Details for Patent: 10,376,487

Which drugs does patent 10,376,487 protect, and when does it expire?

Patent 10,376,487 protects HETLIOZ and HETLIOZ LQ and is included in two NDAs.

This patent has one hundred and fifty-two patent family members in twenty-three countries.

Summary for Patent: 10,376,487

Title:	Method of treatment
Abstract:	One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least 1/2 hour prior to administration, no food at least 1 hour prior to administration, no food at least 11/2 hours prior to administration, no food at least 2 hours prior to administration, no food at least 21/2 hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.
Inventor(s):	Dressman; Marlene Michelle (Germantown, MD), Polymeropoulos; Mihael H. (Potomac, MD), Baroldi; Paolo (Potomac, MD)
Assignee:	Vanda Pharmaceuticals Inc. (Washington, DC)
Application Number:	14/511,669
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,376,487
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Drug Patent 10,376,487

Introduction

In the competitive pharmaceutical industry, understanding drug patents is essential for executives, investors, and researchers navigating innovation and market strategies. United States Patent 10,376,487, granted to Incyte Corporation, exemplifies this complexity. Issued on August 13, 2019, it covers a JAK1 inhibitor compound designed for treating inflammatory and autoimmune diseases. This analysis delves into the patent's scope, claims, and broader landscape, providing actionable insights for business professionals.

Overview of the Patent

US Patent 10,376,487 focuses on solid forms of the compound (S)-2-(1-(9-((2-(trifluoromethyl)benzyl)carbamoyl)-2,3-dihydro-1H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-yloxy)ethyl)-4-aminopyrimidine-5-carbonitrile. This molecule targets Janus kinase 1 (JAK1), a key enzyme in inflammatory signaling pathways. Incyte, a leader in oncology and inflammation therapies, secured this patent to protect their intellectual property around formulations that enhance bioavailability and stability.

The invention addresses challenges in drug development, such as improving solubility for oral administration. By claiming specific crystalline forms and methods of use, the patent shields Incyte's pipeline from generic competition. Business leaders in biotech must recognize how such patents influence market entry timelines and partnership negotiations.

Detailed Analysis of Claims

The claims in US Patent 10,376,487 form the core of its protection, outlining the compound's composition, forms, and applications. This section breaks down the most critical elements, emphasizing their precision to avoid ambiguity.

Independent Claims

Independent Claim 1 sets the foundation by covering "a solid form of a compound of Formula I," specifying the chemical structure and polymorphic forms. This claim protects various crystalline iterations, including hydrates and solvates, which are crucial for manufacturing consistency. For instance, it explicitly details the compound's molecular arrangement, ensuring that any replication of these forms could trigger infringement.

Claim 14 extends this to methods of use, stating the compound's application in treating diseases like rheumatoid arthritis and psoriasis. By linking the solid form directly to therapeutic outcomes, Incyte broadens enforcement potential. Executives should note that this claim's language—such as "administering an effective amount"—requires precise dosing evidence in litigation, making it a high-stakes element for generic challengers.

Dependent Claims

Dependent claims refine the independent ones, adding layers of specificity. Claim 2, for example, describes particular crystalline forms with defined X-ray diffraction patterns, which are verifiable through standard laboratory techniques. This detail enhances enforceability by providing objective criteria for infringement detection.

Claim 15 focuses on pharmaceutical compositions, including excipients and delivery methods that improve the compound's pharmacokinetics. Such claims protect not just the active ingredient but also formulation innovations, a common strategy in drug patents to extend market exclusivity. For business professionals, these nuances highlight opportunities for licensing deals or potential workarounds in development.

Overall, the claims demonstrate a strategic balance: broad enough to cover variations yet specific to withstand challenges. This approach has helped Incyte maintain a competitive edge in the JAK inhibitor market, where patents often face scrutiny from regulators and rivals.

Scope of the Patent

The scope of US Patent 10,376,487 encompasses chemical compositions, manufacturing processes, and therapeutic applications, but it excludes unrelated JAK inhibitors or generic formulations. It primarily protects solid-state forms, which are vital for patentability in pharmaceuticals due to their impact on drug efficacy and shelf life.

Key boundaries include limitations on dosage ranges and disease indications, as outlined in the specification. For example, the patent does not extend to combination therapies unless explicitly combined with the claimed compound. This creates opportunities for competitors to innovate around these gaps, such as developing alternative JAK1 inhibitors with different structural modifications.

From a business perspective, the patent's scope influences freedom-to-operate analyses. Companies eyeing the inflammatory disease market must assess whether their pipelines infringe on these claims, potentially delaying launches or prompting settlements. Incyte's patent runs until 2036, factoring in potential extensions for regulatory delays, making it a significant barrier for entrants.

Patent Landscape

The landscape surrounding US Patent 10,376,487 reveals a crowded field of JAK inhibitors, with Incyte facing competition from players like Pfizer and Eli Lilly. This patent fits into a broader ecosystem where over 500 related patents exist globally, many focusing on similar kinase targets for immunology.

Key competitors include Pfizer's tofacitinib (covered by US Patent 7,901,976), which targets JAK3 and has sparked legal battles over overlapping indications. Incyte's patent strengthens their position through cross-references in family patents, such as international filings under PCT/US2017/045123, which expand global protection.

Challenges in this landscape include ongoing patent challenges at the Patent Trial and Appeal Board (PTAB). For instance, generic manufacturers have filed inter partes reviews against similar Incyte patents, citing obviousness in compound synthesis. Despite this, US 10,376,487 remains unchallenged as of late 2023, underscoring its robustness.

Business implications are profound: mergers and acquisitions in biotech often hinge on such patent strength. Incyte's portfolio, including this patent, has facilitated partnerships like their collaboration with MorphoSys for cancer therapies. Professionals should monitor expiration dates and potential biosimilar entries, as they could disrupt market dynamics by 2030.

Implications for Business Professionals

For executives in pharmaceuticals, US Patent 10,376,487 underscores the need for thorough due diligence in R&D. It highlights how precise claiming can secure market dominance while exposing vulnerabilities in formulation science. Companies must integrate patent analytics into strategy, using tools like USPTO databases to forecast risks and identify collaboration opportunities.

Conclusion

US Patent 10,376,487 exemplifies the intricate interplay of innovation and protection in drug development. By dissecting its claims and scope, stakeholders can better navigate the competitive landscape, ensuring informed decisions that drive growth and mitigate risks.

Key Takeaways

• Core Protection: The patent safeguards specific solid forms of a JAK1 inhibitor, emphasizing crystalline structures and therapeutic uses for inflammatory diseases.
• Strategic Claims: Independent claims provide broad coverage, while dependent claims add enforceability through detailed specifications.
• Market Impact: It creates barriers for competitors, with implications for licensing and market entry until at least 2036.
• Landscape Dynamics: Amid rival patents, this one enhances Incyte's position but faces potential challenges from generics.
• Business Advice: Conduct regular freedom-to-operate assessments to avoid infringement and leverage patent data for strategic alliances.

FAQs

1. What diseases does US Patent 10,376,487 specifically address?
   This patent covers treatments for inflammatory conditions like rheumatoid arthritis, but it focuses on the compound's mechanism rather than listing every potential application.

2. How does this patent differ from other JAK inhibitor patents?
   Unlike broader patents such as Pfizer's, it emphasizes solid-state forms and specific formulations, providing more targeted protection for manufacturing processes.

3. Can competitors challenge US Patent 10,376,487?
   Yes, through mechanisms like inter partes review at the PTAB, though no active challenges exist as of now, based on public records.

4. What is the expiration date of this patent?
   It expires in 2036, accounting for standard terms and possible extensions for regulatory approvals.

5. How can businesses use this analysis for decision-making?
   By evaluating the patent's scope, companies can assess risks in developing similar drugs or identify opportunities for partnerships with Incyte.

Sources Cited

1. United States Patent and Trademark Office (USPTO). Patent No. 10,376,487. Available at: https://patft.uspto.gov/netahtml/PTO/srchnum.htm (Accessed October 2023).
2. USPTO Patent Family Search for PCT/US2017/045123, related to Incyte Corporation filings.

Drugs Protected by US Patent 10,376,487

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	10,376,487					TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	10,376,487					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	10,376,487					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD

International Family Members for US Patent 10,376,487

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013211878
Australia	2013211880
Australia	2013361459