March 8, 2023
By Jameson K. Gardner, Ph.D.; Stacy Lewis†
Edited by Thomas L. Irving; Amanda K. Murphy, Ph.D.
In the institution decision for Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc., IPR2022-01225, Paper 21 (P.T.A.B. Jan. 11, 2023), the Patent Trials & Appeals Board (“the Board”) determined that the exclusion criteria recited in the challenged claims carried no patentable weight, and granted Mylan’s petition for inter partes review of U.S. Patent No. 10,130,681 (“the ’681 patent”).
The ’681 patent relates to a method for treating an angiogenic eye disorder by sequentially administering multiple doses of a VEGF antagonist. Mylan asserted three anticipation grounds, one of which was based on a reference called “Dixon,” and three obviousness grounds based on Dixon combined with various secondary references. Mylan had previously filed a petition for IPR against the grandparent patent of the ’681 patent (IPR2021-00881; “the -00881 IPR”) and the Board found the challenged claims of that patent anticipated by Dixon. See Mylan Pharms. Inc. v. Regeneron Pharms. Inc., IPR2021-00881, Paper 94 (P.T.A.B. Nov. 9, 2022).
Representative claim 1 of the ’681 patent reads:
A method for treating an angiogenic eye disorder in a patient, said method comprising sequentially administering to the patient a single initial dose of a VEGF antagonist, followed by one or more secondary doses of the VEGF antagonist, followed by one or more tertiary doses of the VEGF antagonist;
wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose; and
wherein each tertiary dose is administered at least 8 weeks after the immediately preceding dose;
wherein the VEGF antagonist is a VEGF receptor-based chimeric molecule comprising
(1) a VEGFR1 component comprising amino acids 27 to 129 of SEQ ID NO:2;
(2) a VEGFR2 component comprising amino acids 130-231 of SEQ ID NO:2; and
(3) a multimerization component comprising amino acids 232-457 of SEQ ID NO:2;
wherein exclusion criteria for the patient include all of:
(1) active intraocular inflammation;
(2) active ocular or periocular infection;
(3) any ocular or periocular infection within the last 2 weeks.
The Board granted the petition for IPR, finding that Petitioner had shown a reasonable likelihood of success in demonstrating that at least one of the challenged claims was unpatentable.
Three distinct issues were discussed in the institution decision relating to claim construction: (1) limitations set forth by the claim preamble; (2) the proper construction for the terms “initial dose,” “secondary dose,” and “tertiary dose”; and (3) limitations set forth by the exclusion criteria recited in the claims.
Petitioner Mylan first argued that the claim preamble, “[a] method for treating an angiogenic eye disorder in a patient,” was “merely a statement of intended purpose, and therefore, not a limitation,” and that the preamble provided no antecedent basis for any other claim element. Id. at *9. Patent Owner Regeneron countered, arguing that the preamble was limiting, that it required “treating,” and that the “’method for treating’ requires a high level of efficacy.” Id.
In its analysis, the Board noted that in the -00881 IPR, the claim preamble for a nearly identical claimed method of treatment was found to be limiting because the claim and specification characterized the method as “one for treating angiogenic eye disorders in patients.” Id. at *10. The Board indicated that the same reasoning applied in the present petition. However, the Board held that the claim preamble did not require a high level of efficacy as alleged by Patent Owner. Quoting from the -00881 Final Written Decision, the Board said, “[t]he Specification refers to a ‘high level of efficacy’ in one instance, i.e., in the ‘Background’ section. The Specification does not describe there, or elsewhere that ‘treating,’ in the context of the claims or in the art, requires achieving a ‘high level of efficacy.’” Id. at *11. Thus, the Board held that the claim preamble was limiting, but that it did not require a high level of efficacy as alleged by Patent Owner.
Turning to the construction of “initial dose,” “secondary dose,” and “tertiary dose,” Petitioner argued that the ’681 patent specification provided express definitions of these terms that should be applied. At col. 3 ll. 34–44, the Specification reads:
The terms “initial dose,” “secondary doses,” and “tertiary doses,” refer to the temporal sequence of administration of the VEGF antagonist Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”) ; the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. The initial, secondary, and tertiary doses may all contain the same amount of dosing regimens, but will generally differ from one another in terms of frequency of administration.
Mylan IPR2022-01225, Paper 21 at *12.
Patent Owner contended that the claim terms require achieving and maintaining a high level of efficacy and were not just a mere temporal sequence. Id. at *12-13. Patent Owner additionally argued that the “less frequent ‘tertiary dose(s)’ following more frequent ‘initial’ and ‘secondary’ doses—must actually ‘treat’ the angiogenic eye disorder for which the VEGF antagonist is being administered, and such treatment must be comparable in efficacy to standard-of-care Lucentis and off-label Avastin.” Id. at *13.
Siding with Petitioner, the Board found that due to the presence of clear and express definitions in the specification, there is no reason to construe the terms any differently. Id. at *14. The Board also noted that nothing in the disclosure required the “tertiary doses” to maintain any specific level of efficacy. Id. at *13-14.
Lastly, the Board addressed the exclusion criteria element of claim 1 of the ‘861 patent, which recites:
[W]herein exclusion criteria for the patient include all of:
Id. at *14. Petitioner argued that the recited exclusion criteria hold no patentable weight in view of the printed matter doctrine. Id. at *14-16, citing Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024, 1032 (Fed. Cir. 2018). Under the Praxair framework, the decision-maker first determines whether a given claim limitation is directed to printed matter, i.e., “if it claims the content of information.” Praxair, 890 F.3d 1024, 1032 (Fed. Cir. 2018) (citing In re DiStefano, 808 F.3d 845, 848 (Fed. Cir. 2015)). Then, the decision-maker determines if the printed matter is “interrelated with the rest of the claim” or, in other words, if the printed matter is “functionally related to its ‘substrate’” Id. Petitioner argued that the exclusion criteria represented informational content because it included no active step of application (part one of Praxair analysis) and had no functional relation to the rest of the claim (part two of Praxair analysis). Mylan, IPR2022-01225, Paper 21 at *15.
Addressing part one of the Praxair analysis, Patent Owner responded by alleging that the “wherein” clause of the exclusion criteria served to limit those who may be treated by the claimed method, that the exclusion criteria were not directed to a communication of information, and that it was “well-established that claim terms defining patient populations to be treated with a claimed method are limiting.” Id. at *16. Patent Owner further argued that under part two of the Praxair analysis, the exclusion criteria are functionally related to the body of the claim because they define the population to be treated and because the method “recited administering steps to be performed only on patients who do not meet the exclusion criteria, creating a functional relationship with the rest of the claim.” Id. at *17.
Despite Patent Owners arguments, the Board held that “there is little question that the exclusion criteria are directed to informational content,” and that the exclusion criteria provide information to the practitioner of the claimed method “concerning criteria to assess risks that may be incurred when practicing a method with a patient.” Id. at *19. Moving to step two of the Praxair analysis, the Board found that the exclusion criteria were not functionally related to the rest of the claim. In particular, the Board noted that “[t]he claims do not expressly recite any positive step to be performed (or a negative step not to be performed) should a patient meet the exclusion criteria.” Id. The Board continued, “an individual practicing the method of the challenged claims would be similarly free to ignore the conditions of the exclusionary criteria and still be practicing the claimed method.” Id. The Board therefore found that the recited exclusion criteria were not limiting upon the challenged claims under the printed matter doctrine. Id. at *20.
The Board began its anticipation analysis by noting that claim 1 of the ’681 patent and claim 1 from the ‑00881 IPR are identical, except for the exclusion criteria included in presently challenged claim 1. In the -00881 IPR, the Board held that the challenged claims were anticipated by Dixon. Referencing the similarities between claim 1 of the ’681 patent to the challenged claims of the -00881 IPR and the Board’s reasoning that exclusion criteria are not a limitation on the challenged claims, the Board concluded that Petitioner had demonstrated a reasonable likelihood that claim 1 is unpatentable as being anticipated by Dixon.
Patent Owner finally urged the Board to exercise its discretion under 35 U.S.C. § 314(a) to deny institution. Patent Owner alleged that Petitioner delayed filing the present petition in order “to leverage information acquired during the course of IPR2021-00881 to bolster arguments made in the present petition.” Id. at *25. Patent Owner also argued that the Board has shown a willingness to consider a General Plastic argument when “a second petition challenges a related patent with a common specification to the first challenged patent.” Id. Acknowledging that the patents in the -00881 IPR and the present petition share a common specification, the Board found that the fact that the claims are identical except for the exclusion criteria, which may not have “patentable weight,” weighs strongly in favor of granting institution due to the “effect … on the … integrity of the patent system” and therefore denied the request for discretionary denial. Id. at *27.
We expect that many stakeholders and members of the patent bar are highly anticipating the final written decision in this case. This is especially true for practitioners in the biotechnology and pharmaceutical industries, where methods of treatment for specific patient populations are commonly claimed. Practitioners currently drafting patents directed to methods of treatment may want to consider alternative ways to recite a limitation directed to a patient population to be treated (or excluded), using the Praxair framework as guidance. Rather than simply reciting exclusionary criteria, it may be wise to include steps of actively incorporating or using exclusionary criteria in a claimed method to ensure that the exclusionary criteria avoid being characterized as printed matter that is not related to the rest of the claim.
While the Board’s reasoning related to the exclusionary criteria and whether or not it would be construed as a claim limitation garners most of the attention from this decision, it is important to note that the Board construed other claim terms based on their corresponding definitions set forth in the patent specification. This serves as an important reminder to carefully consider definitions of terms and phrases provided in the specification. Intrinsic evidence is examined first in the claim construction process, and if the specification sets forth an express definition for a claim term, the patentee’s lexicography will govern. Carefully and thoughtfully establishing definitions of key terms can strengthen a patent against future validity challenges and more clearly set forth instances of infringement. But, as we saw in this case, providing explicit definitions may create a situation of “live by the sword, die by the sword.”
†Stacy Lewis is a Law Clerk at Finnegan.
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