United States Patent 5,648,333: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,648,333, titled "Peptides Having Bradykinin Antagonist Action," is a significant patent in the pharmaceutical sector, particularly in the treatment of conditions related to bradykinin. Here, we will delve into the scope, claims, and the patent landscape surrounding this patent.
Background and Inventors
The patent was issued on July 15, 1997, to a group of inventors including Stephan Henke, Hiristo Anagnostopulos, Gerhard Breipohl, Jochen Knolle, Jens Stechl, Bernward Schölkens, Hans-Wolfram Fehlhaber, Hermann Gerhards, and Fran Hock[1].
Patent Scope and Claims
Claim 14: The Asserted Claim
The patent's scope is primarily defined by its claims, with Claim 14 being the most relevant in recent legal disputes. Claim 14 describes a specific peptide formula: "H-D-Arg-Arg-Pro-Hyp-Gly-Thia-Ser-D-Tic-Oic"[2][4].
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count. For U.S. Patent 5,648,333, the independent claims are detailed and specific, indicating a narrower scope compared to broader, more general claims. This specificity is crucial for patent validity and enforceability[3].
Patent Term and Extensions
Original Expiration Date
The original expiration date of the patent was July 15, 2014. However, due to regulatory review periods, the patent term was eligible for extension under 35 U.S.C. § 156[1].
Regulatory Review Period
The regulatory review period for this patent included the time between the submission of the Investigational New Drug (IND) application and the approval of the New Drug Application (NDA). This period, totaling 2,661 days, was used to calculate the extension. The maximum extension allowed under the law is five years, which resulted in a new expiration date of July 15, 2019[1].
Legal Disputes and Challenges
Infringement and Invalidity Claims
The patent has been involved in several legal disputes, notably between Shire Orphan Therapies, LLC, and Fresenius Kabi USA, LLC. Fresenius filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, challenging the validity of the '333 Patent. Shire Orphan Therapies sued Fresenius for infringement, while Fresenius counterclaimed for declaratory judgment of invalidity and non-infringement[2][4].
Obviousness-Type Double Patenting and Prosecution Laches
Fresenius also asserted that the '333 Patent was invalid due to obviousness-type double patenting and that prosecution laches barred recovery. However, the court ruled that the asserted claims were not invalid and that there was no unreasonable delay in prosecution[2][4].
Patent Landscape and Industry Impact
Pharmaceutical Sector
The '333 Patent is significant in the pharmaceutical sector, particularly for drugs targeting bradykinin-related conditions. The peptide described in Claim 14 is used in the drug icatibant, which is marketed under the brand name Firazyr for the treatment of hereditary angioedema[5].
Competitive Landscape
The legal battles surrounding this patent highlight the competitive nature of the pharmaceutical industry. Companies often engage in extensive litigation to protect their intellectual property and market share. The defense of the '333 Patent by Haug Partners against invalidity and unenforceability allegations underscores the importance of robust patent protection in this sector[5].
Metrics for Patent Scope
Independent Claim Length and Count
Studies on patent scope suggest that narrower claims, as seen in the '333 Patent, are associated with a higher probability of grant and a shorter examination process. The examination process tends to narrow the scope of patent claims, which can impact the patent's validity and enforceability[3].
Conclusion
United States Patent 5,648,333 is a critical patent in the pharmaceutical industry, particularly for treatments involving bradykinin antagonists. The patent's scope, defined by specific claims like Claim 14, has been subject to legal challenges. The successful defense of this patent against invalidity and unenforceability allegations highlights its importance and the competitive landscape of the pharmaceutical sector.
Key Takeaways
- Patent Scope and Claims: The patent's scope is defined by specific claims, with Claim 14 being crucial.
- Patent Term Extensions: The patent term was extended to July 15, 2019, due to regulatory review periods.
- Legal Disputes: The patent has been involved in significant legal disputes regarding infringement and validity.
- Industry Impact: The patent is vital in the pharmaceutical sector, particularly for hereditary angioedema treatments.
- Competitive Landscape: The patent's defense underscores the competitive nature of the pharmaceutical industry.
FAQs
What is the main subject of United States Patent 5,648,333?
The main subject of the patent is peptides having bradykinin antagonist action, specifically used in treatments like icatibant for hereditary angioedema.
Who are the inventors of the patent?
The inventors include Stephan Henke, Hiristo Anagnostopulos, Gerhard Breipohl, Jochen Knolle, Jens Stechl, Bernward Schölkens, Hans-Wolfram Fehlhaber, Hermann Gerhards, and Fran Hock.
What was the original expiration date of the patent?
The original expiration date was July 15, 2014, but it was extended to July 15, 2019.
What legal challenges has the patent faced?
The patent has faced challenges related to infringement, invalidity under various sections of the U.S.C., and prosecution laches.
How does the patent impact the pharmaceutical industry?
The patent is crucial for the development and marketing of drugs targeting bradykinin-related conditions, highlighting the competitive and legally complex nature of the pharmaceutical industry.
Cited Sources
- In re - Regulations.gov: Downloaded from Regulations.gov.
- United States District Court: In the United States District Court, District of Delaware.
- Hoover Institution: Patent Claims and Patent Scope by Alan C. Marco et al.
- Casetext: Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC.
- Haug Partners: Haug Partners Successfully Defends Firazyr® Patent Against Invalidity and Unenforceability Allegations.
