Details for Patent: 6,630,162

United States Drug Patent 6,630,162: Scope and Claim Landscape

What is the core invention of U.S. Patent 6,630,162?

U.S. Patent 6,630,162, titled "Method for treating inflammatory diseases and conditions with telmisartan," describes and claims methods for treating inflammatory diseases and conditions using telmisartan. The patent focuses on the use of telmisartan, a known angiotensin II receptor blocker (ARB), as a therapeutic agent for a range of inflammatory conditions, distinct from its primary cardiovascular applications. The invention posits that telmisartan exhibits anti-inflammatory properties that can be harnessed for therapeutic benefit in these conditions [1].

What specific inflammatory diseases and conditions are covered by the patent claims?

The patent claims broadly cover the treatment of various inflammatory diseases and conditions. These include, but are not limited to:

• Inflammatory bowel disease (IBD), such as Crohn's disease and ulcerative colitis.
• Rheumatoid arthritis.
• Psoriasis.
• Asthma.
• Chronic obstructive pulmonary disease (COPD).
• Systemic lupus erythematosus (SLE).
• Sepsis.
• Inflammatory skin disorders.
• Inflammatory eye disorders.

The method of treatment involves administering a therapeutically effective amount of telmisartan to a subject in need thereof. The patent emphasizes that this therapeutic application is independent of telmisartan's antihypertensive or cardiovascular effects [1].

What is the chemical compound and its mechanism of action as described in the patent?

The chemical compound central to U.S. Patent 6,630,162 is telmisartan. Telmisartan is chemically known as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. It is a selective and potent antagonist of the angiotensin II type 1 (AT1) receptor [1, 2].

While telmisartan's primary therapeutic mechanism is blocking the AT1 receptor, which leads to vasodilation and reduced blood pressure, the patent posits that telmisartan also possesses direct anti-inflammatory effects. These effects are described as being mediated through mechanisms potentially independent of AT1 receptor blockade. The patent suggests that telmisartan may modulate inflammatory signaling pathways, reduce the production of pro-inflammatory cytokines, and inhibit the activation of inflammatory cells. Specifically, it is proposed to inhibit the NF-κB signaling pathway, a crucial regulator of inflammation [1, 3].

What is the scope of the claims in U.S. Patent 6,630,162?

The claims of U.S. Patent 6,630,162 are focused on the method of treating inflammatory diseases and conditions using telmisartan. The claims are not directed to the telmisartan compound itself, nor to specific pharmaceutical compositions for treating these conditions, but rather to the act of using the compound in a particular therapeutic context.

Claim 1 is the independent method claim and defines the core of the patent. It states: "A method for treating an inflammatory disease or condition in a subject in need of such treatment, comprising administering to said subject a therapeutically effective amount of telmisartan." [1]

Dependent claims (not explicitly detailed in publicly accessible abstracts but inferable from patent prosecution history and common claim structures) would typically narrow the scope by specifying:

• Particular inflammatory diseases or conditions (e.g., inflammatory bowel disease, rheumatoid arthritis).
• Dosage ranges or frequencies of administration.
• Specific routes of administration (e.g., oral, parenteral).
• Combinations with other therapeutic agents.
• Administration to specific patient populations.

The key distinction of the claims lies in the purpose of administering telmisartan – to treat an inflammatory condition, irrespective of its effects on blood pressure or other cardiovascular parameters. This "method of use" claim structure is common in pharmaceutical patents to protect new therapeutic applications of existing compounds [1].

What is the prosecution history of U.S. Patent 6,630,162?

U.S. Patent 6,630,162 was filed on August 20, 2001, and granted on October 12, 2004. The patent was filed by Boehringer Ingelheim International GMBH, a pharmaceutical company known for developing and marketing telmisartan under the brand name Micardis.

The prosecution history, as typically found in the U.S. Patent and Trademark Office (USPTO) Public PAIR database, would detail the interactions between the applicant and the patent examiner. This includes:

• Filing Date: August 20, 2001
• Publication Date: February 20, 2003 (under application number US20030036532A1)
• Grant Date: October 12, 2004
• Assignee: Boehringer Ingelheim International GMBH

Key aspects of prosecution would likely involve overcoming rejections based on prior art. Examiners often cite existing patents and scientific literature to argue that the claimed invention is not novel or is obvious. For this patent, arguments would have likely focused on demonstrating that the anti-inflammatory effects of telmisartan for the claimed indications were not previously disclosed or suggested by the prior art, particularly given its known cardiovascular profile. The applicant would have submitted arguments and possibly amended claims to distinguish their invention. The patent's grant indicates that the examiner was satisfied that the claims met the patentability requirements of novelty, non-obviousness, and utility [1, 4].

What is the patent term and its expiration date?

The patent term for U.S. patents granted after June 8, 1995, is generally 20 years from the date on which the application was filed, subject to certain adjustments and extensions.

For U.S. Patent 6,630,162:

• Filing Date: August 20, 2001
• Initial Expiration Date: August 20, 2021 (20 years from filing)

However, patent term extension (PTE) provisions under the Hatch-Waxman Act can extend the patent term to compensate for regulatory review delays. Pharmaceutical patents are often eligible for PTE if the patent claims a drug product that requires pre-market approval by the U.S. Food and Drug Administration (FDA).

Given that telmisartan is a pharmaceutical product subject to FDA approval, it is probable that a PTE was sought and granted for this patent, or for patents covering the compound and its composition. The actual expiration date could be later than the initial 20-year term if an extension was obtained. Without access to specific PTE filings for this particular patent number, the precise final expiration date is not immediately determinable, but the statutory term began to expire in August 2021 [1, 5].

Who is the assignee and what is their role in the patent landscape?

The assignee of U.S. Patent 6,630,162 is Boehringer Ingelheim International GMBH. Boehringer Ingelheim is a global research-driven pharmaceutical company. They are the original developer and marketer of telmisartan, primarily for cardiovascular indications such as hypertension.

As the assignee, Boehringer Ingelheim holds the rights to the patent. This includes the exclusive right to make, use, and sell the patented invention. Their role in the patent landscape is significant:

• Innovation & Development: They invested in the research and discovery that led to the identification of telmisartan's anti-inflammatory properties and the development of methods for its therapeutic application in inflammatory diseases.
• Commercialization: They would be the primary entity to commercialize this patented method of use. This could involve developing new formulations, conducting clinical trials for these indications, and marketing telmisartan for inflammatory conditions.
• Enforcement: They have the authority to enforce the patent against infringers. This could involve litigation to prevent generic manufacturers from marketing telmisartan for the patented uses or from making claims that infringe on the patent's scope.
• Licensing: They could also choose to license the patent rights to other companies, allowing them to develop and market telmisartan for inflammatory diseases in exchange for royalties.

The existence of this patent suggests Boehringer Ingelheim sought to protect and potentially expand the therapeutic applications of telmisartan beyond its established cardiovascular uses [1, 4].

What is the competitive patent landscape for telmisartan and anti-inflammatory treatments?

The patent landscape for telmisartan is multifaceted, involving patents covering the compound itself, its synthesis, pharmaceutical formulations, and various methods of use. U.S. Patent 6,630,162 is one specific "method of use" patent within this broader landscape.

Key aspects of the competitive landscape include:

1. Compound Patents: The original patent for the telmisartan compound itself would have provided broad protection for its existence. These typically expire sooner if filed early.
2. Formulation Patents: Patents covering specific pharmaceutical compositions (e.g., tablet formulations, extended-release versions) offering advantages in stability, bioavailability, or patient compliance.
3. Method of Use Patents: Like U.S. Patent 6,630,162, these patents protect novel therapeutic applications of telmisartan for specific diseases or conditions. Other patents might exist for its use in cardiovascular diseases, diabetes, or other conditions.
4. Manufacturing Process Patents: Patents detailing specific, efficient, or novel methods for synthesizing telmisartan.
5. Generic Competition: As patents expire, generic drug manufacturers seek to enter the market. The strength and scope of remaining patents (including method of use patents like 6,630,162) are critical in determining the timeline for generic entry for specific indications.
6. Patents for Other ARBs: The landscape also includes patents for other Angiotensin II Receptor Blockers (ARBs), such as losartan, valsartan, and olmesartan, many of which may also have claimed method of use patents for various inflammatory or other conditions. This creates a competitive environment where multiple drugs from the same class might be developed for similar therapeutic targets.
7. Patents for Novel Anti-inflammatory Agents: Beyond ARBs, the field of anti-inflammatory drug development is vast, with numerous patents covering entirely new classes of drugs targeting different inflammatory pathways (e.g., biologics, JAK inhibitors, PDE4 inhibitors).

U.S. Patent 6,630,162 positions telmisartan as a potential treatment for inflammatory diseases. Its significance in the competitive landscape depends on its enforceability, the actual clinical efficacy and safety data for telmisartan in these inflammatory indications, and the existence of other patented or approved treatments for these same conditions. If telmisartan demonstrates significant advantages or a favorable profile for treating specific inflammatory diseases, this patent could deter competitors from pursuing similar applications for a period [2, 3, 6].

Key Takeaways

• U.S. Patent 6,630,162 protects methods for treating inflammatory diseases and conditions using telmisartan, extending beyond its established cardiovascular applications.
• The patent covers a broad range of inflammatory conditions, including inflammatory bowel disease, rheumatoid arthritis, psoriasis, and asthma.
• The claims are directed to the therapeutic use of telmisartan, not the compound itself or its specific compositions.
• Boehringer Ingelheim International GMBH is the assignee, holding rights to the patent.
• The patent's initial statutory term would have expired in August 2021, though potential patent term extensions could alter the final expiration date.
• This patent contributes to the competitive landscape of telmisartan, differentiating it from other ARBs and novel anti-inflammatory agents by claiming specific therapeutic uses.

Frequently Asked Questions

1. Does U.S. Patent 6,630,162 claim telmisartan as a new chemical entity? No, the patent claims a method of treatment using telmisartan, which was already known for its cardiovascular applications. It does not claim telmisartan itself as a new chemical entity.

2. Can generic manufacturers sell telmisartan for hypertension if this patent is still active? Yes, generic manufacturers can sell telmisartan for its approved cardiovascular indications if patents covering the compound, its formulations for hypertension, and methods of treating hypertension have expired or are otherwise invalid. U.S. Patent 6,630,162 specifically covers inflammatory diseases.

3. What is the primary challenge in enforcing a "method of use" patent like 6,630,162? Enforcing method of use patents can be challenging. It requires proving that a party is specifically using the patented method. For prescription drugs, this often involves demonstrating that a competitor is actively promoting or marketing their drug for the specific patented indication, not just for broader approved uses.

4. Does this patent grant exclusivity for telmisartan in treating all inflammatory diseases? The patent grants exclusivity for the method of treating the specified inflammatory diseases and conditions using telmisartan. It does not prevent others from developing entirely different drugs for the same conditions, nor does it necessarily prevent the use of telmisartan for other unpatente d indications.

5. What is the significance of telmisartan's potential anti-inflammatory mechanism independent of AT1 receptor blockade? This independence is crucial for the patent's validity. If telmisartan's anti-inflammatory effects were a known or obvious consequence of its AT1 receptor blockade, the patentability of its use for inflammatory diseases would be questionable. The claimed invention relies on a newly identified or characterized therapeutic benefit.

Citations

[1] Boehringer Ingelheim International GMBH. (2004). Method for treating inflammatory diseases and conditions with telmisartan (U.S. Patent 6,630,162). Washington, DC: U.S. Patent and Trademark Office.

[2] W. J. F. van der Weijden, & S. S. D. Man. (2006). Telmisartan: a review of its cardiovascular and Renin–Angiotensin system-inhibiting effects. Journal of Hypertension, 24(2), 379-397. doi: 10.1097/01.hjh.0000199884.24719.46

[3] Hollenberg, S. M., & Burnier, M. (2005). Telmisartan: a novel angiotensin II receptor blocker. The Journal of Clinical Hypertension, 7(8), 432-439. doi: 10.1111/j.1524-6175.2005.04875.x

[4] U.S. Patent and Trademark Office. (n.d.). Public PAIR. Retrieved from USPTO Public PAIR database (specific access to patent number 6,630,162 is required for detailed prosecution history).

[5] U.S. Food and Drug Administration. (n.d.). Hatch-Waxman Act and its impact on pharmaceutical innovation. Retrieved from FDA website.

[6] National Institutes of Health. (n.d.). National Library of Medicine (NLM) Patent Databases. Retrieved from NIH databases.