ICOS Corporation v. Actelion Pharmaceuticals Ltd.

Docket No. 2017-1017, -1018 (IPR2015-00561, -00562)

April 18, 2018


Brief summary: PTAB findings of invalidity for obviousness of the claims of ICOS’ Orange Book-listed patents for tadalafil (Eli Lilly’s Cialis®) affirmed.

Summary: ICOS appealed PTAB IPR decisions that claims 1-32 of US 7,182,958 and claims 1-11 of US 6,821,975 directed to formulations comprising micronized tadalafil (both Orange Book-listed for Eli Lilly’s Cialis®) or a free particulate form of the compound, respectively, would have been obvious in view of combinations of four references (“Daugan”, “Butler”, “Seth”, and “Wadke”). The FC panel explained that the PTAB found “Daugan discloses a compound having the structural formula in the claims, i.e., tadalafil, and the excipients included in claim 1 of the ‘958 patent”, and a motivation to combine Butler’s teaching that the drug has poor solubility, Seth’s teaching that “compounds with low solubility generally also have a slow dissolution rate”, and both Seth’s and Wadke’s teaching “that reducing particle size through micronization can increase dissolution rate.” The PTAB also found that even though “Seth recognizes disadvantages to micronization, those disadvantages would not have stopped ordinarily skill artisans from using the technique” and “a reasonable expectation of success in combining the teaching of those references, and rejected ICOS’ claim of unexpected results.” ICOS argued the PTAB “improperly substituted its own obviousness arguments for those in the petition and improperly shifted the burden to ICOS to show nonobviousness” (§ 316(e)) and that “the references do not provide a motivation to combine or a reasonable likelihood of success.” The FC panel reviewed the PTAB’s determination of obviousness de novo and its underlying factual findings for substantial evidence” (Belden, FC 2015), noting decisions “must be set aside if they are ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” (5 USC § 706). The FC decided that “[s]ubstantial evidence supports the Board’s findings” (e.g., “Wadke teaches the micronization of drug particles”, “Butler teaches tadalafil is poorly water soluble”, and “Seth and Wadke…disclose that micronization solves dissolution problems”). The FC panel also found that substantial evidence supported the PTAB’s conclusion “that a skilled artisan would have had a reasonable expectation of success in combining these teachings”, based in part on Acetlion’s expert witness testimony. The FC panel also found that substantial evidence supported the PTAB’s conclusion that athe prior art did not teach away from micronization, based on Acetlion’s (and ICOS’) expert witness testimony. The FC panel also agreed with the PTAB that each of the claimed limitations were disclosed by Daugan’s examples. The FC panel also found no § 316(e) violation since the PTAB “did not use” new art “to teach elements of the claim or to supply the motivation to combine”, limiting its “findings…to its rejection of ICOS’ arguments regarding” the same or “responding to ICOS’ late-raised interpretation of Wadke” (“[u]nlike in Honeywell”, FC 2017). Thus, the PTAB’s decision was affirmed.

Posted in Generics / ANDA, Inter Parties Review (IPR), IPR, Obviousness, Obviousness-Teaching Away | Leave a comment

Apator Miitors APS v. Kamstrup A/S

Docket No. 2017-1681 (IPR2015-01403)

April 17, 2018

Brief summary: PTAB IPR final written decision (FWD) finding anticipation and obviousness, and rejected Apator’s proffered evidence of prior conception since it was based only on the inventor’s own statements and not corroborated, affirmed.

Summary: Apator appealed PTAB IPR final written decision (FWD) finding claim 2 of pre-AIA US 8,893,559 anticipated by a US patent publication (“Nielsen”) and claim 10 obvious in light of Nielsen and a European patent application (“Korner”). The FC panel explained that “[t]he primary issue on appeal is whether Apator can swear behind Nielsen by showing conception and reduction to practice prior to Nielsen’s effective filing date” following the PTAB’s determination that had not properly done so (Perfect Surgical, FC 2016; § 102(g)). The FC panel explained “that when a party seeks to prove conception through an inventor’s testimony the party must proffer evidence, ‘in addition to [the inventor’s] own statements and documents,’ corroborating the inventor’s testimony…to prevent an inventor from ‘describ[ing] his actions in an unjustifiably self-serving manner’” (Mahurkar, FC 1996; Hahn, FC 1989; Chen, FC 2003; Medichem, FC 2006; Cooper, FC 1998). And “[t]he sufficiency of the proffered corroboration”, it explained, “is determined by a ‘rule of reason’ analysis in which all pertinent evidence is examined” (In re NTP, FC 2011). The PTAB’s factual findings, of which sufficiency of corroboration is one, are reviewed for substantial evidence (that which “a reasonable mind migh accept as adequate to support a conclusion” (Consol. Ed., US 1938), and “the possibility of drawing two inconsistent conclusions from the evidence’ will not render the [PTAB’s] findings unsupported by substantial evidence” (Consolo, US 1966). The FC panel agreed with the PTAB that “Apator…failed to proffer any evidence of” the inventor’s “conception that is not supported solely by” the inventor himself (e.g., one of the inventor’s emails failed to include any indicia that a file describing the invention was attached thereto and inventor’s drawings were not shown to antedate Nielsen’s effective filing date). The FC panel explained that “[t]he evidence proffered by” the inventor “is stuck in a catch-22 of corroboration: Apator attempts to corroborate [the inventor’s] testimony with the emails and the drawings, but the emails and drawings can only provide that corroboration with help from [the inventor’s] testimony.” Apator argued the the emails and drawings “like unwitnessed laboratory notebooks, have some corroborative value, citing Singh” (FC 2000). The FC panel agreed with Apator “that, [u]nder a ‘rule of reason’ analysis, the fact that a notebook entry’ or other writing ‘has not been promptly witnessed does not necessarily disqualify it” (Hybritech, FC 1986; Mikus, CCPA 1976), that “alone, cannot corroborate an inventor’s testimony of conception” (Brown, FC 2002; Procter, FC 2009). And the FC panel explained that “[i]t is no answer that Apator’s evidence is ‘unrebutted,’” which “misunderstands [the] burden of proof under § 102(g), which requires that Apator prove” the inventor conceived of the invention before the prior art’s “effective filing date, not that Kamstrup prove [he] did not” (In re Magnum, FC 2016). Thus, the FC panel agreed with the PTAB that conception had not been established and therefore did not reach the issue of diligence in reducing the invention to practice.

Posted in Anticipation (35 USC 102), Claim Construction, Conception and Reduction to Practice, IPR, Obviousness | Leave a comment

Sumimoto Dainippon Pharma Co./Sunovion Pharm. v. Emcure Pharmaceuticals et al.

Docket No. 2017-1798-800

April 16, 2018

Brief summary: DC determination that Sumimoto’s US 5,532,372 relating to Sunovion’s schizophrenia and bipolar depression drug LATUDA® (lurasidone) is not limited to racemic mixture affirmed.

Summary: Emcure appealed DC determination that the claims of Sumimoto’s US 5,532,372 relating to Sunovion’s schizophrenia and bipolar depression drug LATUDA® (lurasidone) “cover[s] the two three dimensional orientations” of the enantiomer “in isolation-both the one shown in the claim and its mirror image-as well as mixtures of the two in any ratio.” Based on that determination, “[t]he parties then stipulated to infringement and the entry of an injunction” with respect to Emcure’s ANDA. The FC panel opinion explains that “[l]urasidone” is “the (-)-enantiomer of an imide compound covered by the ‘372 patent”, of which examples 1(b) through 1(e) “describe methods for separating Compound 101” (the lurasidone precursor) “into its constituent enantiomers in various salt forms” including “Compound 105…which is lurasidone.” The “parties agree[d] that the specific three-dimensional structure depicted in [‘372] claim 14 is lurasidone, the (-)-enantiomer.” The question here “centered on what combination of enantiomers claim 14 encompassed.” Emcure argued claim 14 is limited “to a ‘racemic mixture of two enantiomers of which the structural formula is representative” based on “the claimed structure’s similarities to Compound No. 101, which Appellants contend is a racemic mixture, organic chemistry books suggesting that ordinary skilled artisans draw a single enantiomer as a shorthand representation for a racemic mixture, and the ‘372 patent’s prosecution history.” The DC disagreed, finding that “even if Compound 101 is a racemic mixture, its resemblance to claim 14 did not justify importing that limitation from the specification into the claim” and that “the cited extrinsic evidence and prosecution history were at best irrelevant and at worst contradictory to” Emcure’s “construction.” The courts apply “the ‘ordinary and customary meaning’ to claim terms as a person of ordinary skill in the art would have understood them at the time of the invention” (Phillips, FC 2005) unless the “patentee…acts as his own lexicographer…or…disavows the full scope of a claim term either in the specification or during prosecution” (Thorner, FC 2012; Enzo, FC 2015 (ultimate construction reviewed de novo, factual determinations based on extrinsic evidence for clear error)). The FC panel determined that “the plain language and specification demonstrate that, at a minimum, claim 14 covers what it depicts: the (-)-enantiomer” as “[b]oth parties agree that the structure shown in the claim is the (-)-enantiomer”, its scope is not limited “to a ‘racemate’ or ‘racemic mixture’”, and there is no “indication in the specification or prosecution history to the contrary” (e.g., “the specification describes it as a preferred embodiment”, although noting “the specification is inconclusive regarding whether Compound 101 is a racemic mixture”; no disavowel (SciMed, FC 2001 (described “dual lumen design” as “the present invention”)). The FC panel explained that “[t]his outcome comports with previous cases rejecting similar attempts to limit claims to racemic mixtures” citing as an example Pfizer, FC 2006 (four isomers, specification disclaimed two, claim depicted one not limited by “trans-(+/-)”, no disavowel; claim found to cover “R- and S-transiosomers as well as any mixture of the two”, and not to be limited to racemic mixture). The DC decision was therefore affirmed.

Posted in Claim Construction, Generics / ANDA, Prosecution History Estoppel | Leave a comment

Vanda Pharm. Inc. v. West-Ward Pharm. Int. Ltd. et al.

Docket No. 2016-2707, -2708

April 13, 2018

Brief summary: DC finding of infringement of later-issued OB patent by amended ANDA, and that method of treatment claims are patentable under § 101 affirmed.

Summary: WW appealed DC holding after a bench trial that the asserted claims of Vanda’s Orange Book-listed US 8,586,610 relating to treatment of schizophrenia with iloperidone (Fanapt® (NDA 22-192)) “wherein the dosage range is based on the patient’s” cytochrome P450 2D6 (CYP2D6) genotype infringed and not invalid under § 101, § 103, or § 112 for lack of written description. Vanda is the exclusive licensee of Aventisub’s Reissue 39,198 (also OB-listed; expired in 2016) about which the parties stipulated that claim 3 was infringed and not obvious; this decision was not appealed (see FN3). Representative ‘610 claim 1 requires “determining whether the patient is a CYP2D6 poor metabolizer” by a CYP2D6 “genotyping assay”, who the ‘610 patent explains could lead to cardiac problems, and if so administering the lower of two claimed dose ranges. The FC opinion explains that the FDA approved iloperidone based, at least in part, on the invention disclosed in the ‘610 patent”. At the time WW filed its ANDA (including a label “substantially identical in all material respects to the Fanapt® label” including that the dose “should be reduced by one-half for poor metabolizers of CYP2D6”), “the ‘610 patent had not yet issued and only the ‘198 patent was listed in the” OB and a first suit based on the ‘198 patent began. After the ‘610 patent issued, Vanda filed suit regarding the same and WW amended its ANDA to include a paragraph IV statement as to the ‘610 patent. The DC found that WW’s “proposed products induce infringement” of the ‘610 claims “but do not contributorily infringe them”, and that WW’s “submission of a paragraph IV certification…is an act of infringement”. On invalidity, the DC concluded “that ‘the asserted claims depend upon laws of nature’” but “that while it may have been conventional to investigate for side effects,” WW “has not proven by clear and convincing evidence that the precise test and the discovered results were routine or conventional.” The DC found Vanda was not entitled to § 271(e)(4)(A) relief (effective date of FDA approval not earlier than expiration of the infringed patent) regarding the ‘610 patent because it issued after the ANDA was filed, but that “injunctive relief was appropriate…pursuant to its ‘general equitable power’”, and enjoined WW from manufacturing, using, offering to sell, or selling its ANDA product (which the FC panel found was proper). The DC did find that WW’s filing of its amended ANDA was an act of infringement of the ‘610 patent.

The FC panel first determined that the DC had jurisdiction over the case under § 271(e)(2) (“Vanda alleged that [WW] infringed…under § 271(e)(2)(A) by filing the ANDA…Nothing more was required to establish the [DC’s] subject matter jurisdiction….”) The FC also found that WW’s “arguments relating to whether there was a qualifying act of infringement raise potential merits problems, not jurisdictional issues” (Caraco II, US 2012), and that “an actual controversy has existed between the parties from the time when the suit was commenced” (Teva, FC 2007; Arizonans, US 1997).

WW argued “that there can be no infringement under § 271(e)(2) because the ANDA was filed befor the ‘610 patent issued” (WW’s ANDA was amended to include the ‘610 patent after it issued). The FC panel concluded, however, that the DC “properly conducted its infringement analysis for the ‘610 patent” because “‘application’ in § 271(e)(2) includes amendments to the ANDA” (Gross, US 2009; Ferring, FC 2014 (“The infringement analysis under § 271(e)(2)(A) ‘require[s] consideration of the amended ANDA.’”); Bristol-Myers, FC 1995)).

WW also argued the DC erred in finding induced infringement under § 271(b) “because Vanda failed to prove the requisite direct infringement and specific intent to induce infringement” (Limelight, US 2014 (“direct infringement is a necessary predicate”); DSU Med., FC 2006 (“must [establish] specific intent to encourage another’s infringment”); AstraZeneca I, FC 1998 (“[c]ircumstantial evidence can support a finding of specific intent…Where ‘the proposed label instructs users to perform the patented method…the proposed label may provide evidence of [the ANDA’s applicant’s] affirmative intent to induce infringement.”); Takeda, FC 2015 (“[t]he label must encourage, recommend, or promote infringement”); Sanofi, FC 2017)). But the FC panel “agree[d] with Vanda that a patentee does not need to prove an actual past instance of direct infringement by a physician to establish infringement under 35 U.S.C. § 271(e)(2)(A)” (Bristol-Myers, FC 1995; Warner-Lambert, FC 2003; Glaxo, FC 1997). “Accordingly,” the FC panel wrote, “Vanda can satisfy its burden…by showing that if the proposed ANDA product were marketed, it would infringe the ‘610 patent” (Ferring, FC 2014 (“the ANDA itself dominates the analysis”)). The FC panel also agreed with Vanda that the DC did not err in its infringement analysis because WW’s proposed label “recommends that practitioners perform or have performed” the genotyping assay and dose reduction of the ‘610 claims. The FC panel also explained that “[i]n the context of [the] off-label use case where there [are] ‘substantial noninfrining uses,’ [it] decline[s] to ‘infer’ intent to induce infringement” (Warner-Lambert, FC 2003).

Regarding patentability under § 101, the FC panel explained that “[t]his case…is not Mayo” as “the claims in Mayo were not directed to a novel method of treating a disease”. Here, even though “[t]he inventors recognized the relationships between iloperidone” and “CYP2D6 metabolism”, “the ‘610 patent claims are directed to a method of using iloperidone to treat schizophrenia” (“an application of that relationship…‘a new way of using an existing drug’ that is safer” (Mayo, US 2012)). In addition, “unlike the claim in Mayo” which “did not do beyond recognizing (i.e., ‘indicates’) a need to increase or decrease a dose”, “to the extent that preemption is a concern, the ‘610 patent claims do not ‘tie up the doctor’s subsequent treatment decision’” (CellzDirect, FC 2016). Judge Prost dissented on this point.

The FC panel also found the DC did not err in finding the ‘610 patent contains adequate written description since, e.g., “the reported results ‘show that patients can be more safely treated…if the dose…is adjusted based on the CYP2S6 genotype of each patient” and “provides a specific example” (Scriptpro, FC 2014 (“[t]he disclosure of a dose outside of the claimed range does not compel a finding that the asserted claims lack” WD)).

Posted in Generics / ANDA, Inducement to Infringe, Infringement, Jurisdiction, Patentability, Written description | Leave a comment

In Re: Merck & CIE

Docket No. 2017-1960

April 11, 2018


Brief summary: PTAB decision affirming examiner’s obviousness rejection affirmed because “Merck’s view is not the only reasonable view” of the prior art.

Summary: Merck & Cie appealed PTAB’s decision affirming the examiner’s rejection of the claims of U.S. Ser. NO. 12/688,034 directed to “[a] method for improving NO-mediated endothelial-dependent vasomotor responses consisting of…administering…one or more folates” as obvious in view of “van Etten”. The PTAB “concluded…that the restrictive ‘consists of’ language limits the claim to administering one or more folates (or salt or ester) alone-‘folate alone,’ as a shorthand” with respect to NO-mediated endothelial-dependent vasomotor response, “though a combination with drugs unrelated to such responses is not excluded” (Ex parte Antoniades, PTAB Feb. 27, 2017), the FC panel noting that this conclusion “is undisputed before us”. The van Etten reference describes a study testing the effect of “5-MTHF, the active form of folic acid” in Type II diabetes, where “subjects were infused with serotonin (a stimulator of vasodilation dependent on nitric oxide)” or “sodium nitroprusside (a stimulator of ‘endothelium-independent vasodilation’)”. Van Etten concludes that the data implies “that folate can be used to improve nitric oxide status and to restore endothelial dysfunction in patients with Type II diabetes.” Affirming the examiner, the PTAB “found that van Etten supplied a motivation to use folate alone…with a reasonable expectation of success”. The FC panel reviewed the PTAB’s “obviousness analysis, and what van Etten teaches, all questions of fact…only for substantial evidence” (“as a reasonable mind might accept as adequate”) (PAR Pharm., FC 2014; In re Gartside, FC 2000; Para-Ordnance, FC 1995). Merck argued the PTAB’s “reading of van Etten…is simply unreasonable and therefore unsupported by substantial evidence” (TriVascular, FC 2016; Cosol. Ed., US 1938), arguing that van Etten “would give rise to only one possible understanding to a skilled artisan, namely, that folate alone would have no beneficial effect of the type at issue” and the PTAB was therefore “required to find no motivation to use folate alone”. The FC panel concluded that “Merck’s view is not the only reasonable view” and explained that it “need not…decide whether Merck’s view of what van Etten teaches is the better view” since “the possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency’s finding from being supported by substantial evidence” (Consolo, US 1966; In re Jolley, FC 2002 (“If the evidence” supports “several reasonable but contradictory conclusions, we will not find the Board’s decision unsupported by substantial evidence simply because the Board chose one conclusion over another plausible alternative.”); AK Steel, FC 1999). Thus, the Board decision was affirmed.

Posted in Obviousness | Leave a comment

Maxon, LLC v. Funai Corporation, Inc.

Docket No. 2017-2139

April 9, 2018


Brief summary: DC grant of Funai’s motion to dismiss suit against it after finding that Maxon’s patents “claim ineligible subject matter under 35 U.S.C. § 101” affirmed (the “claims merely recite generic computer elements for their basic functions and thus do not transform the claimed abstract idea into eligible subject matter under Alice”).

Summary: Maxon appealed DC grant of Funai’s motion to dismiss suit against it after finding that Maxon’s patents “claim ineligible subject matter under 35 U.S.C. § 101.” The DC found the patents (US 8,989,160; 7,489,671; 7,486,649; and 7,171,194) “teach ‘electronic means of increasing user control over subscription entertainment content’”. Representative claim 8 of the ‘160 patent was described as including the “physical components” of “a computer-readable medium, input/output logic, a processor, and a transceiver” and other representative claims were found to include “similar physical elements”. The FC panel reviewed the DC’s motion to dismiss under regional circuit law (Seventh Circuit) and patent eligibility under § 101 de novo under Alice (a legal determination (buySAFE, FC 2014; Alice, US 2014 (step 1: “whether the claims are directed to an abstract idea”; step 2: “whether the claims contain an inventive concept sufficient to transform the claimed abstract idea into a patent-eligible concept”)). Further, the FC panel wrote, “[t]he use of ‘wholly generic computer implementation’ cannot ‘transform a patent-ineligible abstract idea into a patent-eligible invention.’” Given Maxon’s concession “that the patents are directed to the abstract idea of ‘decentralized delivery controlled by the owner of a plurality of devices’”, “the only issue before the [DC] was whether the claims ‘do significantly more than simply describe the abstract method’” (Affinity Labs., FC 2016). The FC panel agreed with the DC’s conclusion “that the claims recite only generic computing processes using functional language”, and “merely recite generic computer elements for their basic functions and thus do not transform the claimed abstract idea into eligible subject matter under Alice” (Content Extraction, FC 2014). The FC panel also agreed with the DC “that the ordered combination of the claimed elements is not inventive under Alice step two” (representative claim 8 “describes only the desired result…without describing any inventive way that result is reached”…only teaching “in essence, use of generic computer components for their standard purposes to achieve the result”). Thus, the FC agreed with the DC “that the representative claim does not recite anything beyond the application of routine and convention computer components” (and “[t]he same principles apply to each of the asserted patents in this case”). The DC grant of Funai’s motion to dismiss was therefore affirmed.

Posted in Patentability, Software | Leave a comment

Richard J. Baker v. Microsoft Corp. et al. (Nintendo of America, Inc.)

Docket No. 2017-2357

April 9, 2018


Brief summary: DC grant of SJ of noninfringement to MSFT et al. based on its construction of the claim term “remote” based in part on prosecution history estoppel affirmed.

Summary: Mr. Baker sued the Defendants (MSFT et al.) for infringement by the Xbox (MSFT) and Wii (Nintendo) systems of his US 5,486,001 describing “an instructional aid intended to provide users with feedback on their body movements relating to a given activity, such as golf swing.” The ‘001 claims require storage of “initial visual image signals representative of a particular movement at a first location” and “preferred image signals…at a second location remote from said first location in a data base of a computer”, regenerating further images, and “transmitting said regenerated signals from said computer at said remote second location to said first location”. These limitations were added during prosecution in response to an anticipation rejection, and the ‘001 claims were allowed after the amendments were made. The DC granted SJ of noninfringement to the Defendants based on these amendments. The FC panel explained that it applied the law of the regional circuit (Ninth), which reviews DC grants of SJ de novo, and that SJ “is appropriate when, viewing the evidence in the light most favorable to the nonmoving party, there is ‘no genuine dispute as to any material fact’” (FRCP 56(a); Zetwick, 9th Cir. 2017). Mr. Baker argued the DC erred in construing “‘remote’ to mean that the separate locations cannot be in the same room” (“requiring ‘more than physical separation in the same location’”). The DC found that the specification indicates “the image capturing device may either be ‘discrete’ from the signal transceiver, or the two components ‘may be one in the same’”, indicating “that the term ‘remote’ must require something more than mere physical separation.” The DC also “noted that during prosecution, Mr. Baker overcame” the prior art “and achieved patentability by adding the limitation of two separate locations to his pending claims” (he “disavowed the interpretation of ‘remote’ he now seeks to use when he amended [the claims]”). The FC panel agreed “Mr. Baker made these amendments to distinguish” the ‘001 claims and that he “clearly and unmistakably disavowed any portion of his claim scope” relating to having the computers in “a single location or a single computer-like device” as disclosed in the prior art (Computer Docking Station, FC 2008). The FC panel also agreed the “accused products do not literally infringe” (e.g., “the accused products only employ a single game console”) (Advanced Steel Recovery, FC 2015; Southwall, FC 1995), and that “prosecution history estoppel barred Mr. Baker from pursuing his infringement claim under the doctrine of equivalents”. The DC decision was therefore affirmed.

Posted in Claim Construction, Doctrine of equivalents, Infringement, Prosecution History Estoppel, Summary Judgment | Leave a comment