Metalcraft of Mayville, Inc. et al. v. The Toro Co. and Exmark Manuf. Co.


Docket No. 2016-2433, -2514

MOORE, HUGHES, STOLL
February 16, 2017

Brief Summary: The DC’s grant of a preliminary injunction against Toro was affirmed.

Summary: Toro/Exmark (a wholly owned subsidiary of Toro) appealed DJ grant of a preliminary injunction (PI) to Metalcraft regarding lawnmowers with a suspended operator platform encompassed by US 8,186,475. The platform supports the entire body of the operator and “can suspend or isolate some controls from the rigid chasis.” Metalcraft (d/b/a Scag Power Equipment) commercialized the technology in its Cheetah line of lawnmowers and Toro introduced a suspended operator platform (MyRIDETM suspension system) in 2015. Toro’s steering controls “are connected to the chasis, not the operator platform.” The FC opinion explains that PIs are reviewed using the law of the regional circuit (7th here) but that FC precedent has “dominant effect…insofar as it reflects considerations specific to patent issues” (Murata, FC 2016, citing Trebro, FC 2014). Both the 7th circuit and the FC review PI decisions for an abuse of discretion which may be established by showing “a clear error in judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings” (Novo, FC 1996). To obtain a PI, a party must show “that [it] is likely to succeed on the merits” (likely to prove infringement (Sciele Pharma, FC 2012)), “that [it] is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in [its] favor, and than an injunction is in the public interest” (Luminara, FC 2016). And a PI “should not issue if the accused infringer ‘raises a substantial question concerning either infringement or validity” (Amazon.com, FC 2001; Senju, FC 2015). Toro argued the DC erroneously rejected its noninfringement defense because the DC’s construction of “‘an entire body of an operator’ excludes the operator’s hands and arms” (although the DC did make the statement “which means that the platform does not support the rider’s arms and hands”) but the FC disagreed. The FC also agreed that only the “[u]nasserted dependent claims…contain limitations that require the steering controls to be connected to the operator platform” (e.g., “the claim language itself keeps these concepts separate”). Thus, the FC concluded the DC did not abuse its discretion on this point. Toro also argued claim 21 would have been obvious in view of two prior art patents but the FC found the DC properly rejected Toro’s motivation to combine argument (“Toro merely identifies a problem that Henriksson sought to solve. However, ‘knowledge of a problem and motivation to solve it are entirely different from motivation to combine particular references…we are left with only hindsight bias that KSR warns against.” Innogenetics, FC 2008; KSR, US 2007). It also declined to consider Toro’s anticipation arguments regarding claims 11 and 14 because of its determinations regarding claim 21 “which reaches all of the accused products.” Regarding irreparable harm, the FC explained that “[t]here is no requirement that the [DC] discuss every fact alleged by Toro” (Fresenius, FC 2009) and “[t]he fact that other infringers may be in the marketplace does not negate irreparable harm” (Pfizer, FC 2005) and found no abuse of discretion. The FC also found no abuse of discretion in its consideration of the balance of equities and the public interest (Hybritech, FC 1988; Atlas Power Co., FC 1985). And it disagreed with Toro that the injunction is too broad as it “discusses both the claims at issue as well as the defendants’ accused products which it enjoins.”

Posted in Claim Construction, Infringement, Injunction, Obviousness | Leave a comment

Personal Web Technologies, LLC v. Apple, Inc.


Docket No. 2016-1174 (appeal from IPR2013-00596)

TARANTO, CHEN, STOLL
February 14, 2017

Brief Summary: Board’s obviousness decision following IPR vacated and remanded as it failed to properly explain its conclusions. Revised 18-month rule regarding claim construction explained.

Summary: PersonalWeb (PW) appealed Board decision in IPR2013-00596 that US 7,802,310 relating to “methods (or devices for carrying out methods) of locating data and controlling access to data by giving a data file a substantially unique name that depends on the file’s content” (a “True Name”) is invalid for obviousness. Apple’s argued for obviousness based on a combination of a US patent “focuse[d] on a system for backing up or restoring data” (Woodhill) and another “focuse[d] on a system for managing rights to access data” (Stefik). In its final decision (March 25, 2015), the Board applied the broadest reasonable interpretation (BRI) standard to the claims and agreed with Apple on obviousness. PW appealed the decision, including denial of its request for rehearing that was filed 13 days before the ‘310 patent expired. PW argued that since the ‘310 patent expired while its request for rehearing was pending, the claims should be construed under Phillips (FC 2005) and not BRI. FN1 explains that in In re CSB-Sys Int’l Inc. (FC 2016), it held that BRI is “inapplicable, outside the IPR setting, where the patent at issue had expired in a reexamination before the Board review the examiner’s decision”. It also noted that revised 37 CFR § 42.100(b) (2016) includes the “18-month rule” under which an IPR party may “request a district court-type claim construction approach” if the patent will expire within 18 months of the IPR petition’s filing and that it would not have applied here based on the timeline. However, this issue was not resolved in this opinion. Instead, the FC panel found that “the meaning of the language is plain from the face of the claims” and affirmed the Board’s construction. The FC panel agreed with PW, though, that “the Board has not done enough to support its conclusion” of obviousness (reviewed de novo and its underlying factual determinations for substantial evidence (In re Gartside, FC 2000; Intelligent Biosys., FC 2016 (“whether a reasonable factfinder could have arrived at the agency’s decision”)). It explained the Board first had to find the alleged prior art disclosed all the elements of the claims (In re Kotzab, FC 2000) and then the motivation to combine the art “in the way claimed by the ‘310 patent claims at issue” with “a reasonable expectation of success” (In re NuVasive, FC 2016; In re Warsaw Orthopedic, FC 2016; Ariosa, FC 2015; KSR, US 2007 (“it can be important to identify a reason that would have prompted” the combination and the “analysis should be made explicit”)). It also noted it reviews IPR decisions to ensure that they are not ‘arbitrary, capricious, an abuse of discretion,…otherwise not in accordance with the law…[or] unsupported by substantial evidence” (Pride Mobility, FC 2016; Synopsys, FC 2016). It found “[t]he Board’s decision here [to be] inadequate” as it did not provide the required explanation regarding either the disclosure of each claim element by the claims or the motivation to combine the references. For example, the Board’s agreement with Apple’s contention that the combination “would have allowed for the selective access features of Stefik to be used with Woodhill” is not enough as it “seems to say no more than that a skilled artisan, once presented with the two references, would have understood that they could be combined” (Belden, FC 2015 (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations….”)) It “nowhere clearly explained, or cited evidence showing, how the combination of the two references was supposed to work” which is required in a case like this in which “complexity or obscurity of the technology or prior art descriptions may well make more detailed explanations necessary” (vs. a case in which “the technology is simple and familiar and the prior art is clear in its language and easily understood”). Thus, the Board’s obviousness decision was vacated and remanded.

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In Re: Lawrence B. Lockwood


Docket No. 2016-1371

PROST, MOORE, CHEN
February 13, 2017

Non-precedential

Brief Summary: Board claim construction and finding of anticipation affirmed.

Summary: Lockwood appealed Board affirmance following ex parte reexamination requested by an anonymous third party of the examiner’s determination that claims of US 7,010,508 relating to systems for loan screening would have been anticipated (claims 8-14) or obvious (claim 15). Claim 1-7, 16 and 17 were found to be patentable. Lockwood appealed the decision as to the obviousness determination of claims 8-14. In its decision, the Board rejected Lockwood’s argument that “a set of stored data” in the claim 8 limitation “means for analyzing and for combining an user’s entry with a set of stored data” “should be broadly construed to ‘read[] on any data in any location (e.g., local data, remote data, or data located somewhere in between).’” Lockwood filed a Request for Rehearing, arguing the Board did not consider the ‘508 prosecution history; the Board then reconsidered its position but maintained its original construction. The FC panel explained the “claim construction is reviewed de novo with any underlying factual determinations reviewed for substantial evidence” (Teva, US 2015; Microsoft, FC 2015). In this appeal, however, Lockwood argued that the Board did not conduct a means-plus-function analysis of the entire “means for” limitation and “failed to limit the claim term in dispute to the algorithms disclosed in the specification (and equivalents thereof).” The FC panel noted that the examiner did so and the Board accepted the examiner’s means-plus-function construction. It also explained that the Board’s focus “on the ‘a set of stored data’ language within the larger limitation is unsurprising” because Lockwood directed his appeal to the Board “to the term ‘stored data’ alone”, “consistenly argued” for a narrow construction of the term, and “the Board was entitled to focus on the portion of the claim at issue between the parties, rather than expending time and resources on those parts of the examiner’s construction that were not in dispute.” The FC panel also found Lockwood’s arguments that the Board did not consider the ‘508 prosecution history “to be without merit” since the Board did consider it. It also found “[n]othing in the plain language of claim 8 requires that the ‘stored data’ be accessed from a remote location” as Lockwood argued and, additionally, “the specification lacks a definition of ‘stored data’”. And it found Lockwood had not made a “clear and unmistakable disclaimer” (Thorner, FC 2012) during prosecution since “[t]hen-applicant Lockwood’s statements to the PTO contain words like ‘may’ and ‘for example’” and his “statements during reexamination fare no better” (“the Board is not obligated to treat a patent owner’s claim construction arguments on appeal as prosecution history disclaimer” (Tempo, FC 2014)). Several of the anticipation arguments Lockwood made to the FC were found to have been waived since those were not made to the Board (In re Baxter, FC 2012; Johns Hopkins, FC 1998) and its remaining argument “misses the mark”. The Board’s decision was therefore affirmed.

Posted in Anticipation (35 USC 102), Claim Construction, Means-plus-function, Prosecution History Estoppel, Reexamination | Leave a comment

Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc.

PGR2015-00011 (US 8,859,623 B1)
Post-Grant Review Decision
November 14, 2016

Brief Summary: Preamble found not to limit the claim; petition for PGR found not to show unpatentability of the claims by a preponderance of the evidence.

Summary: The grounds for post-grant review (PGR) may included any that could be raised under 35 U.S.C. § 101, 102, 103, or 112 (except for best mode) and must be filed no later than nine months after the date of grant of the patent or issuance of a reissue patent. The only grounds available under IPR, on the other hand, are those raised under 35 U.S.C. § 102 or 103 and only on the basis of patents or printed publications (and the time requirements differ from PGR). In this PGR proceeding, Altaire petitioned for review of claims 1-1 of Paragon Bioteck’s US 8,859,623 B1 relating to methods for using an ophthalmic composition “wherein the composition comprises R-phenylephrine hydrochloride having a chiral purity of at least 95% when administered after storage” (at “between -10 to 10 degree Celsius prior to administration”). Trial was instituted to determine whether the claims would have been obvious over Altaire’s Product. The Broadest Reasonable Construction (BRC) standard applies to PGR (In re Cuozzo, FC 2015). Under that standard, the Board disagreed with Paragon that the method step should be limited “by adding a six-months-cold-storage requirement” even though the preamble to claim 1 indicates “the chiral purity of R-phenylephrine hydrochloride is at least 95% of the initial chiral purity after 6 months”, “consistent with the prosecution history, in which the applicants argued, and the examiner agreed, that claim 1 was patentable” for that reason. The Board reasoned, however, that that requirement “simply describes a property of the composition to be administered” and “does not add a limitation on the duration of storage at cold temperatures recited in the ‘administering’ step”. “In other words, the step of claim 1 defines the chiral purity of the composition at the time of administration after cold storage for an unspecified time period” and claim 1 does not “require an active step of cold storage for six months.” The Board also identified Alaire’s proposed expert witness as only a “fact witness” since no bases was provided for his qualification as an expert which changes on what he may “testify compentently” (e.g., an expert may, but a lay witness may not, testify as to “prior art teachings or the level of ordinary skill”), and denied its attempt to enter his “new” declaration showing his expertise (“improper reply evidence”). Regarding the obviousness challenge, the Board qualified the ophthalmic solution lots Altaire including the package insert with dosing and storage directions (e.g., one drop in each eye for pupil dilation, store at 2-8 degrees Celsius, within the limitations of ‘623 claim 1) submitted as prior art under § 102(a)(1) (“in public use, on sale, or otherwise available to the public”). The parties disputed the accuracy of Altaire’s HPLC-based chiral purity testing. The Board noted that in a PGR, as in an IPR, “the burden of persuasion is on the petitioner to prove unpatentability, and that burden never shifts to the patentee” (35 USC § 326(e), Dynamic Drinkware (FC 2015)) and “[w]here, as here, the only question presented is whether due consideration of the four Graham factos renders a claim or claims obvious, no burden [of production] shifts from the patent challenger to the patentee” (In re Magnum Oils, FC 2016). And while PGR may be instituted on the “more likely than not” standard (35 USC § 324(a)), “the petitioner must prove unpatentability by a preponderance of the evidence” (35 USC § 326(e)). And Altaire was found not to have sufficiently shown that its HPLC data shows the Product “meets the chiral purity limitations of claim 1” (e.g., it “fail[ed] to explain…how the test was performed and how the data was generated” as required under 37 CFR § 42.65, Paragon did not waive its challenge of the sufficiency of the evidence, that Paragon knew the details of Altaire’s testing procedure is not relevant (“it is the Board, not the Patent Owner, who must evaluate patentability”), and it was not satisfied by Altaire’s optical rotation data). Since it determined unpatentability had not been shown, the real-part-in-interest issue was not reached.

Posted in Inter Parties Review (IPR), IPR, Obviousness, Post-grant review, Preamble | Leave a comment

Roxane Laboratories, Inc. v. Novartis AG

IPR2016-01461 (US 9,006,224 B2)
Decision denying institution
February 13, 2017

Brief Summary: Roxane’s petition for IPR of Novartis’ US 9,006,224 related to the use of Afinitor® (everolimus) to treat pancreatic cancer dismissed as a reasonable likelihood of success in showing obviousness was not presented.

Summary: Roxane petitioned for IPR of Novartis’ US 9,006,224 related to methods for treating pancreatic neuroendocrine tumors (PNETs) by administering a rapamycin analogue (Afinitor® (everolimus)) “as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.” The decision notes that two infringement actions are pending against Roxane and Par, respectively. Par has also challenged claims 1-3 of the ‘224 patent in IPR2016-01479. In this IPR, Roxane challenged claims 1 and 2 as obvious in view of two (Lane and Tabernero) or three (von Wichert, Dutcher, Cottens, and Tabernero) references. The Board agreed with Novartis that “advanced” means “metastatic or unresectable” under the broadest reasonable interpretation (BRI) in view of specification (e.g., which implies “that not all solid tumors are ‘advanced’”) and “evidence of ordinary and customary usage, such as the ACS Cancer Glossary. The Board also agreed with Novartis that ‘advanced,’ in the usage of claim 1, is different than ‘after failure of cytotoxic chemotherapy’” (“advanced tumors…are present prior to” treatment failure). Tabernero is an abstract “regarding a Phase I study of the use of everolimus in patients with advanced solid tumors” which the Board, agreeing with Novartis, found does not “contain an explicit reference to either advanced PNETs or the failure of cytotoxic chemotherapy.” The Board saw “no reason to conclude that Tabernero intended to depart from” the above-mentioned “ordinary and customary usage” of “advanced” and, therefore, could not conclude the reference “would have been understood by a person of ordinary skill in the art as describing tumors that have failed to respond to cytotoxic chemotherapy.” It explained that Roxane’s expert testimony was only a “bare conclusion” which is therefore “entitled to little or no weight” (citing Monsanto, IPR2013-00022) (“Where, as here, the conclusory testimony is the sole basis for establishing that a claim limitation is taught or suggested by the prior art, we find it insufficient to establish a reasonable likelihood of prevailing regarding that claim.”) This rationale was applied to both combinations of references. The Board therefore concluded a reasonable likelihood of success was not shown.

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Wockhardt Bio AG v. Jannsen Oncology, Inc.

IPR2016-01582 (US 8,882,438 B2)
Decision Instituting IPR
January 17, 2017

Brief Summary: IPR instituted as Wockhardt showed a reasonable likelihood of prevailing, Amerigan did not need to be named, and no “second bite at the apple by an identical petitioner”.

Summary: Wockhardt filed a Petition for IPR of Jannsen’s US 8,882,438B2 related to methods for treating prostate cancer using the CYP17 enzyme (involved in testosterone synthesis) inhibitor abiraterone (ZYTIGA®) and prednisone, alleging the claims (“method…comprising administering…a therapeutically effective amount of abiraterone…and a therapeutically effective amount of prednisone”) would have been obvious in view of three prior art references and two declarations. Four litigations and two IPRs related to the ‘438 patent are described as pending. Under the broadest reasonable interpretation (Cuozzo, US 2016), the Board applied its constructions of “treat”, “treating,”, “treatment,” and “therapeutically effective amount of prednisone,” as previously determined in IPR2016-00286 (instituted and joined with IPR2016-01337 on Sept. 19, 2016) using the ‘438 specification (“treat”, “treating,”, “treatment,” “includes the eradication, removal, modification, management or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer”; “therapeutically effective amount of prednisone” means “an amount of prednisone effective for treating prostate cancer”). The Gerber reference was found to teach that PSA levels in patients with rising PSA are decreased following treatment with ketoconazole and prednisone. The O’Donnell reference was found to teach “that the need for concomitant therapy of abiraterone with a glucocorticoid needs to be further investigated.” And the Board explained that the Sartor reference showed prednisone can decrease PSA in one-third of patients “and hypothesizes ‘a dose-responsive relationship between glucocorticoid dose and PSA decline.” The Board concluded that based on these disclosures, “a person of ordinary skill in the art ‘would have reasonably expected each of abiraterone acetate and prednisone to treat prostate cancer when co-administered” (i.e., Wockhardt showed a reasonable likelihood of prevailing). Wockhardt argued Jannsen would not be able to rely on secondary considerations but since no such evidence was presented, the Board did not address this issue. Jannsen argued Amerigan should have been named as a real party in interest (§ 312(a)(2); e.g., the companies are co-defendants in a lawsuit) but the Board disagreed (e.g., “the focus of our real-party-in-interest inquiry is the relationship between a party and a proceeding” (Aruze Gaming, IPR2014-01288 (Paper 13) and the submitted “email exchange…[is] not supportive of Patent Owner’s allegations”). Jannsen also argued the Board should use its discretion under § 325(d) to decline initiation of this IPR because “the same prior art and substantially the same arguments” have been presented in the co-pending IPRs, but the Board disagreed (e.g., same prior art but different declarants, “it appears this case will involved arguments concerning objective indicia of non-obviousness, which involves a fact-specific analysis that often turns on evidence presented during trial”, “we do not perceive that either Patent Owner or the Board will be overwhelmed”, “we are not presented with a second bite at the apple by an identical petitioner”). Thus, this IPR was instituted.

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Shire Development, LLC et al. v. Watson Pharmaceuticals, Inc. et al.


Docket No. 2016-1785

PROST, TARANTO, HUGHES
February 10, 2017

Brief Summary: DC decision that Watson’s ANDA Product to Shire’s Lialda® reversed for not meeting the Markush requirements of the claims.

Summary: Shire sued Watson for infringement of US 6,773,720 directed to a controlled-release oral mesalamine (mesalazine or 5-amino-salicylic acid) composition for treatment of inflammatory bowel diseases (Shire, FC 2015, remanded and vacated by SCOTUS) by Watson’s ANDA 203817. Claim 1 requires “an inner lipophilic matrix consisting of substances selected from the group consisting of” various compounds, “an outer hydrophilic matrix…consist[ing] of compounds selected from the group consisting of” various compounds, and “optionally other excipients….” The DC determined that “[w]hen a matrix is hydrophilic, it ‘has an affinity for water’ and therefore ‘readily dissolves in’ it” (stipulated to by the parties as “having an affinity to water”) and “when…lipophilic, it ‘has an affinity for lipids’ and therefore ‘resists dissolving in water” (stipuled as having a “poor affinity towards aqueous fluids”). In its 2015 decision (including after remand), the FC determined the ‘720 matrices as having “mutually exclusive spatial characteristics-one inner, one outer-and mutually exclusive compositional characteristics-one hydrophilic, one lipophilic” and “that a ‘matrix-not just an excipient within the matrix’-must exhibit the appropriate characteristic” (“the inner volume contains substances from the group described for the inner lipophilic matrix (which are all lipophilic substances), and the outer volume separately contain substances from the group described for the outer hydrophilic matrix (which are all hydrophilic)”). In addition, it concluded “that the matrix compositions are ‘limited by the Markush groups’ added during prosecution ‘to overcome the examiner’s rejection of the claims as obvious.” The DC determined Watson’s ANDA Product satisfied these limitations since “the excipients falling outside the respective Markush groups were ‘unrelated’ to the invention since they did not drive the water-affinity property of their respective matrices.” The FC panel explained that it reviews a DC’s conclusions of law de novo and its finding of fact for clear error (Allergan, FC 2015) and that use of “consisting of” or “consists of” “creates a very strong presumption that that claim element is ‘closed’ and therefore ‘exclude[s] any elements, steps, or ingredients not specified in the claim” (Multilayer, FC 2016). And that presumption can only be overcome where “‘the specification and prosecution history’…’unmistakably manifest an alternative meaning,’ such as when the patentee acts as its own lexicographer” (Multilayer, FC 2016; Norian, FC 2004 (infringement not avoided by the addition of a spatula to a calcium phosphate chemical kit claim since it “has no interaction with the chemicals, and is irrelevant to the invention.”) The FC panel concluded “Watson’s ANDA Product does not facially satisfy the claim 1(b) Markush limitation” (“outer hydrophilic matrix”) by the inclusion of magnesium stearate which is outside of the Markush group but that the DC, in finding infringement based in part on expert testimony, concluded was “unrelated to the invention” (“not sufficiently lipophilic to render the outer matrix lipophilic” (as Shire also argued here). The FC panel, in contrast, concluded it “structurally and functionally relates to the invention” (“Norian did not restrict ‘related’ components to only those that advance or are intended to advance a Markush group’s allegedly inventive elements” and “consisting of” not equivalent to “comprising” (“open-ended”) or “consisting essentially of” (other components that “do not ‘materially affect the basic and novel properties of the invention’” may be included). And Shire’s argument that the examples include magnesium stearate in the outer matrix was not found to “‘overcome the exceptionally strong presumption’ that Markush groups are closed.” Thus, the DC decision was reversed.

Posted in Claim Construction, Generics / ANDA, Infringement | 2 Comments