Last updated: February 4, 2026
What is the case about?
Auxilium Pharmaceuticals filed a patent infringement suit against Upsher-Smith Laboratories, asserting that Upsher-Smith's generic version of Testim (testosterone gel) infringes on Auxilium’s patents. The case centers on patent validity, infringement, and the scope of patent claims related to testosterone gel formulations.
Case background
- Filed: 2014 in the United States District Court for the District of New Jersey.
- Patents involved: U.S. Patent Nos. 8,249,027 and 8,465,372, covering methods of delivering testosterone via topical gels.
- Claims asserted: Auxilium claimed Upsher-Smith’s generic testosterone products infringe the patents.
- Defendant’s defense: Challenged patent validity, argued that the patents failed to meet the requirements under 35 U.S.C. §§ 101, 102, 103, and 112.
Key legal issues
- Patent validity in view of obviousness and patentable subject matter.
- Infringement of patent claims based on formulation and method of delivery.
- Enforceability of patents post-Alexa et al. v. Merck & Co. (2014), which considered patentable subject matter.
Summary of proceedings and decisions
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Pre-trial motions: Upsher-Smith moved for summary judgment, asserting that the patents were patent-ineligible under § 101 and invalid under § 103 due to obviousness.
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District court ruling (2015):
- Court found certain claims of the '027 patent invalid under § 101, citing that the claims did not amount to patent-eligible subject matter.
- Court upheld other claims as valid, ruling they did not constitute obvious subject matter.
- The court granted in part and denied in part summary judgment motion, allowing infringement claims on the valid patent claims to proceed.
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Outcome:
- The court issued a preliminary injunction against Upsher-Smith, preventing the sale of infringing testosterone gel formulations.
- The case proceeded toward trial, focusing on whether Upsher-Smith’s product infringed the valid patent claims.
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Post-trial developments (if any):
- The case was appealed, but the outcome details are limited as of the last update. The appellate court may examine procedural and substantive issues related to patent validity and infringement.
Patents involved and claim specifics
| Patent No. |
Title |
Key Claims |
Patent Date |
Legal challenge |
| 8,249,027 |
Topical testosterone gel |
Delivery methods, formulation ratios |
August 28, 2012 |
Validity challenged under §§ 101, 103 |
| 8,465,372 |
Methods of treatment |
Application of testosterone gels |
July 2, 2013 |
Validity challenged |
Legal points of interest
- Patent eligibility: The district court's invalidation of claims based on § 101 reflects heightened scrutiny post-Alice decision, emphasizing that patents claiming laws of nature or natural phenomena are vulnerable.
- Obviousness: The case highlights the importance of non-obvious formulation innovations, particularly in pharmaceutical delivery systems.
- Infringement: Claims covering specific formulations and delivery methods are challenged to establish direct infringement.
Implications for pharmaceutical patent strategies
- Patent drafting: Emphasis on patent claims that specify inventive step in formulation or delivery mechanism rather than broad claims susceptible to § 101 rejections.
- Validity challenges: Clear documentation of inventive aspects is essential when defending patent validity against obviousness and patent-eligibility attacks.
- Infringement enforcement: Effective against generics seeking to challenge patents through invalidity defenses.
Key Takeaways
- Patent claims in pharmaceutical filings face increased scrutiny after the Supreme Court’s decision in Alice.
- Obviousness remains a central challenge; specific formulation claims are more resilient than broad method claims.
- Courts are willing to invalidate claims under § 101 if they are deemed directed to laws of nature or natural phenomena.
- Enforcement strategies should include detailed documentation of inventive steps and formulations.
FAQs
1. How has the Alice decision impacted pharmaceutical patent filings?
It has increased the requirement for patent claims to focus on specific, inventive features rather than broad formulations, making patents more vulnerable to § 101 invalidity challenges.
2. Can formulations be protected if they mimic natural compounds?
Yes, but patent claims must demonstrate novelty and non-obviousness, especially in the formulation process, to overcome § 101 and § 103 hurdles.
3. What is the significance of the district court's partial invalidation of the patents?
It signals that courts are scrutinizing patent eligibility closely, especially for claims that involve natural phenomena or obvious modifications.
4. How do obviousness defenses influence patent litigation in pharmaceuticals?
They can be decisive, particularly when prior art renders the claimed invention predictable, or the formulation appears straightforward to a person skilled in the art.
5. What are the prospects of Upsher-Smith’s appeal?
The outcome hinges on whether the appellate court agrees that the claims deemed invalid are or are not eligible under § 101 and valid under § 103, influencing future patent stability.
References
- Federal Circuit Court opinion, Auxilium Pharmaceuticals v. Upsher-Smith Laboratories, Case 14-1268.
- U.S. Patent and Trademark Office guidelines, Section 101, 2019.
- Supreme Court decision, Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014).
