EmPower Clinic Services, L.L.C. v. Eli Lilly & Co.

EmPower Clinic Services, L.L.C., operating as Empower Pharmacy, filed an inter partes review (IPR) petition, IPR2025-01024, challenging U.S. Patent 9474780, owned by pharmaceutical giant Eli Lilly & Co. Empower Pharmacy is a compounding pharmacy based in Houston, Texas, with additional facilities in New Jersey, specializing in compounded medications. Eli Lilly & Co. is a global pharmaceutical company known for developing and marketing a wide range of drugs. The core of the dispute centers around Eli Lilly's highly successful drug tirzepatide, the active ingredient in its branded products Mounjaro® and Zepbound®, which are used for treating type 2 diabetes, obesity, and sleep apnea. Empower Pharmacy has been compounding and selling versions of tirzepatide, leading to legal actions from Eli Lilly alleging trademark infringement and the sale of unapproved "knockoff" drugs.

The patent at issue, U.S. Patent 9474780, is titled "GIP and GLP-1 co-agonist compounds" or "GIP/GLP-1 Receptor Co-agonist Peptide Compounds." It technically describes dual incretin peptide mimetic compounds that activate receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), making them useful for treating conditions such as type 2 diabetes mellitus.

This IPR proceeding was filed on May 22, 2025, before the Patent Trial and Appeal Board (PTAB). However, the PTAB denied institution of the IPR on October 10, 2025, for discretionary reasons. This denial was heavily influenced by the Fintiv factors, which consider the existence and status of parallel district court litigation involving the same patent. Eli Lilly had specifically requested discretionary denial in its preliminary response, highlighting its ongoing infringement lawsuits against Empower and the substantial commercial success and revenue generated by its tirzepatide products.

The case is notable due to the significant market impact of Eli Lilly's tirzepatide products, Mounjaro and Zepbound, which have generated billions in revenue for the company and are critical in the treatment of diabetes and obesity. The IPR's denial based on PTAB's discretionary authority under Fintiv underscores the Board's evolving stance on parallel litigation, especially in cases where a district court trial date is approaching and there has been significant investment in the parallel proceeding. Furthermore, Empower Pharmacy has faced scrutiny and warning letters from the FDA regarding deficiencies in its compounding practices, adding a regulatory dimension to the broader legal landscape surrounding compounded tirzepatide.

The provided case, IPR2025-01024, is an Inter Partes Review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB), not a district court patent infringement litigation. Therefore, many of the requested litigation milestones (e.g., complaint, answer, Markman, discovery, trial) are not directly applicable to this specific IPR. The IPR proceeding focused on challenging the validity of US Patent 9474780.

Key Legal Developments and Outcome for IPR2025-01024

1. IPR Filing:

• 2025-05-22: EmPower Clinic Services, L.L.C. filed a petition for Inter Partes Review (IPR2025-01024) challenging the validity of U.S. Patent No. 9,474,780, owned by Eli Lilly & Co.

2. IPR Institution Decision:

• October 2025: The Patent Trial and Appeal Board (PTAB) denied institution of the IPR. The denial was based on discretionary grounds.
  • Specifics of Denial: The PTAB often denies institution on discretionary grounds under 35 U.S.C. § 314(a) when parallel district court litigation is advanced, particularly if a trial date is imminent, or when the petitioner has unduly delayed in filing the IPR petition relative to a co-pending district court case. The provided information explicitly states the denial was for "discretionary reasons".

3. Outcome:

• Terminated: The IPR proceeding terminated in October 2025, with the PTAB's decision to deny institution. This means the Board did not proceed to an inter partes review of the challenged patent claims, and the validity of U.S. Patent No. 9,474,780 was not assessed on the merits within this IPR.

Parallel Proceedings and Their Effect

While the prompt identifies IPR2025-01024 as "the case", the denial of institution for discretionary reasons strongly suggests the existence of a parallel district court patent infringement litigation involving the same patent and parties, or closely related parties. The PTAB frequently exercises its discretion to deny institution when a district court case is further along. Without further information about such a parallel district court case, the impact of this IPR's denial is that the district court litigation (if it exists) would proceed without the benefit of a PTAB validity determination on the challenged patent.

To confirm any parallel litigation and its impact, further investigation into federal court dockets for EmPower Clinic Services and Eli Lilly & Co. involving U.S. Patent No. 9,474,780 would be necessary. No specific district court case number or status was provided in the initial case metadata, and searches for "EmPower Clinic Services v. Eli Lilly & Co. patent litigation 9474780" did not immediately yield a direct parallel district court case. Therefore, the direct effect on a specific litigation beyond the IPR itself cannot be detailed without additional information.The information provided in the prompt and confirmed by web searches indicates that IPR2025-01024 is an Inter Partes Review (IPR) proceeding, not a patent infringement litigation in a district court. Therefore, many of the requested litigation milestones (e.g., complaint, answer, Markman, discovery, trial) are not applicable to this IPR.

Here's a summary of the key legal developments and outcome for IPR2025-01024, incorporating information from the search results:

Key Legal Developments and Outcome for IPR2025-01024

1. IPR Filing:

• 2025-05-21 (or 2025-05-22): EmPower Clinic Services, L.L.C. (d/b/a Empower Pharmacy) filed a petition for Inter Partes Review (IPR2025-01024) challenging claims 1-7, 9-10, and 12-18 of U.S. Patent No. 9,474,780, owned by Eli Lilly & Co. The patent is titled "GIP/GLP-1 Receptor Co-agonist Peptide Compounds" and relates to therapeutic use for conditions such as type 2 diabetes. The petition asserted obviousness grounds based on combining known peptide compounds and methods for improving metabolic stability and extending half-life.

2. IPR Institution Decision & Discretionary Denial:

• 2025-10-09: The Patent Trial and Appeal Board (PTAB) issued a Director Discretionary Decision to deny institution of the IPR. This denial was based on discretionary grounds, specifically invoking the "Director Discretionary Decision: Deny" status.
  • Context of Discretionary Denial: During 2025, the USPTO, under Acting Director Coke Morgan Stewart, implemented an "Interim Process for PTAB Workload Management" memo (issued March 26, 2025) which expanded the bases for discretionary denials, often considering factors like "settled expectations" and the proximity of parallel district court trial dates. These discretionary denials occurred even when the substantive merits of the IPR challenge might have been strong. While the specific reasoning for the discretionary denial in IPR2025-01024 is not fully detailed in the snippets, such denials frequently arise when there is a parallel district court litigation that is advanced, or where the petitioner had a long awareness of the patent.
• 2025-11-09: Petitioner EmPower Clinic Services filed a "Request for Director Review - Institution Decision."
• 2026-01-11: The Board issued an "Order Denying Director Review of Institution Decision."

3. Outcome:

• 2025-10-09: The IPR proceeding officially terminated. The PTAB's denial of institution meant that the Board did not proceed to an inter partes review of the challenged patent claims, and the validity of U.S. Patent No. 9,474,780 was not assessed on the merits within this IPR.

Parallel PTAB IPR/PGR Proceedings and Their Effect

The discretionary denial of institution strongly suggests the existence of parallel district court litigation. Web searches reveal that Eli Lilly and Company filed a lawsuit against Empower Clinic Services, LLC (d/b/a Empower Pharmacy) in federal court in New Jersey on 2025-04-01.

• Case Details: This lawsuit, Case 2:25-cv-02183, was filed by Eli Lilly and Company against Empower Clinic Services, LLC, primarily alleging violations of state and federal law related to the sale of "tirzepatide knockoff drugs" and misuse of Lilly's clinical studies. While the primary focus of this lawsuit appears to be on Lanham Act and state law claims regarding unapproved compounded drugs (tirzepatide, the active ingredient in Lilly's Mounjaro® and Zepbound®), the existence of this parallel litigation would have been a significant factor in the PTAB's discretionary denial of the IPR petition.
• Effect of IPR Denial: The PTAB's denial of institution in IPR2025-01024 means that the parallel district court litigation (Eli Lilly and Company v. Empower Clinic Services, LLC, Case 2:25-cv-02183) would proceed without a PTAB decision on the patentability of U.S. Patent No. 9,474,780. This places the burden of challenging patent validity solely within the district court proceedings, potentially increasing the complexity and duration of that case if validity is asserted as a defense or counterclaim.

Here is the counsel of record representing EmPower Clinic Services, L.L.C. in IPR2025-01024:

Wilson Sonsini Goodrich & Rosati

• Jad A. Mills
  • Role: Petitioner Counsel
  • Firm Office Location: Not specified in search results; firm has multiple offices.
  • Relevant Experience: Further research would be needed to identify specific patent litigation experience or notable past cases for Mr. Mills.
• A. Richard Torczon
  • Role: Petitioner Counsel
  • Firm Office Location: Not specified in search results; firm has multiple offices.
  • Relevant Experience: Further research would be needed to identify specific patent litigation experience or notable past cases for Mr. Torczon.
• Michael Rosato
  • Role: Petitioner Counsel
  • Firm Office Location: Not specified in search results; firm has multiple offices.
  • Relevant Experience: Further research would be needed to identify specific patent litigation experience or notable past cases for Mr. Rosato.
• Matthew J. Bresnahan
  • Role: Petitioner Counsel
  • Firm Office Location: Not specified in search results; firm has multiple offices.
  • Relevant Experience: Further research would be needed to identify specific patent litigation experience or notable past cases for Mr. Bresnahan.

Additional Attorneys (Role in IPR2025-01024 unclear from current results):

• W. Stella Mao
  • Role: Granted pro hac vice admission in related IPR proceedings for Petitioner. It is not explicitly stated in the provided search results if she is counsel of record for IPR2025-01024 specifically, but she is representing the Petitioner in similar IPRs.
  • Firm Office Location: Not specified in search results.
  • Relevant Experience: Demonstrated sufficient litigation experience and legal familiarity with the subject matter to be granted pro hac vice admission in related PTAB proceedings.
• Alex Yap
  • Role: Listed as counsel for Petitioner in related IPR proceedings, but not explicitly for IPR2025-01024.
  • Firm Office Location: Not specified in search results.
  • Relevant Experience: Further research would be needed to identify specific patent litigation experience or notable past cases for Mr. Yap.
• Mehran Arjomand
  • Role: Listed as counsel for Petitioner in related IPR proceedings, but not explicitly for IPR2025-01024.
  • Firm Office Location: Not specified in search results.
  • Relevant Experience: Further research would be needed to identify specific patent litigation experience or notable past cases for Mr. Arjomand.

The provided search results indicate "Mills, Jad et al." as petitioner counsel, and a more detailed listing for IPR2025-01024 specifically names Jad A. Mills, A. Richard Torczon, Michael Rosato, and Matthew J. Bresnahan under "Wilson Sonsini Goodrich & Rosati" as attorneys for the Petitioner. While W. Stella Mao, Alex Yap, and Mehran Arjomand were mentioned in the context of other related IPRs where EmPower Clinic Services was also a petitioner, their direct involvement as counsel of record for IPR2025-01024 is not definitively established by the current search results.

No information regarding in-house counsel or local counsel specifically for this PTAB IPR was found in the search results.

Eli Lilly & Co., the patent owner in IPR2025-01024, was represented by counsel from at least two firms: Wilson Sonsini Goodrich & Rosati, and potentially others.

Here are the identified attorneys representing Eli Lilly & Co.:

• Michael Morin (Counsel for Patent Owner)

  • Firm: Not specified in direct search results, but often associated with major firms handling Eli Lilly's patent defense. Further search needed to pinpoint firm and office.
  • Experience: Further search needed for specific patent litigation experience.

• Richard Torczon (Attorney)

  • Firm: Wilson Sonsini Goodrich & Rosati
  • Office Location: Needs to be confirmed via firm website.
  • Experience: Needs to be confirmed via firm website.

To provide a complete answer with firm details and experience, I need to conduct further specific searches for Michael Morin's firm and both attorneys' office locations and relevant experience.Eli Lilly & Co., the patent owner in IPR2025-01024, was represented by counsel from Latham & Watkins LLP and Wilson Sonsini Goodrich & Rosati.

Here is the identified counsel of record:

• Michael Morin

  • Role: Partner, Global Chair of the Intellectual Property Litigation Practice, likely lead counsel.
  • Firm: Latham & Watkins LLP, Washington, D.C.
  • Experience: A nationally recognized first-chair litigator, he represents clients in high-stakes IP trials and appeals, with particular expertise in life sciences patent disputes. He was named a 2025 Law360 Intellectual Property MVP for securing jury trial victories in major patent disputes.

• Richard Torczon

  • Role: Senior Counsel.
  • Firm: Wilson Sonsini Goodrich & Rosati, Washington, D.C.
  • Experience: Prior to joining Wilson Sonsini, he served as an Administrative Patent Judge at the Patent Trial and Appeal Board (PTAB) for nearly two decades, where he authored many of the PTAB's rules and wrote over a thousand opinions and orders on patent appeals and interferences across various technologies, including biotechnology and pharmaceuticals.