The Patent Trial and Appeal Board (PTAB) issued a final written decision on IPR2023-00442 determining that claims 1, 3-11, 13, 14, 16-24, and 26 of U.S. Patent No. 10,130,681 ("the '681 patent") were unpatentable. The '681 patent is owned by Regeneron Pharmaceuticals, Inc., and was challenged in an IPR by Samsung Bioepis Co., Ltd. The '681 patent claims priority to a number of patents that were invalidated in previous IPR proceedings.
The claims of the '681 patent are directed to a method of treating an angiogenic eye disorder by administering a vascular endothelial growth factor (VEGF) antagonist according to the following dosage pattern: an initial dose, a secondary dose 2-4 weeks after the initial dose, and a tertiary dose at least 8 weeks after the secondary dose. The claims also include exclusion criteria for patients who have active or recent ocular infections or inflammation.
In the Decision, the Board applied the Phillips claim construction standard to address two key parts of the challenged claims. First, the preamble of the independent claims recites a "method for treating an angiogenic eye disorder in a patient." Regeneron argued that the preamble required a "high level of efficacy" that would not have been obvious to a person of ordinary skill in the art given the dosages presented in the claim. For instance, Regeneron stated that the claimed dose frequencies would have been considered inferior to the standard of care at the time of filing and thus would not have been considered as a form of treatment.
The Board disagreed and stated that the specification of the '681 patent does not provide a specific definition of treatment or levels of efficacy. The Board further determined that a method of treating an eye disorder is sufficiently performed "upon administration of the VEGF antagonist [...] for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves the intended result."
The second limitation addressed in claim construction was the three "exclusion criteria," which are taken from Regeneron's clinical trial protocols for testing VEGF. The Board determined that these criteria do not hold patentable weight under the printed matter doctrine and Praxair analysis, which have previously been discussed on this site. According to the PTAB, the criteria is informational content that is merely recited "absent an adequate functional relationship" with the limitations of the claims. The claims do not require a practitioner to act or refrain from acting based on the criteria. If a patient were to be excluded based on the criteria, the method would simply not be carried out; therefore, the criteria themselves do not have a function (e.g., providing a "discrete manipulative difference in the steps by which the method, as practiced, should be altered") within the claim.
With the exception of the exclusion criteria, the challenged independent claims of the '681 patent were identical to claims that had been deemed unpatentable in previous IPR proceedings. Since the exclusion criteria were not given patentable weight, the PTAB was able to rely on the reasonings of previous IPR decisions to determine that the claims of the '681 patent were similarly unpatentable under 35 U.S.C. § 102. Specifically, the Board reiterated that the independent claims were anticipated by a literature review on VEGF by Dixon, et al. ("Dixon") published in 2009. Dixon describes a protocol in which aflibercept, a VEGF antagonist meeting the molecular characteristics recited in the '681 claims, is administered at 0, 4, 8, and 12 weeks.
The PTAB decision highlights the importance of claim construction for evaluating treatment claims. Administration of a drug alone may sufficiently read on a method of treatment, especially in the absence of any written description that would otherwise characterize claim language directed to treatment results. Furthermore, conditions for a method of treatment should be integrated into the functionality of the claim in order to hold patentable weight in the assessment of the claim as a whole.
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