DCT

1:20-cv-00690

Novartis Pharma AG v. Regeneron Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00690, N.D.N.Y., 08/02/2021
  • Venue Allegations: Venue is alleged to be proper based on Regeneron having a regular and established place of business within the Northern District of New York.
  • Core Dispute: Plaintiff alleges that Defendant’s EYLEA® pre-filled syringe infringes a patent related to the specific combination of physical and chemical properties of pre-filled, terminally sterilized syringes for ophthalmic injections.
  • Technical Context: The technology concerns pre-filled syringes used to deliver sensitive biologic drugs known as VEGF-antagonists into the eye to treat conditions such as Wet Age-related Macular Degeneration (Wet AMD), a leading cause of vision loss.
  • Key Procedural History: The complaint references a prior International Trade Commission (ITC) investigation where an Administrative Law Judge found Regeneron infringed the patent-in-suit. It also alleges extensive pre-suit history, including licensing discussions initiated by a third party on Novartis's behalf. Public records, including an Inter Partes Review (IPR) certificate attached to the patent, indicate that an IPR was filed against the patent-in-suit prior to this complaint, and that all claims were subsequently cancelled. This IPR proceeding and its outcome may significantly impact the viability of the present infringement claims.

Case Timeline

Date Event
2012-07-30 '631' Patent Priority Date
Late 2013 Regeneron allegedly contacted about licensing pending application
2014-02-01 Regeneron allegedly requested technical information from Vetter
2015-12-29 U.S. Patent No. 9,220,631 Issues
2019-12-01 Regeneron launches accused EYLEA® PFS product
2020-06-19 ITC Administrative Law Judge finds infringement of '631 patent
2021-04-16 Inter Partes Review (IPR2021-00816) filed against '631 patent
2021-08-02 First Amended Complaint Filed
2025-02-28 IPR Certificate issues cancelling all claims of the '631 patent

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,220,631 - "Syringe"

  • Patent Identification: U.S. Patent No. 9,220,631, "Syringe," issued December 29, 2015.

The Invention Explained

  • Problem Addressed: The patent describes challenges in delivering sensitive biologic therapeutics via pre-filled syringes for ophthalmic injections ('631 Patent, col. 4:20-33). Key problems include ensuring sterility of the pre-filled device without damaging the drug, preventing contamination from syringe components like silicone oil lubricant, and ensuring the syringe is easy for a physician to operate with a low and smooth application of force during a delicate procedure ('631 Patent, col. 4:33-42, col. 5:50-58).
  • The Patented Solution: The invention is a pre-filled syringe that claims to solve these problems by combining a specific set of characteristics. It specifies a small-volume glass syringe that is terminally sterilized, contains a VEGF-antagonist solution with a very low particle count, is lubricated with a specific low quantity of silicone oil, and, despite the low lubrication, exhibits a low "stopper break loose force" for smooth operation ('631 Patent, Abstract; col. 4:50-65). This combination of features is presented as a solution that balances the competing requirements of sterility, drug integrity, and ease of use.
  • Technical Importance: The claimed invention addresses the need for a safer, more reliable, and user-friendly delivery system for intravitreal injections, which are a cornerstone of treatment for prevalent, sight-threatening retinal diseases (Compl. ¶1).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 ('631 Patent, Compl. ¶19).
  • The essential elements of independent claim 1 are:
    • A pre-filled, terminally sterilized syringe for intravitreal injection
    • Comprising a glass body, a stopper, a plunger, and an ophthalmic solution with a VEGF-antagonist
    • Wherein the syringe has a nominal maximum fill volume between about 0.5 ml and 1 ml
    • Wherein the syringe barrel comprises from about 1 µg to 100 µg of silicone oil
    • Wherein the solution has no more than 2 particles > 50 µm in diameter per ml
    • And wherein the syringe has a stopper break loose force of less than about 11N
  • The complaint reserves the right to assert other claims and specifically alleges inducement of claim 24 (Compl. ¶30).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Regeneron's EYLEA® (aflibercept) product when supplied in its pre-filled syringe ("PFS") presentation (Compl. ¶2).

Functionality and Market Context

  • The EYLEA® PFS is a drug-device combination product consisting of a single-dose, pre-filled syringe containing the VEGF-antagonist drug aflibercept (Compl. ¶2, ¶22). It is intended for intravitreal injection by a physician to treat various ophthalmic conditions, including Wet AMD (Compl. ¶16, ¶28). The complaint alleges that the EYLEA® PFS product is commercially significant and directly competes with Novartis's own products (Compl. ¶33).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'631 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pre-filled, terminally sterilized syringe for intravitreal injection... EYLEA® PFS is described as a pre-filled, terminally sterilized syringe for intravitreal injection. ¶20 col. 19:2-3
...the syringe comprising a glass body forming a barrel, a stopper and a plunger... The EYLEA® PFS syringe is alleged to comprise a glass body forming a barrel, a stopper, and a plunger. ¶21 col. 19:3-5
...and containing an ophthalmic solution which comprises a VEGF-antagonist... The EYLEA® PFS is alleged to contain an ophthalmic solution of the VEGF-antagonist aflibercept. ¶22 col. 19:5-7
...the syringe has a nominal maximum fill volume of between about 0.5 ml and about 1 ml... The EYLEA® PFS is alleged to have a nominal maximum fill volume that falls within this range. ¶23 col. 19:8-10
...the syringe barrel comprises from about 1 µg to 100 µg silicone oil... The EYLEA® PFS barrel is alleged to comprise silicone oil in an amount that falls within this range. ¶24 col. 19:10-11
...the VEGF antagonist solution comprises no more than 2 particles >50 µm in diameter per ml... The aflibercept solution in the EYLEA® PFS is alleged to meet this particulate matter limitation. ¶25 col. 19:12-13
...and wherein the syringe has a stopper break loose force of less than about 11N. The EYLEA® PFS is alleged to have a stopper break loose force below this threshold. ¶26 col. 19:13-14

Identified Points of Contention

  • Validity: The primary point of contention, though not detailed in the complaint, will be the validity of the '631 patent. The existence of an IPR that resulted in the cancellation of all claims raises the fundamental question of whether this suit for past damages can proceed.
  • Technical Questions: The complaint makes several conclusory allegations regarding quantitative metrics (silicone oil amount, particle count, break loose force). A key question for the court will be what evidence Novartis relies upon for these specific measurements of the accused product. The factual basis for these numbers will likely be a central focus of discovery and expert testimony.
  • Scope Questions: The claim uses the term "about" for several limitations (e.g., "about 1 ml," "about 11N"). Should the accused product's specifications fall near the boundaries of these ranges, the proper construction of "about" could become a significant point of dispute.

V. Key Claim Terms for Construction

The Term: "terminally sterilized"

  • Context and Importance: This term, appearing in the preamble of claim 1, describes a critical step in manufacturing the claimed invention. The patent emphasizes achieving sterility while preserving the integrity of the sensitive drug and the syringe's physical properties ('631 Patent, col. 4:20-33). The definition of this term is important because the infringement analysis may depend on whether the specific sterilization process used for the EYLEA® PFS falls within the term's scope as understood in light of the patent's teachings.
  • Evidence for a Broader Interpretation: The specification mentions multiple sterilization processes, such as ethylene oxide (EtO) and hydrogen peroxide (H2O2), which may support an interpretation that the term is not limited to a single method ('631 Patent, col. 9:48-54).
  • Evidence for a Narrower Interpretation: A party could argue the term is implicitly limited to sterilization processes that achieve the specific outcomes described in the patent—namely, a sterile product where the biologic drug is not unacceptably compromised and the syringe's functional characteristics (e.g., break loose force) are maintained within the claimed limits.

The Term: "about 1 µg to 100 µg silicone oil"

  • Context and Importance: This quantitative range is a core element of the claim, distinguishing the invention from prior art syringes that allegedly used more silicone oil ('631 Patent, col. 5:56-60). The construction of "about" is critical to determining the literal scope of the claim.
  • Evidence for a Broader Interpretation: The use of "about" itself suggests the numbers are not strict, absolute limits. The specification's discussion of various low levels of silicone oil (e.g., less than 75 µg, less than 50 µg) could support a flexible reading of the upper bound ('631 Patent, col. 5:61-65).
  • Evidence for a Narrower Interpretation: The patent frames the invention as a solution to problems caused by higher levels of silicone oil (100-800 µg). A party might argue that "about 100 µg" must be construed narrowly to preserve this distinction from the prior art, meaning it cannot extend to values significantly above 100 µg.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement of method claim 24. The basis for this allegation is that Regeneron provides physicians with instructions for administering the EYLEA® PFS to treat various eye diseases, which allegedly directs them to perform the steps of the patented method (Compl. ¶30).
  • Willful Infringement: The complaint makes extensive allegations to support willfulness. It claims Regeneron had pre-suit knowledge of the patent application as early as 2013 through licensing discussions, and of the issued patent since 2015 (Compl. ¶35-37). The complaint further alleges that Regeneron knew its product would infringe, citing the prior ITC investigation and alleged internal documents, but chose to launch its product regardless (Compl. ¶39, ¶41-42).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue for the court will be the legal effect of patent cancellation: Given that all claims of the '631 patent were cancelled in a subsequent IPR proceeding, the threshold question is whether Novartis can maintain an action for damages that allegedly accrued during the period before the patent was cancelled. This involves the complex interplay between the presumption of validity and a later determination of unpatentability.
  • A key evidentiary question will be one of quantitative proof: The infringement case hinges on specific numerical values for silicone oil content, particle count, and break-loose force. The dispute may turn on whether the plaintiff can produce reliable, admissible evidence to prove the accused EYLEA® PFS product meets these precise, multi-faceted technical limitations as defined in the patent.
  • Finally, should the case proceed, a critical question will be one of culpability and willfulness: The complaint details a long history of alleged pre-suit knowledge, including licensing offers and a prior ITC proceeding. The court will need to determine if Regeneron’s decision to market its product, in light of this alleged knowledge, constituted the type of egregious conduct that would justify an award of enhanced damages.