During the week of July 9, the Board issued four decisions in Technology Center 1600, three decisions denying institution of inter partes review and one Final Decision finding the challenged claims patentable. In addition to these four decisions the Board, in ABS Global, Inc. v. XY, LLC, No. IPR2017-02184, also granted Patent Owner’s request for an adverse judgement. The four decisions are as follows:
Pfizer, Inc. v. Genentech, Inc., No. IPR2018-00330 (Decision Entered July 9, 2018). In its petition, Pfizer challenged claims 1¬–3 of U.S. Patent No. 6,339,142 (“the ’142 patent”) on anticipation and obviousness grounds—the same three claims it challenged on anticipation and obviousness grounds in its petition filed on August 29, 2017, in IPR2017-02019. Genentech argued that the Board should exercise its discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d). The Board agreed and denied institution under both provisions. With respect to § 314(a), the Board agreed with Genentech that all seven factors provided in General Plastic Industrial Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) supported exercising its discretion to deny institution. Pfizer failed to address the General Plastic factors and the Board was “left to wonder why [Pfizer] . . . filed a second petition challenging the same claims over the same grounds covered in a first petition.” As such, the Board exercised its discretion to deny institution under § 314(a). Regarding § 325(d), Genentech asserted that the same grounds were raised by Pfizer in IPR2017-02019. The Board observed that Pfizer did not provide a reason why the Board should not exercise its discretion under § 325(d). Accordingly, the Board declined to institute under § 325(d).
Pfizer, Inc. v. Genentech, Inc., No. IPR2018-00331 (Decision Entered July 10, 2018). In its petition, Pfizer challenged claims 1 and 5–7 of U.S. Patent No. 9,249,218 (“the ’218 patent”) on anticipation and obviousness grounds—the same three claims it challenged on anticipation and obviousness grounds in its petition filed on August 29, 2017, in IPR2017-02020. Like in IPR2018-00330, discussed above, the Board exercised its discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d). Here, like in IPR2018-00330, Pfizer did not address the General Plastic factors. The Board found Genentech’s request to deny institution under § 314(a) “well-reasoned and persuasive.” Similarly, Pfizer failed to assert a reason why the Board should deny institution under § 325(d).
Pfizer, Inc. v. Biogen, Inc., No. IPR2018-00285 (Decision Entered July 9, 2018). In ground 1 of its petition, Pfizer challenged claim 1 of U.S. Patent No. 8,329,172 (“the ’172 patent”) as obvious based on the Hochster I, Maloney, and McNeil references. In ground 2, Pfizer challenged claim 1 of the ’172 patent as obvious over a combination of Hochster I, the Rituxan label, and McNeil. The claim at issue relates to a method of treatment for patients with low grade B-cell non-Hodgkin’s lymphoma (LG-NHL), comprising the steps of administering “chemotherapy consisting of CVP therapy to which the patient responds, followed by rituximab maintenance therapy, wherein the maintenance therapy comprises four weekly administrations of rituximab at a dose of 375 mg/m2 every 6 months” for two years. The Board instituted inter partes review, observing that “[t]he fact that a safe and effective maintenance dosing regimen had not been conclusively identified in the prior art does not demand a conclusion of nonobviousness[.]” The Board also held that Pfizer provided sufficient information to support a reasonable likelihood of success in showing that one of skill in the art would have been motivated to use with a reasonable expectation of success (i) selecting rituximab as an anti-CD20 agent in the maintenance therapy method of Hochster I, and (ii) using a “known, FDA-approved dosing regimen for rituximab (disclosed in Maloney or Rituxan Label), at the frequency and duration suggested for rituximab maintenance therapy as disclosed in McNeil.” The Board acknowledged Biogen’s arguments that there would be a certain degree of unpredictability establishing maintenance therapy, and that there existed differences between the scope and content of the prior art and the claims (e.g., McNeil involved elderly patients suffering from intermediate-grade NHL and the present claim is directed to a method of treatment for patients with LG-NHL). The Board concluded that even in light of Biogen’s arguments, Pfizer offered sufficient evidence to demonstrate a reasonable likelihood of success. The Board declined Biogen’s request to deny institution under 35 U.S.C. § 325(d) because Pfizer presented new arguments regarding Hochster I not previously considered by the Board. The Board also declined Biogen’s request to deny institution under 35 U.S.C. § 314(a) because in a previous decision challenging the ’172 patent, the Board, in a divided panel, concluded that the petitioner failed to establish that the Rituxan Label was publicly accessible and denied institution. In that decision, the Board did not conduct claim construction, “[t]herefore, the particular facts of this case do not present a situation in which Petitioner is ‘using our decisions as a roadmap’ regarding those issues.” Accordingly, the Board instituted inter partes review.
Apotex Inc. v. Novartis AG, No. IPR2017-00854 (Final Written Decision Entered July 11, 2018). In the petition, Apotex Inc. and Apotex Corp., Argentum Pharmaceuticals LLC, Actavis Elizabeth LLC, Teva Pharmaceuticals USA, Inc., Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., and Sun Pharma Global FZE (collectively “Petitioner”) challenged claims 1¬–6 of U.S. Patent No. 9,187,405 (“the ’405 patent”) on two grounds of obviousness based on the references of (i) Kovarik and Thomson, and (ii) Chiba, Kappos 2005, and Budde, and on an anticipation ground based on the reference of Kappos 2010. The ’405 patent relates to “the use of an S1P receptor modulator in the treatment or prevention of neo-angiogenesis associated with a demyelinating disease, e.g. multiple sclerosis.” The three independent claims at issue relate to methods of “treating,” “reducing or preventing or alleviating relapses,” or “slowing progression” of “Relapsing-Remitting multiple sclerosis [RR-MS] in a subject” by orally administering 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1, 3-diol (fingolimod) in free form or as a pharmaceutically acceptable salt. The three dependent claims at issue “specify that the 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1, 3-diol is the hydrochloride salt form—i.e., fingolimod hydrochloride.”
With respect to ground 1, the Board credited Patent Owner’s argument that Kovarik was insufficient to link treating RR-MS to administering a 0.5 mg daily dose of fingolimod because Kovarik relates to loading dose rates and ratios which are expressly excluded from the challenged claims. Similarly, the Board agreed that Thomson failed to teach or suggest the claimed 0.5 mg daily dose would be effective at treating RR-MS because Thomson disclosed the drug effectively treats RR-MS at 1.25 and 5 mg daily doses. Accordingly, the Board found that Petitioner did not show by a preponderance of the evidence that claims 1–6 would have been obvious based on the combination of Kovarik and Thomson. Regarding ground 2, the Board rejected Petitioner’s argument that claims 1–6 would have been obvious because (i) Chiba teaches treating MS by orally administering fingolimod hydrochloride, (ii) Kappos 2005 confirms the drug’s utility in RR-MS patients, and (iii) Budde confirms the efficacy of a 0.5 mg daily dose. Patent Owner argued that prior art references Webb, Kahan 2003, and the Park references taught away from the claimed dosing regimen. In light of all the evidence, the Board concluded that Patent Owner established that the prior art taught away from Petitioner’s proposed combination. As such, Petitioner failed to demonstrate by a preponderance of the evidence that claims 1–6 would have been obvious.
Petitioner also argued that claims 1–6 were anticipated by Kappos 2010. Patent Owner did not dispute that Kappos 2010 discloses each element of the challenged claims, but instead argued that Petitioner’s anticipation argument was “a ruse to unlawfully smuggle a 112 written description argument into an IPR” and that Kappos 2010 is not prior art. The Board rejected Patent Owner’s first argument that Petitioner’s anticipation argument was an attempt to subvert 35 U.S.C. § 311(b) and “smuggle” in a written description argument. However, the Board rejected Petitioner’s argument that Kappos 2010 was prior art because—contrary to Petitioner’s assertion—the Board found the claims at issue had written description support in an earlier application. The Board concluded that Petitioner failed to demonstrate by a preponderance of the evidence that Kappos 2010 qualified as anticipatory prior art.
Accordingly, in its Final Written Decision, the Board determined Petitioner failed to demonstrate that claims 1–6 are unpatentable.
During the week of July 16, the Patent Trial and Appeal Board (“the Board”) issued one decision in Technology Center 1600. A summary of the decision follows:
Initiative for Medicines, Access & Knowledge (“I-MAK”), Inc. v. Gilead Pharmasset LLC (“Gilead”), IPR2018-00390 (Decision Denying Institution Entered July 19, 2018): The Board denied institution in the final of ten inter partes review petitions filed by I-MAK since October 2017, challenging claims in eight separate patents owned by Gilead. All but one of the eight challenged patents were listed in the Orange Book as covering one or a combination of SOVALDI®, HARVONI®, EPCLUSA®, and VOSEVI®, approved for the treatment of hepatitis C. See Summary Table.
In the current Petition, I-MAK challenged claims 1-37 of U.S. Patent No. 8,889,159 (“the ’159 patent”) on anticipation and obviousness grounds. The ’159 patent is directed to a pharmaceutical composition and unit dosage form of a specific agent, also known as “sofosbuvir,” for treating hepatitis C virus. Specifically, the ’159 patent discloses a polymorphic form of sofosbuvir identified as “Form 6.”
While the Board agreed with I-MAK that a cited reference disclosed Form 6 of sofosbuvir, they disagreed that the mere fact that the range of active compound specified in the independent claim (“about 25% to about 35% w/w”) fell within the range disclosed in the cited reference (“about 5% to about 95% w/w”) showed sufficiently that the reference anticipated the narrower claimed range. The Board agreed that the I-MAK failed to address, much less show sufficiently, how or why a person of ordinary skill in the art would ‘at once envisage’ the claimed formulation of Form 6. Accordingly, the Board found I-MAK failed to show the cited reference anticipated the narrower range required by the claimed invention. Because the Board determined that the Petition did not provide a separate analysis of the obviousness challenge, but rather asserted in a conclusory fashion as part of the anticipation challenge, the Board held that I-MAK was not reasonably likely to prevail at trial to show that the claimed subject matter would have been obvious to an ordinarily skilled artisan based on the disclosure in the cited reference.
I-MAK also cited a second reference that had been cited during prosecution of the ’159 patent. Gilead acknowledged that the claims had been amended to recite the polymorphic Form 6 of sofosbuvir in order to overcome an obviousness rejection. The Board agreed with Gilead that a question arises whether it is unnecessary and wasteful to re-adjudicate issues that were previously fully considered and expressly decided upon by the Office and determined that I-MAK had failed to show a reasonable likelihood of prevailing that the claims at issue would be unpatentable as either anticipated or obvious in view of the second reference.
The Board therefore denied the Petition and did not institute inter partes review.
The Patent Trial and Appeal Board issued one decision in TC 1600, which denied institution of an IPR. The petition was filed by Argentum Pharmaceuticals LLC (“Argentum”) against Merck Patentgesellschaft (“Merck”). The decision is as follows:
Argentum Pharms. LLC v. Merck Patentgesellschaft, No. IPR2018-00423 (Decision Entered July 23, 2018): In this Petition, Argentum challenged US Patent No. 8,673,921 (“the ’921 patent”) as anticipated by the Böttcher reference and obvious in view of the Böttcher, Bartoszyk, Pavia, and Byrn references. Merck filed a preliminary response to the Petition. The ’921 patent relates to polymorphic forms of vilazodone hydrochloride (VHCl), which is the active ingredient of antidepressant VIIBRYD®. The claims at issue recite a crystalline modification of VHCl or a specific crystalline form of VHCl anhydrate (Form IV).
The Board exercised its discretion to deny the Petition under 35 U.S.C. § 325(d) because the same or substantially the same prior art or arguments were previously presented to the Office. Among the four references cited by Argentum, Böttcher was identified in the prosecution as the closest prior art; Bartoszyk was referenced in the background section of the ’921 patent; and Pavia and Byrn are excerpt from textbook related to routine crystallization technique at the time of the invention and were not before the Examiner. Argentum asserted that the Examiner erred in evaluating Böttcher due to a failure to identify a specific example in Böttcher as the closest prior art, which discloses a mixture of crystallized VHCl, amorphous VHCl, and vilazodone free base. The Board disagreed and found that because the Examiner already identified Böttcher as the closet prior art, it is not necessary for the Examiner to narrow “the closest prior art” to the specific example in Böttcher. The Board found Bartoszyk cumulative or substantially cumulative to Böttcher because Argentum failed to identify any material differences between Bartoszyk and Böttcher. Thus, the fact that Bartoszyk was not cited in any office action rejection or discussed in the Notice of Allowability of the ’921 patent did not mean that Bartoszyk was not before and considered by the Examiner. The Board found Pavia and Byrn cumulative or substantially cumulative to Böttcher because Argentum failed to show that the Examiner would not have been aware of the textbook crystallization techniques disclosed by Pavia and Byrn. Finally, to support its obviousness arguments, Argentum presented experimental data showing that routine recrystallization of a present-day commercial VHCl could result in the claimed Form 4, and alleged that the use of the present-day commercial VHCl rather than the VHCl mixture disclosed in Böttcher would not likely result in different recrystallization outcomes. The Board agreed with Merck and found Argentum’s effort to create the claimed Form IV from the present-day commercial VHCl 16 years after the filing of the ’921 patent involved improper hindsight and did not warrant reconsideration of the art that was before and considered by the Examiner.
The Board issued three decisions in TC 1600 during the week of July 30, all denying institution of inter partes review. Summaries of the decisions follow.
Envirologix Inc. (“Envirologix”) v. Ionian Techs., Inc. (“Ionian”), IPR2018-00405 and Envirologix v. Ionian, IPR2018-00406 (Decisions Denying Institution, Entered July 30, 2018). Envirologix submitted two Petitions, challenging claims 1-8 and 10-35 of U.S. Patent No. 9,562,263 (“the ’263 patent) and claims 1-6 and 8-29 of U.S. Patent No. 9,562,264 (“the ’264 patent). Each of the two Petitions included three grounds of anticipation by three primary references (“Ehses,” the “Ehses Dissertation,” and “Piepenburg”), and five grounds of obviousness. Ionian filed a preliminary response. Both challenged patents relate to methods for amplifying a target polynucleotide sequence using a nicking enzyme. The sole independent claims of the ’263 and the ’264 patents are illustrative of such methods, both of which require the following dispositive limitations:
- “without first subjecting [a] target nucleic acid to a thermal denaturation step associated with amplification of the target polynucleotide sequence”;
- an “amplification reagent mixture” that includes, among other things, “a first oligonucleotide comprising a 5′ portion that comprises a nicking binding site that is non-complementary to the target nucleotide sequence and a 3′ portion that hybridizes to the target polynucleotide sequence” and “a second oligonucleotide comprising a 5′ portion that comprises a nicking binding site that is non-complementary to the target nucleotide sequence and a 3′ portion that hybridizes to the target polynucleotide sequence” (the “first and second oligonucleotide” limitations); and
- “detecting the amplified target polynucleotide sequence in real time within 10 minutes of subjecting the reaction mixture to essentially isothermal conditions”
In virtually identical decisions, the Board denied institution based on the three anticipation grounds asserted in both of Envirologix’s Petitions. First, the Board denied institution based on anticipation by the Ehses reference because the Ehses does not teach steps of omitting a thermal denaturation or detecting the amplified target polynucleotide sequence within 10 minutes.
Turning to the Ehses Dissertation, Envirologix relied on the date of the oral dissertation defense—August 7, 2005—to establish that the dissertation qualifies as prior art as a printed publication. The date of an oral dissertation defense, however, was not sufficient to establish that the dissertation was made publicly accessible as of that date. Without any additional evidence regarding the public availability of the Ehses Dissertation, the Board determined that Envirologix failed to make a threshold showing that the reference qualified as a printed publication and consequently declined to institute inter partes review based on the Ehses Dissertation.
The Board also denied institution based on anticipation by Piepenburg because Piepenburg lacks disclosure of an amplification reagent mixture that requires both a first and a second oligonucleotide, and lacks a step of detecting the amplified target polynucleotide sequence within 10 minutes.
Finally, having found that the challenged claims are not anticipated by Ehses, the Ehses Dissertation, or Piepenburg, the Board declined to institute Envirologix’s five obviousness grounds because none of the alleged prior art combinations remedy the deficiencies with respect to the anticipation grounds.
Pfizer, Inc. v. Genentech, Inc., IPR2018-00373 (Decision Denying Institution, Entered August 2, 2018). In its petition, Pfizer challenged claims 1-18 of U.S. Patent No. 9,795,672 (“the ’672 patent”) on seven grounds based on anticipation and/or obviousness by four primary references: Kabbinavar, Chen, Yang, and Patent Application Publication No. WO01/74360 to Curwen et al. (“PCT’360”). Genentech filed a preliminary response. The ’672 patent relates to methods for treating cancer in a patient who has hypertension as a result from treatment with bevacizumab—a humanized anti-VEGF antibody known as “rhuMAb VEGF” or “Avastin™.” The claimed methods require steps of “administering to a patient an effective amount of bevacizumab, wherein the patient has a grade III hypertensive event resulting from the bevacizumab administration” and “administering to the patient an antihypertensive agent in an amount sufficient to manage the grade III hypertensive event while continuing bevacizumab treatment being carried out without altering the dosage regimen.”
In its decision construing the claims, the Board agreed with Pfizer that “a grade III hypertensive event” should be construed according to the National Cancer Institute’s Common Toxicity Criteria to mean “hypertension requiring therapy or more intensive therapy than previously administered.” But the Board’s agreement with Pfizer ended at claim construction.
First, the Board denied institution of the two grounds related to the Yang reference because Pfizer failed to establish Yang was available as prior art for the challenged claims. The ’672 patent claims priority to a provisional patent application filed on May 30, 2003—two months before Yang’s publication date of July 31, 2003. In its Petition, Pfizer argued that the ’672 patent was not entitled to the May 30, 2003, priority date because the claims lacked written description support in the provisional application. The Board disagreed, finding that Genentech provided relevant written description support for the challenged claims in the provisional application that Pfizer had failed to address. Having found that the ’672 patent claims are entitled to the priority date of the provisional application, the Board concluded that Yang did not qualify as prior art and declined to institute an inter partes review based on that reference.
Next, the Board exercised its discretion under 35 U.S.C. § 325(d) to deny institution of the three grounds related to Kabbinavar and Chen. Pfizer acknowledged that both Kabbinavar and Chen were considered by the Examiner during prosecution, but urged the Board to reconsider both references because the Examiner had not considered Pfizer’s argument that the ’672 patent is not entitled to the May 2003 priority date, and because Kabbinavar “was only avoided by an In re Katz declaration insufficient in this proceeding.” Pfizer did not address why the Board should ignore the fact that Chen was already considered during prosecution. Citing its decision regarding the provisional application as it related to the Yang reference, and Pfizer’s failure to address Chen, the Board exercised its discretion under section 325(d) and declined to consider grounds based upon Kabbinavar and Chen that had already been considered by the Patent Office.
Finally, the Board considered the last two grounds based on the PCT’360 reference. The PCT’360 reference was directed to therapeutic combinations of antihypertensive and antiangiogenic agents that may be beneficial in several diseases associated with angiogenesis, including cancer. Among the numerous antiangiogenic agents disclosed by PCT’360 is an anti-VEGF antibody—but the only relevant experimental results related to treatment using a small-molecule VEGF receptor tyrosine kinase inhibitor. Pfizer argued that the challenged claims would have been obvious in view of the drug combinations disclosed in PCT’360, further combined with standard clinical practice and a secondary reference, Presta. Siding with Genentech, the Board recognized that although PCT’360 included an anti-VEGF antibody in the laundry list of potential anti-angiogenic agents, Pfizer failed to demonstrate that one skilled in the art would have reasonably expected the teaching and experimental results related to the VEGF receptor tyrosine kinase inhibitor in PCT’360 to apply to an anti-VEGF receptor antibody like bevacizumab. Placing the final nail in the coffin for Pfizer’s challenge to the ’672 patent, the Board therefore declined to institute inter partes review for the grounds based on PCT’360.