During the week of October 29, 2018, the Board issued three decisions in Technology Center 1600: one Final Written Decision and two institution decisions. The decisions are summarized as follows:
Pfizer, Inc. v. Biogen, Inc., IPR2017-01168 (Final Written Decision, October 31, 2018). Petitioner Pfizer challenged the patentability of claims 1-5 of U.S. Patent No. 8,821,873 (the ’873 patent) as being obvious over Moreau, Link, McNeil, Maloney, and Coiffier. The Board found the challenged claims unpatentable.
The ’873 patent relates to methods for treating a patient who is older than 60 and has diffuse large cell lymphoma (DLCL). The claimed treatment includes administration of CHOP chemotherapy and a chimeric anti-CD20 antibody (e.g., rituximab), wherein the antibody is administered in combination with stem cell transplantation. The Board found the broadest reasonable construction of the claim phrase directed to administering rituximab “in combination with stem cell transplantation” means that rituximab may be administered at any time “during bone marrow or stem cell transplant for the purpose of improving the survival rate of transplant recipients.” Thus, the Board agreed with Pfizer that the claimed method encompasses an administration of rituximab at the induction of CHOP chemotherapy but before the actual collecting or transplanting of stem cells.
The Board found that Pfizer established by a preponderance of the evidence that a POSITA would have had a reasonable expectation of success carrying out the claimed treatment by modifying the method disclosed in Moreau. Moreau taught an effective and tolerable method of treating patients over the age of 60 with DLCL by administering CHOP at the induction stage of the stem cell transplant and again after stem cell collection. And a POSITA would have understood from the teachings of the other references that an alternative to CHOP in elderly patients may be CHOP plus rituximab. The CHOP-rituximab combination may provide an increased response and significant anti-lymphoma activity in DLCL patients without impairing their bone narrow reserves. Thus, a POSITA would have understood the CHOP-rituximab combination to be a well-tolerated and effective treatment, especially for elderly patients who are known to have larger risk of toxicity.
Accordingly, the cited references not only provided motivation for combining rituximab with Moreau’s method, but also supported a POSITA’s reasonable expectation of success in the CHOP-rituximab combination treatment. Accordingly, the Board found all challenged claims unpatentable as obvious.
Grünenthal GMBH v. Antecip Bioventures Ii LLC, PGR2018-00062 (Decision Instituting Post-Grant Review, October 30, 2018). Petitioner Grünenthal challenged claims of U.S. Patent No. 9,707,245 (the ’245 patent). Patent Owner Antecip did not file a preliminary response. The Board found that Petitioner demonstrated that it is more likely than not that 1) claims 1-4, 9, 10, 12, 14, 16-18, 23, 24, and 27-29 are anticipated by Varenna published in 2012 (Varenna 2012); and 2) claims 1-30 are obvious over Varenna 2012 alone or in combination with one or more other references. Thus, the Board instituted a post grant review. The Board was not persuaded that Petitioner was likely to prevail on asserted written description or enablement grounds.
The challenged claims relate to a method for treating pain associated with complex regional pain syndrome (CRPS) using a salt or acid form of neridronic acid, wherein bone fracture is a predisposing event for CRPS. The challenged claims were allowed after Patent Owner submitted data published in 2016 (Varenna 2016) that demonstrated patients “with fractures as the predisposing factor” exhibited a response to neridronic acid that “was superior” to the response in patients “with other pre-disposing factors.”
The Board agreed with Petitioner that the earlier-published Varenna 2012 showed that neridronate effectively mitigated pain in CRPS patients having bone “fracture” as a “[p]recipitating event” for CRPS. Furthermore, the Board agreed with Petitioner that Varenna 2012 disclosed that “the particular type of precipitating event did not influence outcomes in the study, indicating that patients with all types of precipitating events, including fractures, benefited from the neridronate treatment.”
For similar reasons, the Board also concluded that claim 1 would have been obvious over the disclosure of Varenna 2012 alone or in combination with Bruehl, Gatti, La Montague, and Muratore because the cited references would have led a POSITA to reasonably expect effectiveness of the claimed method. In particular, bone fracture was recognized as one of the most common triggering events for CRPS, neridronic acid was known to effectively treat CRPS pain generally, and Varenna 2012 suggested that neridronate would successfully relieve pain in patients presenting with fracture-induced CRPS.
The Board rejected, however, Petitioner’s challenges based on lack of written description support and enablement. The Board found that the specification of the ’245 patent described suitable dosing regimens, and the disclosure of Varenna 2012 would have informed an ordinary artisan how to administer neridronic acid with an expectation of mitigating pain associated with fracture-induced CRPS.
Celltrion, Inc. v. Genentech, Inc., IPR2018-01019 (Decision Instituting Inter Partes Review and Granting Motion for Joinder, October 30, 2018). Petitioner Celltrion challenged claims 1-14 of U.S. Patent No. 7,976,838 (“the ’838 patent”) and filed a motion for joinder to join this proceeding to IPR2017-01923 filed by Pfizer, Inc. (Pfizer IPR).
The Pfizer IPR was already instituted and pending before the Board. Patent Owner Genentech filed a preliminary response to Celltrion’s petition and an opposition to the motion for joinder. Because Celltrion’s petition was concededly a “copycat” of the instituted petition in the Pfizer IPR, the Board concluded that Celltrion demonstrated a reasonable likelihood that it would prevail on Celltrion’s petition.
The Board rejected Genentech’s arguments that the Board should exercise discretionary authority under 35 U.S.C. § 314(a) to deny institution based on a follow-on petition on the same patent. The Board also rejected Genentech’s arguments that the Board should deny review because Celltrion previously had filed two petitions challenging the ’838 patent (Celltrion voluntarily dismissed the first, and the second was denied). The Board concluded that instituting an inter partes review on Celltrion’s petition would not unduly prejudice Genentech, in substantial part because Celltrion sought to join with the already-granted Pfizer IPR. In addition, because Celltrion represented that it would play an “understudy” role when joined with the Pfizer petition, the Board concluded that joinder would not unduly burden or interfere with the Pfizer IPR. Finally, even if Pfizer and Genentech were to settle their dispute and seek to terminate the Pfizer IPR, the Board found that granting Celltrion’s petition would not result in undue prejudice against Genentech because: 1) the Board may enter a decision even after the petitioner settles and drops out of the proceeding; and 2) Celltrion cannot “strategically stage their prior art and arguments in multiple petitions, using our decisions [in Pfizer IPR] as a roadmap,” since once joined, this case will be on the same schedule as Pfizer IPR for all the filings and oral hearing.
Accordingly, the Board granted Celltrion’s petition to institute an inter partes review of claims 1-14 of the ’838 patent on all grounds. The Board also granted Celltrion’s motion for joinder and joined Celltrion as a petitioner in the Pfizer IPR. The Board ordered Celltrion to play an “understudy” role with respect to Pfizer in Pfizer IPR.
During the week of November 5, 2018, the Board issued one decision granting institution of inter partes review.
Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited, IPR2018-00943 (Decision Granting Institution of IPR November 7, 2018). Petitioner Amneal challenged the patentability of claims 1-13 of United States Patent No. 7,919,499 (“the ᾽499 patent”) on two grounds of anticipation and four grounds of obviousness. IPR2018-00953 at 4. The ᾽499 patent is directed to methods for treating alcohol-dependent patients with a long-acting formulation of naltrexone. Id. at 3. Claim 1 includes a step of administering “a long acting formulation comprising about 310 mg to about 480 mg of naltrexone and a biocompatible polymer” in which “the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration.” Id. at 4-5.
Petitioner asserted two anticipation grounds: anticipation of claims 1, 3-5, and 10-12 by Comer as evidenced by Nuwayser and anticipation of claims 1, 3-5, 11, and 12 by Nuwayser. The Board found a reasonable likelihood of success that Petitioner would prevail on its asserted ground of anticipation by Comer, as evidenced by Nuwayser, because Comer teaches, either explicitly or inherently, every limitation of claim 1. Id. at 20-21. The Board disagreed with Patent Owner that Petitioner’s anticipation ground was improper because it relies on multiple references (i.e., Comer as evidenced by Nuwayser). Instead, the Board found that Nuwayser evidenced what a skilled artisan would have understood Comer’s reference to a specific drug to have meant; Nuwayser was not supplementing missing limitations in Comer. Id. at 23. The Board also questioned whether certain dependent claims were properly challenged as anticipated. However, in view of SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018), the Board also instituted claims 3-5 and 10-12 as anticipated by Comer, as evidenced by Nuwayser. Id. at 25. Regarding the second ground of anticipation, the Board expressed “concern” with Petitioner’s “circular logic” to support its anticipation claim in view of Nuwayser alone, but nevertheless instituted IPR in view of SAS. Id. at 27.
Petitioner also asserted four obviousness grounds for claims 1-13 using different combinations of prior art references including Comer, Nuwayser, Rubio, Wright, Kranzler, Alkermes 10-K, and Vivitrex Specimen. Id. at 6. As the first two grounds included both Comer and Nuwayser, the Board found a reasonable likelihood of success that Petitioner would prevail with respect to showing that claims 1-13 are unpatentable over the two combinations. Id. at 33.
Regarding the last two obviousness grounds, the Board found that Petitioner failed to establish a reasonable likelihood of success that Petitioner would prevail on either asserted ground. Id. at 33 and 35. In particular, the Board found that Petitioner failed to show Alkermes 10-K qualifies as a printed publication because Petitioner did not demonstrate that a skilled artisan interested in preparing long-acting naltrexone formulations “would have known to locate the Alkermes 10-K.” Id. at 37. The Board also dismissed Petitioner’s reason to combine the Alkermes 10-K with Vivitrex Specimen, a trademark application for the drug Vivitrex. The Board found that Petitioner’s argument that a skilled artisan looking at the Alkermes 10-K reference would take a step to determine what trademark was pending to see what information was covered by the trademarked product “seems to us both haphazard and tenuous.” Id. at 38. Nevertheless, in view of SAS, the Board instituted IPR of all challenged claims. Id. at 34 and 38.
During the week of November 26, 2018, the Patent Trial and Appeal Board (“the Board”) issued seven decisions in TC 1600, one denying institution of inter partes review (“IPR”), one termination decision, and five final written decisions. Summaries of the decisions follow:
Willowood USA, LLC (“Willowood”) v. BASF SE (“BASF”), IPR2018-01096 (Decision Denying Institution Entered November 29, 2018).
In its petition, Willowood challenged claims 1-17 of U.S. Patent No. 7,816,392 (“the ’392 patent”), which is directed to novel crystalline modifications of pyraclostrobin, preparation processes, and to their use for preparing compositions for crop protection.
Willowood challenged the claims as anticipated by Australian Pesticides and Veterinary Medicines Authority (“APR”) and obvious based on APR and references by Vogel and Beckmann. As an initial matter, the Board construed the claim term “crystalline modification IV of pyraclostrobin” to be:
a crystalline structure of pyraclostrobin having a specific X-ray diffraction pattern at 25°C showing at least three of the following reflexes: d=6.02 ± 0.01 Å, d=4.78 ± 0.01 Å, d=4.01 ± 0.01 Å, d=3.55 ± 0.01 Å, d=3.01 ± 0.01 Å and a heat of fusion of about 72 to 78 J/g.
The Board declined to include melting point language, as reasoned by Willowood, when construing the relevant claims. The Board was further not persuaded by Willowood’s argument that APR necessarily disclosed the claimed crystalline polymorph in part because references cited by BASF supported that melting point alone is insufficient evidence of the crystalline structure, including art authored by and seemingly contradicting Willowood’s own technical expert. Because the Board concluded that, at best, the pyraclostrobin disclosed in APR may be the claimed crystalline polymorph, there was insufficient evidence to establish inherency. The Board further held that Vogel and Beckmann failed to resolve the deficiencies of APR and therefore Willowood had not demonstrated a reasonable likelihood the challenged claim would have been obvious over the cited references. As such, the Board denied institution of inter partes review of the ’392 patent.
Micro Labs Limited and Micro Labs USA Inc. (“Micro Labs”) v. Santen Pharmaceuticals Co., Ltd. and Asahi Glass Co., Ltd. (“Santen”), IPR2017-01434 (Termination Decision with Respect to Petitioner and Final Written Decision Entered November 27, 2018).
In its petition, Micro Labs challenged claims 1-14 of U.S. Patent No. 5,886,035 (“the ’035 patent”), directed to fluorine-containing prostaglandin derivatives and salts thereof and their use in treating or preventing eye diseases.
Two days prior to the statutory deadline for filing a final written decision, the parties reached a settlement agreement and filed a joint motion to terminate the proceedings and a joint request that the settlement agreement be kept confidential, which the Board granted-in-part and granted, respectively. In light of the advanced stage of the proceeding, the Board proceeded to a final written decision, terminating the proceeding with respect to Micro Labs, but not with respect to Santen. See Paper 52 of IPR2017-01434.
Micro Labs challenged claims 1-14 of the ’035 patent as obvious over the combined teachings of: (1) Klimko, Kishi, and Ueno and/or (2) Klimko, Kishi, Bezuglov 1982 and/or Bezuglov 1986, and Ueno. The challenged claims are directed to fluorine-containing prostaglandin derivatives having two fluorine atoms at the 15-position, or salts thereof, and medicines containing the compounds as the active ingredient. In particular, the compound 16-phenoxy-15-deoxy-15,15-difluoro-17,18,19,20-tetranorprostaglandin F2α (“tafluprost”) was the focus of the petition. Tafluprost and the other claimed derivatives are considered superior to known naturally occurring prostaglandins for long lasting effects of lowering intraocular pressure, while mitigating irritation to the eyes.
Micro Labs argued that it would have been obvious to start with “Compound C” of Klimko, to recognize the hydroxyl group at the C-15 position as the cause of negative side effects, and to replace the hydroxyl with two fluorine atoms to arrive at the claimed compound, tafluprost. See figure below, from page 17 of Paper 52, the Final Written Decision. 
The Board agreed with Santen that even if one of skill in the art selected Compound C, Micro Labs failed to show the prior art suggested making the required modifications to arrive at tafluprost. Santen also argued that the view in the art at the time of the invention was, in fact, that the C-15 position was particularly important for allowing the reduction in intraocular pressure. Thus, the Board concluded that even if one were motivated to remove the C-15 hydroxyl group from Compound C, Micro Labs had not presented sufficient support to conclude one would have also been motivated to difluorinate the C-15 position with a reasonable expectation of success at retaining the intraocular pressure effects.
The Board found that Micro Labs “attempt[ed] to imbue one of ordinary skill in the art with knowledge of tafluprost and its properties, when no prior art reference, references of record, or other evidence conveys or suggests that knowledge” and that the “proposed rationale relies upon general and conclusory statements from [the expert].” See page 34 of Paper 52, the Final Written Opinion.
As such, the Board concluded that Micro Labs failed to demonstrate by a preponderance of the evidence that claims 1-14 the ’035 patent would have been obvious.
Pfizer, Inc. (“Pfizer”) v. Chugai Pharmaceutical Co. Ltd. (“Chugai”), IPR2017-01358 (Final Written Decision Entered November 28, 2018).
In its petition, Pfizer challenged claims 1-7, 12, and 13 of U.S. Patent No. 7,927,815 (“the ’815 patent”), which is directed to protein purification methods, specifically methods for removing contaminant DNA in a sample using an acidic aqueous solution of low conductivity and neutralizing the resulting sample by adjusting the pH to a neutral level.
Independent claim 1 is representative and recites:
A method for removing contaminant DNA in a sample containing a physiologically active protein, which comprises the following steps:
1) converting the sample containing a physiologically active protein into an acidic aqueous solution of low conductivity of 300 mS/m or less and having a molarity of 100 mM or less at pH of 1.5 to 3.9;
2) adjusting the pH of the resulting sample from step (1) to pH of 4 to 8 to form particles, wherein the molarity of the adjusted sample is 100 mM or less; and
3) removing the particles thereby to remove contaminant DNA in the sample.
The claims were challenged on one ground of anticipation and one ground of obviousness over Shadle. At the outset, and despite Pfizer’s assertion otherwise in its petition and at oral argument, the claim term “molarity” was interpreted as the “the total concentration of solute present in the solution,” rather than the concentration of one particular solute.
The Board found that because Pfizer did not account for the contribution to the molarity of the eluate of any solute other than citrate, as required under the Board’s interpretation of the term “molarity,” Pfizer’s arguments as to any express or inherent teachings of Shadle were unpersuasive. Notably, the Board pointed out that in IPR proceedings, unlike district court litigation, parties have an obligation to make their case in their petition and to show with particularity why the challenged claims are unpatentable. As such, the Board held Pfizer’s inherency arguments, absent from the petition, to be impermissible and even if timely, insufficient to support a finding of anticipation.
The Board also found that Pfizer’s petition and subsequent reply addressed obviousness with mere conclusory assertions. In view of these deficiencies, the Board held Pfizer had not established, by a preponderance of the evidence, that the challenged claims would have been obvious in view of Shadle.
As such, the Board concluded that Pfizer failed to demonstrate by a preponderance of the evidence that claims 1-7, 12, and 13 of the ’815 patent were unpatentable.
Pfizer, Inc. (“Pfizer”) v. Chugai Pharmaceutical Co. Ltd. (“Chugai”), IPR2017-01357 (Final Written Decision Entered November 28, 2018).
In its petition, Pfizer challenged claims 1-8 and 13 of U.S. Patent No. 7,332,289 (“the ’289 patent”), which is directed to protein purification methods, specifically methods for removing contaminant DNA in an antibody-containing sample using an acidic aqueous solution of low conductivity and neutralizing the resulting sample by adjusting the pH to a neutral level.
Independent claim 1 is representative and recites:
A method for removing contaminant DNA in an antibody-containing sample, which comprises the followings steps:
1) applying the antibody-containing sample to affinity chromatography on Protein A or Protein G;
2) eluting the antibody with an acidic aqueous solution of low conductivity having a molarity of 100 mM or less;
3) neutralizing the eluate from step (2) to form particles by addition of a buffer to raise the pH to 4 to 8, wherein the molarity of the neutralized eluate is 100 mM or less; and
4) removing the particles to thereby remove contaminant DNA from the antibody-containing sample.
The claims were challenged on one ground of anticipation and one ground of obviousness over Shadle. At the outset, and despite Pfizer’s assertion otherwise in its petition and at oral argument, the claim term “molarity” was interpreted as the “the total concentration of solute present in the solution,” rather than the concentration of one particular solute.
The Board found, for reasons nearly identical to those discussed above regarding IPR2017-01358, Pfizer’s inherency arguments, absent from the petition, to be impermissible and even if timely, insufficient to support a finding of anticipation. Similarly, the Board found that Pfizer’s petition and subsequent reply addressed obviousness with mere conclusory assertions. In view of these deficiencies, the Board held Pfizer had not established, by a preponderance of the evidence, that the challenged claims would have been obvious in view of Shadle.
As such, the Board concluded that Pfizer failed to demonstrate by a preponderance of the evidence that claims 1-8 and 13 of the ’289 patent were unpatentable.
Celltrion, Inc. (“Celltrion”) v. Genentech, Inc. (“Genentech”), IPR2017-01374 (Final Written Decision Entered November 29, 2018).
In its petition, Celltrion challenged claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of U.S. Patent No. 6,407,213 (“the ’213 patent”), which is directed to methods for the preparation and use of variant antibodies, in particular, for use in immunology and cancer. The ’213 patent provides methods for rationalizing the selection of substitution sites for deriving humanized antibodies having increased efficacy. Notably, the ’213 patent is the subject of nine IPR proceedings, five of which are currently pending. The claims were challenged under two novelty and six obviousness grounds.
At the outset, Genentech convinced the Board that two of the cited references did not qualify as prior art under § 102(b) as to certain claims that were determined to have a priority date less than one year before the publication dates of the references. In addition, the Board was not persuaded by Celltrion’s arguments regarding the credibility of the inventor’s testimony or insufficient evidence of corroboration. As such, the Board concluded that Genentech had sufficiently demonstrated reduction to practice of two humanized antibodies prior to the publication of two of the cited references and therefore held that Celltrion had failed to establish any of claims 12, 42, 60, 65, 71, 72-77, and 79 were unpatentable.
Second, Genentech expressly waived its defenses with respect to claims 1, 2, 25, 29, 80, and 81. In view thereof, the Board interpreted such decision as a request for adverse judgment as to those claims or, in the alternative, held the those claims unpatentable as anticipated and obvious in view of the cited references.
The Board then held claims 63, 66, 72, and 78 to be anticipated by a prior art reference that inherently arrived at the claimed invention, particularly the substitutions of residues within the Markush groups of the challenged claims. However, claims 75 and 76 were found to not be anticipated because they require at least two substitutions and the art provided little guidance as to which substitutions to use, which would have amounted to improper picking and choosing. The Board further held that a second reference taught each and every element, in particular, the “consensus human variable domain,” limitation of claims 4, 62, and 64.
The Board further agreed with Celltrion that an ordinary artisan would have had reason to combine the teachings of the prior art references, to choose framework region substitutions having improved binding to arrive at the claimed invention, and that these would have been routine optimization for one of skill in the art. Genentech also argued the claims were not obvious based on evidence of unexpected results and commercial success. However, the Board determined Genentech had not provided adequate evidence that was commensurate in scope with the breadth of the challenged claims. Even with respect to claims 30, 31, and 33, which were determined to embody Herceptin®, on balance the Board concluded Celltrion had demonstrated by preponderance of the evidence that claims 30, 31, and 33 were obvious over the cited references.
In sum, the Board found Celltrion had demonstrated by a preponderance of the evidence that claims 1, 2, 4, 25, 29, 30, 31, 33, 62-64, 66, 67, 69, 72, 78, 80, and 81 were unpatentable, but did not make the required showing with respect to claims 12, 42, 60, 65, 71, 72-77, and 79.
Pfizer, Inc. and Samsung Bioepis Co., Ltd. (“Pfizer”) v. Genentech, Inc. (“Genentech”), IPR2017-01488 (Final Written Decision Entered November 29, 2018).
In its petition, Pfizer challenged claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of U.S. Patent No. 6,407,213 (“the ’213 patent”). The disclosure of the ’213 patent is summarized above. Samsung Bioepis (“Bioepis”) timely submitted a petition with substantially the same challenges along with a request for joinder which was granted. The claims were challenged under similar novelty and obviousness grounds as summarized above for IPR2017-01374, and for nearly identical reasons, the Board found Pfizer had demonstrated by a preponderance of the evidence that claims 1, 2, 4, 25, 29, 30, 31, 33, 62-64, 66, 67, 69, 72, 76, 78, 80, and 81 were unpatentable, but did not make the required showing with respect to claims 12, 42, 60, 65, 71, 73-75, and 79.