United States Patent 6,011,068: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 6,011,068, titled "Calcium receptor-active molecules," is a significant patent in the pharmaceutical sector, particularly involving compounds related to calcium receptor activity. This patent, held by Brigham and Women's Hospital, Inc., NPS Pharmaceuticals, Inc., and Amgen Inc., has been at the center of several legal disputes. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent in question, U.S. Patent No. 6,011,068 (the "'068 patent"), was granted based on the application numbered 08/353,784. It is part of a series of patents related to cinacalcet hydrochloride compounds, which are used in the treatment of conditions such as secondary hyperparathyroidism and hypercalcemia[4].
Scope of the Patent
The '068 patent covers a broad range of calcium receptor-active molecules. Here are some key aspects of its scope:
Calcium Receptor-Active Molecules
The patent describes various compounds that interact with calcium receptors, influencing cellular and body processes. These molecules are crucial for regulating calcium ion levels, which is vital for numerous physiological functions[4].
Genera of Compounds
The patent claims include descriptions of genera of compounds and their pharmaceutically acceptable acid addition salts and complexes. For example, claims 7 and 32 of the '068 patent describe these genera, while claim 74 specifies the property of causing an increase in calcium ions in bovine parathyroid cells at a particular concentration of these compounds[1].
Pharmaceutically Acceptable Compositions
Claim 84 of the '068 patent details a pharmaceutically acceptable composition of a group of compounds. This is significant as it covers the formulation aspects of the drugs, ensuring they are safe and effective for medical use[1].
Claims of the Patent
The '068 patent includes several claims that define its scope and protect the inventions described:
Representative Claims
In the litigation involving Teva Pharmaceuticals, the plaintiffs selected specific claims for trial, including claims 7, 32, 74, and 84 of the '068 patent. These claims are representative of the broader scope of the patent and were central to the infringement and validity arguments[1].
Claim 7: Genera of Compounds
Claim 7 describes a genus of compounds that are calcium receptor-active. This claim is broad and encompasses a wide range of molecules that could be developed based on the disclosed structures[4].
Claim 32: Pharmaceutically Acceptable Salts and Complexes
Claim 32 extends the protection to include pharmaceutically acceptable acid addition salts and complexes of the compounds described in claim 7. This ensures that various forms of the drug can be protected under the patent[1].
Claim 74: Biological Activity
Claim 74 specifies the biological activity of the compounds, particularly their ability to increase calcium ions in bovine parathyroid cells. This claim is critical as it ties the chemical structure to a specific biological effect[1].
Claim 84: Pharmaceutically Acceptable Composition
Claim 84 describes a pharmaceutically acceptable composition of the compounds, ensuring that the final drug product is safe and effective for medical use[1].
Patent Landscape and Litigation
The '068 patent has been involved in significant litigation, particularly against generic drug manufacturers:
Infringement and Validity
Teva Pharmaceuticals and Barr Laboratories filed Abbreviated New Drug Applications (ANDAs) with the FDA, which led to a lawsuit by the patent holders. The defendants argued that the '068 patent was invalid due to inequitable conduct during the prosecution of the patent application and that the claims were overly broad or anticipated by earlier patents[1].
Inequitable Conduct
The defendants alleged that the plaintiffs engaged in inequitable conduct before the U.S. Patent and Trademark Office (PTO) by failing to disclose material information. This is a serious allegation, as it can render the patent unenforceable if proven[1].
Anticipation and Double Patenting
The defendants also argued that the '068 patent was anticipated by an earlier patent (U.S. Patent No. 5,648,541) and that it impermissibly double-patented claims already covered by another patent (the '244 patent)[1].
Impact on Patent Scope and Quality
The debates surrounding the '068 patent reflect broader issues in patent law regarding patent scope and quality:
Metrics for Measuring Patent Scope
Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This suggests that the scope of patent claims, such as those in the '068 patent, can significantly impact the patent's validity and enforceability[3].
Examination Process
The examination process tends to narrow the scope of patent claims, which can affect the breadth and clarity of the final granted patent. This process is crucial in ensuring that patents are not overly broad and do not diminish innovation incentives due to increased licensing and litigation costs[3].
Conclusion
The United States Patent 6,011,068 is a complex and significant patent in the pharmaceutical industry. Its scope and claims cover a broad range of calcium receptor-active molecules, including their formulations and biological activities. The patent has been at the center of litigation, highlighting issues of inequitable conduct, anticipation, and double patenting. Understanding the scope and claims of this patent is essential for navigating the patent landscape in the pharmaceutical sector.
Key Takeaways
- Broad Scope: The '068 patent covers a wide range of calcium receptor-active molecules, including their pharmaceutically acceptable salts and complexes.
- Biological Activity: The patent specifies the biological activity of these compounds, particularly their effect on calcium ion levels in cells.
- Litigation: The patent has been involved in significant litigation regarding infringement, validity, and inequitable conduct.
- Patent Quality: The debates surrounding this patent reflect broader issues in patent law regarding patent scope and quality.
- Examination Process: The patent examination process can significantly narrow the scope of claims, impacting the patent's validity and enforceability.
FAQs
What is the main subject of the United States Patent 6,011,068?
The main subject of the United States Patent 6,011,068 is calcium receptor-active molecules, including their use and formulations.
Which companies are involved in the litigation surrounding this patent?
The litigation involves Brigham and Women's Hospital, Inc., NPS Pharmaceuticals, Inc., Amgen Inc., Teva Pharmaceuticals USA, Inc., and Barr Laboratories, Inc.
What are the key claims of the '068 patent?
Key claims include descriptions of genera of compounds (claims 7 and 32), biological activity (claim 74), and pharmaceutically acceptable compositions (claim 84).
Why is inequitable conduct a significant issue in this patent litigation?
Inequitable conduct allegations suggest that the plaintiffs failed to disclose material information to the PTO, which could render the patent unenforceable if proven.
How does the patent examination process affect the scope of patent claims?
The examination process tends to narrow the scope of patent claims, making them more specific and reducing the likelihood of overly broad patents.
Sources
- Brigham & Women's Hospital Inc. v. Teva Pharmaceuticals USA, Inc. - Casetext
- CIVIL ACTION INC., et al. : : v. - District of Delaware - District of Delaware
- Patent Claims and Patent Scope - SSRN
- US6011068A - Calcium receptor-active molecules - Google Patents
- Brigham Women's Hospital v. Teva Pharmaceuticals USA - Casetext
