Gene Co Pty Ltd v. Trustees Of Columbia University In City Of New York

1. Case Identification

• Case #: IPR2024-00313
• Patent #: RE47,045
• Filed: December 20, 2023
• Petitioner(s): Gene Company Pty Ltd
• Patent Owner(s): The Trustees of Columbia University in the City of New York
• Challenged Claims: 1-54

2. Patent Overview

• Title: Compositions and Methods for Treating Macular Degeneration
• Brief Description: The ’045 patent discloses methods for retarding the accumulation of lipofuscin pigment in the retina and treating macular degeneration. The methods comprise administering a pharmaceutical composition containing a vitamin A retinoid that is deuterated at the C-20 position.

3. Grounds for Unpatentability

Ground 1: Obviousness over Ortho Pharma and Olson - Claims 1-9, 19-23, 25-26, 28-36, 46-50, and 52-53 are obvious over Ortho Pharma in view of Olson 1988.

• Prior Art Relied Upon: Ortho Pharma (German Patent Application No. 20 2006 014 588) and Olson 1988 (a 1988 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Ortho Pharma taught administering vitamin A compositions, including various vitamins and minerals in a pharmaceutically acceptable carrier, to treat or prevent eye diseases such as age-related macular degeneration. Olson 1988 was argued to expressly disclose the synthesis and purification of the specific C20-D3-retinoids claimed in the ’045 patent, including C20-D3-retinol and C20-D3-retinol acetate, for use in biological studies. Together, Petitioner asserted these references teach all limitations of the independent claims, with Ortho Pharma providing the therapeutic method and formulation and Olson providing the specific deuterated compound.
  • Motivation to Combine (for §103 grounds): Petitioner contended that a person of ordinary skill in the art (POSA) would combine the teachings because it was well-known that a toxic byproduct of the visual cycle, A2E/lipofuscin, contributed to macular degeneration. The formation of A2E required the removal of a hydrogen atom (deprotonation) at the C-20 position of vitamin A. A POSA would have understood from the well-established deuterium kinetic isotope effect that replacing hydrogen with deuterium at the C-20 position would slow this rate-limiting deprotonation step, thereby reducing the formation of toxic A2E. This knowledge would motivate a POSA to substitute the C20-deuterated vitamin A disclosed by Olson into the vitamin A therapy for macular degeneration taught by Ortho Pharma to improve its efficacy.
  • Expectation of Success (for §103 grounds): Petitioner asserted a POSA would have a high expectation of success because Olson already provided the exact claimed compounds and the deuterium kinetic isotope effect was known to be a predictable phenomenon, making the slowing of A2E formation a reasonably expected outcome.

Ground 2: Obviousness over Ground 1 plus Mata - Claims 10-15, 18, 37-42, and 45 are obvious over Ortho Pharma and Olson 1988 in further view of Mata.

• Prior Art Relied Upon: Ortho Pharma, Olson 1988, and Mata (a 2000 journal article).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground built upon Ground 1 to address dependent claims reciting specific patient populations, including those with dry age-related macular degeneration, Stargardt disease, or macular degeneration characterized by mutations in the ABCA4 gene. Petitioner argued that Mata explicitly disclosed that these specific conditions are associated with the accumulation of A2E/lipofuscin in the retina. Mata further identified the biosynthetic pathway of A2E and suggested that pharmacologic inhibition of this pathway would be an effective treatment strategy for such diseases.
  • Motivation to Combine (for §103 grounds): Petitioner argued Mata provided the explicit rationale to apply the therapeutic approach from Ground 1 (using C20-deuterated vitamin A to slow A2E formation) to the specific diseases recited in the dependent claims. Since Mata directly linked dry AMD, Stargardt disease, and ABCA4 mutations to the A2E/lipofuscin accumulation mechanism targeted by the Ground 1 combination, a POSA would be motivated to use the C20-deuterated compounds to treat these specific patient populations.
  • Expectation of Success (for §103 grounds): A POSA would have reasonably expected success in treating the specific patient groups in these claims because Mata taught they all shared the same underlying pathology (lipofuscin accumulation) that the combination of Ortho Pharma and Olson was designed to address.

• Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 3) against claims 16-17, 24, 27, 43-44, 51, and 54 based on the combination of Ortho Pharma, Olson, and Mata, in further view of Widder (WO 2006/007314). Widder was argued to provide teachings for treating other macular degeneration diseases (e.g., retinitis pigmentosa), co-administering phospholipids, and administering the composition directly to the eye.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that institution is warranted and discretionary denial under 35 U.S.C. §325(d) is inappropriate because the core prior art and arguments presented in the petition are materially different from those considered during prosecution. Petitioner contended that the primary references—Olson 1988, Ortho Pharma, and Mata—were never asserted by the Examiner. During prosecution, the patent owner allegedly prevailed by arguing that the prior art of record did not disclose C20-deuterated retinoids. Petitioner asserted that Olson 1988 directly contradicts this position and that this failure by the Examiner to consider the most relevant art constitutes a material error warranting institution.

5. Relief Requested

• Petitioner requests the institution of an inter partes review and cancellation of claims 1-54 of the RE47,045 patent as unpatentable under 35 U.S.C. §103.