BPI Labs, LLC v. Eli Lilly & Co.

This case involves an Inter Partes Review (IPR) proceeding initiated by BPI Labs, LLC against Eli Lilly & Co. before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office. BPI Labs, LLC is a specialized pharmaceutical manufacturer and an FDA-registered 503B outsourcing facility, functioning as an operating company that produces high-quality sterile injectable medications, including generic injectables. Eli Lilly & Co. is a prominent American multinational pharmaceutical operating company, globally recognized for developing, manufacturing, and marketing a wide array of pharmaceutical products, with a strong focus on areas such as diabetes, oncology, and immunology, and known for blockbuster drugs like Mounjaro and Zepbound.

The IPR petition specifically targeted U.S. Patent 9474780, titled "GIP and GLP-1 co-agonist compounds". This patent broadly describes dual incretin peptide mimetic compounds that activate receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), which are useful for treating type 2 diabetes mellitus (T2D). Crucially, this patent protects tirzepatide, the active pharmaceutical ingredient found in Eli Lilly's highly successful drugs Mounjaro® (for type 2 diabetes) and Zepbound® (for chronic weight management). The alleged infringing activity, though not directly litigated in the IPR itself, stems from BPI Labs' (in collaboration with Empower Pharmacy) efforts to challenge Eli Lilly's exclusivity over tirzepatide for use in compounded products, implying that compounded tirzepatide is the technology at issue.

The procedural posture of this case is an IPR (IPR2025-01346) filed at the PTAB on August 4, 2025, which was discretionarily denied by the PTAB Director on December 11, 2025. The PTAB is a significant venue for patent validity challenges as it offers a faster and often more cost-effective alternative to district court litigation, with technically experienced administrative patent judges reviewing claims under a lower burden of proof than in federal court. However, the discretionary denial means the PTAB chose not to institute the review even before examining the substantive merits of BPI Labs' challenge, often based on factors such as the "settled expectations" of the parties regarding a long-standing patent or the presence of parallel district court litigation.

This case is particularly notable due to the immense market impact of the underlying drug, tirzepatide, which is a major player in the lucrative diabetes and obesity treatment markets and has generated billions in revenue for Eli Lilly. The discretionary denial of the IPR petition by BPI Labs, following a similar denial for Empower Pharmacy's challenge on the same patent, highlights the pharmaceutical industry's fierce battles over patent exclusivity for blockbuster drugs and the PTAB's recent trend of increasing discretionary denials. This outcome strengthens Eli Lilly's patent position on tirzepatide, at least in the PTAB context, making it more challenging for generic or compounding pharmacies to bring alternative versions to market and potentially cementing Lilly's short-term intellectual property defense.

The Inter Partes Review (IPR) proceeding IPR2025-01346, initiated by BPI Labs, LLC against Eli Lilly & Co. concerning US Patent 9,474,780, was discretionarily denied by the Patent Trial and Appeal Board (PTAB) Director. This denial effectively preserved Eli Lilly's patent claims related to its tirzepatide drugs, such as Mounjaro and Zepbound. The IPR was closely related to a broader patent infringement litigation landscape surrounding the '780 patent.

Here are the key legal developments and outcomes:

Parallel District Court Litigation (Contextual)

• Early 2024: Eli Lilly & Co. filed a patent infringement lawsuit in federal court against Empower Pharmacy. The lawsuit alleged that Empower Pharmacy infringed the US Patent 9,474,780 through its compounded tirzepatide products. Empower Pharmacy subsequently challenged the validity of the '780 patent at the PTAB.

PTAB IPR2025-01346 Proceedings (BPI Labs v. Eli Lilly)

• 2025-08-04: IPR Petition Filed. BPI Labs, LLC filed an IPR petition with the Patent Trial and Appeal Board, challenging the validity of US Patent 9,474,780 owned by Eli Lilly & Co. The petition argued that Lilly's patent claims were obvious in light of prior publications by Alsina-Fernandez, DiMarchi, and Lau. BPI Labs collaborated with Empower Pharmacy in challenging Lilly's patent on tirzepatide.
• 2025-10-14: Patent Owner's Request for Discretionary Denial. Eli Lilly, as the Patent Owner, filed a request for discretionary denial of institution for IPR2025-01346. Eli Lilly argued that its "long-settled expectations" in the '780 patent, which was issued in October 2016 and had been in force for nearly nine years, favored discretionary denial. The company highlighted its substantial investments in the research, development, and commercialization of Mounjaro and Zepbound, which embody the patented invention.
• 2025-11-03: Precedential Director Decision. The Director issued a precedential decision in Revvo Technologies, Inc. v. Cerebrum Sensor Technologies, Inc., IPR2025-00632, Paper 20. This decision established or clarified the application of "settled expectations" as a factor for discretionary denials, considering the length of time a patent has been in force.
• 2025-11-12: Petitioner's Opposition and Patent Owner's Preliminary Response. BPI Labs filed an opposition brief to Eli Lilly's request for discretionary denial, and Eli Lilly filed its preliminary response to the IPR petition.
• 2025-12-11: Discretionary Denial of Institution. The PTAB Director issued a decision discretionarily denying institution of IPR2025-01346. The denial was made "in view of Revvo Technologies, Inc. v. Cerebrum Sensor Technologies, Inc.," indicating that the "settled expectations" doctrine likely played a significant role due to the age of the '780 patent.
• 2026-01-09: Request for Director Review. Following the discretionary denial, the USPTO Director acknowledged BPI Labs' request for Director Review of the denial decision.
• 2026-01-12: Related IPR Director Review Rejected. In a related IPR (IPR2025-01024) filed by Empower Pharmacy against the same '780 patent, Empower's request for Director Review was officially rejected. This indicated a consistent stance by the Director on challenges to the '780 patent.

Outcome

The IPR2025-01346 proceeding was terminated on December 11, 2025, with a status of "Discretionarily Denied." This outcome means the PTAB did not institute a trial to review the patentability of the challenged claims of US Patent 9,474,780, leaving Eli Lilly's patent rights intact in this particular proceeding. The discretionary denial, based on factors such as "settled expectations," strengthens Eli Lilly's intellectual property position for its tirzepatide products.

Robins Kaplan LLP represented BPI Labs, LLC in IPR2025-01346. The following attorneys from Robins Kaplan LLP are identified as counsel with relevant experience in PTAB proceedings and pharmaceutical patent litigation:

• Cyrus A. Morton

  • Role: Partner, Chair of the Patent Office Trials Group
  • Firm & Office Location: Robins Kaplan LLP, Minneapolis, MN
  • Relevant Experience: Morton is a trial attorney whose practice emphasizes patent litigation and includes experience as lead counsel in well over 100 Inter Partes Reviews (IPRs). He is noted as the first attorney to handle all four types of post-grant proceedings under the America Invents Act.

• Emily E. Niles

  • Role: Partner
  • Firm & Office Location: Robins Kaplan LLP, Minneapolis, MN
  • Relevant Experience: Niles is a registered patent attorney with experience in inter partes review proceedings before the Patent Trial and Appeal Board (PTAB) and high-stakes intellectual property and business disputes.

• Miles A. Finn, Ph.D.

  • Role: Counsel
  • Firm & Office Location: Robins Kaplan LLP, Minneapolis, MN and New York, NY
  • Relevant Experience: Finn focuses on Patent Trial and Appeals Board (PTAB) litigation and has extensive litigation and licensing experience in electrical engineering matters and medical and high-technology industries. He holds a Ph.D. in physics.

• Steven C. Carlson

  • Role: Partner
  • Firm & Office Location: Robins Kaplan LLP, Redwood City, CA (Silicon Valley office)
  • Relevant Experience: Carlson is an intellectual property litigator who teaches advanced patent litigation focusing on PTAB and International Trade Commission cases and has invalidated patents at the Patent Trial and Appeal Board. His experience covers various technologies including medical devices and pharmaceuticals.

Counsel for Defendant Eli Lilly & Co. in IPR2025-01346

Eli Lilly & Co. was represented by both outside counsel from Latham & Watkins LLP and in-house counsel during the IPR proceedings for U.S. Patent 9474780.

Here are the details of the identified counsel:

• Michael A. Morin

  • Role: Likely lead counsel or significant role.
  • Firm: Latham & Watkins LLP.
  • Office Location: While the specific office for this case is not listed in the provided search results, Latham & Watkins is a global firm with numerous offices. For patent litigation, their attorneys are often located in offices such as Washington D.C., New York, or California.
  • Relevant Experience: Michael A. Morin is identified with a "L5A" rating, indicating substantial experience, though specific past cases or detailed experience are not immediately available from the provided snippets.

• Inge Osman

  • Role: Counsel.
  • Firm: Latham & Watkins LLP.
  • Office Location: Not specified in the search results.
  • Relevant Experience: Inge Osman is identified with a "L4A" rating.

• David P. Frazier

  • Role: Counsel.
  • Firm: Latham & Watkins LLP.
  • Office Location: Not specified in the search results.
  • Relevant Experience: David P. Frazier is identified with a "L3E" rating.

• Aaron F. Barkoff

  • Role: In-house counsel.
  • Firm: Eli Lilly Company.
  • Office Location: Eli Lilly and Company is headquartered in Indianapolis, Indiana, suggesting this as the likely office location for their in-house counsel.
  • Relevant Experience: Aaron F. Barkoff is also listed as counsel for Eli Lilly in a related IPR (IPR2025-01024) concerning the same patent, indicating involvement in patent office disputes for the company.

• Danica L. Hostettler

  • Role: In-house counsel.
  • Firm: Eli Lilly Company.
  • Office Location: Likely Indianapolis, Indiana, given Eli Lilly's headquarters.
  • Relevant Experience: Danica L. Hostettler is listed with Eli Lilly Company as counsel in this IPR.