United States Patent 7,772,209: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,772,209, owned by Eli Lilly and Company, is a method-of-use patent that has been at the center of several significant patent infringement cases. This patent pertains to the co-administration of the chemotherapy drug pemetrexed disodium (marketed as ALIMTA®) with specific nutrients to mitigate its side effects.
Patent Overview
Issuance and Ownership
The '209 Patent was issued to Eli Lilly on August 10, 2010. It covers a method of administering pemetrexed disodium in conjunction with folic acid and vitamin B12 to reduce patient toxicity associated with the drug[1].
Claims and Scope
Asserted Claims
The patent includes several claims, with the litigation focusing on claims 9, 10, 12, 14, 15, 18, 19, and 21. These claims are specific to the method of co-administering pemetrexed disodium with folic acid and vitamin B12[1].
Method of Administration
The patented method involves the administration of pemetrexed disodium in a way that minimizes its toxic effects. This is achieved by co-administering the drug with folic acid and vitamin B12, which are known to protect against the side effects of ALIMTA®[1].
Patent Validity and Infringement
Validity Challenges
The defendants in various cases have challenged the validity of the '209 Patent on grounds of obviousness, obviousness-type double patenting, inadequate description, and lack of enablement. However, the court has consistently found that the defendants failed to provide clear and convincing evidence to invalidate the patent[1].
Obviousness
To prove obviousness, the defendants must demonstrate that the differences between the claimed invention and the prior art would have been obvious to a person of ordinary skill in the art at the time of the invention. The court has ruled that the defendants did not meet this burden, and the asserted claims were not obvious[1].
Infringement
The court has held that the submission of New Drug Applications (NDAs) by defendants such as Teva Parenteral Medicines, Inc., Hospira, Inc., and Dr. Reddy’s Labs., Ltd., under 21 U.S.C. § 355(b)(2), would infringe the '209 Patent if the claims are found valid and enforceable[2][4].
Litigation History
Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.
This case involved a bench trial where the court upheld the validity of the '209 Patent against challenges by Teva. The defendants stipulated that their ANDA products would infringe the asserted claims if the patent was found valid[1].
Eli Lilly & Co. v. Hospira, Inc.
In this case, Hospira filed a motion for summary judgment of non-infringement, arguing that there was no plausible theory of infringement and that the doctrine of equivalents did not apply. The court rejected this motion, finding that Hospira's NDA submission would infringe the '209 Patent[5].
Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd.
Similar to the Hospira case, Dr. Reddy’s Labs., Ltd. faced infringement claims for their NDA submission. The court ruled that the submission would infringe the '209 Patent under 35 U.S.C. § 271(e)(2)[2][4].
Patent Landscape and Post-Issuance Review
Post-Issuance Review Proceedings
The America Invents Act (AIA) introduced post-issuance review proceedings, including Inter Partes Review (IPR) and Covered Business Method (CBM) reviews. These proceedings have led to duplicative litigation, with patents often being challenged in both federal courts and the Patent Trial and Appeal Board (PTAB)[3].
Court-PTAB Duplication
Studies have shown that about 24.5% of patents that reach a final validity determination in the PTAB also receive at least one validity determination in U.S. district courts. This duplication can lead to conflicting outcomes, with PTAB decisions sometimes disregarding prior judicial conclusions[3].
Doctrine of Equivalents
Limitations on Infringement Claims
The doctrine of equivalents allows for infringement claims beyond the literal scope of the patent claims but is subject to important limitations. Courts have emphasized that this doctrine is an exception rather than the rule and must be balanced against the statutory claiming requirement[4].
Prosecution History Estoppel
The doctrine of equivalents is further limited by prosecution history estoppel, which prevents a patentee from asserting infringement under the doctrine if the patentee made amendments or arguments during patent prosecution that would preclude such claims[4].
Statistical Insights
Litigation and PTAB Statistics
- 86.8% of patents challenged in IPR and CBM proceedings are also involved in litigation before federal courts.
- 70% of petitioners challenging patents in the PTAB do so as a defensive response after being sued for infringement.
- The Northern District of Illinois and the District of Delaware have seen significant variations in grant rates for motions to stay litigation pending PTAB review[3].
Industry Impact
Pharmaceutical Sector
The '209 Patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of generic versions of ALIMTA®. The patent's validity and the associated infringement claims have delayed the entry of generic competitors into the market[2][4].
Commercial Success
The commercial success of ALIMTA®, which is protected by the '209 Patent, is a factor considered in determining non-obviousness. The patent's validity has contributed to the drug's market dominance and revenue generation for Eli Lilly[1].
Key Takeaways
- The '209 Patent covers a method of administering pemetrexed disodium with folic acid and vitamin B12 to reduce toxicity.
- The patent has been upheld as valid against challenges of obviousness and other grounds.
- Infringement claims have been successful against several generic drug manufacturers.
- Post-issuance review proceedings have led to duplicative litigation and conflicting outcomes.
- The doctrine of equivalents is limited and subject to prosecution history estoppel.
Frequently Asked Questions (FAQs)
What is the '209 Patent, and what does it cover?
The '209 Patent, owned by Eli Lilly, covers a method of administering the chemotherapy drug pemetrexed disodium (ALIMTA®) in conjunction with folic acid and vitamin B12 to reduce patient toxicity.
Why is the '209 Patent significant in patent litigation?
The '209 Patent is significant because it has been the subject of several high-profile patent infringement cases involving generic drug manufacturers. Its validity has been upheld against various challenges, impacting the entry of generic versions of ALIMTA® into the market.
What are the implications of post-issuance review proceedings for the '209 Patent?
Post-issuance review proceedings, such as IPR and CBM reviews, have led to duplicative litigation and potential conflicting outcomes between PTAB decisions and federal court rulings. This can result in repeated challenges to the patent's validity.
How does the doctrine of equivalents apply to the '209 Patent?
The doctrine of equivalents is limited and subject to prosecution history estoppel. It cannot be used to extend the scope of the patent claims in a way that contradicts the patent's prosecution history or amendments made during that process.
What are the commercial implications of the '209 Patent's validity?
The validity of the '209 Patent has significant commercial implications, as it protects Eli Lilly's market exclusivity for ALIMTA® and delays the entry of generic competitors, thereby maintaining revenue generation for the company.
Cited Sources:
- Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. - Casetext
- United States Court of Appeals for the Federal Circuit - GovInfo
- Patent Inconsistency - Digital Repository @ Maurer Law
- APPENDIX - Supreme Court
- Eli Lilly & Co. v. Hospira, Inc. - Casetext
