One of the criticisms of the post-grant review proceedings instituted under the Leahy-Smith America Invents Act (post-grant review, inter partes review, and covered business method review) was the (relative) unavailability of pursuing amendments during the proceedings, making them "all or none" propositions for patent owners. The Federal Circuit improved this situation in its en banc decision in Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017). Earlier this month, the Federal Circuit took another step in the process of making amendments more frequently considered in IPRs in Sanofi Mature IP v. Mylan Laboratories Ltd.
The case arose in an IPR over U.S. Patent No. 8,927,592, directed to methods for treating prostate cancer, and particularly metastatic cancer resistant to traditional treatment regimens. The challenged claims in the '592 patent (claims 1-5 and 7-30) were directed to treatment regimens comprising a combination of a cabazitaxel (an antitumor agent) and a corticoid. In the IPR, Sanofi filed a motion to amend its claims by adding the italicized limitations to proposed new claim 31 (corresponding to original claim 27):
31. A method of increasing survival comprising administering to a patient in need thereof (i) an antihistamine, (ii) a corticoid, (iii) an H2 antagonist, and (iv) a dose of 20 to 25 mg/m2 of cabazitaxel, or a hydrate or solvate thereof, wherein said antihistamine, said corticoid, and said H2 antagonist are administered prior to said dose of 20 to 25 mg/m2 of cabazitaxel, or hydrate or solvate thereof, in combination with prednisone or prednisolone, wherein said patient has castration resistant or hormone refractory, metastatic prostate cancer that has progressed during or after treatment with docetaxel.
The Board invalidated the challenged claims for obviousness, and Sanofi did not challenge this decision on appeal. The Board denied Sanofi's motion to amend (which was the basis of this appeal), based on its determination that Sanofi had not shown that the amended claims were patentable. In making this decision, the Board construed the amended claim language in the preamble: "[a] method of increasing survival." Sanofi argued that this language was limiting, as a "statement of intentional purpose for how the method is to be performed," in reliance on the Federal Circuit's decision in Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003). The Board rejected this argument, applying the Federal Circuit's decision in Bristol–Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1375–78 (Fed. Cir. 2001). In that case, the Court held that "a method of treatment preamble stating the intended purpose of the treatment does not impose a result limitation on the recited method step." Because the Board found the survival preamble not to be limiting, the Board dismissed Sanofi's argument on the merits that the prior art did not "disclose or suggest" that the combination of cabazitaxel and prednisone and prednisolone would increase overall survival. The Board rejected other arguments not relevant to the Court's decision, and this appeal followed.
The Federal Circuit vacated the Board's decision and remanded for reconsideration of the motion to amend claims, in an opinion by Judge O'Malley, joined by Chief Judge Prost and Judge Stoll. Citing Aqua Products, the panel recited the fundamental principle that "the petitioner bears the burden of proving that proposed amended claims are unpatentable." The Board (a creature of the PTO) imposed this burden on Sanofi, using the generic requirement that a party before the Office (whether an Examiner or the Board) has the burden of showing that an amended claim is patentable. Mylan contended that this error was harmless because they had established that the proposed amended claims were unpatentable. The panel was unconvinced on the record. Accordingly, the opinion stated that "[w]e therefore decline to speculate as to how the Board would resolve this case under the correct legal standard," citing several post-Aqua cases coming to the same decision under similar circumstances in those cases.
The Court also rejected Mylan's argument that Sanofi had waived its opportunity for a remand because it had not requested rehearing before the Board, saying that Sanofi was not required to request rehearing based on In re Magnum Oil Tools Int'l, Ltd., 829 F.3d 1364, 1377 (Fed. Cir. 2016), and the plain language of the appeal statute, 35 U.S.C. § 141(c). Finally, the panel rejected Mylan's argument for "administrative exhaustion."
Turning to the PTAB's claim construction, the opinion asserts a de novo standard of review with all factual determinations reviewed for substantial evidence, based on PPC Broadband, Inc. v. Corning Optical Commc'ns RF, LLC, 815 F.3d 747, 751 (Fed. Cir. 2016). Under this review standard, the Federal Circuit held the Board erred in holding that the preamble language was not limiting, based on its Jansen decision and Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001). And in a footnote, the panel indicates that its decision was based on the "broadest reasonable interpretation" standard applied by the Board. It may be instructive to consider the preambles in these prior cases for comparison with the preamble in Sanofi's proposed amended claim 31:
Rapoport:
A method for treatment of sleep apneas comprising administration of a therapeutically effective regimen of a Formula I azapirone compound . . . to a patient in need of such treatment.
For this claim the Federal Circuit found the "method of treatment" term in the preamble to be limiting because without it, the phrase "a patient in need of such treatment" would have no antecedent basis. Applying this reasoning to the case at bar, the Federal Circuit held that the "method of treatment" term was limiting because "the method–administering a certain compound–must be practiced to achieve the purpose stated in the preamble."
Jansen:
A method of treating or preventing macrocytic megaloblastic anemia in humans which anemia is caused by either folic acid deficiency or by vitamin B12 deficiency which comprises administering a daily oral dosage of a vitamin preparation to a human in need thereof comprising at least about 0.5 mg. of vitamin B12 and at least about 0.5 mg. of folic acid.
Similarly, the Court's decision that the preamble in the Jansen claim was limiting supported the decision here that the "method of treating" preamble was limiting because "it articulated the 'purpose for which the method must be performed,'" i.e., "increasing survival."
Analogizing the preamble in the Sanofi claim in light of this precedent, the Federal Circuit concluded the PTAB had erred in finding Sanofi's preamble not to be limiting. The panel also found support for this construction in the '592 specification, which contained an Example and other disclosure relating to increasing patient survival as an important feature of the claimed invention. In contrast, the Federal Circuit was unpersuaded by Mylan's arguments that Bristol-Myers Squibb (where the preamble was held not to be limiting) was more compelling precedent, because in that case "the claim language 'strongly suggest[ed] the independence of the preamble from the body of the claim'" whereas here the claim language suggested the opposite to the panel. And the Court also rejected Mylan's argument that the prosecution history of the '592 patent supported its position, saying that "Mylan conflates concepts of curing cancer or sending it into remission with longer survival while the cancer remains intact."
Because the Board erred in its claim construction, and procedurally in imposing the burden of patentability improperly on the patent owner, the Court vacated the PTAB's claim construction and remanded for further consideration based on the Court's claim construction.
The opinion also included an interesting footnote regarding the Board's claim construction:
To the extent the Board disregarded Jansen simply because it was on appeal from a district court, '592 Decision, 2017 WL 4221400 at *30 ("Jansen is distinguishable from the present case because it was an infringement case . . . ."), it erred. Claim construction standards vary between district court litigations and inter partes reviews, but basic principles of construction do not. Cf. Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1326 (Fed. Cir. 2015) [emphasis added].
Sanofi Mature IP v. Mylan Laboratories Ltd. (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges O'Malley and Stoll
Opinion by Circuit Judge O'Malley
