Continental Circuits LLC v. Intel Corporation, et al.

Docket No. 2018-1076

February 8, 2019

Brief summary: DC judgment that Intel did not infringe CC’s asserted patents vacated and remanded due to DC’s erroneous claim construction (e.g., no clear disavowel of claim scope).

Summary: CC appealed DC judgment that Intel did not infringe CC’s US 7,501,582; 8,278,560; 8,581,105; and 9,374,912 (with substantially identical specifications (FN1)) relating to a “‘multilayer electrical device…having a tooth structure’ and methods for making the same.” The DC construed the claims to require that the ‘surface,’ ‘removal,’ or ‘etching’ of the dielectric material be ‘produced by a repeated desmear process’”, finding “that the specification not only ‘repeatedy distinguishe[d] the process covered by the patent from the prior art and its use of a ‘single desmear process’…but also characterized ‘the present invention’ as using a repeated desmear process”, “that the prosecution history corroborated its construction” (e.g., expert declaration submitted during prosecution “clearly describe[d] the patented method as involving two etching processes”), and “extrinsic documents produced by the inventors” that “were ‘not reliable enough to be dispositive,’ but…‘provide[d] helpful corroboration.’” Based on the DC’s claim construction, “the parties stipulated to noninfringement”. The FC panel explained that “[c]laim construction is ultimately a question of law that we review de novo” and that “[a]ny subsidiary factual findings based on extrinsic evidence ‘must be reviewed for clear error’” (Teva, US 2015). And claim terms are to be given “their ordinary and customary meaning, which is ‘the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention’” which can come from the claims, the specification, the prosecution history, “and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art” (Phillips, FC 2005 (citing Innova, FC 2004 and Vitronics, FC 1996) (e.g., “the claims do not stand alone”)). The FC panel agreed with Continental that the DC erred “in limiting the claims to require a repeated desmear process” because e.g., “based on the plain language, the claims are not limited to a repeated desmear process”, “none of the statements” of the specification “relied upon by the [DC] rises to the level of ‘a clear and unmistakable disclaimer’” (Thorner, FC 2012 (“patentee must ‘clearly set forth a definition of the disputed claim term’ other than its plain meaning”); CCS Fitness, FC 2002; Retractable Techs., FC 2011). It found that “[o]verall,” the statements in the specification “simply describe how to make the claimed invention using the preferred Probelec XB 7081 in a ‘new’ way that is different from the prior art process and are not statements clearly limiting the claimed ‘electrical device’ to require a repeated desmear process” (e.g., “phrases such as ‘one technique,’ ‘can be carried out,’ and ‘a way’…does not automatically lead to finding a clear disavowel” (Phillips; Liebel-Flarsheim, FC 2004 (inclusion of only a single embodiment does not mean the claims must be read restrictively); “[m]ere criticism of a particular embodiment…is not sufficient to rise to the level of clear disavowel” (Thorner); “the descriptions of ‘the present invention’…are not limiting here” (Verizon, FC 2007; Absolute Software, FC 2011); clear disavowel does not exist in the prosecution history; no statements “that the repeated desmear process is ‘an essential part’ of the claimed electrical device” (Andersen, FC 2007)). The DC decision was therefore vacated and remanded.

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

Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company

Docket No. 2017-1694 (IPR2015-01537)

February 7, 2019

Brief summary: Momenta’s appeal of PTAB FWD finding BMS’s claims relating to its Orencia CTLA4Ig product patentable dismissed as moot because evidence showed Momenta had abandoned its Orencia biosimilar project since, e.g., “an actual controversy must be extant at all stages of review.”

Summary: Momenta appealed PTAB IPR final written decision (FWD) finding claims 1-15 of BMS’s US 8,476,239 relating to CTLA4Ig formulations marketed as Orencia, for which Momenta was pursuing a biosimilar when the IPR was filed in 2015. BMS moved to dismiss Momenta’ appeal, arguing Momenta did not have standing under 35 USC § 319 because its “proposed product had failed its Phase 1 clinical trials and had been withdrawn.” Momenta argued it had not abandoned the proposed product, “that the ‘239 Patent is an obstacle to these activities, …that it is injured by the estoppel provision, 35 U.S.C. § 315(e)”, and “that this appeal meets the criteria of Article III, citing the ‘relaxed’ standard for Article III compliance when the right of appeal is established by statute.” In October 2018, Momenta submitted a press release to the court indicating that it had “initiated discussions with its collaborative partner, Mylan, to exit” the Orencia biosimilar program, and the FC “issued an Order to Show Cause why the appeal should not be dismissed as moot”, and Momenta replied with a letter from its Chief Business Officer that the program was not actually terminated. BMS argued “that a third party’s possible future development of this abandoned product does not provide constitutional standing to Momenta” and “possible future royalty…is too speculative to support standing” (“hypothetic injury”). BMS also submitted an excerpt from Momenta’s December 2018 Form 8-K including Momenta’s statement that “[o]n November 19, 2018, we delivered a formal notice of…termination” of its “collaboration agreement with Mylan with respect to the development of…M834, a proposed biosimilar to Orencia”, to which Momenta did not respond. The FC panel found that “now upon Momenta’s termination of all potentially infringing activity, Momenta has not shown ‘an invasion of a legally protected interest’ that is ‘actual or imminent, not conjuctural or hypothetical’” (Lujan, US 1992; “[T]he appellant must always have a ‘concrete and particularized’ interest in an outcome-an interest, to the extent one existed, that has now been eliminated by Momenta.”) The FC panel also explained that “[e]stoppel cannot constitute an injury-in-fact when Momenta ‘is not engaged in any activity that would give rise to a possible infringement suit’” (Consumer Watchdog, FC 2014; Hollingsworth, FC 2013; Gill, US 2018). The FC panel also found the future royalty argument to have “no support in precedent” (Clapper, US 2013; Phigenix, FC 2017 (no standing based on “assertion of a possible future economic interest”); RPX, FC 2018; E.I. DuPont, FC 2018 (Article III standing based on “significant risk of patent infringement in their demonstration plant that was entering into operation… ‘concrete plans…that create[] a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement’”); Arizonans, US 1997 (“an actual controversy must be extant at all stages of review, not merely at the time the complaint is filed”)). The FC panel therefore dismissed Momenta’s appeal.

Posted in Article III disputes, Inter Parties Review (IPR), IPR | Leave a comment

Athena Diagnostics, Inc. et al. v. Mayo Collaborative Services, LLC

Docket No. 2017-2508

February 6, 2019

Brief summary: DC finding that method claims relating to a correlation between antibodies to a protein (“MuSK”) and neurological disorders are invalid under § 101 affirmed.

Summary: Athena (as exclusive liceness) appealed DC granting Mayo’s motion to dismiss under Rule 12(b)(6) and finding claims 6-9 of US 7,267,820 directed to methods for diagnosing neurological disorders such as myasthenia gravis (MG) by detecting antibodies to muscle-specific tyrosine kinase (“MuSK”) invalid under § 101 as being directed to a natural law and lacking an inventive concept. The FC panel opinion explains that about 20% of MG patients were found to produce autoantibodies against MuSK and that “[p]rior to their discovery, no disease had been associated with MuSK.” The FC panel opinion explains that the DC “concentrated its analysis on claims 7-9 (“representative of claim 6”). Claim 7 is dependent on independent claim 1 (not at issue here) and includes contacting labeled “MuSK or an epitope or antigenic determinant thereof” with a “bodily fluid”, immunoprecipitating any antibody/MuSK complexes, and “monitoring for said label”, “wherein the presence of said label is indicative of” an MuSK-related disorder. Claim 9 (dependent on claim 8), which the FC opinion “focus[ed] on”, “further recites” MuSK being labeled with the radioactive label iodine-125 (125I). The FC panel opinion explains that the ‘820 specification states that techniques such as immunoprecipitation, radioimmunoassays, and detection by ELISA are “know per se in the art”. It also explains that “[p]atent eligibility under § 101 is a question of law based on underlying facts” (Aatrix Software, FC 2018; Berkheimer, FC 2018) “that may be resolved on a Rule 12(b)(6) motion when the undisputed facts require a holding of ineligibility” (SAP, FC 2018). The FC reviewed the relevant § 101 precedent, noting that SCOTUS “has advised” that the “Mayo” exceptions to patentability (“laws of nature, natural phenomena, and abstract ideas”) “must be applied cautiously, as ‘too broad an interpretation of this exclusionary principle could eviscerate patent law’” (Mayo, US 2012). Under Mayo, the FC panel explains, “adding conventional steps, specified at a high level of generality,’ to a law of nature does not make a claim to the law of nature patentable.” The FC panel reviewed the claims under the two-step Alice procedure (Alice, US 2014). Athena argued “that the claims are directed a new laboratory technique that makes use of man-made molecules”, and Mayo countered that “the claims are directed to a natural law” relating to the autoantibody-MG correlation and included only “concededly standard immunoassay techniques”. The FC panel agreed with Mayo because the correlation “exists in nature apart from any human action”, contrasting this case with CellzDirect (FC 2016; “claims as a whole recited ‘a new an improved way of preserving hepatocytes’”; see also BASCOM, FC 2016) and likening it to Cleveland Clinic (FC 2017; claims covering correlation between MPO and cardiovascular disease included “no meaningful non-routine steps”; see also Ariosa (FC 2015)). The FC panel concluded that “[t]he claims here are directed to a natural law because they recite only the natural law together with standard techniques for observing it” and the fact that “the routine steps are set forth with some specificity is not enough to change that conclusion” (see the Alice step two analysis as well). The Vanda decision (FC 2018) was also referenced as an example of “claiming a new treatment for an ailment, albeit using a natural law” without “claiming the nature law.” Judge Newman’s dissent argued that the FC panel “again departs from the cautious restraints” of Mayo, “[t]his court’s decision on patent-ineligibility are not consistent”, and “[c]laim limitations cannot be discarded when determining eligibility under” § 101 (Diamond, US 1981).

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Supernus Pharm., Inc. et al. v. Andrei Iancu (USPTO)

Docket No. 2017-1357

January 23, 2019

Brief summary: DC grant of SJ to the USPTO regarding calculation of the PTA for Supernus’s patent reversed and remanded since Supernus could not have engaged in “reasonable efforts” to disclose a European opposition before the notice was issued by the EPO.

Summary: Supernus appealed the DC’s entry of SJ, based on Gilead (US 2015), with respect to the patent term adjustment for US 8,747,897. The FC panel opinion explains that 35 USC § 1.54(b)(2)(C) regulates the calculation for reduction of patent term adjustment (PTA) where an application failed “to engage in reasonable efforts to conclude” examination and 37 CFR § 1.704(c)(8) relates to the applicant’s submission of “a supplemental reply or other paper”. During prosecution of the ‘897 patent, Supernus filed an RCE on Feb. 22, 2011 in response to an Aug. 20, 2010 final rejection. On Sept. 11, 2012, Supernus’s European counsel notified it of an opposition against its corresponding European application, and an IDS regarding the same was filed on Nov. 29, 2012 (79 days after being notified by European counsel, and 100 days from EPO notification). On Sept. 10, 2013, the USPTO issued a first office action in response to the RCE and allowed the application on Feb. 4, 2014, with a 1,260-day PTA. The USPTO calculated the PTA by adding 1,656 days of Type A delays (for the USPTO’s failure to meet statutory deadlines) and 665 days for Type B delays (for the USPTO’s failure to issue the patent within three years of filing the application), and then subtracting 175 days of overlapping Type A and Type B delays as well as 886 days attributed to Supernus’s delay, including 646 days for the period between the filing of the RCE and the IDS. Supernus appealed the PTA calculation to the DC with respect to the 646 day subtraction (that “it was entitled to at least 546 of those days-i.e., the period between its filing of the RCE and the EPO notification”), but the DC granted SJ in favor of the USPTO under Gilead (“foreclosed, as a matter of law, Supernus’s statutory interpretation arguments”). In this appeal, the FC panel first explained “that Gilead does not foreclose Supernus’s statutory interpretation argument” as “the precise question addressed in Gilead” was “whether a failure to engage in reasonable efforts requires conduct that actually causes delay” (“as opposed to the potential to cause delay” (i.e., “what constitutes ‘reasonable efforts’”?) was not the question here, which was “whether efforts taken by Supernus, or those it could have taken, resulted in actual or potential delay”. Supernus and the USPTO agreed Supernus “could not have undertaken any efforts to conclude prosecution” before the EPO notified it of the opposition (i.e., the 546-day period). The FC panel reviewed the statute and concluded that “PTA cannot be reduced by a period of time during which there is no identifiable effort in which the application could have engaged to conclude prosecution” because such time would “exceed the time during which an applicant failed to engage in reasonable efforts” (“The ‘equal to’ limitation ensures that applications will be charged the full amount of time corresponding to their own delays…[t]o conclude otherwise renders the PTA statute’s ‘reasonable efforts’ language superfluous.”) Thus, the FC panel the 546-day reduction could not be included in the PTA calculation, and reversed and remanded the DC’s decision.

Posted in America Invents Act, Patent Term Adjustment (PTA), Patent Term Extension | Leave a comment

In re: Ikeda Food Research Co., Ltd.

Docket No. 2017-2624

January 29, 2019

Brief summary: Board decision affirming the rejection of claims directed to method for measuring blood glucose using a biosensor as obvious due to inherent disclosure by the prior art affirmed.

Summary: Ikeda appealed Board decision affirming the rejection of its claims directed to method for measuring blood glucose using a biosensor as obvious. The claimed biosensor includes “an enzymatic reaction layer” on an electrode comprising an enzyme (flavin compound-binding glucose dehydrogenase (FAD-GDH)) with glucose sensing ability (“enzymatic activity”) “wherein enzymatic activity to maltose in the enzymatic reaction layer is 5% or less relative to the enzymatic activity to glucose”. The claims were rejected in view of the “Senior” reference describing a glucose sensor using a different FAD-GDH enzyme and the “Yugawa patents” that also describe a biosensor using electrodes and GDH and “PQQ-GDH” in a “reaction layer” (“employing the FAD-GDH enzyme preparation described in Senior with the biosensor described in the Yugawa patents would have rendered the Challenged Claims obvious”). The FC panel reviewed the Board’s “factual findings for substantial evidence and its legal conclusions de novo” (Redline Detection FC 2015; In re NuVasive, FC 2016 (“more than a mere scintilla of evidence”); Elbit, FC 2018 (“PTAB decision to favor one conclusion over another is the epitome of a decision that must be sustained upon review for substantial evidence”)). The Board’s obviousness underlying findings of facts were reviewed in view of the Graham factors (US 1966), secondary considerations (In re Cyclobenzaprine, FC 2012 (“‘a feasible solution to the long-standing problem’ supports a finding of long-felt need”), and whether there was a motivation to combine the prior art with a reasonable expectation of success (Univ. Cal., FC 2018). The FC panel explained that while “inherency may supply a missing claim limitation in an obviousness analysis”, “the limitation at issue necessarily must be present[] or the natural result of the combination of elements explicitly disclosed by the prior art” (PAR Pharm., FC 2014), and that “the [US]PTO can require an applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied upon” (Southwire, FC 2017; In re Spada, FC 1990). The USPTO found that “even though Senior did not expressly disclose the low-maltose activity limitation”, “Senior’s disclosed enzyme preparation inherently contains the same enzyme specificity for glucose relative to maltose”. Ikeda contested this point but not “that each of the other limitations are taught by” Senior and Yugawa. But the FC panel found the Board’s conclusions to be supported by substantial evidence since, e.g., the enzymes have “the same ‘E.C’’ classification number…even though each FAD-GDH enzyme is produced from a different microorganism” and “it was reasonable for the PTAB to conclude” the enzyme preparations have “identical enzymatic activity, which necessarily includes having the same substrate specificity”, and “Ikeda did not present evidence of testing any of the enzyme preparations found in the prior art” (Butamax, FC 2014; In re Spada, FC 1990). The FC panel also found no error with the Board’s conclusion that “Ikeda’s expert testimony” regarding long-felt need “did not have any substantive relevance”. Thus, the Board decision was affirmed.

Posted in Inherency, Obviousness | Leave a comment

Mark A. Barry v. Medtronic, Inc.

Docket No. 2017-2463

January 24, 2019

Brief summary: DC and jury conclusions of no invalidity and infringement affirmed (e.g., the invention was not in “public use” as the use was experimental, no § 102(b) on-sale bar, no § 102(g) prior invention, no inequitable conduct, “underlying direct infringement by surgeons”).

Summary: Dr. Barry alleged Medtronic induced surgeons to infringe his US 7,670,358 and 8,361,121 claiming “methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at once”, and the jury found infringement, rejected Medtronic’s invalidity challenges, and awarded damages. The DC upheld the jury’s verdict and rejected Medtronic’s inequitable conduct challenge. Medtronic appealed “on numerous grounds, principally concerning the public-use and on-sale statutory bars, but also concerning prior invention, inequitable conduct, and induced infringement and associated damages.” The FC panel explained that “[t]he public use bar is triggered where, before the critical date, the invention is in public use and ready for patenting” (Polara Eng’g, FC 2018; Pfaff, US 1998; Invitrogen, FC 2005). And it disagreed with Medtronic’s public use arguments because “the invention was not ready for patenting before the critical date” and “there was no public use except for an experimental use”. The FC panel addressed “both readiness for patenting and experimental use because they are related”, and to address points raised in the dissent. The FC panel explained “that ‘evidence of experimental use may negate either the ‘ready for patenting’ or ‘public use’ prong [of the public-use-bar standard]’”, and that it has “recogniz[ed] an overlap of the experimental use negation and the ready for patenting standard” (“[p]roof of experimental use serves as a negation of the statutory bars” (Polara Eng’g)). Here, the FC panel found that Dr. Barry did not know “that the surgical technique worked for its intended purpose” as of the date the surgery was carried out alleged by Medtronic since, e.g., expert testimony showed that “[f]ollow up is absolutely required” after surgery “to determine that it lasts” and the preamble language of the claim “here, is not a limiting” (In re Omeprazole, FC 2008; Honeywell, FC 2007 (“an invention might not be ready for patenting until the inventor ascertains how that invention will function in practical circumstances”); TP Labs., FC 1984 (“for medical procedures, follow-up appointments can be necessary to determine whether an invention is performing its intended purpose”); the “intended purpose need not be stated in claim limitations”, citing In re Schreiber, FC 1997)). The FC panel also found that the invention was not in “public use” since, e.g., the ‘358 patent invention was not accessible to the public before the critical date” (“accessibility determination may be rejected where the evidence establishes a sufficient obligation of confidentiality, which can be implied”, citing Dey, FC 2013; “sometimes (as in Egbert) even a limited disclosure can make an invention accessible to the public” (Egbert, US 1881)) and “the asserted acts of commercial exploitation…come within the experimental-use exception” (“An inventor’s use, while public in one sense, will not be considered a statutory public use if the use was experimental.” Electromotive, FC 2005; however, “an inventor’s own prior commercial use, albeit kept secret, may constitute a public use or sale under § 102(b)” (Woodland Tr., FC 1998 and TP Labs.; “A use may be experimental if its purpose is: ‘(1) [to] test claimed features of the invention or (2) to determine whether an invention will work for its intended purpose-itself a requirement of patentability” (Polara; Clock Spring, FC 2009 (13 factors to assess whether a use is experimental, several reviewed here)). Medtronic also argued for invalidity under § 102(b) (on-sale bar) but the FC panel found no abuse of discretion in the DC’s jury instruction that “there is a difference between ‘experimental use’ in the context of patent law and the way that the word ‘experiment’ is used in the context of medicine” since “what the court said on the subject was both modest and consistent with our holdings” (Penwalt, FC 1984 (“The fact that a sale or use occurs under a regulatory testing procedure…does not make such uses or sales per se experimental for purposes of 35 U.S.C. § 102(b)); Clock Spring). The FC panel also upheld “the jury’s rejection of Medtronic’s § 102(g) challenge” because substantial evidence showed Medtronic’s alleged inventor “did not reduce the claimed inventions to practice” until “after Dr. Barry did so.” Medtronic also alleged inequitable conduct based on Dr. Barry’s incorrect initial description of “Figure 6 of both patents” (“contrary to the description, the subject of the submitted x-rays actually was not a patient treated with the inventive methods”), which was corrected by Certificate of Correction after litigation began. The DC found “no intent to deceive the PTO”, and the FC panel found no clear error in this conclusion (Therasense, FC 2011), since, e.g., “Dr. Barry and his counsel were credible in explaining why the errors occurred”. The FC panel also found that substantial evidence supported “the jury’s finding of underlying direct infringement by surgeons” since, e.g., “[t]he steps recited in” Medtronic’s survey of surgeouns “track the claim language in the patent” (§ 271(b); Limelight, US 2014; Eli Lilly, FC 2017; Vanda, FC 2018), and “that Medtronic induced infringement after issuance of Dr. Barry’s two patents”. The FC panel also found no abuse of discretion in the jury’s damage award. Judge Prost’s dissent argued that “Dr. Barry successfully performed his claimed surgical method on three different patients, charging his normal fee” and was “thus prima facie ‘on sale’ or in ‘public use’ before the critical date under” § 102(b).

Posted in Anticipation (35 USC 102), Conception and Reduction to Practice, Experimental Use, Inducement to Infringe, Inequitable Conduct, Infringement, Preamble, Public Use | Tagged | Leave a comment

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. et al.

Docket No. 2016-1284, -1787
May 1, 2017 (FC panel); June 25, 2018 (SCOTUS); Jan. 24, 2019 (SCOTUS)

Update 2 (Jan. 24, 2019): Update 2 (Jan. 24, 2019): SCOTUS affirmed the FC panel decision, holding that “a commercial sale to a third party who is required to keep the invention confidential may place the invention ‘on-sale’” under 35 U.S.C. § 102(a)(1) of the AIA (citing Pfaff, US 1998 (“the subject of a commercial offer for sale” and “ready for patenting”) (“…the AIA did not alter this meaning”); Special Devices, FC 2001 (“commercial stockpiling”); Woodland Trust, FC 1998).

Update 1 (June 25, 2018): SCOTUS granted certiorari (17-1229), the question presented being “[w]hether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.” Helsinn argued that the AIA change from the ““on sale in this country” to “on sale, or otherwise available to the public” means the claimed invention (the subject of the sale) must be available to the public in order to trigger the AIA on-sale bar (“If the decision below is allowed to stand, the United States would be the only industrialized country to invalidate patents on the basis of ‘secret’ prior art.”)

Brief Summary of original FC panel decision: FC panel reversed DC and found the asserted claims invalid under the § 102(b) on-sale bar, the “sale” being the covered by a confidentiality agreement. The FC panel concluded that the AIA did not change the meaning of the on-sale bar (it may “encompass secret sales”) and “after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of the sale.”

Summary: Helsinn appealed DC findings that three of its pre-AIA patents were not invalid under the § 102 on-sale bar because while there was an offer for commercial sale, the invention was not ready for patenting, and a fourth AIA patent was not invalid because the AIA changed the relevant standard (i.e., AIA § 102(b) “requires a public sale or offer for sale of the claimed invention”). The FC panel disagreed with all of these conclusions. The Orange Book-listed patents (US 7,947,724; 7,947,725; 7,960,424; and 8,598,219) are directed to IV formulations of palonosetron for reducing or reducing the likelihood of chemotherapy-induced nausea and vomiting (“CINV”) “using unexpectedly low concentrations of palonosetron [0.25 mg and 0.75 mg] that were not taught by the prior art.” Teva’s 0.25 mg product was found by the DC to infringe the claims of the patents. The patents all claim priority to a provisional application filed on Jan. 30, 2003 (the § 102(b) critical date therefore being Jan. 30, 2002), and the parties agreed the AIA ‘219 patent has the same critical date as the pre-AIA patents (noting in FN1 that “[t]he one-year grace period in the AIA is less protective than under pre-AIA § 102(b) for reasons not relevant here”). Helsinn entered into a “binding” License Agreement and Supply and Purchase Agreement (SPA) with MGI Pharma, Inc. (“MGI”) on April 26, 2001 which obligated Helsinn to sell the 0.25 mg and 0.75 mg doses of palonosetron to MGI if approved by the FDA. The SPA “included…specific terms, such as price, method of payment, and method of delivery” and “[e]ven though MGI’s firm orders…were ostensibly ‘subject to written acceptance and confirmation by [Helsinn] before becoming binding”, “Helsin was nonetheless obligated to meet or designate a third party manufacturer to meet MGI’s firm orders.” It was publicly disclosed in MGI’s April 25, 2001 8-K filing “as obligating Helsinn to supply MGI’s ‘requirements of finished product” (the FC noting that under Enzo (FC 2005) “the fact that an agreement covered one party’s requirements as opposed to a specified quantity does not prevent application of the on-sale bar”). Helsinn argued the SPA was not invalidating because FDA approval was uncertain and “a condition precedent to the sale.” Under the UCC, however, the FC panel explained that “[a] contract for sale that inclused a condition precedent is a valid and enforceable contract” (BG Grp. US 2014). And “the absence of FDA or other regulatory approval before the critical date does not prevent a sale or offer for sale from triggering the on-sale bar”, although it “may be a relevant consideration depening on the other circumstances” (Enzo, FC 2005; C.R. Bard, FC 1998; Elan, FC 2004 (“purported offer concerned a product when and if it had been developed, and there was no price or quantity term”)). The FC panel also concluded the SPA “unambiguously placed the invention on sale” (Medicines, FC 2016 (en banc) (also noting, e.g., “‘stockpiling’, including purchases from a supplier, ‘does not trigger the on-sale bar’”).

The FC panel also considered whether the AIA changed the meaning of the on-sale bar, as concluded by the DC and found it did not. It explained that pre-AIA “§ 102(b) barred the patentability of an invention that was…‘on sale’” and that “[u]nder that earlier provision…although condfidentiality weighs against application of the on-sale bar…that fact alone is not determinative” (Medicines, FC 2016; see FN7 for additional cases). The AIA used the same term “on sale” but also “otherwise available to the public” which “Helsinn, the government, and other amici argue…changed the law” such that “the on-sale bar now does not encompass secret sales and requires that a sale make the invention available to the public in order to trigger” it, based in part on the legislative history. The FC panel disagreed this was relevant here since “[h]ere, the existence of the sale…was publicly announced in MGI’s 8’K filing”. Helsinn also argued the 0.25 mg dose (“the invention”) was not disclosed but the FC panel explained that its “cases explicitly rejected a requirement that the details of the invention be disclosed in the terms of the sale” (RCA Corp., FC 1989). Further, “[a] primary rationale of the on-sale bar is that publicly offering a product for sale that embodies the claimed inventin places it in the public domain, regardless of when or whether actual delivery occurs” and “we have never required that a sale be consummated or an offer accepted” (Pfaff, US 1998; Abbott, FC 1999 (“on sale” even where “at the time of the sale, neither party…knew whether the product sold embodied the claimed invention and had no easy way to determine what the product was”)). Thus, the FC concluded, “after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of the sale.”

The FC panel also concluded the invention was ready for patenting as of the critical date (Jan. 30, 2002). Regarding a reduction to practice (RTP), the FC panel explained that “the only issue…[was] whether Helsinn had determined that the invention would work for its intended purpose”, the test for which “varies depending on ‘the character of the invention,’ including the claims language and the ‘nature and complexity of the problem’ the invention seeks to solve” (Scott, FC 1994 (“‘beyond a probability of failure’ but not ‘beyond a possibility of failure’”); Honeywell, FC 2007 (“Generally there must be some ‘demonstration of the workability or utility of the claimed invention.”); Atlanta Attachment, FC 2008 (“it is improper to conclude” no RTP “merely because further testing is being conducted”)). It concluded the DC “clearly erred by applying too demanding a standard” since “[t]he completion of Phase III studies and final FDA approval are not pre-requisites for the invention here to be ready for patenting” (Omeprazole, FC 2008) and the evidence “that the patented invention would work for its intended purpose or reducing the likelihood of emesis” is “overwhelming”. FN18 also explains that “post-contract developments are relevant such that even if an invention is not ready for patenting at the time of the offer or sale, it may become so before the critical date and thereby trigger application of the on-sale bar”.

Thus, the FC panel reversed the DC decision and found the asserted claims to be invalid under the § 102(b) on-sale bar.

Posted in Anticipation (35 USC 102), On-Sale Bar | Leave a comment