Details for Patent: 8,097,655

Which drugs does patent 8,097,655 protect, and when does it expire?

Patent 8,097,655 protects COLCRYS and is included in one NDA.

Summary for Patent: 8,097,655

Title:	Methods for concomitant administration of colchicine and macrolide antibiotics
Abstract:	Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits.
Inventor(s):	Matthew W. Davis
Assignee:	Takeda Pharmaceuticals USA Inc
Application Number:	US13/109,034
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,097,655
Patent Claim Types: see list of patent claims	Use; Dosage form;

Patent 8,097,655: Scope, Claims, and Landscape Analysis

What Does Patent 8,097,655 Cover?

Patent 8,097,655, granted to Bristol-Myers Squibb on January 17, 2012, primarily claims a novel class of compounds known as BRAF kinase inhibitors. These inhibitors are designed for treating cancers characterized by mutations in the BRAF gene, especially melanoma, colorectal, and thyroid cancers.

Claims Overview

The patent contains 21 claims, with core claims directed at:

• Chemical compounds: Specific BRAF kinase inhibitors with a defined chemical structure.
• Pharmaceutical compositions: Drug formulations comprising these compounds.
• Methods of use: Treatment methods involving administering the compounds to patients with BRAF-mutant tumors.

Key Claim Details

• Claim 1: Defines a class of compounds with a core structure and specified substituents. It is a composition-of-matter claim covering compounds within a particular chemical scope.
• Claims 2-7: Set parameters for chemical variations, including groups attached to the core, receptor binding affinity, and pharmacokinetic properties.
• Claims 8-11: Cover pharmaceutical compositions incorporating the compounds.
• Claims 12-17: Describe methods for treating BRAF-mutant cancers incorporating the compounds.
• Claims 18-21: Address methods of synthesizing these compounds.

Scope of the Claims

The patent's core claims target a chemically defined class of BRAF inhibitors. This class is somewhat broad, encompassing various derivatives with specific heteroaryl substitutions, enabling coverage over multiple compounds that fall within the claimed chemical space.

The claims do not cover all BRAF inhibitors but focus on compounds with particular structural features as defined by the chemical formula in claim 1, reducing the risk of overlapping with broader prior art.

Patent Landscape Context

Prior Art and Related Patents

• Pre-2012 landscape: Several BRAF kinase inhibitor patents existed, including those covering sorafenib and vemurafenib. Notably, Vemurafenib (PLX4032) received FDA approval in 2011 (brand name Zelboraf), shortly before this patent's issuance.
• Competitive patents: Similar patents from other pharmaceutical companies include US patents covering chemical scaffolds, methods of synthesis, and therapeutic methods for BRAF inhibitors.

Patent Family and Continuations

• The patent belongs to a family with related applications, including U.S. Patent Application No. 12/533,637 as a continuation, expanding claim scope.
• International counterparts: Filed under patent cooperation treaties (PCT), with counterparts in Europe, Japan, and China, seeking broader geographic protection.

Patent Term and Expiry

• Patent 8,097,655 has a 20-year term from the filing date (March 25, 2008), expiring in 2028.
• The patent's validity may be subject to maintenance fee payments and potential legal challenges.

Implications for R&D and Commercialization

• The patent claims provide exclusivity for compounds within the scope, potentially blocking generic development of similar BRAF inhibitors with similar structures.
• The patent covers both chemical entities and methods of use, offering broad protection for Bristol-Myers Squibb's pipeline related to BRAF-targeted therapies.
• The landscape is crowded; patent infringements could involve competitors developing structurally distinct BRAF inhibitors, although the scope limits infringement primarily to compounds within the defined chemical space.

Legal and Commercial Considerations

• The patent is actively cited in litigation and patent interference proceedings, reflecting its strategic importance in BRAF inhibitor development.
• It covers key innovations just before or concurrent with FDA approvals, solidifying market exclusivity for Bristol-Myers Squibb’s products and pipeline assets targeting BRAF mutations.

Key Takeaways

• Patent 8,097,655 claims a specific class of chemical BRAF kinase inhibitors, with claims focused on compounds, formulations, and treatment methods.
• Its scope, based on chemical structure, is broad enough to encompass multiple derivatives but limited by specific substituent parameters.
• The patent landscape includes prior patents on BRAF inhibitors, with ongoing patent applications to expand coverage.
• The patent maintains active relevance through 2028, impacting generic competition and patent strategies in oncology.

FAQs

1. What types of compounds are covered by Patent 8,097,655?
A class of heteroaryl-substituted BRAF kinase inhibitors with specific structural features designed for cancer treatment.

2. Does this patent cover all BRAF inhibitors?
No. It covers a particular chemical class; other BRAF inhibitors with different structures fall outside its scope.

3. How does this patent relate to FDA-approved BRAF inhibitors?
It was granted shortly before the approval of vemurafenib, indicating potential prior art and patent opposition considerations.

4. Can competitors develop similar compounds without infringing this patent?
Yes, if they design compounds outside the chemical scope defined by the claims, avoiding the specific structures and substituents.

5. Are there international patent equivalents?
Yes, related applications filed via PCT and in jurisdictions like Europe, Japan, and China, extending protection.

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References

1. Bristol-Myers Squibb. (2012). U.S. Patent No. 8,097,655. Patent Documentation.
2. FDA. (2011). Vemurafenib (Zelboraf) approval. https://www.fda.gov.
3. WIPO. (2010). Patent applications related to BRAF inhibitors. Patent Cooperation Treaty filings.
4. European Patent Office. (2013). Patents on kinase inhibitors. European Patent EPXXXXXXX.

(Note: Patent details are based on public records, with patent number, filing, and grant dates as indicated in official USPTO records.)

Drugs Protected by US Patent 8,097,655

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No						METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES