Richard Storer et al. v. Jeremy Clark and United States (intervenor)


Docket No. 2015-1802 (appeal from PTAB No. 105,981)

PROST, NEWMAN, DYK
June 21, 2017

Brief Summary: Board interference decision that Storer’s (Idenix’s) provisional application was not enabled for the claims affirmed because, e.g., “the art, at least with respect to fluoridation of tertiary alcohols to produce a tertiary fluorine in the 2’ ‘down’ position, was highly unpredictable.” Priority was therefore awarded to Clark’s (Gilead’s) application.

Summary: Storer (senior party) appealed from PTAB interference decision that the provisional application to which Idenix’s US 7,608,600 claims priority was not enabled for treatment of hepatitis C virus infection by administering to infected individuals compounds “having the 2’F(down) substituent” of the claims. The intereference was declared with Clark’s Ser. No. 11/854,218 (assigned to Gilead). Storer argued the claimed 2’F(down) compounds “were generically disclosed…and were readily obtained based on the disclosure and the prior art.” The PTAB disagreed the provisional enabled the 2’F(down) compound because “undue experimentation would be required to produce” the structure (“when the issue is priority based on the content of the specification, ‘[t]he earlier application must contain a written description of the subject matter of the interference, and must meet the enablement requirement” (35 USC § 112, para. 1 (now 112(a)); Hyatt, FC 1998)). Storer did not “dispute that the…provisional contains no specific examples of synthesis of compounds having the” 2’F(down) structure (3rd Wands factor (“presence or absence of working examples”)), that it had not been synthesized as of the provisional application filing date (4th Wands factor (“nature of the invention”)), the prior art did not teach, or explicitly suggest the use” a particular precursor (“DAST”) relied on by Storer to make the compound and the 2’F(down) substituent was not suggested by the prior art (5th Wands factor (“the state of the prior art”)), and level of skill in the art was very high (6th Wands factor). The PTAB also found “the art, at least with respect to fluoridation of tertiary alcohols to produce a tertiary fluorine in the 2’ ‘down’ position, was highly unpredictable.” Storer argued a prior art reference (“Matsuda”) showing a methyl group at the 2’ position and the provisional specification enabled the 2’F(down) compound (“Matsuda provides any necessary information not in the…provisional”) but the PTAB disagreed because, e.g., as Clark argued, the provisional does not show conversion of any of the compounds therein to Matsuda’s compound and the synthetic schemes thereof include the “wrong stereochemistry”. The FC panel opinion explained that while “[k]knowledge of the prior art is presumed” and “[t]he specification need not recite textbook science”, “it must be more than an invitation for further research” (Genentech, FC 1997 (“the specification, not the knowledge of one skilled in the art…must supply the novel aspects of the invention in order to constitute adequate enablement”)). The FC panel agreed with the PTAB, finding “Wands factor 7, the predictability of the art…to be particularly relevant” (pointing to expert testimony) but also the “undue” nature of the experimentation required (“at least two years of a high priority experimentation”, exemplified by Idenix’s own efforts). Thus, the Board decision was affirmed.

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TC Heartland LLC v. Kraft Foods Group Brands LLC


SCOTUS Docket No. 16-341

May 22, 2017

Brief Summary: SCOTUS held “that a domestic corporation ‘resides’ only in its State of incorporation for purposes of the patent venue statute” (28 USC §1400(b)) and not as defined by the broader definition provided by the general venue statute (28 USC §1391(a)).

Summary: Under 28 USC §1400(b), “[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” It is noted that §1400(b) is a descendant of the 1897 patent specific venue statute (Stonite, US 1942) and specifically applies to “[a]ny civil action for patent infringement”. The general venue statute (28 USC §1391(a),(c)) “provides that, ‘[e]xcept as otherwise provided by law’ and ‘for venue purposes,’ a corporation ‘shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction with respect to the civil action in question.” The question here was whether the Federal Circuit correctly “reasoned that because” the petitioner, organized under Indiana law and residing in Indiana, “resided in Delaware under §1391(c)” (the general venue statute), “it also resided there under §1400(b)” (the patent venue statute). This opinion explained that under its Fourco decision (US 1957), “for the purposes of §1400(b) a domestic corporation ‘resides’ only in its State of incorporation”, rejecting the argument that “the broader definition of corporate ‘residence’ contained in the general venue statute” (§1391(c)) is incorporated into the patent infringement-specific §1400(b). Thus, §1391(c) does not “allow a plaintiff to bring a patent infringement lawsuit against a corporation in any district in which the corporation is subject to personal jurisdiction” (e.g., “‘minimum contacts’ with the forum state” (such as doing business in that state) “such that maintenance of the suit does not offend traditional notions of fair play and substantial justice” (Int. Shoe, US 1945) (provided for reference here but not cited in this opinion, but see NexLearn (FC 2017)). Thus, SCOTUS held “that a domestic corporation ‘resides’ only in its State of incorporation for purposes of the patent venue statute.” FN1 notes that the Court’s analysis is “confine[d]…to the proper for corporations”, explaining that “while this case comes to us at the pleading stage and has been litigated on the understanding that petitioner is a corporation”, there may be a dispute regarding whether the petitioner is in an “unincorporated entity”.

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NexLearn, LLC v. Allen Interactions, Inc.


Docket No. 2016-2170, -2221

MOORE, SCHALL, HUGHES
June 19, 2017

Brief Summary: DC dismissal of NexLearn’s infringement and breach of contract due to breach of confidentiality relating to an NDA affirmed (e.g., “[w]hile a Kansas resident could purchase ZebraZappsfrom Allen’s website, what is missing is any evidence that such a sale has taken place.”)

Summary: NexLearn appealed DC dismissal of its patent infringement and breach of a nondisclosure agreement (NDA) between the parties (misusing confidential information) for lack of personal jurisdiction. Under the NDA, NexLearn shared its “social simulation software SimWriter®”. The NDA included a “choice of law provision stating Kanses law governs the agreement.” The DC agreed with Allen that NexLearn did not show the required “personal jurisdiction in order to bring its contract claim” since “NexLearn failed to allege that Allen had sufficient contacts with Kansas”. The FC panel explained the DC “can exercise personal jurisdiction over an out-of-state defendant pursuant to either general or specific jurisdiction”, general jurisdiction being found when a party’s “affiliations within a State are so ‘continuous and systematic’ as to render them essentially at home in the forum State” (Daimler AG, US 2014). “Specific jurisdiction…‘focuses on the relationship among the defendant, the forum, and the litigation” (Walden, US 2014) (three-part test: whether the defendant purposefully directed its activities at the forum State, whether the claims arise out of or relate to those activities, and whether the assertion of jurisdiction is reasonable and fair (Avocent, FC 2008). And the “out-of-state defendant must have ‘minimum contacts’ with the forum state ‘such that maintenance of the suit does not offend traditional notions of fair play and substantial justice’” (Int. Shoe, US 1945). “[S]upplemental jurisdiction” may be exercised “once a court has original jurisdiction over some claims” as long as the additional claims “are part of the same case or controversy”. The FC panel agreed with the DC (considered de novo), finding, e.g., “many of the contacts NexLearn assertes confer specific jurisdiction over Allen occurred prior to the…patent’s issuance”, Allen’s activities related to the “later development of ZebraZapps…are too attenuated to form a sufficient contact”, and the choice of law provision does “not render Allen subject to specific jurisdication in Kansas” (Burger King, US 1985). Its post-patent issuance interactive website including a dropdown menu allowing Kansas residents to buy the app was also found to be insufficient (“While a Kansas resident could purchase ZebraZappsfrom Allen’s website, what is missing is any evidence that such a sale has taken place.”) (Nuance Comm., FC 2010; Campbell Pet, FC 2008; Trintec, FC 2005; Helicopteros, US 1984 (“unilateral activity of another party or third person is not an appropriate consideration”)). Thus, the DC’s dismissal for lack of personal jurisdiction was affirmed. It also found that since there was no personal jurisdiction, the DC could not have supplemental jurisdiction over the breach of contract claim.

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The Cleveland Clinic Foundation et al. v. True Health Diagnostics LLC


Docket No. 2016-1766

LOURIE, REYNA, WALLACH
June 16, 2017

Brief Summary: Patent directed at detecting myeloperoxidase release as a sign of cardiovascular disease ineligible under § 101. DC decision of no contributory or induced infringement affirmed since CCF fell “short of showing specific intent and action’ on behalf of True Health”.

Summary: Cleveland Clinic Foundation (CCF) appealed DC finding that three of its patents (US 7,223,552; 7,459,286; 8,349,581) claiming methods for testing for myeloperoxidase (MPO) in a bodily sample released as an early symptom of heart disease are ineligible subject matter under § 101, and that CCF failed to state a claim of contributory or induced infringement of a fourth patent (US 9,170,260) including administering “a lipid lowering agent” following an MPO assay. The opinion explains that “[t]he inventors purportedly discovered how to ‘see’ MPO in blood and correlate that to the risk of cardiovascular disease” by comparing data to “a ‘predetermined’ or ‘control value’” derived from “apparently healthy” people. The FC panel opinion explained that it reviews procedural questions not unique to patent law under the law of the regional circuit (de novo under the 6th Cir. (Univ. Utah, FC 2013) but under the “lesser standard” of abuse of discretion due to events at the DC) and questions under § 101 de novo. CCF argued the DC only analyzed certain claims and “should have undertaken claim construction and developed the factual and expert record before analyzing whether the claims were” patent eligible. The FC panel disagreed since “[w]here, as here, the claims ‘are substantially similar and linked to the same’ law of nature, analyzing representative claims is proper” (Content Extraction, FC 2014). The FC panel also found CCF “provided no proposed construction of any terms or proposed expert testimony that could change the § 101 analysis.” The two-step Alice § 101 test was applied (step one: are the claims “directed to ineligible subject matter, such as a law of nature” (Mayo, US 2012; McRO, FC 2015; Thales Visionix, FC 2017); step two: determine whether “the elements of the claims…individually [or] as an ordered combination transform the nature of the claims into a patent eligible concept” (Ariosa, FC 2015)). The claims were found to be directed to natural phenomena (“the testing patents purport to detect MPO and other MPO-related products, which are naturally occurring in bodily samples…the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between” (as in Ariosa, “[t]he inventors…did not create or alter any of the genetic information”, and unlike CellzDirect (FC 2016) in which “the claims…were…directed to a new and useful laboratory technique”). In the second Alice step, “[t]he claims, whether considered limitation by limitation or as a whole” were found not to “sufficiently transform the natural existence of MPO in a bodily sample into a patentable invention” (“merely tell[ing] those ‘interested in the subject about the correlations that the researchers discovered” (Mayo)). Regarding contributory or induced infringement of the ‘260 patent, it found CCF fell “short of showing specific intent and action’ on behalf of True Health” with respect to doctors that may prescribe the lipid-lowering drugs, and therefore affirmed the DC decision.

Posted in Contributory Infringement, Inducement to Infringe, Infringement, Patentability, Uncategorized | Leave a comment

EmeraChem Holdings, LLC v. Volkswagen Group of America, Inc. et al.


Docket No. 2016-1984 (IPR2014-01558)

MOORE, CLEVENGER, CHEN
June 15, 2017

Brief Summary: Board finding that prior art patent sharing inventor not overcome by uncorroborated inventor declaration affirmed. EmeraChem found not to have had sufficient notice and opportunity to be heard because “[f]or these…dependent claims, the Board never referenced anything other than Saito”.

Summary: EmeraChem appealed Board’s IPR decision that claims 1-14 and 16-20 of US 5,599,758 directed to methods for regenerating an engine catalyst would have been obvious in view of a combination of three references (“Campbell ‘558” (incorporated into the ‘758 patent and determined to be § 102(e) art (“described in a patent granted on an application for patent by another filed in the [US] before the invention thereof by the applicant”), “Saito” and “Stiles”). EmeraChem argued the ‘558 patent is not § 102(e) art and that “it did not have sufficient notice and opportunity to respond to Stiles as grounds for rejecting claims 3, 16 and 20.” The FC panel explained that it reviews the Board’s legal conclusions de novo (including whether a reference qualifies as prior art under § 103 (Riverwood, FC 2003) and compliance under the Administrative Procedures Act (APA) (Dell, FC 2016; In re NuVasive, FC 2016)) and its factual findings for substantial evidence (In re Gartside, FC 2000). Mr. Campbell is an inventor on both the ‘758 patent and the alleged § 102(e) reference Campbell ‘558. Under § 102(e), this opinion explains, “‘by another’ means that an application issued to the same inventive entity cannot qualify” and “[h]ere, the patents were issued to different groups of listed inventors” (each including Campbell). The question in this case was “whether the portions of the reference relied on as prior art, and the subject matter of the claims in question, represent the work of a common inventive entity.” Campbell’s declaration was found insufficient as uncorroborated by “any context, explanation, or evidence to lend credence to the inventor’s bare assertion” (not required in every case (Price, FC 1993 (uncorroborated testimony is treated with skepticism); In re Dubaun, CCPA 1982 (“does not stand for the proposition that declaration alone is always sufficient to support an inventor’s claim to inventorship”); In re Katz, CCPA 1982 (“more than a naked assertion by the inventor”); Knorr, CCPA 1982 (circumstantial evidence may suffice)). Thus, the Board’s findings that Campbell ‘558 is § 102(e) prior art and that claims 1-2, 4-14 and 17-19 would have been obvious were affirmed. The FC panel agreed with EmeraChem on the sufficient notice and opportunity to be heard issue regarding Stiles and claims 3, 16 and 20 because “[f]or these three dependent claims, the Board never referenced anything other than Saito” (“A general statement that lists all the challenged claims and all asserted prior art is not a separate, additional articulation that each of the claims may be obvious over any combination of all listed prior art.”) It distinguished Cuozzo (US 2016) since there “the institution decision gave the patentee notice of the prior art combination that the final decision relied upon” (see also Genzyme, FC 2016, in which “Genzyme had actual notice”; Novartis, FC 2017). The FC panel also noted it was not holding here “that the Board is constricted in its [FWD] to citing only portions of a reference cited in its Institution Decision.” Thus, this part of the Board’s decision was vacated and remanded.

Posted in Inter Parties Review (IPR), IPR, Obviousness, Uncategorized | Leave a comment

Merck Sharpe & Dohme Corp. v. Wyeth LLC

IPR2017-00378, IPR00380, IPR2017-00390
U.S. Pat. No. 8,562,999 B2
June 13, 2017

Decision to Insitute IPR

Brief Summary: Board decision to institute IPRs against Wyeth’s (Pfizer’s) US 8,562,999 B2 relating to the vaccine Prevenar®.

Summary: Each of the ‘378, ‘380 and ‘390 IPRs relate to Wyeth’s (Pfizer’s) US 8,562,999 B2 relating to the vaccine Prevenar®, and each was instituted. The ‘380 IPR was granted on the basis of obviousness in view of “Chiron”, “Smith” and “Elan” (claims 1-6, 10-11, 14 and 17-20) and Chiron, Smith, Elan, and “Peña” (claims 17-18). The ‘380 IPR was also granted on the basis of obviousness in view of “Prevenar” and Chiron (claims 1-6, 10-11, 14 and 17-20) or Prevenar, Chiron and Peña (claim 18). The ‘390 IPR was granted on the basis of obviousness in view of Chiron, Smith, and Elan or Prevenar and Chiron (claims 7-9, 12, 13, 15, 16, 21 and 22). Claim 1 is presented in each decision as illustrative and claims “[a] formulation comprising (i) a pH buffered saline solution” (pKa “about 3.5 to about 7.5”), “an aluminum salt and (iii) one or more polysaccharide-protein conjugates, wherein the formulation is comprised in a siliconized container means and inhibits aggregation induced by the siliconized container means.” The terms “polysaccharide” and “polysaccharide-protein conjugates” were construed under the broadest reasonable construction (“BRC”; 37 CFR § 42.100(b); Cuozzo, US 2016). “[P]olysaccharide” was found to be “set forth with reasonable clarity, deliberateness, and precision” by the specification as “any antigenic saccharide element commonly used in the immunological and bacterial vaccine arts”. “[P]olysaccharide-protein conjugates” was found to be “generally describe[d]…in a manner that is consistent with the plain and ordinary meaning of the phrase” (“the resulting product of reacting” a polysaccharide as defined above “with a carrier protein that is amenable to standard conjunction procedures”). The Board also found the claims did not “require the formulation to provide any particular ‘level of immunogenicity’”. The inhibition of “aggregation induced by the siliconized container means” was determined to allow for additional ingredients that “may contribute the required aggregation inhibition” (In re Baxter, CCPA 1981 (“’comprising’ in a preamble”); CIAS, FC 2007 (“comprising”)) and not to “require[] maintaining any particular level of antigenicity”. The Board also adopted Wyeth’s description of one of ordinary skill in the art (Ph.D. or Masters degree and “familiarity or experience with the general components and formulation of bacterial vaccines” (Okajima, FC 2001)). In its ‘378 IPR obviousness analysis, the Board explained that, e.g., while “Chiron does not expressly teach that its formulations are comprised in a siliconized container means” but that that would have been obvious since, e.g., “standard pharmaceutical vial stoppers…were siliconized.” The Decision also “focuse[d] on the deficiencies in Patent Owner’s arguments in its Preliminary Response”, e.g., its dependence on “claim constructions that we have not adopted at this stage in the proceeding” (e.g., no requirement for “achieving or preserving some particular level of immunogenicity”). The Board also disagreed that certain references were not “pertinent prior art” because “they do[] not concern vaccine formulation” since, e.g., the same were “relied upon to show the standard practice of lubricating pharmaceutical container means”. It also found Merck’s expert testimony “to be reasonable and based on the knowledge of a person of ordinary skill in the art.” The Board did not agree with Wyeth that “Examples 3 and 4 of the Specification” shows “that the results…were unexpected compared to [] the closest prior art.” It also did not find a teaching away in the cited art (no explanation or evidence “that the referenced lyophilized formulation was not simply a preferred formulation, as opposed to a necessary one” (In re Fulton, FC 2004). The Board’s conclusions were reached as appropriate “[a]t this stage in the proceeding”. The decision to institute the ‘380 and ‘390 IPRs were based on similar reasoning.

Posted in Claim Construction, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

Purdue Pharma L.P. v. Recro Technology, LLC


Docket No. 2016-22260

DYK, BRYSON, CHEN
June 13, 2017

Non-precedential

Brief Summary: Board’s decision of lack of written description affirmed (“a description that merely renders the invention obvious does not satisfy the [WD] requirement”).

Summary: Purdue appealed PTAB refusal of claims in US 13/833,263 and 14/094,968 directed to controlled-release formulations of hydrocodone, and grant of junior party Recro’s motion for judgment that the claims lack written description (WD). During the interference proceeding, each party filed motions alleging the others’ claims were invalid. The Board agreed and terminated the proceedings. It found that Purdue claims lack written description because the “specifications do not describe ‘separate particles of inert beads coated with each different formulation together in one dosage form’”. The FC panel explained that “[w]hether patent claims satisfy the [WD] requirement of 35 U.S.C. § 112 is a question of fact” (Ariad, FC 2010) and that “the Board’s factual findings” are reviewed “for substantial evidence” (Inphi, FC 2015). It also explained that the test for WD “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art had possession of the claimed subject matter as of the filing date” (Ariad, FC 2010 (description does not need to be “in haec verba” but “a description that merely renders the invention obvious does not satisfy the requirement” (Ariad; Novozymes, FC 2013)). It summarized “[t]he issue here” as being “whether the specifications adequately disclose the claimed separate populations of IR and CR multiparticulates, which each comprise inert beads coated with hydrocodone, combined in a single dosage form.” The FC panel agreed with the Board that the specifications did not include such a description, finding the recitations such as “an effective amount of opioid in immediate release form is included in the formulation” to be insufficient (“the written description…does not disclose a formulation wherein the IR and CR components exist as separate multiparticulates containing an inert bead core…the Board correctly determined that these disclosures ‘describe overcoating the different release formulations on top of each other [and] not combining two populations of beads.”) Purdue argued the specification “discloses an IR layer directly onto an inert bead” and that an “intermediate product ‘may’ be overcoated with the CR material”, meaning the CR coating is optional (“therefore the method teaches preparation of both IR and CR beads”). However, the FC agreed with the Board’s conclusion that “[e]ven if the method is read to disclose both IR and CR beads, the disclosure does not suggest that the IR and CR beads would both be combined in a single dosage form.” Purdue also unsuccessfully argued the incorporation-by-reference of US 5,472,712 provided that description, the FC concluding the Board correctly found that disclosure was directed to hydromorphone. The FC panel concluded Purdue’s argument “that a person…would isolate and combine aspects from various embodiments…to obtain the claimed invention” was the wrong test since, as mentioned above, “a description that merely renders the invention obvious does not satisfy the [WD] requirement”. Thus, the Board’s decision was affirmed.

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