Amgen, Inc. et al. v. Sandoz Inc.

Docket Nos. 2015-1499

December 14, 2017

Brief summary: DC’s dismissal of Amgen’s state law unfair competition and conversion claims was affirmed due to preemption by federal law (BCPIA).

Summary: In its 2017 Sandoz v. Amgen decision relating to Sandoz’s eBLA for a biosimilar filrastim product, SCOTUS “held that an injunction under federal law is not available to enforce 42 U.S.C. § 262(l)(2)(A); and a biosimilar applicant may provide the notice required by 42 U.S.C. § 262(l)(8)(A) either before or after receiving FDA approval, i.e., the applicant need not defer giving notice of commercial marketing until FDA licensure of the biosimilar in order to begin the running of the 180-day clock”, reversing-in-part and vacating-in-part the FC’s 2015 decision, and remanding it to the FC for proceedings consistent with SCOTUS’s opinion. SCOTUS instructed the FC to consider “whether California law would treat noncompliance with § 262(l)(2)(A) as ‘unlawful’”. “If the answer is yes,” SCOTUS wrote, “then the court should proceed to determine whether the BPCIA pre-empts any additional remedy available under state law” (e.g., Amgen’s state law unfair competition and conversion claims) “for an applicant’s failure to comply with § 262(l)(2)(A) (and whether Sandoz has forfeited any preemption defense…)”, adding that “[t]he court is also of course free to address the preemption question first by assuming that a remedy under state law exists.” Amgen argued that Sandoz waived its preemption defense but this FC panel disagreed since “Sandoz preserved its ability to assert preemption by pleading the defense in its answer.” The FC panel then “turn[ed] to the question whether Amgen’s state law claims are preempted by the BPCIA”, a “question of law that [it] review[s] de novo” (Ultra-Precision, FC 2015). It concluded that “both field” (where state law “regulates conduct in a field that Congress intended the Federal Government to occupy exclusively”) “and conflict preemption” (where state law conflicts with federal law) “exist here.” The FC panel also concluded “that the BCPIA preempts state law claims predicated on an applicant’s failure to comply with § 262(l)(2)(A)…because biosimilar patent litigation ‘is hardly ‘a field which the States have traditionally occupied’” (Buckman, US 2001), “patents are ‘inherently federal in character’ because a patent ‘originates from, is governed by, and terminates according to federal law’”, and “Congress has granted federal courts ‘exclusive jurisdiction over cases ‘arising under any Act of Congress relating to patents’” (Gunn, US 2013 and 28 USC § 1338(a)). Thus, “assuming arguendo that there are any state-recognized interests in play here, California law must ‘give way to federal law’” (Arizona, US 2012). The FC panel also concluded that “conflict preemption also bars Amgen’s state law claims” since “state law claims ‘clash’ with the BPCIA, and the differences in remedies between the federal scheme and state law claims support concluding that those claims are preempted” and compliance with the BCPIA “in the shadow of 50 States’ tort regimes…could dramatically increase the burdens’ on biosimilar applicants.” The DC’s dismissal of Amgen’s state law unfair competition and conversion claims was affirmed.

Posted in Biosimilars, Generics / ANDA | Leave a comment

Forest Laboratories, Inc. et al. v. Teva Pharmaceuticals USA, Inc.

Docket Nos. 2016-2550, -2553

December 11, 2017


Brief summary: DC finding of indefiniteness of claims requiring a comparison of immediate and extended release formulations affirmed.

Summary: Forest appealed DC finding that all of the asserted claims regarding the NMDA receptor antagonist memantine (extended release Namenda XR®, NDA 22525 “indicated for the treatment of moderate to severe dementia of the Alzheimer’s type”) are invalid for indefiniteness. During claim construction, the parties disputed the meaning of the phrase “change in meantime concentration as a function of time (dC/dT) that is less than 50% that of an immediate release dosage form comprising the same dose of memantine as the composition” (“[a] solid pharmaceutical composition in a unit dosage form for once daily oral administration comprising an extended release formulation of 5 to 40 mg memantine”) appearing in four of the six Orange Book patents (that “have materially the same specification”, see FN2). Teva argued the term is indefinite because “neither the claim language nor the specification adequately describes how to conduct the studies to obtain” the required concentration profiles, “and differences in study design lead to variable results”, or “would call for both…release profiles to be measured in the same human study.” Forest argued that “the dC/dT of the extended-release formulation is to be derived from a human study, and then compared to the dC/dT from the computer-derived curve of the immediate-release formulation shown for Namenda 20 mg in Figures 1A and 2D of the specification.” The DC construed the claims to require determining the concentration profiles “in human pharmacokinetic studies”, that “the intrinsic evidence does not disclose a specific human-study design or provide guidance as to how to design a study”, and that the extrinsic evidence showed “measurements from human [pharmacokinetic] studies vary widely…’ for any particular memantine formulation”, and concluded the claims were invalid as indefinite. The FC panel explained that indefiniteness is shown where “the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention” (Nautilus, US 2014). The FC panel found Forest’s proposed construction to be “contrary to the intrinsic evidence” (e.g., “the specification does expressly define terms, such as ‘dC/dT,’…but it does not use such language for the immediate-release concentration profile”), and “that human-study comparisons are required.” The FC panel also found the DC’s ruling to be “supported by precedents that hold claims indefinite in particular circumstances where the claims require measured quantities (absolute or relative), different techniques are known in the art and some product infringing results and others not, the intrinsic evidence does not adequately specify the technique or techniques to use, and extrinsic evidence does not show that a relevant skilled artisan would know what technique or techniques to use” (Dow, FC 2015; Honeywell, FC 2003). The FC panel also dismissed Forest’s newly presented claim construction arguments. Judge Lourie’s concurrence argued the claims are indefinite for “attempt[ing] to encompass an extended release formulation…without including any of the materials that cause the extended release” (“the epitome of an indefinite claim”).

Posted in Generics / ANDA, Indefiniteness | Leave a comment

Inventor Holdings, LLC v. Bed Bath & Beyond, Inc.

Docket Nos. 2016-2442

December 8, 2017

Brief summary: DC grant of attorney’s fees under § 285 for post-Alice decision conduct affirmed (“[i]t was IH’s responsibility to reassess its case in view of new controlling law”).

Summary: IH sued BBB for infringement of US 6,381,582 in April 2014, before SCOTUS’s Alice June 2014 decision. Following the Alice decision, the DC granted BBB’s motion for judgment on the pleadings under FRCP 12(c) that the ‘582 patent was invalid under § 101, which was affirmed without opinion by the FC in 2016. The DC then granted BBB’s request for attorney fees under § 285 “from the date of the Alice decision, including fees incurred during the § 101 appeal”, “holding that, ‘following the Alice decision, IH’s claims were objectively without merit’” (“exceptional”). IH unsuccessfully argued that the ‘582 claims were similar to those of DDR Holdings (FC 2014) and “satisfy the ‘machine or transformation test’” (Bilski, US 2010). IH appealed that decision here. The ‘582 patent relates “to a method of purchasing goods at a local point-of-sale [POS] system from a remote seller” by generating an “order code” that can be entered at the POS in a local retail store which is “implemented using conventional computer technology” (Internet connection). The FC panel explained that it reviews “all aspects of a [DC’s] § 285 determination’ for abuse of discretion” (Highmark, US 2014 (“based…on an erroneous view of the law or clearly erroneous assessment of the evidence”). And it explained “[a]n exceptional case under § 285 is ‘simply one that stands out from others with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated.” The FC panel concluded the DC “acted within the scope of its discretion in finding this case to be exceptional based on the weakness of IH’s § 101 arguments and the need to deter similarly weak arguments in the future” (Octane Fitness, US 2014). The ‘582 claims, it explained, “are manifestly directed to [the] abstract idea” (Alice step one) of “local processing of payments for remotely purchased goods” a “basic concept” (“processing information through a clearinghouse”) that is unpatentable subject matter “because no entity is entitled to ‘wholly preempt’ such concepts” (Dealertrack, FC 2012). And regarding Alice’s second step, it explained “the only components disclosed in the specification for implementing the asserted method claims are unambiguously described as ‘conventional’” and “do not supply an inventive concept” (Alice; Mayo, US 2012). IH argued “§101 was” (before Alice), “and is, an evolving area of law and that the § 101 inquiry in this case was therefore difficult”, which the FC panel concluded was “meritless” and “dubious even before the Alice decision” (DC; Mortgage Grader, FC 2013 (“a § 101 defense previously lacking in merit may be meritorious after Alice”)). The FC panel wrote that “[i]t was IH’s responsibility to reassess its case in view of new controlling law” (Taurus IP, FC 2013) and “[t]here were obvious issues…IH should have recognized post-Alice, and these issues persisted throughout the § 101 appeal.” Accordingly, the DC decision was affirmed.

Posted in Attorney's Fees, Patentability, Software | Leave a comment

Arctic Cat Inv. V. Bombardier Recreational Products Inc. et al.

Docket Nos. 2017-1475

December 7, 2017

Brief summary: DC denial of BRP’s JMOL that the asserted claims would have been obvious and that the royalty, willfulness and trebling of damages were improper affirmed. Patent marking issue vacated and remanded as the alleged infringer is only initially required to put the patentee “on notice that he or his authorized licensees sold specific unmarked products which the alleged infringer believes practice the patent”; “the patentee” then “bears the burden to prove the products identified do not practice the patented invention.”

Summary: BRP appealed DC denial of JMOL that the asserted claims of AC’s US 6,568,969 and 6,793,545 relating to personal watercraft (PWC) “including…a controlled thrust steering system” would have been obvious, that AC failed to mark patented products, that the jury’s royalty award was based on improper expert testimony, that BRP did not willfully infringe the claims, and the award of treble damages and an ongoing royalty. The FC panel opinion explained that JMOL decision are reviewed under the law of the regional circuit (here, the Eleventh Circuit so de novo) “unless the issue pertains to or is unique to patent law” (AbbVie, FC 2014), viewing the evidence in the light most favorable to the non-moving party.

It also explained that an obviousness determination “requires consideration of all the facts”, including “all four Graham factors” (including “objective indicia of nonobviousness”), whether an “explicit or implicit[]” motivation to combine references existed (KSR, US 2007), whether there was a teaching away that would have “discouraged” one from “following the path set out in the reference” or “taken by the applicant” (Allergan, FC 2015; WL Gore, FC 1983 (must consider art in its entirety); In re Gurley, FC 1994), and a reasonable expectation of success (PAR Pharm., FC 2014) and that the failure to do so is erroneous (Millenium Pharm., FC 2017). On appeal, the FC panel explained, “[t]he only question” for it is “whether substantial evidence supports the jury’s presumed finding” (here, the motivation to combine) (Apple, FC 2016), and “[e]vidence suggesting reasons to combine cannot be viewed in a vacuum apart from evidence suggesting reasons not to combine.” And here it found “the same reference suggests a reason to combine, but also suggests reasons that a skilled artisan would be discouraged from” the same and “[u]nder such circumstances, the jury’s fact finding regarding motivation is supported by substantial evidence” (e.g., “a reasonable jury could have determined that more than four solutions existed” and “modifying a PWC with the Challenger system would not have been a predictable solution yielding expected results”). The FC panel also refused to reverse the jury’s finding that AC’s secondary consideration evidence of industry praise and a long-felt need, finding these “weigh[] in favor of nonobviousness.” Thus, no error was found “in the conclusion that BRP failed to prove that the asserted claims would have been obvious by clear and convincing evidence.”

“Under 35 U.S.C. § 287(a), a patentee who makes or sells a patented article must mark his articles or notify infringers in order to recover damages”, and “[a] patentee’s licensees must also comply” (Dunlap, US 1894; Maxwell, FC 1996; Motorola, FC 1984 (§ 287 is “a limitation on damages, and not an affirmative defense”)). AC licensed its products to Honda and did not require it to mark the products. The dispute here is whether “Honda sold PWC products covered by the patents at issue” (“were required to be marked”); if it did, then AC “has failed to satisfy the marking requirements.” The DC concluded the burden of proof on this issue was on BRP. The FC panel noted “[t]here is a split among the” DCs on this point, but held the “initial burden” is on the alleged infringer, but that “this a low bar” only requiring that the patentee be put “on notice that he or his authorized licensees sold specific unmarked products which the alleged infringer believes practice the patent” (“a burden of production, not one of persuasion or proof”). “[T]he patentee” then “bears the burden to prove the products identified do not practice the patented invention.” And, here, the FC panel concluded, BRP satisfied its burden and the DC erred in not placing the burden to prove Honda’s products “do not practice the patent-at-issue.” The marking issue was therefore vacated and remanded.

The FC panel affirmed the DC’s denial of JMOL regarding the jury’s reasonable royalty rate, the ongoing royalty rate (“hypothetical negotiation using the Georgia-Pacific factors” (Fresenius, FC 2009)), and wilfullness (“jury’s willfulness finding is supported by substantial evidence” (Halo, US 2016 (“subjective willfulness alone…can support an award of enhanced damages”); Octane Fitness, US 2014 (preponderance of the evidence); WesternGeo, FC 2016). The FC panel also found the DC did not abuse its discretion by trebling damages even though it did not allow the parties to brief the issue and its decision was “initially…without much explanation” since it subsequently “explained its decision in a subsequent thorough and well-reasoned opinion” (Read, FC 1992).

Posted in Damages, Obviousness, Obviousness-Teaching Away, Royalties, Willfullness | Leave a comment

CRFD Res. V. USPTO (IPR2015-00055 (“Iron Dome FWD”)); CRFD Res. v. DISH et al. (IPR2015-00627 (“DISH FWD”)); Hulu/Spotify v. CRFD Res. (IPR2015-00259 (“HULU FWD”))

Docket Nos. 2016-2198, 2016-2298, 2016-2437

December 5, 2017

Brief summary: Findings of no invalidity in two IPRs (Iron Dome and DISH) affirmed, but Hulu FWD finding of no obviousness reversed because the PTAB “failed to perform a proper obviousness analysis” (e.g, it “failed to consider whether Bates suggests transmitting a session history”).

Summary: Three appeals were decided together from final written decisions (the Iron Dome FWD (the USPTO Director intervened in CRFD’s appeal), the DISH FWD, and the Hulu FWD) following IPRs relating to CFRD’s US 7,191,233 describing “user-directed transfer of an on-going software-based session from one device to another device”. The prior art reviewed during IPR were “Phan San Jose”, “Phan Helsinki”, and “Bates” (US 6,693,901). CFRD challenged the PTAB’s decision that certain ‘233 claims are anticipated or obvious in view of Phan San Jose and Phan Helsinki. Hulu/Netflix/Spotify (“Hulu”) challenged the PTAB’s decision that certain claims are not anticipated by Bates. The FC panel explains that it reviews the PTAB’s “factual findings for substantial evidence and its legal conclusions de novo” (In re Gartside, FC 2000; In re Mouttet, FC 2012 (“more than a mere scintilla of evidence”); In re Applied Mat., FC 2012 (“such relevant evidence as a reasonable mind might accept”)). On anticipation, the FC panel explained that it “is established when ‘one skilled in the art would reasonably understand or infer from the prior art reference’s teaching that every claim [limitation] was disclosed in that single reference” (Akamai, FC 2003). The FC panel found the PTAB’s conclusion in the Iron Dome FWD that Phan San Jose “teaches all steps of claim 1” to be supported by substantial evidence. The FC panel also found CRFD did not show the PTAB erred in concluding other claims would have been obvious in theh Iron Dome FWD in view of Phan San Jose and Phan Helsinki (factual findings supported by substantial evidence, legal conclusions reviewed de novo (Dynamic Drinkware, FC 2015)). Regarding the DISH FWD, the FC panel found the PTAB’s anticipation decision was supported by substantial evidence, including “CFRD’s expert testimony and its own attorney argument”. Hulu appealed the PTAB determination in the Hulu FWD that certain claims are not anticipated by Bates and would not have been obvious in view of three combinations of references. The FC panel did not find error in the PTAB’s anticipation analysis but did find it “failed to conduct a separate analysis as to each of the instituted grounds”, “perform[ing] limited fact-finding in its obviousness inquiry, only examining the level of ordinary skill in the art and then relying primarily on its determination that Bates did not anticipate the challenged claims.” The FC panel explained that “the tests for anticipation and obviousness are different” (Cohesive, FC 2008); “anticipation is a question of fact, while obviousness is a question of law based on underlying factual findings” (Kennametal, FC 2015) and “require different elements of proof” (Duro-Last, FC 2003; Nike, FC 2016; Aqua Prods., FC 2017 (en banc)). The FC panel also agreed with Hulu that the PTAB should have considered its arguments based on the Bates reference, upon which IPR was not instituted but that Hulu incorporated into its other obviousness arguments. The FC panel also concluded the PTAB “failed to perform a proper obviousness analysis” (e.g, it “failed to consider whether Bates suggests transmitting a session history”) and “misread[]…the Batees reference”, and found many of the ‘233 claims invalid as obvious.

Posted in Anticipation (35 USC 102), Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

Microsoft Corporation and IBM v. Parallel Networks Licensing, LLC

Docket No. 2016-2515, -2517-19, -2642, -2644-2646 (IPR2015-00483-00486, -01729, 01732, -01734)

December 1, 2017


Brief summary: PTAB’s claim construction affirmed but decisions of no anticipation and obviousness vacated and remanded because it did not provide adequate explanations.

Summary: MSFT and IBM were sued by PN for infringement of previously reexamined (both patents) US 5,894,554 and US 6,415,335 (“the Parallel Patents”) that “describe and claim systems for managing…requests for [web] pages having dynamic (changing) content.” The PTAB finally decided MSFT and IBM “failed to demonstrate anticipation or obviousness.” MSFT and IBM appealed, arguing the PTAB erred in construing “request” in the term “dynamic Web page generation request” and rejecting their anticipation and obviousness arguments. Construction was performed under “judicial claim-construction principles” rather than the broadest reasonable construction because the Parallel Patents expired before the PTAB issued its Final Written Decisions (In re Rambus, FC 2012; Black & Decker, FC 2016). During IPR, the parties agreed “request” means “a message that asks for a Web page”. MSFT argued the PTAB “imposed requirements on what can be a ‘request’”, those requirements being “(1) the particular route the request travels; (2) the particular URL or destination specified; and (3) who or what the request contacts along its route.” The FC panel disagreed, acknowledging “at best (for Microsoft’s purposes), there is ambiguity…[b]ut if there is such ambiguity…, it is apparent on the face of the term…[y]et Microsoft agreed” to it at the DC and “never presented…a request for further claim construction” to the Board. The FC panel also agreed with the Board that the agreed-to construction is “the best construction in the context of this patent” (“the more natural understanding of a ‘request,’ as of ‘message,’ is one denoting each discrete act of communicating”). MSFT challenged the Parallel Patents as being anticipated (Dayco, FC 2003; In re Rambus, FC 2014; Connell, FC 1983) by the “URL redirection” and “UNIX sockets package” modification disclosures of the “SWEB” reference, and the FC panel affirmed the Board’s rejection of the URL argument. However, it vacated the finding of no anticipation because “the Board failed to address” MSFT’s UNIX argument, noting “the Board should address Parallel’s contention that [the] disclosure in SWEB is not enabled-applying our law that generally accords a presumption of enablement to printed-publication and patent prior art” (In re Antor, FC 2012 (publications); Amgen, FC 2003 (patents)). The FC panel also vacated the PTAB’s rejection of MSFT’s obviousness arguments because the PTAB “provided insufficient explanation to justify rejecting the challenge” (In re Nuvasive, FC 2016). For instance, the FC panel explained, the PTAB “did not address the legal significance” of MSFT’s expert testimony “in light of some of the KSR formulation” (e.g., “the ‘combination of familiar elements according to known methods’ that ‘does no more than yield predictable results’”). Thus, the PTAB’s claim construction was affirmed but decisions of no anticipation and obviousness vacated and remanded.

Posted in Anticipation (35 USC 102), Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

AIP Acquisition LLC v. Cisco Systems, Inc.

Docket No. 2016-2371 (IPR2015-00307)

November 30, 2017


Brief summary: Board claim construction and conclusion of invalidity for obviousness following IPR affirmed.

Summary: AIP appealed PTAB decision invalidating the claims of expired US 7,269,247 relating to the interconnection of telephone networks using the internet for obviousness in view of three different combinations of prior art. AIP argued the PTAB “erred by relying on extrinsic evidence to conclude the claim terms ‘internet protocol’ and ‘Internet protocol’ were not limited to the Internet Protocol of TCP/IP.” The terms were construed separately for claims 1 and 16, respectively, “based on the terms’ differing capitalization.” The PTAB construed the terms as relating to “data transmission between two devices on different networks” (internet protocol) or “between two devices over the Internet” (Internet protocol), noting “that the intrinsic evidence neither demonstrated the inventor’s intent to ascribe a certain definition to either claim term nor clarified the terms’ ordinary and customary meanings” and “that the extrinsic evidence made clear that neither term shold be limited to a specific protocol.” The PTAB also rejected AIP’s arguments that its amendments and statements made during prosecution “were sufficient to disavow the claim scope that the Board attributed to the claims” and, therefore, “the terms should receive the same construction”. The FC panel explained that the PTAB “construes claims of an expired patent pursuant to” Phillips (FC 2005 (ordinary and customary meaning as would be understood by an ordinarily skilled artisan at the time of the invention); Wasica, FC 2017). And it reviews the PTAB’s “ultimate claim construction de novo and any underlying factual determinations that involve extrinsic evidence for substantial evidence” (Apple, FC 2016; Cosol. Edison, US 1938). The FC panel concluded that “the claim language here supports the Board’s construction” (e.g., “The patent applicant could have claimed a specific protocol, such as the IP of TCP/IP, perhaps by capitalizing the ‘i’ in ‘internet’ and the ‘p’ in ‘protocol’ in both claims or, more definitively, by reciting the ‘Internet Protocol of TCP/IP’” but “did not, however, and the use of the lowercase letters suggests that ‘I/internet protocol’ is not confined to any particular protocol.”) The specification was also found to support this construction (“The specification’s reference to a specific protocol-TCP/IP-stands in stark contrast to the claims’ recitation of the generic terms ‘I/internet protocol,’ and confirms that the claims have a broader scope.”) The FC panel also concluded the PTAB properly relied on the prior art and a dictionary as extrinsic evidence to further support its position. The FC panel concluded that while AIP’s argument that the claims’ recitation of “‘I/internet protocol’ instead of ‘an I/internet protocol’” (“the absence of an indefinite article”) “signifies that these terms are proper nouns referring to a specific protocol” “weigh[s] in” AIP’s favor, “the patent applicant’s arguments accompanyning the claim amendments cut the other way.” The FC panel also disagreed with AIP’s argument that the PTAB raised a new invalidity theory (In re NuVasive, FC 2016).

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