Details for Patent: 6,060,499

Summary for Patent: 6,060,499

Title:	Anti-migraine methods and compositions using 5-HT agonists with long-acting NSAIDs
Abstract:	This invention comprises a method of treating migraine in a human comprising co-timely administering of a therapeutically effective amount of a 5-HT agonist coordinated with a therapeutically effective amount of an analgesic, particularly a long-acting NSAID, and in some instances, doses below those ordinarily considered as minimum effective doses as to one or both 5-HT agonist and long-acting NSAID. Dosage forms are also included herein.
Inventor(s):	Plachetka; John R. (Chapel Hill, NC)
Assignee:	Pozen, Inc. (Chapel Hill, NC)
Application Number:	09/151,912
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 6,060,499: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 6,060,499, filed on September 11, 1998, is a pivotal patent held by Pozen Inc., focusing on methods and compositions for treating migraines. This patent, along with two other related patents (U.S. Patent Nos. 6,586,458 and 7,332,183), has been at the center of significant litigation involving generic drug manufacturers. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Invention

The patent describes a method of treating migraines by co-administering a therapeutically effective amount of a 5-HT agonist (such as sumatriptan) and a nonsteroidal anti-inflammatory drug (NSAID) like naproxen. This combination is designed to provide both immediate relief from migraine symptoms and prevention of symptom recurrence[4].

Key Claims of the Patent

The '499 patent includes several key claims that define the scope of the invention:

• Claim 1: This claim describes a method of treating migraine in a human by co-administering a therapeutically effective amount of a 5-HT agonist and an NSAID.
• Subsequent Claims: These claims specify various aspects of the method, including the timing of administration, the dosage forms, and the specific combinations of drugs used[4].

Patent Scope and Construction

The scope of the '499 patent is crucial in determining its validity and infringement. Here are some key points:

• Co-administration: The patent emphasizes the co-administration of a 5-HT agonist and an NSAID, which is a critical aspect of the claimed method.
• Therapeutically Effective Amount: The claims specify that the amounts of the drugs administered must be therapeutically effective, indicating a focus on clinical efficacy.
• Quantitative Construction: In the litigation involving this patent, the court construed certain qualitative claim limitations quantitatively. For example, the court defined "substantially all" of the triptan and naproxen being in separate layers as meaning at least 90%, and preferably greater than 95%, of each drug in distinct layers[1][5].

Litigation and Infringement

The '499 patent has been subject to significant litigation, particularly against generic drug manufacturers such as Par Pharmaceutical Inc., Alphapharm Pty Ltd., and Dr. Reddy’s Laboratories Inc.

• Infringement Claims: Pozen Inc. filed complaints against these generic manufacturers for infringement under the Hatch-Waxman Act, alleging that their Abbreviated New Drug Application (ANDA) filings with the FDA constituted an artificial act of infringement[1][2].
• District Court Ruling: The district court held that the generic manufacturers' ANDA products infringed the claims of the '499 patent, among others. This ruling was based on the doctrine of equivalents and the court's construction of the patent claims[1][2].
• Federal Circuit Affirmation: The Federal Circuit affirmed the district court's decision, upholding the validity of the '499 patent and the infringement findings. The court ruled that the appellants failed to rebut the presumption of validity of the issued patents and provided no basis for unsettling the district court’s finding on infringement[2][5].

Patent Landscape

Understanding the patent landscape around the '499 patent involves analyzing related patents, prior art, and the strategic positioning of these patents within Pozen Inc.'s intellectual property portfolio.

• Related Patents: The '499 patent is part of a family of patents that include U.S. Patent Nos. 6,586,458 and 7,332,183. These patents collectively protect the method of treating migraines using a combination of sumatriptan and naproxen, as well as specific formulations and tablet designs[2][5].
• Prior Art: The generics manufacturers challenged the validity of the '499 patent in light of prior art references. However, the court found that the patents were not invalid due to obviousness or lack of written description[1][2].
• Patent Analytics: Effective management of these patents involves using patent analytics tools to track claims, scope concepts, and coverage gaps. This helps in maintaining a robust patent landscape and identifying future design opportunities[3].

Strategic Importance

The '499 patent is strategically important for Pozen Inc. and its partner GlaxoSmithKline, as it protects their migraine treatment product, Treximet.

• Market Protection: The patent ensures that generic versions of Treximet cannot be marketed until the patent expires, providing a significant market advantage.
• Innovation Incentive: The protection afforded by this patent incentivizes further innovation in migraine treatment, as companies can invest in research and development with the assurance of exclusive rights to their inventions.

Conclusion

The United States Patent 6,060,499 is a cornerstone in the intellectual property portfolio of Pozen Inc., protecting a novel method for treating migraines. The patent's scope, claims, and the litigation surrounding it highlight its importance in the pharmaceutical industry. Understanding the patent landscape and the strategic implications of this patent is crucial for both Pozen Inc. and other companies operating in the field.

Key Takeaways

• The '499 patent protects a method of treating migraines using a combination of a 5-HT agonist and an NSAID.
• The patent has been upheld in litigation against generic drug manufacturers.
• The Federal Circuit affirmed the district court's findings on validity and infringement.
• Effective patent analytics is essential for managing and leveraging this patent.
• The patent is strategically important for protecting market share and incentivizing innovation.

FAQs

1. What is the main invention protected by the '499 patent? The '499 patent protects a method of treating migraines by co-administering a therapeutically effective amount of a 5-HT agonist and an NSAID.

2. Which companies were involved in the litigation over the '499 patent? The litigation involved Pozen Inc. and generic drug manufacturers Par Pharmaceutical Inc., Alphapharm Pty Ltd., and Dr. Reddy’s Laboratories Inc.

3. What was the outcome of the Federal Circuit's ruling on the '499 patent? The Federal Circuit affirmed the district court's decision, upholding the validity of the '499 patent and the infringement findings against the generic manufacturers.

4. How does the '499 patent fit into Pozen Inc.'s intellectual property portfolio? The '499 patent is part of a family of patents that collectively protect the method of treating migraines using a combination of sumatriptan and naproxen, as well as specific formulations and tablet designs.

5. What is the significance of the '499 patent in the pharmaceutical industry? The patent is significant as it protects a novel method for treating migraines, ensuring market exclusivity for Pozen Inc.'s product Treximet and incentivizing further innovation in migraine treatment.

Sources

1. Pozen Inc. v. Par Pharm., Inc., 696 F.3d 1151 - Casetext
2. Pozen Migraine Drug Patent Win Upheld By Federal Circuit - Mandour Law
3. Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
4. US6060499A - Anti-migraine methods and compositions using 5-HT agonists and NSAIDs - Google Patents
5. Last Month at the Federal Circuit Newsletter - October 2012 - Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Drugs Protected by US Patent 6,060,499

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 6,060,499

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	286393
Australia	3596500
Australia	3984597
Australia	711741
Canada	2260943
Germany	69732189
Denmark	0957914