PTAB

IPR2023-00442

Samsung Bioepis Co Ltd v. Regeneron Pharmaceuticals Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Using a VEGF Antagonist to Treat Angiogenic Eye Disorders
  • Brief Description: The ’681 patent discloses methods for treating angiogenic eye disorders by sequentially administering the anti-VEGF molecule aflibercept. The claims recite a specific dosing regimen (an initial dose, one or more secondary doses at 2-4 weeks, and tertiary doses at ≥8 weeks) combined with a set of three patient exclusion criteria.

3. Grounds for Unpatentability

Ground 1: Obviousness over Dixon in view of CATT, MACTEL, and PIER Studies - Claims 1, 3-11, 13-14, 16-24, and 26 are obvious over Dixon in view of the CATT, MACTEL, and PIER studies.

  • Prior Art Relied Upon: Dixon (a 2009 journal article), the CATT Study (a 2010 clinical trial publication), the MACTEL Study (a 2008 clinical trial publication), and the PIER Study (a 2008 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the primary reference, Dixon, discloses every limitation of the challenged claims except for the three recited exclusion criteria. Dixon describes the Phase III clinical trials for aflibercept (VEGF Trap-Eye) for treating age-related macular degeneration (AMD) and explicitly teaches the claimed dosing regimen: three initial monthly doses followed by dosing every 8 weeks. Petitioner asserted that Dixon’s disclosure of VEGF Trap-Eye, which has the "same molecular structure" as aflibercept, inherently discloses the specific amino acid and nucleic acid sequences recited in the claims, a position previously adopted by the Board in the Final Written Decision (FWD) for the related ’338 patent. The sole missing elements—the exclusion criteria—were well-known safety precautions for intravitreal injections. The CATT, MACTEL, and PIER studies, which evaluated other anti-VEGF agents (ranibizumab and bevacizumab) administered via the same intravitreal injection method, expressly disclosed these same criteria: (1) active intraocular inflammation, (2) active ocular or periocular infection, and (3) recent ocular or periocular infection.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine the aflibercept dosing regimen from Dixon with the exclusion criteria from the CATT, MACTEL, and PIER studies for safety reasons. Petitioner contended that the risks of endophthalmitis and inflammation are known complications of the intravitreal injection procedure itself, not the specific drug being injected. A POSA would therefore have been motivated to apply these standard, known safety criteria from studies of similar intravitreally-injected anti-VEGF agents to mitigate the same known risks when administering aflibercept according to Dixon’s regimen.
    • Expectation of Success: A POSA would have had a reasonable expectation of success in applying these exclusion criteria. The criteria were established safety precautions designed to address the general risks of intravitreal injections. Applying these routine safety measures to a new drug (aflibercept) administered via the same method would be a simple and predictable application of a known solution to a known problem.

4. Key Claim Construction Positions

  • "A method for treating an angiogenic eye disorder in a patient": Petitioner argued, consistent with the Board's finding in the related ’338 FWD, that this preamble term is limiting but does not require a specific level of efficacy. It only requires that the claimed method be administered for the purpose of treatment. This construction is important because it prevents the Patent Owner from arguing that the prior art fails to anticipate or render the claims obvious merely because a disclosed treatment might not be effective for every patient.
  • "Initial dose," "secondary dose," and "tertiary dose": Petitioner proposed these terms be construed according to their express definitions in the specification, referring simply to the temporal sequence of administration. This construction, also adopted in the ’338 FWD, rejects any implied efficacy requirement for a dose to qualify as "initial," "secondary," or "tertiary."

5. Arguments Regarding Discretionary Denial

  • Petitioner presented substantial arguments that discretionary denial would be unwarranted under both 35 U.S.C. §325(d) and §314(a).
  • §325(d) (Becton Dickinson Factors): Petitioner argued that the art and arguments in its petition were not the same or substantially the same as those before the examiner during prosecution. The secondary references (CATT, MACTEL, and PIER studies) and the specific obviousness combination were never considered by the examiner, whose rejections were limited to non-statutory double patenting.
  • §314(a) (General Plastic Factors): Petitioner argued against denial based on a prior IPR petition filed by Mylan Pharmaceuticals against the same patent. Petitioner asserted it has no relationship with Mylan and that its single ground of invalidity is different and non-cumulative. Specifically, Petitioner's art expressly discloses all three exclusion criteria, whereas Mylan’s art did not, forcing Mylan to rely on arguments that the criteria were inherent or not entitled to patentable weight—arguments Petitioner did not make. Because Petitioner is not the "same petitioner" and presents different art and arguments, denial under General Plastic was argued to be inappropriate. The Fintiv factors were considered inapplicable as the patent was not being litigated.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1, 3-11, 13-14, 16-24, and 26 of the ’681 patent as unpatentable.