Understanding the Scope and Claims of United States Patent 8,067,416
Introduction
The United States Patent 8,067,416, hereafter referred to as the '416 patent, is a significant intellectual property asset in the pharmaceutical industry. This patent is part of a series of patents held by BioMarin and Merck, and it plays a crucial role in protecting their innovations related to specific pharmaceutical formulations.
Overview of the Patent
The '416 patent, titled "Stable Tablet Formulation," was issued by the United States Patent and Trademark Office (USPTO) on November 29, 2011. This patent is one of several related to the formulation and use of sapropterin dihydrochloride, a drug used in the treatment of phenylketonuria (PKU), a genetic disorder[1].
Claims of the Patent
The '416 patent includes multiple claims that define the scope of the invention. Here are some key aspects:
Independent Claims
- These claims define the broadest scope of the invention. For example, Claim 1 might describe a stable tablet formulation comprising sapropterin dihydrochloride and specific excipients that enhance stability and bioavailability[1].
Dependent Claims
- These claims are narrower and depend on the independent claims. They may specify particular ratios of ingredients, manufacturing processes, or specific uses of the formulation.
Method Claims
- These claims cover the methods of preparing the formulation, administering the drug, or using the drug for therapeutic purposes.
Patent Scope and Landscape
Patent Scope
The scope of the '416 patent is defined by its claims, which delineate what is protected and what would constitute infringement. The patent scope includes:
- Composition of Matter: The specific formulation of sapropterin dihydrochloride and other ingredients.
- Method of Manufacture: The processes used to prepare the stable tablet formulation.
- Method of Use: The therapeutic uses of the formulation, particularly in treating PKU[1].
Patent Landscape
The patent landscape surrounding the '416 patent involves other related patents and potential generic competitors. Here are some key points:
- Related Patents: The '416 patent is part of a portfolio that includes other patents such as the '462, '126, '745, and '624 patents. These patents collectively protect various aspects of the drug formulation and its use[1].
- Generic Competition: Companies like Aurobindo Ltd. have sought to develop generic versions of the drug, which has led to infringement disputes. For instance, BioMarin and Merck have alleged that Aurobindo’s generic product would infringe on the '416 patent upon FDA approval[1].
Infringement and Litigation
The '416 patent has been at the center of several infringement disputes. Here are some key points:
Direct Infringement
- BioMarin and Merck have alleged that Aurobindo’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for approval of a generic version of sapropterin dihydrochloride would constitute direct infringement of the '416 patent[1].
Induced Infringement
- The plaintiffs have also claimed that Aurobindo would induce infringement by intentionally encouraging acts of direct infringement with knowledge of the '416 patent and knowledge that their acts are encouraging infringement[1].
Contributory Infringement
- Additionally, BioMarin and Merck have alleged that Aurobindo would contributorily infringe the '416 patent by manufacturing and selling a product that is especially made or adapted for a use that infringes the patent, with no substantial non-infringing use[1].
Economic and Strategic Impact
The '416 patent has significant economic and strategic implications:
Market Protection
- The patent protects BioMarin and Merck’s market share by preventing generic competition until the patent expires.
- Revenue Impact: The exclusivity provided by the patent ensures that the companies can maintain higher prices and revenue streams from the sale of the drug.
Innovation Incentives
- The patent system incentivizes innovation by providing a period of exclusivity for inventors to recoup their investment in research and development.
- Research and Development: The protection afforded by the '416 patent allows companies to invest in further research and development, potentially leading to new and improved treatments.
Public Access and Research
The USPTO provides various tools for accessing and analyzing patent information, including the '416 patent:
Public Search Facility
- The USPTO Public Search Facility in Alexandria, VA, offers access to patent and trademark information, including the '416 patent, in various formats such as online, microfilm, and print[4].
Patent Claims Research Dataset
- The USPTO also provides the Patent Claims Research Dataset, which contains detailed information on claims from U.S. patents, including those related to the '416 patent. This dataset can be used to analyze patent scope and trends[3].
Future of Patent Litigation and Small Claims Courts
The landscape of patent litigation is evolving, with discussions around the establishment of a small claims patent court:
Small Claims Patent Court Study
- The Administrative Conference of the United States (ACUS) has conducted a study on the feasibility and structure of a small claims patent court, which could potentially streamline and reduce the costs associated with patent litigation[5].
Key Takeaways
- Patent Scope: The '416 patent protects a specific stable tablet formulation of sapropterin dihydrochloride and its methods of manufacture and use.
- Infringement Disputes: The patent has been involved in infringement disputes with generic competitors like Aurobindo Ltd.
- Economic Impact: The patent provides market protection and incentives for innovation, affecting revenue and research investments.
- Public Access: The USPTO offers various tools for accessing and analyzing patent information.
- Future of Litigation: There are ongoing discussions about the establishment of a small claims patent court to address patent litigation more efficiently.
FAQs
Q: What is the main subject of the '416 patent?
A: The '416 patent is related to a stable tablet formulation of sapropterin dihydrochloride, used in treating phenylketonuria (PKU).
Q: Who are the holders of the '416 patent?
A: The '416 patent is held by BioMarin and Merck.
Q: What are the allegations against Aurobindo Ltd. regarding the '416 patent?
A: BioMarin and Merck have alleged that Aurobindo’s generic product would directly, inducedly, and contributorily infringe the '416 patent upon FDA approval.
Q: How does the '416 patent impact the market?
A: The patent protects the market share of BioMarin and Merck by preventing generic competition, thereby maintaining higher prices and revenue streams.
Q: What resources are available for accessing and analyzing the '416 patent?
A: The USPTO Public Search Facility and the Patent Claims Research Dataset provide access to detailed information about the '416 patent.
Sources
- Charles M. Lizza William C. Baton Sarah A. Sullivan One Riverfront ... - Complaint filed by BioMarin and Merck against Aurobindo Ltd.
- U.S. Patent and Trademark Office (USPTO) | USAGov - General information about the USPTO.
- Patent Claims Research Dataset - USPTO - Information on the Patent Claims Research Dataset.
- Search for patents - USPTO - Information on searching for patents.
- U.S. Patent Small Claims Court - Study on the feasibility of a small claims patent court.
