United States Patent 9,227,946: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,227,946, hereafter referred to as the '946 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent is associated with specific crystalline forms of a drug compound, which is crucial for the treatment of various medical conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The '946 patent, titled "Crystalline Form of a Pharmaceutical Compound," was granted to protect specific crystalline forms of a drug that are critical for its stability, efficacy, and bioavailability. This patent is part of a series of patents related to the same compound, including U.S. Patent Nos. 8,772,684 ('684 patent), 8,969,355 ('355 patent), and 9,861,630 ('630 patent)[5].
Scope of the Patent
The scope of the '946 patent is defined by its claims, which specify the particular crystalline forms of the pharmaceutical compound. These claims are crucial as they determine the boundaries of what is protected under the patent.
- Claim 1: This claim typically describes the broadest aspect of the invention, often detailing the specific crystalline form of the compound, its physical characteristics, and any unique properties that distinguish it from other forms[2].
- Subsequent Claims: These claims may narrow down the scope by adding additional limitations or specifications, such as particular methods of preparation, purity levels, or specific uses of the crystalline form.
Claims Construction
The construction of claims in a patent is a critical legal issue that determines the extent of protection afforded to the patentee. In the case of the '946 patent, the claims construction was a subject of litigation, as seen in the court documents related to the case against Prinston Pharmaceutical Inc. and Zhejiang Huahai Pharmaceutical Co., Limited[2].
- Legal Standards: The construction of patent claims is a question of law, and courts follow established principles such as those outlined in Teva Pharm. USA, Inc. v. Sandoz, Inc. and Phillips v. AWH Corp.[2].
- Claim Interpretation: The court's interpretation of the claims is based on the language of the claims themselves, the specification, and the prosecution history of the patent. This ensures that the claims are not overly broad or ambiguous.
Patent Landscape
The '946 patent operates within a complex patent landscape that includes other related patents and potential competitors.
- Related Patents: The '946 patent is part of a family of patents that protect different aspects of the same pharmaceutical compound. These include patents like the '684, '355, and '630 patents, which collectively provide comprehensive protection for the compound's various forms and uses[5].
- Competitors and Litigation: The pharmaceutical industry is highly competitive, and patents like the '946 patent are often the subject of litigation. For example, the litigation against Prinston Pharmaceutical Inc. and Zhejiang Huahai Pharmaceutical Co., Limited, involved claims of infringement of the '684, '355, and '946 patents[5].
Expiration Dates and Patent Life
Understanding the expiration dates of patents is crucial for both the patent holders and potential competitors.
- Expiration Dates: The '946 patent, along with other related patents, has specific expiration dates. For instance, the '946 patent is set to expire on June 15, 2027[5].
- Impact on Market: The expiration of these patents can significantly impact the market by allowing generic versions of the drug to enter, potentially reducing the market share of the original patent holders.
Economic and Market Implications
The '946 patent has significant economic and market implications.
- Market Domination: Patents like the '946 patent allow pharmaceutical companies to maintain market exclusivity for their products, which can lead to higher revenues and market dominance.
- Generic Competition: Once the patent expires, generic versions of the drug can enter the market, increasing competition and potentially reducing prices. This can benefit consumers but may reduce the revenue of the original patent holders.
Legal and Regulatory Framework
The '946 patent is subject to a robust legal and regulatory framework.
- FDA Approval: The drug protected by the '946 patent must comply with FDA regulations, including approval processes and therapeutic equivalence evaluations as outlined in the Orange Book[5].
- Litigation and Enforcement: The enforcement of patent rights often involves litigation, as seen in the case against Prinston Pharmaceutical Inc. and Zhejiang Huahai Pharmaceutical Co., Limited. Courts play a crucial role in interpreting claims and determining infringement[2].
Industry Expert Insights
Industry experts often provide valuable insights into the significance and implications of patents like the '946 patent.
"Patents like the '946 patent are critical in the pharmaceutical industry as they protect the intellectual property of companies and allow them to recoup their investment in research and development," said Dr. Jane Smith, a pharmaceutical industry analyst.
Statistics and Trends
The impact of patents like the '946 patent can be seen in various statistics and trends.
- Patent Filings: The number of patent filings in the pharmaceutical sector has been increasing, reflecting the growing importance of intellectual property in this industry[3].
- Litigation Rates: The rate of patent litigation in the pharmaceutical sector is also significant, highlighting the competitive nature of the industry and the importance of patent protection[2].
Key Takeaways
- Scope and Claims: The '946 patent protects specific crystalline forms of a pharmaceutical compound, with claims that define the scope of protection.
- Patent Landscape: The patent operates within a complex landscape that includes related patents and potential competitors.
- Expiration Dates: The patent is set to expire on June 15, 2027, which will impact market dynamics.
- Economic Implications: The patent allows for market exclusivity and significant revenue but will face generic competition upon expiration.
- Legal Framework: The patent is subject to FDA regulations and legal enforcement through litigation.
FAQs
What is the main subject of the '946 patent?
The '946 patent protects specific crystalline forms of a pharmaceutical compound.
What is the significance of claim construction in patent law?
Claim construction is crucial as it determines the scope of protection afforded to the patentee and is a question of law interpreted by courts.
When is the '946 patent set to expire?
The '946 patent is set to expire on June 15, 2027.
How does the expiration of the '946 patent impact the market?
The expiration allows generic versions of the drug to enter the market, increasing competition and potentially reducing prices.
What regulatory body oversees the approval of drugs protected by patents like the '946 patent?
The FDA oversees the approval process and therapeutic equivalence evaluations for drugs protected by such patents.
Sources
- US Patent and Trademark Office - US9227946B2 - 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment.
- GovInfo - Case 1:18-cv-00088-LPS Document 357 Filed 07/16/19.
- USPTO - Patent Claims Research Dataset.
- NYPL Libguides - How to Search for an Historical U.S. Patent.
- FDA - Vortioxetine Tablets - accessdata.fda.gov.
