Yeda Res. Dev. Co., Ltd. v. Mylan Pharm., Amneal Pharm.

Docket No. 2017-1594-56 (IPR2015-00643, -0064, -00830, -01976, -01980-81

October 12, 2018

Brief summary: Board IPR decisions finding Yeda’s patents relating to relating to COPAXONE® invalid for obviousness affirmed.

Summary: Yeda appealed PTAB final written decisions (FWDs) finding US 8,232,250; 8,399,413; and 8,969,302 relating to COPAXONE® (glatiramer acetate (GA), “a mixture of polypeptides”; 40 mg/ml for relapsing-remitting multiple sclerosis (RRMS)) unpatentable as obvious following three IPRs. FN1 indicates the “companion” Teva decision (also Oct. 12, 2018) concerns the appeal of the DC decision invalidating the same three patents and US 9,155,776. The FC panel opinion explains that “a key limitation of the claims is the administration of a 40 mg GA dose in three subcutaneous injections over seven days with at least one day between every subcutaneous injection” (representative ‘250 claim 1; ‘302 claim 1 does not require “at least one day between” injections). Mylan’s and Amneal’s IPRs (-00643-44, -00830) were instituted regarding the ‘250, ‘413, and ‘302 patents on obviousness grounds based on prior art relating to clinical trials. The Board credited Mylan/Amneal’s expert in its conclusion that there would have been a motivation to use a 40 mg dose and a motivation to modify those regimens by eliminating “one injection every other week to increase patient compliance” and a reasonable expectation of success in doing so. The FC panel reviewed the Board’s decision for substantial evidence. Yeda argued that its due process rights and the ADA were violated because it did not have notice of, and an opportunity to respond to a non-statutory prior art reference (Khan 2009) that was raised as part of an expert declaration but the FC panel disagreed (e.g. “Yeda could have, but did not, address Kahn 2009 at the oral hearing”). The FC panel also found that while “Khan 2009 indisputably does not qualify as prior art”, “the Board can rely on evidence other than prior art” (§ 312(a)(3), 42.104(b); “non-prior art evidence of what was known ‘cannot be applied, independently, as teachings separately combinable; with other prior art, but ‘can be relied on for their proper supporting roles’” (Dominion, IPR2014-00684 (2014)). The FC panel did find the Board improperly relied on Khan 2009 to find a reasonable expectation of success, but found this error to be harmless based on other evidence. Yeda also appealed the Board’s obviousness findings, arguing “this case is ‘indistinguishable from In re Cyclobenzaprine” (FC 2012 (“bioequivalence alone could not establish obviousness…there were no prior art clinical studies to suggest what would be a therapeutically effective formulation”)) and “that a reasonable expectation of success is categorically impossible in the absence of a pk/pd profile”. But the FC panel disagreed since, e.g., “the expectation of success need only be reasonable, not absolute” (Pfizer, FC 2007), “[t]he only difference” being “thrice weekly and every other day administration” and “far from a ‘sea of prior art,’ the references…presented a finite and known pool of dose and frequency options” (WBIP, FC 2016; Ortho-McNeil, FC 2008; KSR, US 2007). Yeda also argued the Board erred in not discussing its “minimum effective dose principle” arguments in the FWDs but the FC panel found this not to be reversible error (Synopsys, FC 2016). The FC panel also disagreed with Yeda that the Board did not sufficiently address the tolerability, side effect, and “particular three-day schedule” limitations. Thus, the Board decisions were affirmed.

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Data Engine Technologies LLC (“DET”) v. Google LLC

Docket No. 2017-1135

October 9, 2018

Brief summary: DC finding certain of DET’s claim ineligible under § 101 affirmed-in-part, reversed-in-part (e.g., claims “not abstract, but rather directed to a specific improved method for navigating through complex three-dimensional electronic spreadsheets”), and remanded.

Summary: DET appealed DC holding that US 5,590,259; 5,784,545; 6,282,551 (“Tab Patents”) and 5,303,146 are ineligible under § 101 as being directed to abstract ideas and failing to provide an inventive concept. The FC panel explained that “[t]he Tab Patents specifically identify problems with navigation through prior art three-dimensional or multipage electronic spreadsheets”, providing a “solution to this problem” by providing a “notebook-tabbed interface” (e.g., in a “preferred embodiment, ‘each page identifier is in the form of a tab member…situated along a bottom edge of the notebook”). The DC concluded that representative ‘259 claim 12 “is ‘directed to the abstract idea of using notebook-type tabs to label and organize spreadsheets’…that humans have commonly performed entirely in their minds, with the aid of columnar pads and writing instruments”, and “that the remaining limitations…fail to recite an inventive concept”, and therefore ineligible under § 101. The DC found the ‘146 patent claims to also be ineligible for similar reasons. Considering the Tab Patents under Alice’s step one (US 2014 (“whether the claims at issue are directed to a patent-ineligible concept”; CellzDirect, FC 2016 (“we must determine whether that patent-ineligible concept is what the claim is ‘directed to’”), the FC panel disagreed with the DC and held the Tab Patents to be directed to patent eligible subject matter because the claims, other than claim 1 of the ‘551 patent, “are not abstract, but rather directed to a specific improved method for navigating through complex three-dimensional electronic spreadsheets” and eligible under § 101” (e.g., “[t]he improvement allowed computers, for the first time, to provide rapid access to and processing of information in different spreadsheets” and “easy navigation”, “applauded by the industry for improving computers’ functionality” (pointing to several articles submitted during prosecution); similar to Core Wireless” (FC 2018 (the “invention…improved the efficiency of…display interfaces…a particular manner of summarizing and presenting information in electronic devices”), Trading Techs., FC 2017 (“require[d] a specific, structured graphical user interface paired with a prescribed functionality”); unlike Affinity Labs (FC 2016 (“[t]he claims were ‘entirely functional in nature’”), Capital One (FC 2017 (“claims ‘directed to the abstract idea of collecting, displaying, and manipulating data’”), and Erie Indemnity (FC 2017 (“claims did not recite any specific structure or improvement of computer functionality”); Enfish, FC 2016 (must claim “a specific improvement to the way computers…operate”)). As it found representative claim 12 not to be abstract under Alice step one, it did not reach step two. Claim 1 of the ‘551 patent was held to be patent ineligible, however, because “under Alice step one, [it] is directed to the abstract idea of identifying and storing electronic spreadsheet pages” (e.g., it “does not recite the specific implementation of a notebook tab interface”) and “fail[s] to provide an inventive concept.” The FC panel agreed with the DC that under Alice step one the ‘146 claims “are akin to those we held ineligible in Content Extraction” (FC 2014 (“must involve more than performance of ‘well-understood, routine, [and] conventional activities previously known to the industry”)), and “do not recite an inventive concept under Alice step two” (“[t]he claims recite the generic steps of creating a base version of a spreadsheet, creating a new version…, and determining changes”).

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Celltrion, Inc. v. Genentech, Inc.

IPR2017-01122 (Final Written Decision)
October 3, 2018

Brief summary: Genentech’s claims 1-11 and 14-17 of US 7,892,549 B2 related to Herceptin® (the humanized anti-ErbB2 antibody trastuzumab) shown obvious by a preponderance of the evidence.

Summary: Celltrion challenged claims 1-11 and 14-17 of US 7,892,549 B2 related to Herceptin® (the humanized anti-ErbB2 antibody trastuzumab). Seven other IPRs regarding Herceptin® patents, both related and unrelated to the ‘549 patent, and final decisions were also issued concurrently with this FWD. Litigation regarding the ‘549 patent is also pending (18-cv-00274 (NJ) and 18-cv-00095 (Del.)). ‘549 claims 1, 5 and 16 are independent. Claim 1 claims a method for treating ErbB2 receptor-overexpressing human breast cancer by “administering a combination of an antibody that binds” “to epitope 4D5” of “ErbB2, a taxoid, and a further growth inhibitory agent”. “Claim 16 is similar to claim 1” and includes the negative limitation “in the absence of an anthracycline derivative”. Claim 5 “recites ‘administering an effective amount of a combination’ of three agents similar to those of claims 1 and 16” (“the taxoid is paclitaxel, and the third element is broadly described as a ‘therapeutic agent’”). Regarding the level of skill in the art, the FWD adopted Genentech’s definition as “a clinical or medical oncologist specializing in breast cancer with several years of experience with breast cancer research or clinical trials” and notes “that the prior art itself demonstrates the level of skill in the art at the time of the invention” (Okajima, FC 2001). “[A]dministering a combination” was construed “to mean that the drugs are administered as part of the same treatment regimen” (as in IPR2017-00737 FWD). The terms “amount effective to extend the time of disease progression” and “an effective amount” were construed to mean “relative to an untreated patient”, which “reflects Applicant’s choice” during prosecution (“Applicants overcame the § 112 rejection by providing an express definition”). Celltrion argued for obviousness in view of Baselga 1996 (stable disease after anti-ErbB2 administration), Seidman 1996 (HER2 overexpression…seems to confer sensitivity…to taxanes”), Pegram 1995 (positive response after treatment with cisplatin and rhuMAb HER-2), 1995 TAXOL PDR, and the knowledge of one of ordinary skill in the art, evidenced, in part by Baselga Abstracts 53 and 2262 (xenograft studies showing combination of hu-4D5 antibody and paclitaxel showed 93% inhibition of tumor growth), and Seidman 1995 (paclitaxel review article describing “strong synergy” shown by Baselga Abstract 2262) (see FN14 explaining that “to establish the knowledge of one of ordinary skill in the art, ‘it is permissible, and sometimes even necessary, to establish such background knowledge by pointing to other prior art’” (Rovalma, FC 2017)). Celltrion (and its experts) argued a motivation to combine because it “particularly made sense because the combination satisfied the four principles of combination therapy” and a “reasonable expectation of success that the three-drug combination would have been safe and effective.” Regarding claim 16, the PTAB found the record to show “that while anthracyclines were widely employed,” the skilled artisan would have selected a taxoid such as paclitaxel rather than an anthracycline” due to, e.g., known “drug resistance or cumulative cardiotoxicity” (Bayer, FC 2017; In re Fulton, FC 2004 (“combination claimed” need not be “the preferred, or most desirable”)). The PTAB also found “the ordinary artisan would have had a reasonable expectation of success in achieving the claimed clinical efficacy.” It therefore found Celltrion had demonstrated obviousness by a preponderance of the evidence. Genentech’s motion to amend the claims was denied as failing “to satisfy the no new matter requirement of 35 U.S.C. § 316(d) and 37 C.F.R. § 42.12(a)(2)(ii)” and the amendments would not overcome the obviousness findings. The PTAB also denied Genentech’s motions to include evidence of secondary considerations and other articles and declarations.

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Roche Molecular Systems, Inc. v. Cepheid

Docket No. 2017-1690

October 9, 2018

Brief summary: DC grant of SJ of invalidity of Roche’s diagnostic method and primer claims under § 101 affirmed (“[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry”).

Summary: Roche appealed DC grant of SJ of invalidity of its US 5,643,723 “directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis” (“MTB”) under § 101. The ‘723 patent relates and claims a polymerase chain reaction (PCR)-based test for detecting “eleven MTB-specific signature nucleotides” in the MTB rpoB gene from a “biological sample” and thereby identifying “whether or not a biological sample contains MTB…and…if MTB is present, predict whether that MTB is a strain that is resistant to rifampin treatment.” Claims 17-20 are directed to primers “having 14-50 nucleotides that hybridize” to an MTB rpoB gene “comprising at least one position-specific” MTB “signature nucleotide” (claim 20 being directed to the “full DNA sequences of certain primers”). Roche brought an infringement suit against Cepheid with respect to Cepheid’s “Xpert® MTB/RIF Assay” for detecting rifampin-resistant MTB, and Cepheid successfully argued that the asserted claims are invalid under § 101. The FC panel reviewed the DC’s grant of SJ under the law of the Ninth Circuit and the § 101 question de novo (Voter Verified, FC 2018). The FC panel considered the § 101 question under the two-step Alice framework which asks: 1) are the claims “directed to” a patent-ineligible concept? and 2) do the claims “contain[] an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-eligible application” (Alice, US 2014; Mayo, US 2012; Enfish, FC 2016; CellzDirect, FC 2016; Ariosa, FC 2015; Genetic Techs., FC 2016; In re BRCA1, FC 2014). Roche argued the primer claims are “directed to artificial, man-made primers that are different from naturally occurring DNA” in having “both a 3-prime end and a 3-prime hydroxyl group”, but the FC panel found that “BRCA1 forecloses Roche’s arguments” (“DNA structure with a function similar to that found in nature can only be patentable as a composition of matter if it has a unique structure, different from anything found in nature” and “[p]rimers do not have such a different structure”; e.g., “a primer having an identical sequence to naturally occurring DNA without further modification is a natural phenomena” and “[t]he eleven position-specific signature nucleotides…are naturally occurring”). The FC panel acknowledged that “Roche’s discover[ies]….are valuable contributions to science and medicine” but explained that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry” (Myriad, US 2013; Ariosa, FC 2015; “being the first to discover a previously unknown naturally occurring phenomena or a law of nature alone is not enough to confer patent eligibility” (Mayo)). The FC panel also concluded that claim 1’s “detecting step…is a mental determination step” and “establishes that the method claims are directed to a relationship between the eleven naturally occurring position-specific signature nucleotides and the presence of MTB in a sample”, “a natural phenomenon, which itself is ineligible for patenting”. The FC panel held “that the method claims do not contain an inventive concept that transforms the eleven position-specific signature nucleotides…into patent-eligible subject matter” since, e.g., “PCR amplification and detection were ‘routine’ when the patent application was filed” and “[i]t is a well-established law of nature that ‘complementary nucleotide sequences bind to each other”. The FC panel likened this case to BRCA1 and differentiated it from CellzDirect in which the invention “created an entirely new laboratory technique that ‘is not simply an observation or detection’”. The FC panel therefore affirmed the DC’s grant of SJ. Judge O’Malley concurred but believes the court “should revisit [its] holding in BRCA1 at least with respect to the primer claims” as only the question of whether the DC abused its discretion” in finding the accused infringer raised a substantial question regarding invalidity under § 101.”

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Real Foods Pty Ltd. v. Frito-Lay North America, Inc.

Docket No. 2017-1959, -2009

October 4, 2018

Brief summary: TTAB’s decision refusing registration of RF’s marks following Frito-Lay’s opposition affirmed-in-part, vacated-in-part, and remanded (“highly descriptive” marks, “TTAB failed to provide any reasoning for its conclusion that the narrowed identification”).

Summary: Real Foods (RF) appealed TTAB refusal to register “CORN THINS” for “crisp-bread slices predominantly of corn, namely popped corn cakes” and “RICE THINS” for “crispbread slices primarily made of rice, namely rice cakes” following Frito-Lay’s opposition. The TTAB found the marks to be “are merely descriptive and have not acquired distinctiveness” and dismissed Frito-Lay’s “genericness claim”. The FC panel explained that it reviews “the TTAB’s legal conclusions de novo and its findings of fact for substantial evidence” (In re N.C. Lottery, FC 2017; Princeton, FC 2015 (“more than a mere scintilla and is such relevant evidence as a reasonable mind would accept as adequate”); Citigroup, FC 2011 (“may be supported by substantial evidence even if two inconsistent conclusions can be drawn from the evidence”)). The FC panel also explained “the fanciful-suggestive-descriptive-generic continuum” that “roughly reflects…eligibility for trademark status and the degree of protection afforded”: 1) “generic (or common descriptive)” (“common descriptive name of a class of goods or services”); 2) “merely descriptive” (must “acquire distinctiveness, which is ‘secondary meaning’” (15 USC § 1052(f); Wal-Mart, US 2000; In re Steelbuilding, FC 2005; in some cases may be registered on the supplemental register (see FN3)); 3) “suggestive”, “arbitrary”, or “fanciful” (“‘inherently distinctive’ and therefore registrable”, “have created in the public consciousness an impression or symbol of the excellence of the particular product in question”; Wal-Mart; In re Chippendales, FC 2010). And, the FC panel explained, “the opposer, Frito-Lay, bears the burden of proving that the term is generic or merely descriptive by a preponderance of the evidence” (Hoover, FC 2001). When condiering descriptiveness, “the TTAB must consider the commercial impression of a mark as a whole, ‘viewed through the eyes of a consumer’…asking ‘whether someone who know what the goods and services are will understand the mark to convey information about them’”. The FC panel disagreed with Real Foods and agreed with the TTAB that the proposed marks “are highly descriptive” (e.g., CORN and RICE were disclaimed apart from the mark, “thins describes physical characteristics”, viewing the marks “as composites ‘do[es] not create a different impression’” (In re Oppdahl, FC 2004)). It also agreed with the TTAB’s finding that RF had not shown “acquired distinctiveness” (no “secondary meaning”; e.g., RF “has done little or no advertising” using the terms, “sales figures, while not insignificant, are not high”; Roselux, CCPA 1962). The FC panel also found error with TTAB’s dismissal of “Frito-Lay’s claim that proposed marks are generic” by “improperly narrow[ing] the genus of the goods at issue” to the amended description submitted during the opposition proceedings (e.g., “the TTAB failed to provide any reasoning for its conclusion that the narrowed identification of goods alone was the appropriate genus to use in its genericness analysis”). The TTAB’s decision was therefore affirmed-in-part, vacated-in-part, and remanded.

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Bennett Regulator Guards, Inc. v. Atlanta Gas Light Co.

Docket No. 2017-1555, -1626 (IPR2015-00826)

September 28, 2018

Brief summary: Board IPR FWD vacated and remaned because the one-year time bar under § 315(b) barred institution (The difference here from Click-to-Call is “that Bennett’s complaint was involuntarily dismissed without prejudice”, but the FC panel found “no reason to distinguish” this case from Click-to-Call on that basis; “no exceptions for dismissed complaints”.)

Summary: Bennett appealed Board IPR decision holding Bennett’s US 5,810,029 unpatentable, arguing that the one-year time bar under “§ 315(b) barred institution, that its claims should have survived, and that the Board should have imposed greater sanctions” on Atlanta Gas (which AG appealed). Bennett served AG with an infringement complaint on July 18, 2012, and in 2013 the DC subsequently granted AG’s motion to dismiss without prejudice. AG filed the IPR on Feb. 27, 2015. Bennett argued § 315(b) “prohibits institution ‘if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner…is served with a complaint alleging infringement of the patent” but the Board disagreed because the DC’s “without-prejudice dismissal of [the] complaint nullified service” (which it confirmed in its Final Written Decision (FWD)). After the FWD was issued, the Board sanctioned AG because it did not notify the Board of a merger and name change, and authorized Bennett “to move for the ‘costs and fees’ it had incurred between the date of the [FWD] and the Board’s grant of sanctions.” The FC panel first explained that “[t]hough statute immunizes the Board’s preliminary decision to institute IPR from review” (§ 314(d)), the FC has “authority to review its compliance with § 315(b)” (Wi-Fi One, FC 2018). The FC panel reviewed the Board’s legal conclusions de novo, its fact findings for substantial evidence (PPC Broadband, FC 2016), and its award of sanctions for abuse of discretion (Midwestern Pet Foods, FC 2012). Under the FC’s 2018 Click-to-Call decision (on which according to FN1 the Board relied), the FC panel explained, “serving a complaint alleging infringement-an act unchanged by the complaint’s subsequent success or failure-unambiguously implicates § 315(b)’s time bar”, with “no exceptions for dismissed complaints”. The difference here from Click-to-Call is “that Bennett’s complaint was involuntarily dismissed without prejudice”, but the FC panel found “no reason to distinguish” this case from Click-to-Call on that basis. Given the 2012 date the complaint was served and the 2015 IPR filing date, the FC panel concluded “[t]he Board lacked authority to institute review” and vacated its FWD and remanded it for dismissal. On the sanctions issue, the FC panel explained that it could not yet review it “[b]ecause…the award remains nonfinal and unappealable” (Special Devices, FC 2001; “We extend pendent jurisdiction only reluctantly, and only to issues ‘inextricably intertwined’ with or necessary to resolution of issues before the court.” (Swint, US 1995)). Accordingly, the Board’s decision was vacated and remanded.

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Natural Alternatives Int., Inc. v. USPTO

Docket No. 2017-1962

October 1, 2018

Brief summary: Board affirmance of examiners rejections affirmed as NAI was not entitled to an earlier priority date from a chain of applications because an intervening CIP disclaimed priority to the earlier applications.

Summary: NAI appealed Board decision following inter partes reexamination of NAI’s US 8,067,381 affirming the examiner’s rejection for anticipation or obviousness and denying NAI’s request for rehearing. The ‘381 patent issued from a chain of eight applications. During reexamination, Woodbolt (which requested the reexamination but is not a party to this appeal; FN2 indicates Woodbolt and NAI settled their lawsuit regarding the ‘381 patent) “alleged that ‘the asserted claim to priority of the ‘381 Patent is defective’ because the ‘applicants deliberately and expressly terminated their claim to the priority of the first four applications[,]’ which thus ‘broke[] the chain of priority between the Fourth and Fifth Applications.” “During reexamination, NAI did not dispute that it had waived priority to the fourth through the first applications in its fifth application” (a continuation-in-part (CIP)) but argued that was irrelevant because “the sixth application maintained priority back to the first application”. The examiner was not persuaded and “rejected the reexamined claims in view of prior art including the ‘596 patent (i.e., the patent that issued from the first application), and then closed prosecution.” Responding to NAI’s appeal, “[t]he Board determined that when NAI filed the eighth application, ‘[t]he fifth application [was] not entitled to the benefit of the fourth application since the specific reference to the fourth application was deleted in the fifth” and, therefore, the ‘381 patent was “not entitled to the benefit of the fourth through the first applications.” The FC panel reviewed the Board’s priority determination (a legal conclusion) de novo as there were no relevant disputed factual issues. The FC panel first explained that it has “previously acknowledged that amending an earlier-filed parent application may affect the priority of its child applications” (In re Janssen, FC 2018; Searle, FC 2015), and found the Board did not err “because the fifth application lacked priority to the first application” and therefore “the eight application’s priority claim to the first application (via the fifth application) did not satisfy all of § 120’s requirements” (application not entitled to priority, the patentee must demonstrate entitlement to the USPTO (In re NTP, FC 2011)). NAI also argued “that although ‘a claimed benefit to an earlier filing date may later be altered in the instant application according to MPEP § 201.11…that alteration only applies to the instant application-not other,…applications”. After first noting “that the MPEP ‘does not have the force of law’” (Molins, FC 1995), the FC panel explained that it “reviewed MPEP § 201.11 and [found] nothing in its text that limits the scope of waiver to only the instant application”. NAI also argued that under “§ 120, the case law”, “merely adding an additional link in a single growing chain…must be interpreted as providing for a new priority claim being created at each new filing” but the FC panel disagreed (Godfrey, US 1863 (“under § 120, parent and continuing applications ‘are to be considered as parts of the same transaction”)). NAI also argued “that the Board’s determination impermissibly ‘limits an applicant’s ability to seek protection’ when ‘amending the priority claim to gain [patent] term” but the FC panel explained that “NAI cannot have it both ways.”

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