Detailed Analysis of the Scope and Claims of United States Patent 4,587,252
Introduction
United States Patent 4,587,252, titled "Hydrocodone/Ibuprofen Pharmaceutical Compositions and Method," was issued on May 6, 1986, to Dr. John D. Arnold. This patent is significant in the pharmaceutical industry, particularly for its claims related to the combination of hydrocodone and ibuprofen as an analgesic.
Background and History
The patent application for U.S. Patent 4,587,252 was filed on December 18, 1984. Dr. Arnold claimed that the specific combination of hydrocodone and ibuprofen produced a greater analgesic effect than using either pain reliever alone[2][4].
Claims of the Patent
The '252 patent claims the composition and method of using a combination of hydrocodone and ibuprofen for analgesic purposes. Specifically, it covers:
- The combination of hydrocodone bitartrate and ibuprofen in specific doses and ratios.
- The method of using this combination to achieve an enhanced analgesic effect compared to using either component separately[2][4].
Commercial Embodiment
The commercial embodiment of the '252 patent is Vicoprofen®, a pharmaceutical product that combines hydrocodone bitartrate and ibuprofen. This product was licensed exclusively to Knoll Pharmaceutical Company in May 1988[1][2].
Patent Extension and Regulatory Review
The patent holders attempted to extend the term of the '252 patent under 35 U.S.C. § 156, which allows for the extension of a patent term due to regulatory review periods. However, the court ruled that the patent did not meet the criteria for extension, as the regulatory review period did not delay the first permitted commercial marketing or use of the product[1].
Patent Validity and Infringement
The validity of the '252 patent was challenged in several legal proceedings. Teva Pharmaceuticals USA filed a motion for summary judgment of patent invalidity, arguing that the patent was anticipated by prior art and obvious in light of published literature. The court granted Teva's motion, finding that the combination of hydrocodone and ibuprofen was obvious based on prior art and the level of ordinary skill in the art at the time of the invention[2][4].
Obviousness
The court's decision was based on several key points:
- The prior art did not teach away from combining hydrocodone and ibuprofen.
- Others had not tried and failed to create an opioid-NSAID analgesic combination.
- The unexpected benefits of the claimed invention were discovered long after the patent had issued.
- The sales of the hydrocodone-ibuprofen product were insufficient to overcome the determination of obviousness[4].
European Patent Counterpart
Dr. Arnold also filed a European patent application for the same invention, which was subject to similar scrutiny. The European Patent Office (EPO) identified relevant prior art, including the Upjohn Application, which was deemed particularly relevant to the claims of the European Application[2].
Patent Landscape Analysis
To understand the broader context of the '252 patent, a patent landscape analysis is useful. Here are some key insights:
Defining Scope and Keywords
A patent landscape analysis begins by defining the scope and identifying relevant keywords. For the '252 patent, keywords would include "hydrocodone," "ibuprofen," "analgesic combination," and "pharmaceutical composition"[3].
Identifying Trends and Key Players
The analysis would reveal trends in patent filings related to opioid-NSAID combinations and identify key players in the field. This includes understanding the competitive landscape and potential legal vulnerabilities[3].
Analyzing Citations and Evolution
Studying how patents reference each other helps in understanding their impact and development. For the '252 patent, analyzing citations would show how it fits into the broader landscape of analgesic combinations and how it has influenced subsequent inventions[3].
Insights for Strategic Decisions
A patent landscape analysis provides actionable insights for strategic decisions. For example, it can help in evaluating the strength of a patent portfolio, identifying new innovations, and understanding technological trends. This information is crucial for inventors and companies looking to navigate the complex landscape of pharmaceutical patents[3].
Key Takeaways
- Patent Claims: The '252 patent claims a specific combination of hydrocodone and ibuprofen for enhanced analgesic effect.
- Commercial Embodiment: The commercial product is Vicoprofen®, licensed exclusively to Knoll Pharmaceutical Company.
- Patent Validity: The patent was found invalid due to obviousness based on prior art.
- Regulatory Review: The patent term extension was denied due to regulatory review criteria not being met.
- Patent Landscape: A comprehensive analysis reveals trends, key players, and the impact of the patent on subsequent innovations.
FAQs
What is the main claim of U.S. Patent 4,587,252?
The main claim is the combination of hydrocodone and ibuprofen in specific doses and ratios for enhanced analgesic effect.
Why was the patent term extension denied for U.S. Patent 4,587,252?
The patent term extension was denied because the regulatory review period did not delay the first permitted commercial marketing or use of the product.
What was the outcome of the patent validity challenge by Teva Pharmaceuticals?
The court granted Teva's motion for summary judgment of patent invalidity, finding the combination of hydrocodone and ibuprofen obvious based on prior art.
How does a patent landscape analysis help in understanding the '252 patent?
A patent landscape analysis helps in identifying trends, key players, and the impact of the patent on subsequent innovations, providing actionable insights for strategic decisions.
What is the significance of the European patent counterpart for the '252 patent?
The European patent counterpart faced similar scrutiny, with the EPO identifying relevant prior art that was particularly relevant to the claims, further supporting the obviousness finding.
Sources
- United States Court of Appeals for the Federal Circuit - Arnold Partnership v. Rogan, 246 F. Supp. 2d 460 (E.D. Va. 2003).
- Casetext - Knoll Pharmaceutical Company v. Teva Pharmaceuticals USA.
- Goldstein Patent Law - How to Do Patent Landscape Analysis.
- Casetext - Knoll Pharm. Co. v. Teva Pharms. USA, Inc..
- University of Houston Law Center - Knoll Pharm. Co., Inc. v. Teva Pharms. USA, Inc., 03-1300 (Fed. Cir. May 19, 2004).
