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Last Updated: December 22, 2024

Details for Patent: 7,868,044


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Summary for Patent: 7,868,044
Title:Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Abstract:Dermatological disorders having an inflammatory or proliferative component, notably common acne, are treated with topically applicable pharmaceutical compositions containing about 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously formulated into topically applicable gels, preferably aqueous gels, creams, lotions or solutions.
Inventor(s): Graeber; Michael (Lawrenceville, NJ), Czernielewski; Janusz (Biot, FR)
Assignee: Galderma Research & Development (Biot, FR)
Application Number:12/772,861
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 7,868,044

Introduction

United States Patent 7,868,044, owned by Galderma Laboratories, L.P., is a significant patent in the pharmaceutical industry, particularly in the treatment of acne. This patent, along with several others, was at the center of a notable patent infringement case, Galderma Labs., L.P. v. Tolmar, Inc. Here, we delve into the details of the patent's scope, claims, and the patent landscape surrounding it.

Background of the Patent

The patent in question, U.S. Patent No. 7,868,044, is part of a series of patents related to topical medications for the treatment of acne. Specifically, it pertains to pharmaceutical compositions containing adapalene, a retinoid used in dermatological treatments. The patent was granted to Galderma Laboratories, L.P., and its affiliates, Galderma S.A., and Galderma Research and Development, S.N.C.[4][5].

Claims of the Patent

The patent includes both composition claims and method claims. The composition claims relate to specific formulations of adapalene, while the method claims pertain to the use of these formulations in treating acne.

  • Composition Claims: These claims specify the exact formulation of the adapalene composition, including the concentration of adapalene. For example, the patent claims a 0.3% adapalene composition, which was a key point of contention in the patent infringement case[4][5].
  • Method Claims: These claims describe the methods of using the adapalene compositions for treating acne. This includes the application method, dosage, and expected outcomes[5].

Patent Landscape and Prior Art

The patent landscape surrounding U.S. Patent No. 7,868,044 is complex and heavily influenced by prior art. Prior art refers to the existing body of knowledge and previous inventions in the field.

  • Prior Art Range: The prior art in this case disclosed a range of adapalene concentrations. The claimed invention, a 0.3% adapalene composition, fell within this disclosed range. This was a critical factor in the determination of obviousness[2][4].
  • Motivation to Combine: The court examined whether there was a motivation to select the specific 0.3% concentration from the range disclosed in the prior art. The burden of production fell on Galderma to show that the prior art taught away from the claimed invention, or that there were new and unexpected results relative to the prior art[2][4].

Obviousness Determination

The obviousness of the patent was a central issue in the Galderma Labs., L.P. v. Tolmar, Inc. case. Here are the key points:

  • Court Ruling: The U.S. Court of Appeals for the Federal Circuit reversed the district court's judgment, finding that the claims of the patent were invalid for obviousness under 35 U.S.C. § 103. The court determined that a skilled artisan would have expected the claimed 0.3% adapalene composition to be within the range of obvious variations from the prior art[2][4][5].
  • Burden of Production: Galderma was unable to meet its burden of production by providing evidence that the prior art taught away from the claimed invention, or that there were new and unexpected results relative to the prior art. The court also found that several secondary considerations, including commercial success, were of minimal probative value[4].

Secondary Considerations

Secondary considerations, such as commercial success and unexpected results, can be crucial in determining nonobviousness.

  • Commercial Success: The court found that the commercial success of Differin® Gel, which contains the 0.3% adapalene composition, was of "minimal probative value" in establishing nonobviousness. This was because the commercial success could be attributed to other factors, such as marketing and branding[4].
  • Unexpected Results: The court also examined whether the results of using the 0.3% adapalene composition were unexpected. However, it concluded that a skilled artisan would have expected the results, and therefore, they did not constitute an unexpected result indicating nonobviousness[4].

Dissenting Opinion

Justice Newman's dissenting opinion highlighted the complexity and closeness of the obviousness question. She argued that the district court's analysis and findings should have been given closer attention, and that the appellate court's decision distorted the burdens of proof and production[4].

Impact on Patent Landscape

The invalidation of U.S. Patent No. 7,868,044 has significant implications for the patent landscape in the pharmaceutical industry.

  • Future Patents: This case sets a precedent for how obviousness is determined, particularly when the claimed invention falls within a range disclosed in prior art. It emphasizes the importance of demonstrating that the prior art taught away from the claimed invention or that there were new and unexpected results[2][4].
  • Competitor Activity: The invalidation opens up the market for other companies to develop similar products without infringing on Galderma's patents. This can lead to increased competition and potentially lower prices for consumers[4].

Key Takeaways

  • Obviousness Determination: The patent was found invalid for obviousness because the claimed 0.3% adapalene composition fell within a range disclosed in prior art, and Galderma failed to provide sufficient evidence of nonobviousness.
  • Burden of Production: The burden of production to show nonobviousness falls on the patentee, especially when the claimed invention is within a disclosed range.
  • Secondary Considerations: Commercial success and unexpected results must be carefully evaluated to determine their probative value in establishing nonobviousness.
  • Impact on Industry: The invalidation of this patent can lead to increased competition and potentially lower prices for consumers.

FAQs

Q: What was the main issue in the Galderma Labs., L.P. v. Tolmar, Inc. case? A: The main issue was whether the claims of U.S. Patent No. 7,868,044 were invalid for obviousness under 35 U.S.C. § 103.

Q: Why was the 0.3% adapalene composition considered obvious? A: The composition was considered obvious because it fell within a range disclosed in prior art, and Galderma failed to provide evidence that the prior art taught away from the claimed invention or that there were new and unexpected results.

Q: What is the significance of secondary considerations in patent cases? A: Secondary considerations, such as commercial success and unexpected results, can be used to establish nonobviousness but must be carefully evaluated for their probative value.

Q: How does the invalidation of U.S. Patent No. 7,868,044 affect the pharmaceutical industry? A: The invalidation opens up the market for other companies to develop similar products, potentially leading to increased competition and lower prices for consumers.

Q: What is the role of the burden of production in determining obviousness? A: The burden of production falls on the patentee to come forward with evidence that the prior art taught away from the claimed invention, or that there were new and unexpected results relative to the prior art.

Sources

  1. USPTO Search for Patents: https://www.uspto.gov/patents/search
  2. Galderma Labs., L.P. v. Tolmar, Inc.: https://casetext.com/case/galderma-labs-lp-v-tolmar-inc-3
  3. Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Galderma Labs Patents Invalidated for Obviousness: https://jafarilawgroup.com/galderma-labs-patents-invalidated-for-obviousness/
  5. Galderma Labs., L.P. v. Tolmar, Inc. - Federal Cases - Case Law: https://case-law.vlex.com/vid/galderma-labs-l-p-893104148

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Drugs Protected by US Patent 7,868,044

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 7,868,044

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
France02 03070Mar 12, 2002

International Family Members for US Patent 7,868,044

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 038924 ⤷  Subscribe
Austria 417610 ⤷  Subscribe
Austria 432072 ⤷  Subscribe
Australia 2003216898 ⤷  Subscribe
Australia 2008203279 ⤷  Subscribe
Brazil 0307550 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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