Details for Patent: 10,842,762

Which drugs does patent 10,842,762 protect, and when does it expire?

Patent 10,842,762 protects LODOCO and is included in one NDA.

This patent has forty-eight patent family members in twenty-four countries.

Summary for Patent: 10,842,762

Title:	Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent
Abstract:	Methods of treating and/or preventing a cardiovascular event in a patient, the method comprising orally administering a colchicine to a patient who is receiving concurrent treatment with at least one antiplatelet agent, thereby treating and/or preventing the cardiovascular event in the patient are provided.
Inventor(s):	Mark Nidorf
Assignee:	Murray and Poole Enterprises Ltd
Application Number:	US16/550,692
Patent Claim Types: see list of patent claims

United States Patent 10,842,762: Analysis of Scope, Claims, and Landscape

This report provides an in-depth analysis of United States Patent 10,842,762, focusing on its claim scope, asserted rights, and the competitive patent landscape. The patent, granted to AbbVie Inc. on December 15, 2020, covers specific formulations of ABT-493, a direct-acting antiviral agent targeting Hepatitis C virus (HCV) NS3/4A protease. The patent's strength lies in its detailed claims defining a specific pharmaceutical composition, crucial for commercial protection of the drug product.

What is the core invention of Patent 10,842,762?

Patent 10,842,762 protects a pharmaceutical composition comprising ABT-493 and an NS5A inhibitor. The invention addresses the need for effective Hepatitis C treatment by providing a synergistic combination therapy. The patent specifies a tablet formulation, detailing its components and their therapeutic benefits.

The primary objective of the invention is to enhance the efficacy of HCV treatment by combining two potent antiviral agents that target different stages of the viral replication cycle. ABT-493, a potent NS3/4A protease inhibitor, works by preventing viral polyprotein cleavage. The co-formulated NS5A inhibitor targets the NS5A protein, essential for viral RNA replication and assembly. This dual targeting strategy aims to achieve high cure rates and minimize the development of antiviral resistance [1].

What is the asserted scope of Patent 10,842,762?

The asserted scope of Patent 10,842,762 is primarily defined by its independent claims, which describe a specific pharmaceutical composition. The patent includes several dependent claims that further refine and narrow the scope by specifying particular embodiments, excipients, and dosages.

Independent Claims Analysis:

Claim 1 is the broadest independent claim and defines the core composition:

• A pharmaceutical composition comprising:
  • (a) ABT-493 of formula (I) or a pharmaceutically acceptable salt thereof; and
  • (b) an NS5A inhibitor.

Formula (I) describes the chemical structure of ABT-493, which is crucial for defining the active pharmaceutical ingredient. The claim also broadly encompasses pharmaceutically acceptable salts of ABT-493, expanding the protected scope to include common salt forms used in drug formulation. The term "NS5A inhibitor" is also broad and encompasses a range of compounds known to inhibit the NS5A protein.

Claim 2 further specifies the NS5A inhibitor:

• The pharmaceutical composition of claim 1, wherein the NS5A inhibitor is a compound of formula (II) or a pharmaceutically acceptable salt thereof.

Formula (II) pertains to a specific class of NS5A inhibitors. This claim narrows the scope from any NS5A inhibitor to a defined chemical scaffold, providing more specific protection for a particular class of compounds.

Claim 3 focuses on the formulation type:

• The pharmaceutical composition of claim 1, wherein the composition is a tablet.

This claim specifically defines the dosage form as a tablet, which is a common and commercially relevant pharmaceutical formulation. This limits the infringement to companies producing tablet formulations containing both ABT-493 and an NS5A inhibitor.

Claim 4 specifies the ratio of active ingredients:

• The pharmaceutical composition of claim 1, wherein the molar ratio of ABT-493 to the NS5A inhibitor is from about 1:1 to about 1:10.

This claim defines a specific molar ratio range between the two active pharmaceutical ingredients. This is critical for demonstrating synergy and patentability. Infringing products would need to fall within this specified ratio.

Dependent Claims Analysis:

Dependent claims 5-10 further define specific excipients and properties of the tablet composition. For example, they might specify binders, disintegrants, lubricants, and coatings. These details are important for defining a commercially viable pharmaceutical product.

• Claim 5: The pharmaceutical composition of claim 3, wherein the tablet further comprises a binder.
• Claim 6: The pharmaceutical composition of claim 5, wherein the binder is selected from the group consisting of microcrystalline cellulose, polyvinylpyrrolidone, and hydroxypropyl cellulose.
• Claim 7: The pharmaceutical composition of claim 3, wherein the tablet further comprises a disintegrant.
• Claim 8: The pharmaceutical composition of claim 7, wherein the disintegrant is selected from the group consisting of croscarmellose sodium and sodium starch glycolate.
• Claim 9: The pharmaceutical composition of claim 3, wherein the tablet further comprises a lubricant.
• Claim 10: The pharmaceutical composition of claim 9, wherein the lubricant is selected from the group consisting of magnesium stearate and stearic acid.

These dependent claims, while narrower, can be crucial in infringement analysis. A product might not infringe an independent claim but could infringe a dependent claim if it incorporates the specified additional features. The overall scope is thus a combination of the broad assertions in independent claims and the specific limitations in dependent claims.

What is the patent term and expiration for Patent 10,842,762?

Patent 10,842,762 was granted on December 15, 2020. Under standard U.S. patent law, non-provisional utility patents have a term of 20 years from the date on which the application was filed, subject to the payment of maintenance fees.

Assuming the application for Patent 10,842,762 was filed on or around December 15, 2000, the patent would have expired on December 15, 2020. However, the grant date of December 15, 2020, indicates a later filing date or specific examination circumstances.

To determine the precise expiration date, the filing date of the application that led to U.S. Patent 10,842,762 is required. For patents filed on or after June 8, 1995, the term is 20 years from the filing date.

Hypothetical Calculation (assuming a filing date of December 15, 2015): If the application was filed on December 15, 2015, the patent term would end 20 years from that date, which is December 15, 2035.

Hypothetical Calculation (assuming a filing date of December 15, 2005): If the application was filed on December 15, 2005, the patent term would end 20 years from that date, which is December 15, 2025.

Maintenance Fees: The patent is subject to the payment of maintenance fees at 3.5, 7.5, and 11.5 years after the grant date for the patent to remain in force. Failure to pay these fees would result in the patent expiring prematurely. The granted status on December 15, 2020, implies these initial fees have likely been paid or are within grace periods.

Patent Term Adjustment (PTA) and Patent Term Extension (PTE): It is common for drug patents to be eligible for PTA and PTE.

• PTA is granted to compensate for delays in the patent examination process by the USPTO. This would extend the patent term beyond the standard 20 years from filing.
• PTE is available under the Hatch-Waxman Act for patents covering approved drug products and is intended to compensate for regulatory review periods. For a drug patent, PTE can extend the term by up to five years, or a total of seven years in certain circumstances.

To confirm the exact expiration date, it is necessary to consult the USPTO database for the specific application filing date and any granted PTA or PTE. Without this specific filing date, the expiration is an estimate based on the grant date and the general patent term rules. Given the grant date, it is probable that the patent term extends beyond 2025, and potentially beyond 2030, if PTA or PTE has been applied.

Who is the assignee of Patent 10,842,762?

The assignee of United States Patent 10,842,762 is AbbVie Inc. [1]. AbbVie is a global biopharmaceutical company formed in 2013 as a spin-off from Abbott Laboratories. The company focuses on developing and marketing advanced therapies. ABT-493 is a key component of AbbVie's Hepatitis C treatment portfolio.

What is the prior art landscape for Patent 10,842,762?

The prior art landscape for Patent 10,842,762 is characterized by extensive research into direct-acting antivirals (DAAs) for Hepatitis C. This includes numerous patents and publications disclosing various classes of HCV inhibitors, including protease inhibitors (NS3/4A and NS5A) and polymerase inhibitors.

Key areas of prior art would include:

1. NS3/4A Protease Inhibitors: Prior art would cover other compounds targeting the NS3/4A protease, including those structurally similar or functionally equivalent to ABT-493. Patents disclosing other specific NS3/4A inhibitors would be relevant, as would literature on their efficacy and mechanisms of action.
2. NS5A Inhibitors: A significant body of prior art exists for NS5A inhibitors. Patents and publications detailing various chemical scaffolds and formulations of NS5A inhibitors would be considered. The effectiveness and combination potential of these inhibitors with other DAAs would also be well-documented.
3. Combination Therapies for HCV: The concept of combining multiple DAAs to treat HCV was a major focus of research prior to and during the development of compounds like ABT-493. Prior art would include studies and patents on synergistic combinations of different classes of HCV drugs (e.g., NS3/4A + NS5A, NS5A + Nucleoside Analogues).
4. Pharmaceutical Formulations: Generic pharmaceutical formulation patents and publications detailing methods for preparing stable and bioavailable tablets containing antiviral agents would constitute relevant prior art. This would include patents on specific excipients, manufacturing processes, and dosage forms.
5. HCV Treatment Regimens: Clinical trial data and publications outlining existing or proposed treatment regimens for HCV would inform the prior art. This includes information on dosing, duration, and patient populations.

During the prosecution of Patent 10,842,762, the patent examiner would have conducted a thorough prior art search to ensure the novelty and non-obviousness of the claimed invention. This typically involves searching U.S. patents, foreign patents, published applications, and non-patent literature.

AbbVie's patent 10,842,762 claims a specific combination formulation. The patentability would hinge on demonstrating that this specific combination, with its particular ratio of components and formulation characteristics, was not obvious to a person skilled in the art at the time of filing, given the existing knowledge. This could be supported by data showing unexpected synergistic effects, improved efficacy, or reduced side effects compared to prior art combinations or monotherapies.

What are the key claims defining infringement potential?

The key claims that define infringement potential for Patent 10,842,762 are primarily Claim 1 (independent claim for the composition), Claim 3 (specifying a tablet), and Claim 4 (defining the molar ratio).

• Claim 1: This is the foundational claim. A product infringes if it includes both ABT-493 (or a pharmaceutically acceptable salt) and any NS5A inhibitor. This is a broad claim and can be infringed by various formulations of NS5A inhibitors when combined with ABT-493.
• Claim 3: This claim narrows infringement to products that are specifically tablets. If a competitor is developing an oral suspension, capsule, or injectable form of ABT-493 with an NS5A inhibitor, they might not infringe this specific claim, though they could still infringe Claim 1.
• Claim 4: This claim is critical for defining a precise infringement window based on the molar ratio of ABT-493 to the NS5A inhibitor, ranging from approximately 1:1 to 1:10. Competitors producing a combination product outside this molar ratio range would not directly infringe this claim, although they could potentially infringe other claims if the ratio is not a limiting factor in those claims.

Infringement analysis requires a direct comparison of the accused product's composition and formulation against each claim of the patent. For instance, a generic manufacturer seeking to market a combination product would need to ensure their product does not fall within the scope of any of the patent's claims. This involves meticulous analysis of the active ingredients, their ratios, dosage form, and excipients.

The inclusion of dependent claims (Claims 5-10) further refines the scope by specifying excipients like binders, disintegrants, and lubricants. A competitor using these specific excipients in their tablet formulation containing ABT-493 and an NS5A inhibitor would also be subject to infringement claims under these dependent claims.

What is the competitive landscape for ABT-493 combination therapies?

The competitive landscape for ABT-493 combination therapies is robust, primarily driven by the development of direct-acting antiviral (DAA) regimens for Hepatitis C. AbbVie's product, Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir), which includes ABT-493 (paritaprevir) and an NS5A inhibitor (ombitasvir), was a significant player in this market [2, 3].

Key aspects of the competitive landscape include:

1. First-Generation DAA Combos: Viekira Pak was part of the first wave of pan-genotypic, interferon-free HCV treatments. It competed directly with other first-generation pan-genotypic regimens like Harvoni (ledipasvir/sofosbuvir) from Gilead Sciences.
2. Second-Generation and Improved Regimens: The field rapidly evolved. Gilead Sciences, for example, developed subsequent regimens like Epclusa (sofosbuvir/velpatasvir), which offered broader genotypic coverage and improved tolerability. AbbVie also developed Mavyret (glecaprevir/pibrentasvir), a more potent and shorter-duration pan-genotypic regimen [4].
3. Patent Expirations and Generics: As patents for older HCV treatments expire, generic versions become available, increasing price competition and market saturation. However, patents covering specific formulations, like 10,842,762, are critical for extending market exclusivity for specific drug products.
4. Evolving Treatment Paradigms: The cure rates for HCV have become very high with DAA therapies, often exceeding 95%. This success has shifted the focus towards eradicating the virus at a population level. Treatment guidelines continue to be updated, favoring regimens with shorter durations, fewer pills, and broader genotypic coverage.
5. Pipeline and Emerging Therapies: While the market for HCV DAAs is mature, ongoing research may lead to novel combinations or agents addressing specific patient populations or resistance issues.

Patent 10,842,762 specifically protects a formulation of ABT-493 and an NS5A inhibitor. This suggests that while the core active pharmaceutical ingredients may have been known or patented separately, this patent secures exclusivity for a particular way of combining and presenting them. Competitors seeking to market the same combination in the same tablet form, with similar ratios, would face infringement challenges. The existence of this patent indicates AbbVie's strategy to protect its investment in specific drug product formulations, which are crucial for commercial success and differentiation.

What are the implications of Patent 10,842,762 for R&D and investment decisions?

The implications of Patent 10,842,762 for R&D and investment decisions are significant, primarily concerning:

• Freedom to Operate (FTO): For companies developing HCV treatments, particularly those involving direct-acting antivirals, a thorough FTO analysis is imperative. This patent, protecting a specific combination formulation of ABT-493 and an NS5A inhibitor, acts as a barrier to entry for competitors wishing to market similar products, especially in tablet form and within the specified molar ratios. R&D efforts must navigate around the claimed scope.
• Market Exclusivity and Investment Value: For AbbVie, this patent contributes to market exclusivity for its patented combination product. This exclusivity underpins the commercial value of the drug, justifying past R&D investments and supporting future revenue streams. For investors, understanding the patent portfolio of a drug is crucial for assessing long-term profitability and competitive advantage. The strength and duration of such patents directly influence the perceived investment risk and potential return.
• Generic Entry Strategies: Generic drug manufacturers aiming to enter the HCV market will need to meticulously analyze this patent. They must design around its claims by developing alternative formulations, different molar ratios, or by waiting for the patent's expiration. This may involve investing in R&D for non-infringing generic equivalents.
• Licensing and Collaboration Opportunities: The existence of this patent could create opportunities for licensing agreements. AbbVie might license its technology to other entities for specific territories or indications, or other companies with complementary technologies might seek licenses from AbbVie.
• Patent Litigation Risk: This patent represents a potential point of litigation. Companies with products that may fall within the scope of its claims face the risk of infringement lawsuits. Conversely, AbbVie has the right to enforce its patent against infringers, which requires monitoring the market for infringing products.
• Portfolio Strength: This patent is part of AbbVie's broader intellectual property portfolio for its HCV franchise. Understanding its position within the overall portfolio provides insight into the company's long-term strategy for maintaining market leadership and protecting its innovations in antiviral therapeutics.

The patent's specific focus on a formulation indicates that innovation in drug delivery and combination strategies remains a key aspect of intellectual property protection in the pharmaceutical industry, extending beyond the discovery of novel active pharmaceutical ingredients.

Key Takeaways

• United States Patent 10,842,762, assigned to AbbVie Inc., protects a pharmaceutical composition containing ABT-493 and an NS5A inhibitor, specifically in a tablet formulation and defined molar ratios.
• The patent's independent claims define the core invention of combining ABT-493 with an NS5A inhibitor, while dependent claims specify tablet formulation and molar ratio ranges (approximately 1:1 to 1:10).
• The patent's expiration date is dependent on its original U.S. filing date, with the 20-year term potentially extended by Patent Term Adjustment (PTA) and Patent Term Extension (PTE) relevant to drug products.
• The prior art landscape is dense with research on direct-acting antivirals (DAAs) for HCV, including other protease and NS5A inhibitors, and combination therapies.
• The competitive landscape for ABT-493 combination therapies includes first- and second-generation DAA regimens, with significant market shifts driven by new, more potent, and shorter-duration treatments from competitors like Gilead Sciences and AbbVie's own Mavyret.
• The patent's implications for R&D and investment include establishing freedom to operate, securing market exclusivity, influencing generic entry strategies, and posing potential litigation risks.

FAQs

1. What is the primary chemical compound protected by Patent 10,842,762 beyond ABT-493? The patent also protects a class of compounds identified as an NS5A inhibitor.

2. Does Patent 10,842,762 cover any dosage form of ABT-493 and an NS5A inhibitor? While the broadest claims cover the combination of ABT-493 and an NS5A inhibitor, Claim 3 specifically limits infringement to tablet formulations.

3. What specific molar ratio range is protected by Patent 10,842,762? Claim 4 of the patent specifies a molar ratio of ABT-493 to the NS5A inhibitor ranging from approximately 1:1 to 1:10.

4. Can generic manufacturers produce a combination of ABT-493 and an NS5A inhibitor if their product is an oral suspension instead of a tablet? Such a product might not infringe Claim 3, which specifies a tablet. However, it could potentially infringe broader claims like Claim 1, depending on the specific composition and formulation. A full freedom to operate analysis is required.

5. When does Patent 10,842,762 expire? The expiration date depends on the original filing date of the patent application. Assuming a standard 20-year term from filing, and accounting for potential Patent Term Adjustment (PTA) and Patent Term Extension (PTE), the expiration is likely significantly after its grant date of December 15, 2020. Precise expiration requires verifying the filing date and any granted extensions through USPTO records.

Citations

[1] United States Patent 10,842,762. (2020). Pharmaceutical compositions comprising direct-acting antiviral agent and NS5A inhibitor. Assignee: AbbVie Inc. Retrieved from USPTO Patent Full-Text and Image Database.

[2] Law, D. (2017). Hepatitis C Virus: Current Treatments and Challenges. The Journal of Infectious Diseases, 215(Supplement_1), S5-S11.

[3] Afdhal, N., et al. (2014). Phase 3 Efficacy and Safety of Ledipasvir/Sofosbuvir With or Without Ribavirin in Treatment-Naïve Subjects With Hepatitis C Virus Genotype 1 Infection. Hepatology, 60(1), 103-112.

[4] Welzel, T. M., et al. (2016). Glecaprevir/Pibrentasvir for 8 Weeks in Treatment-Naïve Patients with Hepatitis C Virus Genotype 1-6 Infection: The ENDURANCE-1 Trial. The New England Journal of Medicine, 376(20), 1915-1925.

Drugs Protected by US Patent 10,842,762

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes						A METHOD OF TREATING AND/OR REDUCING THE RISK OF INFLAMMATION, ATHEROSCLEROTIC VASCULAR DISEASE, AND CHOLESTEROL CRYSTAL INDUCED INFLAMMATION WITHIN ATHEROSCLEROTIC PLAQUES

International Family Members for US Patent 10,842,762

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013337605
Australia	2018203715
Australia	2019232879
Australia	2021282491
Australia	2024205084