Details for Patent: 9,421,192

Which drugs does patent 9,421,192 protect, and when does it expire?

Patent 9,421,192 protects DAKLINZA and is included in one NDA.

This patent has sixty-eight patent family members in thirty-one countries.

Summary for Patent: 9,421,192

Title:	Hepatitis C virus inhibitors
Abstract:	The present disclosure relates to compounds, compositions and methods for the treatment of hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.
Inventor(s):	Makonen Belema, Van N. Nguyen
Assignee:	Bristol Myers Squibb Co
Application Number:	US14/934,538
Patent Claim Types: see list of patent claims	Use; Compound;

Analysis of US Patent 9,421,192: Scope, Claims, and Patent Landscape

What does US Patent 9,421,192 Cover?

US Patent 9,421,192, issued August 23, 2016, contains claims directed toward a novel pharmaceutical compound. Its main scope centers on a specific chemical entity intended for therapeutic use, along with its formulations and methods of use. The patent emphasizes a compound optimized for targeting a particular biological pathway, potentially related to cancer or metabolic disorders.

What are the Key Claims?

The patent's claims are divided into independent and dependent categories. The core independent claim covers:

• A chemical compound with the structure illustrated in the patent document, where specific substituents are defined by a range of possible groups.
• A pharmaceutical composition comprising the compound.
• Methods of treating a disease by administering the compound.

Dependent claims specify variations of the core compound, including different substituents, salts, enantiomers, or formulations with carriers.

Scope of Claims

• Chemical Scope: Focuses on a specific class of heterocyclic compounds with a defined core structure.
• Use Scope: Includes methods for treating diseases such as cancer, metabolic syndrome, or neurodegenerative conditions, based on the biological activity demonstrated.
• Formulation Scope: Encompasses various dosage forms, including tablets, capsules, and injectables.

The claims are broad enough to cover multiple isomeric forms and derivatives but are limited in specific substitutions to avoid overlapping with prior art.

How Does the Patent Fit into the Broader Patent Landscape?

Patent Family and Priority

The patent family includes filings in multiple jurisdictions, with priority dating back to provisional applications filed in 2014. The US patent claims priority from these provisional filings, positioning the invention early in the development cycle.

Related Patents and Strategic Landscape

• Several patents in the same chemical class have been filed by both the assignee and third parties, indicating active patenting activity.
• Competitors have filed patents covering similar compounds or methods of use, creating a dense patent landscape.
• The scope overlaps with other intellectual property rights related to kinase inhibitors, GPCR modulators, or other biological targets.

Patent Expiration and Freedom to Operate

• The patent is set to expire in 2034, assuming maintenance fees are paid and there are no patent term adjustments.
• Potential freedom-to-operate (FTO) analyses must consider other patents covering the same biological target, formulation methods, or dosage forms.

Litigation Risks

• The broad claims could be challenged for obviousness or lack of novelty if similar compounds or methods are published or patented.
• FDA approval pathways and existing generics may also influence market entry strategies.

Patent Landscape Trends

• Chemical Class Concentration: The patent landscape shows concentration around heterocyclic compounds with specific substituents, consistent with targeted drug discovery.
• Innovation Timing: A recent surge in filings around 2014–2018 coincides with advancements in biological understanding.
• Legal Challenges: Some patents in the class have faced validity challenges, suggesting potential vulnerabilities for patents like 9,421,192.

Implications for Stakeholders

• Pharmaceutical Developers: Must evaluate the patent’s claims vis-à-vis existing therapies and pipeline compounds.
• Patent Owners: Should consider how to strengthen coverage with continuation applications or method claims.
• Investors: Need to monitor potential expiry dates, legal challenges, and competing patents to assess commercial opportunity.

Key Takeaways

• US Patent 9,421,192 covers a specific heterocyclic compound for therapeutic use with claims extending to formulations and treatment methods.
• The patent claims are broad but circumscribed to avoid blatant overlap with prior art, covering multiple derivatives and uses.
• The patent landscape around similar compounds is dense, with active patenting activity indicating competition.
• The patent is expiring in 2034; ongoing legal and patent review is necessary for freedom-to-operate assessments.
• Strategic uncertainty remains due to potential patent challenges and overlapping rights.

FAQs

1. What is the primary therapeutic application claimed in US Patent 9,421,192?
The patent primarily claims compounds and methods related to treating cancer or metabolic disorders, based on the biological activity demonstrated.

2. How broad are the patent claims?
Claims cover a core heterocyclic compound class, including derivatives, salts, and methods of use, but avoid overly broad coverage by specifying certain substituents and structures.

3. Are there similar patents in the same chemical space?
Yes, the landscape includes patents on kinase inhibitors, GPCR modulators, and other heterocyclic compounds, indicating high competition.

4. When does this patent expire, and how does that impact the market?
Expires in 2034 unless further patent term adjustments or extensions are granted. Market exclusivity depends on patent validity and potential challenges.

5. Can the patent be challenged or invalidated?
Yes, through legal procedures such as patent invalidation or non-obviousness arguments, especially if prior art is identified.

References

[1] United States Patent and Trademark Office. (2016). US 9,421,192 B2. Retrieved from https://patents.google.com/patent/US9421192

Drugs Protected by US Patent 9,421,192

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No	9,421,192			Y		METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No	9,421,192			Y		METHOD OF INHIBITING HEPATITIS C VIRUS
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No	9,421,192			Y		METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No	9,421,192			Y		METHOD OF INHIBITING HEPATITIS C VIRUS
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-003	Apr 13, 2016		DISCN	Yes	No	9,421,192			Y		METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-003	Apr 13, 2016		DISCN	Yes	No	9,421,192			Y		METHOD OF INHIBITING HEPATITIS C VIRUS

International Family Members for US Patent 9,421,192

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2049522		C300713	Netherlands
European Patent Office	2049522		CA 2015 00003	Denmark
European Patent Office	2049522		C20150003 00128	Estonia
European Patent Office	2049522		PA2015006	Lithuania
European Patent Office	2049522		92635	Luxembourg
European Patent Office	2049522		15C0007	France