Other than quickly granting Petitioner’s unopposed motion to dismiss with prejudice in Pfizer, Inc. v. Biogen, Inc., No. IPR2018-00231 (Decision Entered June 6, 2018), during the week of June 4, the Patent Trial and Appeal Board issued three decisions in TC 1600, two denying institution of IPR petitions filed by Sandoz, Inc. and Sanofi Pasteur, Inc., respectively, and one final decision finding all challenged claims unpatentable in an IPR filed by Acrux DDS Pty Ltd., joined to an IPR filed by Argentum Pharmaceuticals LLC. The decisions are as follows:
Sandoz Inc. v. AbbVie Biotechnology Ltd., No. IPR2018-00156 (Decision Entered June 5, 2018). In its petition, Sandoz challenged claims 1–30 of U.S. Patent No. 9,187,559 (“the ’559 patent”) as obvious over the combination of a 2003 Humira Package Insert and WO 02/100330 A2 (“WO ’330”) in view of Goodman & Gilman, a 2002 Remicade Package Insert, and Hanauer. AbbVie filed a preliminary response. As a threshold matter, the parties disputed whether the 2003 Humira Package Insert qualified as a “printed publication” under 35 U.S.C. § 102(b). The Board agreed with Sandoz that the Insert qualified as a prior art printed publication because it was publicly accessible on the effective filing date, based on: (i) a Wayback Machine screenshot and supporting affidavit indicating the packaging was on the FDA website as of March 31, 2003, and (ii) testimony of one skilled in the art regarding how one skilled in the art could have located the package insert with reasonable diligence on the FDA website, speaking from his personal experience. The Board acknowledged AbbVie’s argument that evidence of indexing is probative of public accessibility, but concluded that such evidence is not required in all cases when testimony such as that provided by Sandoz’s expert supports availability. On the merits, the claims at issue relate to methods for treating tumor necrosis factor α (TNFα) related disorders, comprising steps of administering a TNFα inhibitor during an “induction or loading phase,” followed by administering the inhibitor during a “maintenance or treatment phase” at a lower dose. The Board denied institution of inter partes review, finding that one skilled in the art, without the benefit of hindsight, would not have had a reason to use a 160 mg induction dose, or to select an intermediate dose as a “baseline” to calculate the induction dose, because the prior art suggested an induction dose 50% lower.
Sanofi Pasteur Inc. v. Pfizer Inc., No. IPR2018-00188 (Decision Entered June 5, 2018). In the petition, Sanofi Pasteur, Inc. and SK Chemicals Co., Ltd. (collectively “Petitioner”) challenged claims 1–45 of U.S. Patent No. 9,492,559 (“the ’559 patent”) on anticipation and obviousness grounds, alleging that Pfizer-099 and Pfizer-302 (two international patent application publications) were prior art to the ’559 patent under 35 U.S.C. § 102(a)(1) or 35 U.S.C. § 102(a)(2). Pfizer Inc. filed a preliminary response. First, Petitioner alleged that the ’559 patent was not entitled to the priority date of its provisional application, U.S. Provisional Patent App. No. 61/929,547 (“the ’547 provisional”) because the ’547 provisional (i) did not describe a polysaccharide to carrier protein ratio range “between 0.4 and 2,” as recited in the sole independent claim of the ’559 patent; (ii) failed to describe sufficient species in the molecular weight range of 1,000–12,500 kDa; and (iii) only exemplified one carrier protein that, according to Petitioner, “cannot represent the entire genus of any carrier proteins.” The Board disagreed, finding that the ’547 provisional provided support for carrier proteins in the claimed ratio range and disclosed species between 1,000 and 12,500 kDa. With respect to carrier proteins, the Board found that the ’547 provisional provided support for the genus because it taught many different carrier proteins. Second, the Board rejected Petitioner’s 35 U.S.C. § 102(a)(2) argument because Pfizer-302 and Pfizer-099 were assigned to Patent Owner prior to the ’559 patent’s filing date and therefore fell within the exception contained in AIA 35 U.S.C. § 102(b)(2)(C) (disqualifying commonly-owned prior art from an invalidity analysis). Accordingly, the Board denied the petition.
Acrux DDS Pty Ltd. v. Kaken Pharmaceutical Co., Ltd., No. IPR2017-00190 (Decision Entered June 6, 2018). In its petition, Acrux DDS Pty Ltd. and Acrux Limited (collectively “Petitioner”) challenged claims 1 and 2 of U.S. Patent No. 7,214,506 (“the ’506 patent”) on six sets of obviousness grounds. Patent Owner filed a preliminary response and the Board instituted inter partes review. After institution, Argentum filed a follow-on petition (IPR2017-01429), and the Board joined the proceedings. The claims at issue relate to a method of treatment wherein a therapeutically effective amount of an antifungal compound of a defined formula (depicted in claims 1 and 2 as “formula I” and “formula II,” respectively) is administered to the nail of a subject having onychomycosis. Formula II (claim 2) is also known as KP-103 or efinaconazole, the active ingredient in Patent Owner’s Jublia® product. As a threshold matter, the Board concluded that Patent Owner demonstrated prior reduction to practice of the invention thereby invalidating one of Petitioner’s references (Ogura) as prior art. Without Ogura as prior art, the Board found that Petitioner’s first three obviousness challenges failed. The remaining three obviousness grounds related to combinations of the “Kaken Abstracts” (three abstracts involving KP-103 or efinaconazole), JP ’639, the ’367 patent, and Hay. The Board agreed with Petitioner that three of the references (JP ’639, the ’367 patent, and Hay) taught the limitation of “a method for treating a subject having onychomycosis wherein the method comprises topically administering to a nail of said subject having onychomycosis a therapeutically effective amount of an antifungal compound” considering the breadth of the definitions of “nail” and “onychomycosis” used in the claims, and that the Kaken Abstracts showed that KP-103 was effective at treating fungal infections. Patent Owner offered evidence of secondary considerations of nonobviousness including unexpected results, commercial success, industry praise, and long-felt, but unmet need for its Jublia® product to support a finding of nonobviousness. The Board concluded that Patent Owner failed to persuasively demonstrate unexpected results, commercial success, industry praise, and long-felt need for Jublia®, but observed that even if it had, the evidence would not outweigh the Petitioner’s strong showing of obviousness in this case. Accordingly, the Board found claims 1 and 2 of the ’506 patent unpatentable.
The Patent Trial and Appeal Board issued seven decisions in TC 1600 during the week of June 11-15, 2018, including four decisions denying institution of inter partes review and three final written decisions. Summaries of the decisions follow:
Initiative for Medicines, Access & Knowledge (“I-MAK”), Inc. v. Gilead Pharmasset LLC (“Gilead”), IPR2018-00123 (Decision Denying Institution Entered June 13, 2018).
I-MAK filed six inter partes review petitions against patents owned by Gilead. The technology of the current case, U.S. Patent No. 8,735,372 (“the ’372 patent”), is directed to a method of treating a human infected by hepatitis C virus by administering an NS5a inhibitor and a prodrug of a nucleoside derivative. In its petition, I-MAK challenged claims 1 and 2 of the ’372 patent as obvious over the combination of Sofia (a conference poster), Congiatu (non-patent literature), and Serrano-Wu (US 2006/0276511).
The Board disagreed with I-MAK and held that I-MAK failed to meet its initial burden of establishing that Sofia qualified as a printed publication. The Board found no evidence that Sofia was published in print or electronic form beyond it being presented as a poster. In addition, the Board noted that I-MAK provided no information regarding (i) how long Sofia was posted, (ii) whether it was sufficiently publicized to, or placed in front of a sufficient number of, those interested in the subject matter, or (iii) the freedom of those viewing the poster to take notes or to copy the poster. Without Sofia available as prior art, I-MAK’s obviousness arguments were undermined because Sofia was the only reference that taught the prodrug.
Accordingly, the Board declined to institute an inter partes review, finding that I-MAK had failed to show a reasonable likelihood that it would prevail with establishing the unpatentability of the challenged claims.
Initiative for Medicines, Access & Knowledge (“I-MAK”), Inc. v. Gilead Pharmasset LLC (“Gilead”), IPR2018-00103 (Decision Denying Institution Entered June 13, 2018).
In a second I-MAK v. Gilead case, I-MAK challenged certain claims of U.S. Patent No. 7,429,572 (“the ’572 patent”) on anticipation and obviousness grounds. The ’572 patent is directed to compounds for the treatment of a host infected with a virus belonging to the Flaviviridae family, including hepatitis C virus, West Nile virus, and yellow fever virus. Claims 1-16 were challenged as anticipated by Klecker, claims 1-19 were challenged as anticipated by Sommadossi, and claims 1-19 were challenged as obvious over Sommadossi and Klecker. Gilead filed a preliminary response.
The Board agreed with Gilead that I-MAK selectively chose teachings of the Klecker reference to arrive at compounds encompassed by the genus of the claim. The Board determined that I-MAK had not pointed to any teaching, other than the broad disclosure, to direct the skilled artisan to select the specific elements and in the claimed position within the sugar ring of the compounds. As such, the Board found that I-MAK had failed to establish a reasonable likelihood that the claims were anticipated by Klecker.
As to Sommadossi, the Board further agreed with Gilead and found that I-MAK had attempted to make obviousness arguments over Sommadossi in the anticipation argument and that any inherency argument would also fail. As such, the Board found that I-MAK had not established a reasonable likelihood that the claims were anticipated by Sommadossi.
Regarding the obviousness challenge, in the patent owner’s response Gilead contended that the petition completely ignored the Board’s decisions and Federal Circuit’s opinion in a prior interference proceeding involving the ’572 patent, which found that the prior art did not teach or suggest fluoridation of tertiary alcohols to produce the claimed compounds, and that arriving at the presently claimed compound would require extensive experimentation to achieve correct synthesis. Accordingly, the Board declined to institute an inter partes review because I-MAK had failed to show a reasonable likelihood that it would prevail with establishing the unpatentability of the challenged claims.
Mylan Technologies, Inc. (“Mylan”) v. Noven Pharmaceuticals, Inc. (“Noven”), IPR2018-00174 and Mylan v. Noven, IPR2018-00173 (Decisions Denying Institution Entered June 12, 2018).
In these two cases, the Board denied institution of inter partes review. In IPR2018-00174, Mylan requested review of claims 1-23 of U.S. Patent No. 9,730,900 (“the ’900 patent”) relating to transdermal drug delivery systems for administering estrogens. In its petition, Mylan challenged claims 1, 2, 8, 10-16, and 18-23 as anticipated by Mueller. Mylan further challenged claims: (i) 1, 2, 8-23 as obvious in view of Mueller and Vivelle-Dot Label, (ii) 3-7 as obvious in view of Mueller, Vivelle-Dot Label, and Kanios, and (iii)1-23 as obvious in view of Mueller, Vivelle-Dot Label, Kanios, and Chien.
In IPR2018-00173, Mylan requested review of claims 1-15 of U.S. Patent No. 9,724,310 (“the ’310 patent”), which also relates to transdermal drug delivery systems for administering estrogens. In its petition, Mylan challenged claims 1, 2, 8, 10-15 as anticipated by Mueller. Mylan further challenged claims: (i) 1, 2, 8-15 as obvious in view of Mueller and Vivelle-Dot Label, (ii) 3-7 as obvious in view of Mueller, Vivelle-Dot Label, and Kanios, and (iii) 1-15 as obvious in view of Mueller, Vivelle-Dot Label, Kanios, and Chien. Noven filed a preliminary response in both proceedings.
As a threshold matter, the Board determined the meanings of the terms “about” and “flux.” The Board agreed with the parties that the specification provided an express definition of the term “about” to mean “up to plus or minus 10% of a particular term.” The Board also agreed with the parties that the specification provided an express definition of the term “flux” and found no reason to deviate from this definition.
The Board agreed with Noven that Mylan failed to establish that Mueller taught a transdermal therapeutic system having the claimed estradiol flux ranges. For similar reasons, the Board also was not persuaded that Mylan established a reasonable likelihood of prevailing on each of its obviousness challenges. Accordingly, the Board declined to institute an inter partes review in both cases.
Merck Sharp & Dohme Corp. (“Merck”) v. Wyeth LLC (“Wyeth”), IPR2017-00378 (Final Written Decision Entered June 8, 2018).
In its petition, Merck challenged claims 1-6, 10, 11, 14 and 17-20 of U.S. Patent No. 8,562,999 (“the ’999 patent”) on obviousness grounds. The ’999 patent relates to formulations comprising an immunogen in the form of a polysaccharide-protein conjugate, a pH buffered saline solution, and an aluminum salt. In particular, the specification discloses surfactants that act to stabilize and inhibit aggregation of an immunogenic composition.
The Board’s obviousness analysis focused on whether the combined disclosures of Chiron, Smith, and Elan taught or suggested placing a formulation in a siliconized container means, and inhibiting aggregation induced by the siliconized container means, as claimed in independent claim 1. The Board agreed with Merck and determined that a preponderance of the evidence supported Merck’s contention that a person of skill in the art would have found it obvious at the time of the invention to store the formulation disclosed in Chiron in a siliconized container means. In addition, the Board also agreed with Merck’s contention that a person of ordinary skill in the art would have appreciated that Chiron’s formulation inhibited aggregation induced by a siliconized container means. The Board disagreed with Wyeth that one of skill in the art would not look to combine the teachings of Chiron and Elan, in part after concluding that Wyeth’s teaching away argument as to Elan was misplaced.
The Board did agree with Wyeth regarding the patentability of claim 18, which recites a 13-valent conjugate having different polysaccharide from S. pneumoniae serotypes. In particular, Wyeth argued that Merck used impermissible hindsight as a blueprint to piece together prior art. The Board concluded that Merck had not established by a preponderance of the evidence that a person of skill in the art would have found it obvious to modify the formulations disclosed in Chiron to reach the 13-valent conjugate recited in claim 18.
Merck also argued obviousness over the combined disclosures of Chiron, Smith, Elan, and Peña. Peña discloses two available vaccines to prevent invasive pneumococcal illness. The Board agreed with Merck as to the obviousness of the 7-valent conjugate (claim 17), but not as to the 13-valent conjugate (claim 18), over the combined prior art.
Accordingly, in its Final Written Decision, the Board determined that Merck had shown by preponderance of the evidence that claims 1-6, 10, 11, 14, 17, 19, and 20 are unpatentable as obvious.
Merck v. Wyeth, IPR2017-00380 (Final Written Decision Entered June 8, 2018).
Claims 1-6, 10, 11, 14 and 17-20 of U.S. Patent No. 8,562,999 (“the ’999 patent”), discussed above, were further challenged in a second inter partes review filed by Merck.
The Board’s obviousness analysis focused on whether the combined disclosures of Prevenar and Chiron, and optionally Peña, rendered the claims unpatentable as obvious. The Board found that Wyeth’s contentions were inadequately supported by expert testimony or declarations and, by preponderance of the evidence, determined that one of ordinary skill in the art would have had a reason to add a histidine buffer to the Prevenar vaccine with a reasonable expectation of enhancing the stability of the formulation and, further, that the recited aggregation inhibition property of the formulation must be present in, or is the natural result of, the combination of elements disclosed by the prior art. Accordingly, the Board determined the claims would have been obvious over the combination of Prevenar and Chiron.
Similar to the decision in IPR2017-00378, the Board agreed with Wyeth regarding the patentability of claim 18, which recites 13-valent conjugate having different polysaccharide from S. pneumoniae serotypes. As such, claim 18 withstood the obviousness challenge. Also, as in IPR2017-00378, Peña was cited as further evidence of obviousness. The Board again agreed with Petitioner as to the obviousness of the 7-valent conjugate (claim 17), but not as to the 13-valent conjugate (claim 18), over the combined prior art.
Accordingly, in its Final Written Decision, the Board determined that Merck had shown by preponderance of the evidence that claims 1-6, 10, 11, 14, 17, 19, and 20 are unpatentable as obvious.
Merck v. Wyeth, IPR2017-00390 (Final Written Decision Entered June 8, 2018).
In a third challenge to claims of U.S. Patent No. 8,562,999 (“the ’999 patent”), the Board determined that claims 7-9, 12, 13, 15, 16, 21, and 22 of the ’999 patent are unpatentable as obvious. As discussed above, the ’999 patent discloses formulations having an immunogen in the form of a polysaccharide-protein conjugate, a pH buffered saline solution, and aluminum salt.
The three obviousness grounds related to the combined teachings of: (i) Chiron, Smith, and Elan; (ii) Prevenar and Chiron; and (iii) WO 2011/100151 and U.S. Patent No. 7,935,787.
The Board agreed with Merck that a person of ordinary skill in the art would have placed Chiron’s formulation into a syringe and that Smith disclosed the common application of lubricating plastic syringe barrels and glass cartridges used as plungers to facilitate ease of use. The Board disagreed with the evidence put forth by the Wyeth and its experts regarding, for example, that laboratories would specifically avoid using siliconized containers, substitute buffers, and use pH slightly below the preferred range.
On June 5, 2018, the Board issued an Order granting a Joint Motion to Limit the Petition. As such, the obviousness challenge over WO 2011/100151 and U.S. Patent No. 7,935,787 was removed from the proceedings and the Board did not address the alleged unpatentability of claims 13 and 16.
Accordingly, in its Final Written Decision, the Board determined that Merck had shown by preponderance of the evidence that claims 7-9, 12, 13, 15, 16, 21, and 22 of the ’999 patent are unpatentable as obvious.
During the week of June 18-22, 2018, the Patent Trial and Appeal Board issued two decisions in Tech Center 1600 denying institution of IPR petitions. The petitions were filed by Samsung Bioepis Co. Ltd. (“Bioepis”) against Genentech, Inc. (“Genentech”), and Initiative for Medicines, Access & Knowledge (I-MAK), Inc. (“I-MAK”) against Gilead Pharmasset LLC (“Gilead”), respectively. The decisions follow.
Samsung Bioepis Co. Ltd. v. Genentech, Inc., No. IPR2018-00192 (Decision Entered June 18, 2018). In this Petition, Bioepis challenged U.S. Patent No. 7,846,441 (“the ’441 patent”) on obviousness grounds based on five prior art references: Lottery, Hayes, Baselga ’94, Baselga ’96, and Gelmon. Genentech filed a preliminary response to the Petition. The claims at issue are directed to a combination therapy for HER2-positive cancers using an anti-ErbB2 antibody that binds to epitope 4D5, and a taxoid, in the absence of an anthracycline derivative.
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 presented in several previously instituted IPRs involving the same claims of the ’441 patent. Prior to this IPR, Pfizer, Inc. and Celltrion, Inc. challenged the same claims of the ’441 patent over the combination of, inter alia, Baselga ’96, and Baselga ’94. Although Lottery, Hayes, and Gelmon were not asserted in the previous IPRs, the Board agreed with Genentech that Bioepis’s arguments based on the newly asserted references were substantially the same as those in the earlier IPRs, and therefore denied Bioepis’s petition.
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. v. Gilead Pharmasset LLC, No. IPR2018-00211 (Decision Entered June 20, 2018). In this Petition, I-MAK challenged U.S. Patent No. 9,393,256 (“the ’256 patent”) on anticipation and obviousness grounds based on a reference by Legrand-Abravanel, an anticipation ground based on a reference by Delaney, and an obviousness ground based on references by Sofia and Guo. Gilead filed a preliminary response to the Petition. The claims at issue recite an interferon-free combination therapy of two compounds (designated Compounds 6 and 10) for HCV infection in humans. Gilead asserted that neither Legrand-Abravanel nor Delaney disclosed the claimed combination of Compounds 6 and 10.
The Board agreed with Gilead and found that Legrand-Abravanel and Delaney at most disclosed a genus of the claimed combination, respectively: 1) Legrand-Abravanel disclosed combinations of an NS5B inhibitor (such as Compound 10) and a genus covering Compound 6; and 2) Delaney disclosed combinations of a list of compounds (such as Compound 6) and a genus covering Compound 10. The Board denied institution on the anticipation ground based on Legrand-Abravanel or Delaney because I-MAK failed to explain whether or how a person of ordinary skill in the art (POSA) would “at once envisage each member of the genus” disclosed in Legrand-Abravanel or Delaney to establish the anticipation of the claimed species by the disclosed genus. The Board denied institution on the obviousness ground based on Legrand-Abravanel, or Sofia and Guo because I-MAK failed to show sufficiently whether or why a POSA would have had a reasonable expectation of success in arriving at the claimed combination from the teachings of the prior art. The Board found that I-MAK failed to provide any analysis of the reasonable expectation requirement for the obviousness ground over Legrand-Abravanel, and further explained that the “general approach and guidance to a field of experimentation” as taught by Legrand-Abravanel is insufficient to establish the requisite reasonable expectation of success. Finally, the Board found I-MAK’s conclusory statement that a POSA would “have also been motivated to test such compound combinations with or without an interferon” was insufficient to render obvious the claim limitation of “wherein the method does not include administering interferon,” in view of Sofia and Guo.
The Board issued two decisions in TC 1600 during the week of June 25, both of which relate to Petitions filed by Trans Ova Genetics, LC (“Trans Ova”) against XY, LLC (“XY”). Summaries of the decisions are below:
Trans Ova Genetics, LC v. XY, LLC, IPR2018-00249 (Decision Denying Institution Entered June 25, 2018). In its petition, Trans Ova challenged claims 1-4, 7, 8, 10, 13, and 14 of U.S. Patent No. 6,372,422 (“the ’422 patent”) on six grounds based on references Hagele, Seidel, Nowshari, Donaldson, Spaulding, Rens, and Johnson. XY filed a preliminary response. The ’442 patent relates to methods for artificially inseminating a female mammal using sperm that are sorted by sex by flow cytometry. Claim 1, the only independent claim, requires steps of “determining a sex of a sperm cell of a male mammal” and “sorting according to said sex of said sperm cells.” In its decision construing the claims, the Board found that the “determining” step must occur before the “sorting” step. Further, the parties did not dispute that the “sorting” step must be performed by flow cytometry. Finding that the Petitioner failed to provide any evidence that the cited references determine the sex of sperm cells prior to sorting them by flow cytometry based upon that determination, the Board denied institution of inter partes review.
Trans Ova Genetics, LC v. XY, LLC, IPR2018-00250 (Decision Granting Institution Entered June 27, 2018). In a second petition, Trans Ova challenged claims 1-16 of U.S. Patent No. 8,652,769 (“the ’769 patent”) on five grounds of obviousness based on references Lu, Seidel, Johnson, and Rens. The ’769 patent is directed to methods for producing a sperm sample for use in artificial insemination. XY filed a preliminary response. Patent Owner first disputed Petitioner’s contention that Lu qualifies as prior art under 35 U.S.C. § 102(a) because all listed authors are also named inventors and thus Lu is not the work of “another.” Although the Petition did not include any argument or evidence that Lu is the work of someone other than the patent’s inventors, the Board determined that Petitioner met its initial burden of production to show that Lu is prior art under § 102(a) because Lu attributes relevant data to an individual named “Green,” who is not named as an author or inventor. In a dissenting opinion, Judge Obermann disagreed with the other members of the panel, stating that instituting trial on issues surrounding Green is unfair to the Patent Owner because not only did the Petition fail to mention Green, Petitioner did not raise the issue of Green until after Patent Owner filed its Preliminary Response in a request to file a reply brief that would raise issues surrounding Green—a request that was expressly denied by the Board.
The Board then turned to the first ground that challenges claim 16 in view of Lu and Johnson. Claim 16 includes a limitation that requires the sperm samples to be “capable of fertilizing an egg at success levels of at least about 70% of the success levels with sperm cells that have not been separated and/or frozen.” During prosecution, the Examiner allowed the claims over Lu and Seidel because neither reference disclosed the claimed 70% fertilization success rate. However, the Board declined Patent Owner’s request to the Board to deny review under 35 U.S.C. § 325(d) because Petitioner presented a new argument that differed substantially from the argument at issue during prosecution. Specifically, Petitioner argued that the data shown in Tables 1 and 3 of Lu does in fact disclose the claimed 70% fertilization success rate by dividing the blastocyst percentage of one of the frozen-thawed sorted samples (Table 3, 17%) by the blastocyst percentage of one of the unfrozen samples (sorted and unsorted) (Table 1, 24%). Consequently, the Board granted institution of inter partes review on all asserted grounds—as required by the Supreme Court’s recent decision in SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359-60 (2018)—because it found that Petitioner showed that there is a reasonable likelihood that it would prevail in showing the unpatentability of claim 16 over the combination of Lu and Johnson.