United States Patent 4,616,006: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,616,006, hereafter referred to as the "`006 Patent," is a significant intellectual property asset in the field of pharmaceuticals, particularly in the development and marketing of oral contraceptives. This patent, owned by Ortho-McNeil Pharmaceutical, Inc., is part of a broader patent landscape that has been the subject of various legal and technical analyses.
Background and Procedural History
The 006 Patent was issued on October 7, 1986, and is titled "Triphasic Oral Contraceptive." It was invented by Dr. Samuel Pasquale and is closely related to another patent, U.S. Patent No. 4,544,554 (554 Patent")[1].
Claims of the `006 Patent
Claim 9: The Core Invention
Claim 9 of the `006 Patent describes a method of contraception involving the administration of a triphasic combination oral contraceptive. This regimen includes the administration of two hormones: norgestimate (a synthetic progestin) and ethinyl estradiol (a synthetic estrogen) for twenty-one consecutive days, followed by seven days without the administration of steroids. The specific dosages are outlined as follows:
- For the first 7 days: 0.180 mg of norgestimate and 0.035 mg of ethinyl estradiol.
- For the next 7 days: 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol.
- For the final 7 days: 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol[1].
Scope of the Invention
The `006 Patent covers a specific triphasic oral contraceptive regimen where the estrogen dosage remains constant throughout the three phases, while the progestogen dosage increases incrementally. This regimen is designed to provide effective contraception while minimizing side effects and ensuring user compliance.
Prior Art and Obviousness
A critical aspect of the `006 Patent's validity is the issue of prior art and obviousness. Barr Laboratories, in a legal challenge, argued that the claimed invention was obvious in light of prior art. Key pieces of prior art include:
- A 1979 article published in the American Journal of Obstetrics and Gynecology by Dr. Pasquale and coauthors, titled "Optimum Dosage of an Oral Contraceptive: A Report on the Study of Seven Combinations of Norgestimate and Ethinyl Estradiol"[1].
- The TriNovum Package Insert, which accompanied the German version of the contraceptive Ortho-Novum 7/7/7.
- An entry in the Journal Officiel de la Republique Francaise.
- U.S. Patent No. 3,957,982 (`982 Patent)[1].
Legal Challenges and Validity
The validity of the `006 Patent has been challenged in court, with Barr Laboratories arguing that the claims were obvious based on the prior art. However, the patent office initially denied requests for reexamination, stating that no substantial new question of patentability was raised by the prior art cited[1].
Patent Landscape and Analytics
Understanding the patent landscape around the `006 Patent involves analyzing the claims and scope concepts to identify gaps and opportunities. Tools like Claim Coverage Matrix and ClaimScape® software can help categorize patents by claims and scope concepts, facilitating a comprehensive analysis of the patent landscape[3].
Claim Charts and Scope Concepts
Claim charts generated by software like ClaimScape® can help technical experts determine whether a particular scope concept is applicable to a target product or method. This approach helps in identifying areas where claim coverage is lacking and highlights future design opportunities[3].
International Patent Search and Global Dossier
To fully understand the global patent landscape, it is essential to search international patent databases. Resources such as the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE® Search Service provide access to international patent applications and prior art[4].
Public Search Facilities and Resources
The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) offer additional resources for conducting thorough patent searches. These facilities provide access to patent and trademark information in various formats and trained staff to assist in search techniques[4].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by participating IP offices, enabling a single-point access to citation data related to patent applications. This tool is crucial for visualizing search results from multiple offices on a single page[4].
Patent Assignment and Examination Data
Tracking patent assignments and changes in ownership through the Patent Assignment Search website and accessing bibliographic data through the Patent Examination Data System (PEDS) are also important for a comprehensive analysis of the patent landscape[4].
Key Takeaways
- The `006 Patent covers a specific triphasic oral contraceptive regimen with incremental progestogen dosages and constant estrogen dosages.
- The patent's validity has been challenged based on prior art, but it has been upheld in certain legal proceedings.
- Advanced tools and resources are available for analyzing the patent landscape, including claim charts and international patent databases.
- Understanding the scope and claims of the `006 Patent is crucial for navigating the complex landscape of pharmaceutical patents.
FAQs
What is the main claim of the `006 Patent?
The main claim of the `006 Patent describes a triphasic oral contraceptive regimen involving the administration of norgestimate and ethinyl estradiol in specific dosages over a 21-day period, followed by a 7-day period without steroids.
What prior art has been cited against the `006 Patent?
Key prior art includes a 1979 article by Dr. Pasquale, the TriNovum Package Insert, an entry in the Journal Officiel de la Republique Francaise, and U.S. Patent No. 3,957,982.
How can one analyze the patent landscape around the `006 Patent?
Using tools like Claim Coverage Matrix and ClaimScape® software to categorize patents by claims and scope concepts, and accessing international patent databases through resources like the USPTO Public Search Facility and Global Dossier.
What resources are available for conducting international patent searches?
Resources include the European Patent Office's esp@cenet, the Japan Patent Office, the World Intellectual Property Organization's PATENTSCOPE® Search Service, and other international intellectual property offices.
Why is the Common Citation Document (CCD) important?
The CCD consolidates prior art cited by participating IP offices, providing a single-point access to citation data related to patent applications and facilitating a more integrated global patent system.
Cited Sources:
- ORTHO-McNEIL PHARMACEUTICAL, INC. v. BARR LABORATORIES, INC. - Casetext
- Ortho-McNeil Pharmaceutical Inc. v. Barr Laboratories, Inc., Civil - Casetext
- Patent Analytics | Intellectual Property Law - Schwegman
- Search for patents - USPTO - USPTO
- Janssen's low dosage oral contraception regime patent valid - Aitken Klee
