United States Patent 8,354,430: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,354,430, assigned to Bioprojet, is a significant patent in the pharmaceutical industry, particularly for the drug WAKIX. This patent protects a specific monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine, which is used in the treatment of central nervous system disorders such as narcolepsy and cataplexy. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Inventors and Assignee
The patent was invented by a team of researchers including Manuel Raga, Juan Sallares, Marta Guerrero, Antonio Guglietta, Jean-Michel Arrang, Jean-Charles Schwartz, Holger Stark, Walter Schunack, Xavier Ligneau, Jeanne-Marie Lecomte, and Charon Ganellin. The assignee of the patent is Bioprojet Société Civile De Recherche, a French research company[1][4].
Patent Claims
The patent includes multiple claims that define the scope of protection. These claims cover the monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine, methods for its preparation, and its use in treating central nervous system disorders. The claims are detailed and specific, ensuring that the patent covers the unique aspects of the invention while avoiding overly broad claims that could be challenged for lack of clarity or validity[4].
Patent Scope and Metrics
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This patent, with its specific claims, aligns with these findings, indicating a well-defined and focused scope[3].
International Patent Protection
The patent has a significant international presence, with twenty-seven patent family members in twenty-one countries. This extensive global protection ensures that Bioprojet's intellectual property is safeguarded across various jurisdictions, preventing unauthorized use or manufacture of the protected compound[1].
Expiration and Generic Entry
The patent's expiration date is crucial for understanding when generic versions of the drug can enter the market. While the exact expiration dates vary by country due to supplementary protection certificates (SPCs), the patent is set to expire in the near future in several countries, paving the way for potential generic competition[1].
Litigation and Patent Disputes
The patent has been involved in several legal disputes, particularly with companies filing Abbreviated New Drug Applications (ANDAs) for generic versions of WAKIX. For instance, MSN Laboratories Private Limited filed a Paragraph IV Certification with the FDA, asserting that the patent claims are invalid or will not be infringed by their generic product. This led to a declaratory judgment complaint and subsequent litigation in the U.S. District Court[2][5].
Hatch-Waxman Act and Regulatory Implications
Under the Hatch-Waxman Act, companies filing ANDAs must submit a patent certification regarding each Orange Book-listed patent for the drug. The Paragraph IV Certification allows the ANDA applicant to challenge the validity or non-infringement of the listed patents. This process is critical in determining the timing of generic entry into the market and has significant regulatory implications for both the brand and generic drug manufacturers[2].
Patent Litigation and Transfer of Venue
In the case involving MSN Laboratories, Bioprojet sued MSN for patent infringement in the District of Delaware, following the filing of MSN's ANDA. The court granted Bioprojet's motion to transfer the case from Virginia to Delaware, citing efficiency and the avoidance of duplicative work. This highlights the strategic importance of venue selection in patent litigation[5].
Impact on Innovation and Patent Quality
The debate over patent quality and scope is ongoing, with some arguing that broader patents can stifle innovation due to increased licensing and litigation costs. However, patents like 8,354,430, with well-defined and specific claims, contribute to a clearer and more predictable patent landscape, which can foster innovation by providing clear boundaries for research and development[3].
Key Takeaways
- Specific Claims: The patent includes detailed and specific claims that protect the monohydrochloride salt and its uses.
- International Protection: Extensive global protection with twenty-seven patent family members in twenty-one countries.
- Litigation: Involved in several legal disputes related to generic entry and patent validity.
- Regulatory Implications: Significant under the Hatch-Waxman Act for determining generic entry timing.
- Patent Scope Metrics: Aligns with research indicating narrower claims are associated with higher grant probabilities and shorter examination processes.
FAQs
What is the main compound protected by United States Patent 8,354,430?
The main compound protected is the monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine.
Which company is the assignee of this patent?
The assignee of the patent is Bioprojet Société Civile De Recherche.
What is the significance of the Hatch-Waxman Act in relation to this patent?
The Hatch-Waxman Act requires ANDA applicants to submit a patent certification, which can include a Paragraph IV Certification challenging the validity or non-infringement of listed patents, affecting the timing of generic entry.
Why is the international patent protection important for this patent?
International protection ensures that Bioprojet's intellectual property is safeguarded across various jurisdictions, preventing unauthorized use or manufacture.
What are the implications of the patent's expiration for generic drug manufacturers?
The expiration of the patent allows generic manufacturers to enter the market, potentially increasing competition and reducing drug prices.
Sources
- DrugPatentWatch: Summary for Patent: 8,354,430.
- RPX Insight: MSN Laboratories Private Limited v. Bioprojet Société Civile De Recherche.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: US8354430B2 - Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine.
- CAFC: In Re MSN Laboratories Private LTD.
