United States Patent 4,544,554: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,544,554, titled "Triphasic Oral Contraceptive," is a significant patent in the pharmaceutical industry, particularly in the field of oral contraceptives. This patent, owned by Ortho-McNeil Pharmaceutical, Inc., was issued on October 1, 1985, and is a crucial part of the company's intellectual property portfolio.
Background
The patent was invented by Dr. Samuel Pasquale and is associated with the commercial product Ortho Tri-Cyclen. The applications leading to this patent were filed as continuations-in-part of an earlier patent, U.S. Patent No. 4,530,839[1].
Scope of the Patent
The scope of the patent revolves around a triphasic oral contraceptive, which involves a specific regimen of norgestimate and ethinyl estradiol. This regimen is designed to provide effective contraception while minimizing side effects.
Claims of the Patent
The patent includes several claims, with Claim 10 being particularly significant. Here is a summary of Claim 10 and its dependencies:
- Claim 10: This claim specifies a triphasic oral contraceptive regimen that includes three phases, each with a different dosage of norgestimate and ethinyl estradiol.
- Dependent Claims: These claims further detail the specific dosages and the duration of each phase in the regimen[1].
Prior Art and Obviousness
The validity of the patent has been challenged based on prior art. Barr Laboratories, in their defense against Ortho-McNeil's infringement claims, argued that the invention was obvious in light of several prior art references.
Key Prior Art References
- Norgestimate Article: A 1979 article published in the American Journal of Obstetrics and Gynecology by Dr. Pasquale and coauthors, which discussed the optimum dosage of norgestimate and ethinyl estradiol in oral contraceptives[1].
- TriNovum Package Insert: A leaflet accompanying the German version of the contraceptive Ortho-Novum 7/7/7, which provided dosage information similar to the claimed invention[1].
- Journal Officiel Reference: An entry in the Journal Officiel de la Republique Francaise that also described similar dosage regimens[1].
- U.S. Patent No. 3,957,982: This patent, known as the '
982 Patent, was another piece of prior art cited by Barr to challenge the novelty of the claimed invention[1].
Patent Landscape
The patent landscape surrounding U.S. Patent 4,544,554 is complex and involves several key players and legal battles.
Legal Challenges
Ortho-McNeil faced a significant challenge when Barr Laboratories filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval for a generic version of Ortho Tri-Cyclen. Barr certified that Ortho's patents were invalid, unenforceable, or not infringed by their generic product. This led to Ortho requesting reexamination of the patents by the PTO, which was subsequently denied[1].
Reexamination and Litigation
The denial of the reexamination requests led Ortho to file an infringement action against Barr. The case involved motions for summary judgment on the issue of obviousness, with both parties presenting extensive arguments based on the prior art[1].
Impact on the Pharmaceutical Industry
The patent and its associated legal battles have significant implications for the pharmaceutical industry.
Generic Competition
The approval of generic versions of branded drugs like Ortho Tri-Cyclen can significantly impact market dynamics. Generic competition can reduce prices and increase accessibility, but it also challenges the patent holder's ability to recoup investment in research and development[1].
Innovation and R&D
The patent landscape influences innovation in the pharmaceutical sector. Patents like U.S. Patent 4,544,554 protect intellectual property, encouraging further research and development. However, challenges to these patents can hinder innovation if companies feel their investments are not adequately protected[3].
Search and Analysis Tools
For professionals involved in patent searches and analysis, several tools are available:
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides various resources, including the Patent Public Search tool, Global Dossier, and Patent and Trademark Resource Centers (PTRCs). These tools help in conducting thorough patent searches and analyzing prior art[4].
International Patent Databases
Access to international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), is crucial for a comprehensive patent landscape analysis[4].
Key Takeaways
- Patent Scope: U.S. Patent 4,544,554 covers a specific triphasic oral contraceptive regimen.
- Claims: Claim 10 and its dependencies are critical for understanding the patent's scope.
- Prior Art: Several prior art references were cited to challenge the patent's validity.
- Legal Challenges: The patent faced significant legal challenges, including reexamination requests and infringement litigation.
- Industry Impact: The patent affects generic competition and innovation in the pharmaceutical industry.
- Search Tools: Various USPTO and international resources are available for patent searches and analysis.
FAQs
What is the main subject of U.S. Patent 4,544,554?
The main subject of U.S. Patent 4,544,554 is a triphasic oral contraceptive regimen involving specific dosages of norgestimate and ethinyl estradiol.
Who is the inventor of the patent?
The patent was invented by Dr. Samuel Pasquale.
What was the basis of Barr Laboratories' challenge to the patent?
Barr Laboratories challenged the patent based on obviousness in light of several prior art references.
What tools are available for conducting patent searches?
Tools available include the USPTO's Patent Public Search, Global Dossier, PTRCs, and international patent databases like those from EPO, JPO, and WIPO.
How does the patent impact the pharmaceutical industry?
The patent affects generic competition and innovation by protecting intellectual property and influencing market dynamics.
Sources
- ORTHO-McNEIL PHARMACEUTICAL, INC. v. BARR LABORATORIES, INC. - Casetext
- Untitled - Marin County
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
