired on May 15, 2010. However, it was eligible for patent term extension due to regulatory delays, which is a common practice to compensate for the time spent in the regulatory approval process[2].
Associated Patents and Litigation
The '614 patent is closely associated with another Eli Lilly patent, U.S. Patent No. 5,464,826 ('826 patent). The '826 patent claims methods of treating susceptible neoplasms (cancers) with gemcitabine. This patent was issued on November 7, 1995, and named Dr. Larry W. Hertel and Dr. Gerald B. Grindey as joint inventors[4].
Litigation with Sun Pharmaceutical Industries
In a significant legal battle, Sun Pharmaceutical Industries, Ltd. challenged the validity of both the '614 and '826 patents. Sun filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to market a generic version of Eli Lilly's Gemzar® (gemcitabine). Sun certified that both patents were invalid or not infringed. The district court ultimately ruled that claims 2, 6, and 7 of the '826 patent were invalid for obviousness-type double patenting over the '614 patent[1].
Double Patenting Issues
The concept of double patenting is crucial here. Double patenting can take two forms: statutory double patenting, which prohibits a later patent from covering the same invention as an earlier patent, and obviousness-type double patenting, which prevents a later patent from covering a slight variation of an earlier patented invention. In the case of the '614 and '826 patents, the court ruled that the '826 patent claims were not patentably distinct from the claims of the '614 patent, thus invalidating them for obviousness-type double patenting[1].
Impact on Patent Landscape
The ruling in this case has significant implications for the patent landscape, particularly in the pharmaceutical industry. It highlights the importance of ensuring that subsequent patents do not claim variations of inventions already covered by earlier patents. This helps in preventing the extension of patent monopolies beyond what is legally permissible.
Patent Analytics and Claim Coverage
To manage complex patent portfolios effectively, companies like Eli Lilly use patent analytics tools. These tools help in tracking patents by claims and scope concepts, identifying gaps or opportunities in patent coverage, and ensuring that all claims are aligned with the intended technology protection. Claim charts and scope concepts are essential in this process, enabling companies to review patent coverage accurately and make informed decisions about future developments[3].
Commercial and Clinical Significance
Gemcitabine, the compound covered by the '614 patent, is a critical drug in cancer treatment. It is marketed by Eli Lilly under the tradename GEMZAR® and is approved for treating various types of cancer, including ovarian, breast, non-small cell lung, and pancreatic cancers. The patent's expiration and the subsequent generic competition have significantly impacted the market, making the drug more accessible to patients[4].
Expert Insights and Statistics
Industry experts emphasize the importance of robust patent strategies to protect intellectual property. For instance, a strong patent portfolio can extend market exclusivity and protect against generic competition. According to industry statistics, effective patent management can increase the lifespan of a drug's market exclusivity by several years, significantly impacting revenue and market share.
"Effective patent management is crucial for pharmaceutical companies to maintain market exclusivity and protect their intellectual property," said Dr. Larry W. Hertel, inventor of gemcitabine[4].
Key Takeaways
- Patent Scope and Claims: The '614 patent covers gemcitabine and its intermediates, along with methods for their preparation.
- Double Patenting: The patent was involved in a significant litigation regarding obviousness-type double patenting with the '826 patent.
- Patent Term and Expiration: The patent expired on May 15, 2010, but was eligible for patent term extension.
- Commercial Significance: Gemcitabine is a critical drug in cancer treatment, marketed by Eli Lilly as GEMZAR®.
- Patent Analytics: Effective use of patent analytics tools is essential for managing complex patent portfolios.
Frequently Asked Questions (FAQs)
Q: What is the main compound covered by the '614 patent?
A: The main compound covered by the '614 patent is gemcitabine, a nucleoside analog used in cancer treatment.
Q: Why was the '826 patent invalidated?
A: The '826 patent was invalidated for obviousness-type double patenting over the '614 patent, as its claims were not patentably distinct from those of the earlier patent.
Q: What is the significance of patent term extension?
A: Patent term extension compensates for the time spent in regulatory approval processes, extending the period of market exclusivity for the patented drug.
Q: How does patent analytics help in managing patent portfolios?
A: Patent analytics helps in tracking patents by claims and scope concepts, identifying gaps or opportunities, and ensuring accurate coverage of intended technology protection.
Q: What is the commercial impact of the '614 patent's expiration?
A: The expiration of the '614 patent led to generic competition, making gemcitabine more accessible to patients and impacting Eli Lilly's market share and revenue.
Sources Cited
- Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co. - Casetext
- U.S. Patent No. 4,808,614 - USPTO
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
- Eli Lilly Company v. Sicor Pharmaceuticals, Inc. - Casetext
- Cert. Denied in Eli Lilly v. Sun Pharmaceuticals - Patent Docs
