Understanding the Scope and Claims of United States Patent 8,372,827
Introduction
The United States Patent 8,372,827, hereafter referred to as the '827 patent, is one of the patents involved in a series of legal disputes between LEO Pharma and various generic drug manufacturers, including Actavis and Perrigo. This patent is part of a broader portfolio related to the drug Picato®, which contains ingenol mebutate, a treatment for actinic keratosis. Here, we will delve into the details of the '827 patent, its claims, and the surrounding patent landscape.
Background of the '827 Patent
The '827 patent, titled "Method of Producing Ingenol Mebutate," is one of the process patents held by LEO Pharma. It was granted on February 12, 2013, and is part of a family of patents that share a common specification and inventors[2].
Claims of the '827 Patent
The '827 patent includes multiple claims that describe specific methods for producing ingenol mebutate. These claims are crucial as they define the scope of protection granted to LEO Pharma.
- Independent Claims: The patent includes independent claims that outline the core processes involved in producing ingenol mebutate. These claims are broad enough to cover the essential steps of the production method but narrow enough to distinguish the invention from prior art[2].
- Dependent Claims: The dependent claims build upon the independent claims, adding specific details or limitations that further define the invention. These claims help to narrow down the scope and ensure that the patent does not overly broaden the invention[3].
Patent Scope and Claim Language
The scope of the '827 patent is determined by the language used in its claims. Here are some key points:
- Claim Length and Count: Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in the '827 patent, are often associated with a higher probability of grant and a shorter examination process[3].
- Claim Interpretation: The interpretation of claim language is critical. Courts may not read back into the claims limitations that were included in the original application but were removed during prosecution. This principle is well-established in patent law and affects how the '827 patent's claims are interpreted[1].
Patent Landscape and Related Patents
The '827 patent is part of a larger family of patents related to Picato®. Here are some key patents and their relationships:
- Process Patents: The '827 patent is closely related to other process patents, such as the '084 and '698 patents, which also cover methods of producing ingenol mebutate. These patents share a common specification and inventors, and the '698 patent is a continuation of the '084 patent[2].
- Other Patents-in-Suit: LEO Pharma has asserted several other patents in conjunction with the '827 patent, including the '656, '292, '828, '919, '163, '271, and '375 patents. These patents collectively form a robust intellectual property portfolio protecting Picato®[5].
Litigation and Challenges
The '827 patent has been involved in several legal disputes, particularly in the context of Hatch-Waxman litigation.
- Infringement Allegations: LEO Pharma has alleged that generic drug manufacturers, such as Actavis and Perrigo, have infringed upon the '827 patent through their Abbreviated New Drug Applications (ANDAs)[5].
- Inequitable Conduct: Actavis and Perrigo have counterclaimed, alleging inequitable conduct by LEO Pharma for failing to disclose relevant prior art, such as the '445 patent, during the prosecution of the '827 patent and other related process patents[4].
Impact of Prosecution History
The prosecution history of the '827 patent is significant in determining its scope and validity.
- Aprotic Solvents: During prosecution, the original application limited the claims to aprotic solvents, but this limitation was subsequently removed. This change affects how the claims are interpreted, as courts cannot generally read back into the claims limitations that were removed during prosecution[1].
- Disclosure of Prior Art: The failure to disclose relevant prior art, such as the '445 patent, has been a point of contention. This omission could potentially render the '827 patent unenforceable due to inequitable conduct[4].
Key Takeaways
- Patent Scope: The '827 patent's scope is defined by its claim language, with narrower claims generally associated with a higher probability of grant and shorter examination process.
- Related Patents: The patent is part of a larger family of process patents related to Picato®, including the '084 and '698 patents.
- Litigation: The '827 patent has been involved in significant litigation, including allegations of infringement and inequitable conduct.
- Prosecution History: The patent's prosecution history, including changes to claim limitations and disclosure of prior art, is crucial in determining its validity and scope.
FAQs
Q: What is the main subject of the '827 patent?
A: The '827 patent covers methods for producing ingenol mebutate, a treatment for actinic keratosis.
Q: How does the claim language affect the patent scope?
A: The claim language, particularly the length and count of independent claims, can influence the patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process.
Q: What are the implications of removing limitations during patent prosecution?
A: Removing limitations during prosecution, such as the aprotic solvent limitation, means that courts cannot read these limitations back into the claims, affecting how the patent is interpreted.
Q: Why is the disclosure of prior art important in patent prosecution?
A: Failure to disclose relevant prior art, such as the '445 patent, can lead to allegations of inequitable conduct and potentially render the patent unenforceable.
Q: How does the '827 patent relate to other LEO Pharma patents?
A: The '827 patent is closely related to other process patents, such as the '084 and '698 patents, which also cover methods of producing ingenol mebutate and share a common specification and inventors.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - LEO Laboratories Limited et al. v. Actavis Laboratories UT, Inc. et al.[1]
- Case 1:16-cv-00333-JFB-SRF Document 332 Filed 06/18/2018 - LEO Pharma A/S v. Actavis Labs. UT, Inc.[2]
- Patent Claims and Patent Scope - SSRN[3]
- LEO Pharma A/S v. Actavis Labs. UT, Inc. - Casetext[4]
- REDACTED PUBLIC VERSION - LEO Pharma A/S v. Perrigo UK Finco Limited Partnership et al.[5]
