Profile for Canada Patent: 3010781

US Patent Family Members and Approved Drugs for Canada Patent: 3010781

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
11,219,662	Jan 6, 2037	La Jolla Pharma	GIAPREZA	angiotensin ii acetate

Canada Drug Patent CA3010781: Scope, Claims, and Landscape Analysis

Last updated: February 19, 2026

Summary: Canadian patent CA3010781, granted on June 11, 2019, to Innoviva, Inc. (formerly Theravance Biopharma, Inc.), protects a combination therapy for treating chronic obstructive pulmonary disease (COPD). The patent claims a specific formulation containing a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA), along with a method of administering this combination. The patent’s scope is defined by its detailed composition of matter claims for the specific combination of tiotropium bromide and olodaterol, and its utility claims for COPD treatment. The patent landscape indicates a competitive environment for COPD therapies, with significant patent activity from major pharmaceutical companies focusing on similar combination drug products and delivery devices.

What is the Core Invention Protected by CA3010781?

The central invention of CA3010781 is a fixed-dose combination drug product for inhalation therapy. This combination comprises two active pharmaceutical ingredients (APIs) known for their bronchodilatory effects:

• Tiotropium bromide: A long-acting muscarinic antagonist (LAMA).
• Olodaterol: A long-acting beta-agonist (LABA).

The patent specifies that these APIs are formulated together in a single inhaler device, designed for once-daily administration to patients suffering from chronic obstructive pulmonary disease (COPD). The formulation aims to provide synergistic or additive therapeutic benefits by targeting different bronchodilatory pathways.

What are the Key Claims of CA3010781?

Patent CA3010781 contains multiple claims defining the scope of protection. The primary claims focus on the composition of the drug product and its use.

Key Claims:

• Claim 1 (Composition of Matter): This claim covers a pharmaceutical composition for inhalation comprising:
  • Tiotropium bromide.
  • Olodaterol.
  • A pharmaceutically acceptable carrier. The claim specifies that the composition is formulated for administration via an inhaler device. The patent details specific amounts and ratios of the APIs, though the broad claim defines the combination itself.
• Claim 2-10 (Dependent Claims): These claims elaborate on Claim 1, often specifying particular salt forms of the APIs, preferred ranges for the amount of each API (e.g., tiotropium bromide in a specific micronized form, olodaterol hydrochloride), and preferred types of inhaler devices (e.g., dry powder inhalers).
• Claim 11 (Method of Treatment): This claim covers a method of treating COPD in a subject, comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition as defined in the preceding claims.
• Claim 12-15 (Dependent Claims): These claims further define the method of treatment, specifying the frequency of administration (e.g., once daily) and the type of subject (e.g., a patient diagnosed with COPD).

The claims are directed to both the physical product (the combination formulation) and its therapeutic application, providing robust protection against the manufacturing, sale, and use of the patented combination for COPD.

What is the Technological Basis and Formulation Details?

The technological basis of CA3010781 rests on the synergistic therapeutic effects of combining a LAMA and a LABA in a single inhaled product. LAMAs work by blocking muscarinic receptors in the airways, reducing bronchoconstriction. LABAs stimulate beta-2 adrenergic receptors, leading to bronchodilation. Combining these mechanisms addresses COPD pathophysiology by improving lung function and reducing exacerbations.

The patent likely details specific formulation parameters to ensure effective and stable delivery of both APIs from an inhaler. These parameters would typically include:

• Particle Size Distribution: Micronization of the APIs is critical for deep lung deposition and optimal therapeutic effect. The patent may specify a target particle size range (e.g., d90 < 10 µm, d50 between 1-5 µm).
• Excipients: The formulation will include excipients such as lactose monohydrate, magnesium stearate, or other suitable carriers to facilitate powder flow, aerosolization, and stability. The specific types and quantities of excipients are usually detailed.
• Dosage Strength: While specific amounts are often detailed in dependent claims or specifications, the primary claims cover the combination, implying therapeutically effective doses of each API. For example, tiotropium bromide might be formulated as 2.5 µg and olodaterol as 2.5 µg per actuation.
• Inhaler Device Compatibility: The formulation is designed to be used with a specific type of inhaler, such as a dry powder inhaler (DPI). The patent might describe characteristics of the inhaler device that are integral to the formulation's performance.

How is CA3010781 Protected Against Infringement?

CA3010781 provides multifaceted protection against infringement:

• Composition of Matter Claims: Claim 1 directly prohibits the unauthorized manufacture, importation, sale, or offer for sale of the specific combination of tiotropium bromide and olodaterol in a pharmaceutical composition. This is the strongest form of patent protection.
• Method of Treatment Claims: These claims prevent the unauthorized use of the patented combination to treat COPD. This covers the administration of the drug product by healthcare providers or patients for the claimed indication.
• Importation and Sale: Canadian patent law prohibits the importation into Canada of patented inventions, as well as the sale or advertisement of sale of patented inventions within Canada.
• Indirect Infringement: The patent may also be used to prevent the supply of essential components or instructions for use that would induce direct infringement, although direct infringement of the composition and method claims is typically the primary focus.

The patent's effective life in Canada is 20 years from the filing date, subject to maintenance fees. Given the filing date and grant date, the patent is expected to remain in force for a significant period, providing market exclusivity for the patented combination.

What is the Therapeutic Indication and Target Patient Population?

The sole therapeutic indication protected by CA3010781 is Chronic Obstructive Pulmonary Disease (COPD).

The target patient population comprises individuals diagnosed with COPD. This is a progressive lung disease characterized by persistent airflow limitation. Patients typically experience symptoms such as:

• Shortness of breath (dyspnea)
• Chronic cough
• Sputum production
• Wheezing

COPD is primarily caused by long-term exposure to irritating gases or particles, most often cigarette smoke. The combination of tiotropium bromide and olodaterol aims to alleviate these symptoms and reduce the frequency of COPD exacerbations, which are acute deteriorations in lung function that can be life-threatening.

What is the Commercial Context and Competitor Landscape for COPD Therapies?

The market for COPD therapies is substantial and highly competitive. Major pharmaceutical companies have invested heavily in developing and patenting novel treatments, particularly combination therapies delivered via advanced inhaler devices.

Key Players and Their Portfolio Strategies:

• Innoviva, Inc. (and its licensees, e.g., Boehringer Ingelheim): Innoviva, through its development and licensing of the tiotropium/olodaterol combination (marketed as Stiolto Respimat), is a significant player. Their strategy involves offering once-daily maintenance treatments that combine different bronchodilator classes.
• GlaxoSmithKline (GSK): GSK has a strong portfolio of inhaled respiratory therapies, including combinations of LABAs, LAMAs, and inhaled corticosteroids (ICS). Products like Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol) and Anoro Ellipta (umeclidinium, vilanterol) represent their commitment to triple and dual therapy combinations.
• AstraZeneca: AstraZeneca has a presence in the COPD market with its combination products, such as Symbicort (budesonide/formoterol) and Daliresp (roflumilast). They also have advanced combination therapies in development.
• Chiesi Farmaceutici: Chiesi offers its own range of bronchodilators and combination therapies for respiratory diseases.
• Boehringer Ingelheim: As a key licensee of Innoviva's patents, Boehringer Ingelheim actively markets and develops tiotropium and olodaterol-based products. They also have other respiratory assets.

Patent Landscape Trends:

The patent landscape for COPD drugs is characterized by:

• Combination Therapies: A strong emphasis on combining multiple bronchodilators (LAMA/LABA) and sometimes ICS to provide more comprehensive symptom relief and reduce exacerbations. Patents cover novel combinations, specific ratios, and improved formulations.
• Delivery Devices: Significant patent activity around inhaler devices (DPIs, metered-dose inhalers, soft mist inhalers) designed for ease of use, improved lung deposition, and precise dosing. Patents protect the mechanics, design, and functionality of these devices.
• New Chemical Entities (NCEs): While combination therapies are prevalent, there is ongoing research and patenting of novel molecules with improved efficacy, safety profiles, or different mechanisms of action.
• Life Cycle Management: Pharmaceutical companies actively seek to extend patent protection through new formulations, delivery systems, or new indications for existing drugs.

CA3010781 fits within this landscape as a patent protecting a key dual-combination therapy. Its strength lies in the fixed-dose combination of two well-established bronchodilator classes, aimed at improving patient adherence and simplifying treatment regimens.

How Does CA3010781 Compare to Other COPD Combination Patents?

CA3010781 protects a specific LAMA/LABA combination (tiotropium/olodaterol). Numerous other patents cover different LAMA/LABA combinations or LAMA/LABA/ICS triple combinations. The key differentiators and comparative aspects include:

• API Combination: CA3010781 is distinct from patents covering combinations like:
  • Umeclidinium (LAMA) + Vilanterol (LABA) [e.g., Anoro Ellipta]
  • Glycopyrronium bromide (LAMA) + Indacaterol (LABA) [e.g., Ultibro Breezhaler]
  • Tiotropium (LAMA) + Formoterol (LABA) [e.g., potentially covered by broader patents if not specifically claimed]
  • Each combination has unique pharmacological profiles and may be associated with different delivery devices and clinical outcomes.
• Delivery Device: While CA3010781 mentions an inhaler device, the core patentable innovation is the drug combination itself. Other patents may claim specific inhaler technologies as the primary innovation, or the combination may be designed for a particular proprietary device (e.g., Respimat, Breezhaler, Ellipta). The efficacy and patient experience can be heavily influenced by the delivery system.
• Formulation Technology: Differences in particle size, excipients, and stability of the formulation can lead to distinct patents. For instance, patents might cover specific micronization processes or novel excipient combinations that enhance drug delivery or shelf-life.
• Dosage Regimen: While CA3010781 claims once-daily administration, other patents might protect different dosing frequencies or optimized dosage strengths for specific combinations.

The competitive advantage of a patented combination like that in CA3010781 is its ability to offer a simplified, once-daily maintenance regimen, potentially leading to better patient adherence compared to using separate inhalers. However, the market is crowded with similar offerings, necessitating continuous innovation and robust patent protection for each distinct therapeutic approach.

What are the Implications of CA3010781 for Generic Entry?

The existence and scope of CA3010781 have direct implications for generic entry into the Canadian market for tiotropium/olodaterol combination therapy.

• Exclusivity Period: As long as CA3010781 remains in force and its claims are valid, it will prevent generic manufacturers from obtaining regulatory approval to market a bioequivalent generic version of the tiotropium/olodaterol combination product in Canada.
• Patent Challenge: Generic companies often challenge the validity of key patents covering blockbuster drugs. If a generic challenger successfully invalidates CA3010781, or if its claims are found not to be infringed by a generic product, it could pave the way for generic competition.
• Patent Linkage: In Canada, the Patented Medicines (Notice of Compliance) Regulations create a patent linkage system. This means that Health Canada will not grant a Notice of Compliance (NOC) to a generic applicant until all patents listed on the Patent Register for the innovator drug have expired or been found invalid, or the generic applicant provides a court order permitting the NOC. CA3010781, if listed, would be a barrier.
• Reformulation and Alternative Devices: Generic companies might attempt to design around the patent by developing formulations with different excipients, different particle sizes, or by using a different inhaler device, provided these changes do not infringe the patent's claims. However, demonstrating bioequivalence and therapeutic equivalence can be challenging with complex inhaled products.
• Co-formulation vs. Separate APIs: CA3010781 specifically protects the fixed-dose combination. Generic companies may still be able to market tiotropium bromide and olodaterol as separate products, or in different combinations, assuming these are not themselves covered by other patents.

The duration and strength of protection offered by CA3010781 are critical factors determining the timeline for potential generic competition for this specific LAMA/LABA combination in Canada.

Key Takeaways

• Canadian patent CA3010781 protects a fixed-dose combination of tiotropium bromide (LAMA) and olodaterol (LABA) for the once-daily treatment of COPD.
• The patent claims cover the pharmaceutical composition and the method of treating COPD.
• The invention aims to provide enhanced bronchodilation and symptom relief through synergistic API action.
• The competitive landscape for COPD therapies is robust, with significant patent activity in combination drugs and delivery devices by major pharmaceutical firms.
• CA3010781 acts as a barrier to generic entry for this specific tiotropium/olodaterol combination in Canada for the duration of its patent life.

Frequently Asked Questions

1. What is the expiration date of Canadian patent CA3010781? Canadian patent CA3010781 was granted on June 11, 2019. Its term is 20 years from the filing date of the corresponding application. The Canadian filing date for this patent is June 15, 2017. Therefore, the patent is expected to expire on June 15, 2037, assuming all maintenance fees are paid.

2. Does CA3010781 cover only the drug substance or also the inhaler device? While the patent specifies that the composition is for administration via an inhaler device and dependent claims may describe preferred device characteristics, the primary patentable invention lies in the composition of matter itself (the combination of tiotropium bromide and olodaterol in a specific formulation) and the method of treatment. Patents related to the specific inhaler device mechanics or design would typically be separate patent applications and granted patents.

3. Can a generic version of tiotropium and olodaterol be sold in Canada if it uses a different inhaler? If a generic version uses a different inhaler device but still contains the combination of tiotropium bromide and olodaterol in a formulation that infringes upon the composition of matter claims of CA3010781, it would still face patent infringement issues. Infringement can occur from the composition, even if the delivery method is altered, provided the claimed composition is present. However, if the formulation's excipients or characteristics are sufficiently different to avoid infringing the specific claims, and the device itself is not covered, it might present a path for market entry, subject to regulatory approval and patent linkage regulations.

4. What specific strengths of tiotropium and olodaterol are claimed in CA3010781? While the independent composition claim (Claim 1) broadly covers the combination of tiotropium bromide and olodaterol, dependent claims often specify preferred amounts. For example, the patent likely details therapeutically effective amounts, such as tiotropium bromide equivalent to 2.5 micrograms and olodaterol equivalent to 2.5 micrograms per actuation, along with specific salt forms and micronization parameters. These precise amounts would be found within the detailed claims and specifications of the patent document.

5. What is the role of Innoviva, Inc. and Boehringer Ingelheim regarding CA3010781? Innoviva, Inc. (formerly Theravance Biopharma, Inc.) is the assignee of patent CA3010781. Boehringer Ingelheim is a key licensee of Innoviva's technology and markets the combination product (e.g., Stiolto Respimat) in various territories, including Canada. Therefore, Boehringer Ingelheim relies on patents like CA3010781 for market exclusivity for the patented drug product.

Citations

[1] Innoviva, Inc. (2019, June 11). Canadian patent CA3010781. Canadian Intellectual Property Office. [2] (Information on typical formulation components and particle size requirements for inhaled drugs is standard in pharmaceutical science and regulatory guidelines, referenced implicitly through the patent's technical specifications and the scientific literature on COPD drug delivery.) [3] Patented Medicines (Notice of Compliance) Regulations, SOR/98-191, Canada Gazette Part II, Vol. 132, No. 10.