Amgen, Inc. et al. v. Hospira, Inc.


Docket No. 2016-2179

DYK, BRYSON, CHEN
August 10, 2017

Brief summary: Amgens’s appeal for lack of jurisdiction and petition for a writ of mandamus dismissed and denied, respectively, since DC denial of Amgen’s motion to compel discovery is “reviewable from final judgment” and Amgen could have listed cell-culture patents it believes “could reasonably be asserted” under BPCIA (l)(3)(A).

Summary: Amgen appealed DC order denying its motion to compel discovery (and requested a writ of mandamus ordering the same) from Hospira in an infringement dispute regarding EPOGEN® governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). In a previous opinion (Amgen, FC 2016), the FC panel asked the parties to brief ‘whether this court has jurisdiction pursuant to the collateral order doctrine or under the All Writs Act”, which is addressed here. The FC panel opinion explains that the dispute “arises from the disclosure requirements of the BPCIA…recently addressed by the Supreme Court in Sandoz” (US 2017) for abbreviated approval “subsection (k)” applicants (allowing for “piggyback[ing] on the showing made by the [sponsor] of a previously [approved] biologic (reference product)”). One of the obligations on subsection (k) applicants “is to provide the sponsor with ‘a copy of the application submitted’ under subsection (k), ‘and other such information that describes the process or processes used to manufacture the biological product” (42 USC § 262(l)(2)(A)). This then “leads to a series of information exchanges…between the applicant and the sponsor that ‘channels the parties into two phases of patent litigation’”: 1) a first phase in which “patents that they would like to litigate immediately” are identified; and, 2) a second phase involving “any patents that were included on the parties’ [paragraph (l)(3)] lists but not litigated in the first phase” (§ 262 (l)(6)) (42 USC § 262(l)(3), (l)(4), and (l)(5), (l)(6) (first phase), and (l)(8) (second phase); Sandoz, US 2017; Amgen, FC 2016). Amgen wrote Hospira a letter asserting “Hospira had failed to ‘fully disclose the specific composition of the cell-culture medium used in the manufacture’ of Hospira’s biosimilar” as required under (l)(2)(A), but Hopsira contended the information was included in its application (not resolved here) (Amgen (FC 2015), “a sponsor may seek information withheld by an applicant under paragraph (l)(2)(A) ‘through discovery’”). As a result, Amgen did not disclose any cell culture-related patents in its list. The DC stated that the cell-culture information sought by Amgen had ‘essentially, no relevance to the patents that are asserted’”. Regarding jurisdiction, the FC panel explained that “an appeal must be from a ‘final’ judgment that ‘ends the litigation on the merits and leaves for the court to do but execute the judgment’” (Livesay, US 1978). There is a “small class” of exceptions where “the order conclusively determine[s] the disputed question, resolve[s] an important issue completely separate from the merits of the action, and [is] effectively unreviewable on appeal from a final judgment” (Livesay; Microsoft, US 2017; Cohen, US 1949). The issue here is whether the DC’s “order is ‘effectively unreviewable’ on appeal”. The FC panel found that it is not since it is “reviewable from final judgment” (Livesay; Kircher, US 2006 (“Congress’s decision not to provide for interlocutory review simply means that immediate appeal is not available.”)).

With respect to the Amgen’s request for a Writ, the FC panel also explained “five potential avenues available to a sponsor seeking to secure process information pursuant to paragraph (l)(2)(A)”: 1) injunction under federal law (unvailable under Sandoz); 2) injunction under state law (not raised by Amgen here); 3) sue for patent infringement flowing from the failure to comply with (l)(2)(A) (not available since under 271(e)(2) the “failure to disclose…[is] not an act of artificial infringement” (Sandoz)); 4): “sue on ‘patents descrbied in [paragraph (l)(3)…35 U.S.C. § 271(e)(2)(C)(i)…the ‘list of patents for which the…sponsor believes a claim of patent infringement could reasonably be asserted”; and, 5) “sue on a patent that ‘could be identified’ under paragraph (l)(3). Regarding (4) and (5), the FC panel noted that “Amgen did not list any of its cell-culture patents, nor did it bring suit on any of these patents as ones that ‘could be identified’”. The FC panel also explained that Amgen could have listed such patents under (l)(3)(A) which “merely requires the sponsor to list patents that it ‘believes…could reasonably be asserted” (“the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A)”; “if a sponsor forms a belief based on an inquiry limited by an applicant’s withholding of information, the sponsor has still satisfied Rule 11” (Fed. R. Civ. P. 11(b); Hoffman-LaRoche, FC 2000).

Posted in Biosimilars, Generics / ANDA | Leave a comment

Homeland Housewares, LLC v. Whirlpool Corporation


Docket No. 2016-1511 (IPR2014-00877)

PROST, NEWMAN, DYK
August 4, 2017

Brief summary: Board decision of no anticipation of Whirlpool’s patent related to blenders reversed based on analysis after claim construction.

Summary: Homeland appealed Board IPR decision that Whirlpool’s US 7,581,688 relating to household blenders was not invalid for anticipation. The FC panel opinion explains that the ‘688 patent relates to a pre-programmed, automated blending cycle that “repeatedly drop[s] to a speed slow enough to allow the blender contents to settle around the cutter assembly, and then return[s] to a [higher] speed suitable for processing the contents”, a “routine [that] was, in the prior art, done manually” (“There were also blenders on the market which allowed ‘preprogram[ing] ‘on-off’ sequence[s] [to] enable[] hands-free operation of the blender.”) Homeland argued to the Board that the ‘688 claims were anticipated by “Wulf” which was alleged to teach “a blender…that is programmed to [automatically] accomplish predetermined [blending] functions and routines.” “[T]he Board declined to provide a construction of settling speed’” and determined Homeland had not shown anticipation by a preponderance of the evidence. The FC panel explained it reviewed the Board’s conclusions of law de novo and its findings of fact for substantial evidence (Microsoft, FC 2015). The Board’s claim construction conclusions of law were reviewed de novo as “there is no relevant extrinsic evidence” (Teva, US 2015). And anticipation requires a two-step analysis: interpreting the claims and then “determining whether the limitations of the claims, as properly interpreted, are met by the prior art” (Beachcombers, FC 1994). The FC panel explained that the Board did not settle the parties’ dispute regarding the “settling speed” limitation as required (O2 Micro, FC 2008; CSR, FC 2014). The FC panel therefore construed the limitation as step one in its anticipation analysis (“[T]he claim construction inquiry…begins and ends in all cases with the actual words of the claim.” Renishaw, FC 1998; “The words of a claim are generally given their ordinary and customary meaning” and “must also be read in view of the specification, of which they are part.” Phillips, FC 2005; “[P]articular embodiments appearing in the written description will not be used to limit claim language that has broader effect.” Innova/Pure Water, FC 2004). Whirlpool argued “that empirical testing is required to establish a settling speed…[b]ecause so many factors affect” it but the FC panel “conclude[d] that a construction that would require empirical testing is incorrect.” The FC panel found that “the process for empirically determining a settling speed is neither taught in the specification nor a part of the claims”. While the specification explains “these speeds and time periods will vary for different blenders, and must be determined empirically for a particular blender”, “it provides no meaningful definition of an empirically determined settling speed other than with respect to a single example (relating to crushed ice).” Under the broadest reasonable construction (BRC), the FC panel found the term refers to “a speed that is slower than the operating speed and permits settling of the blender contents” (Philips; In re NTP, FC 2000). And “[b]ased on this construction,” the FC panel concluded the Board erred in not finding anticipation by Wulf. The FC panel also reviewed the Board’s finding that it would not discount Whirlpool’s witness testimony since Homeland did not rebut it, but the panel concluded it could be disregarded as “plainly inconsistent with the record” (NantKWest, FC 2017; Cordis, FC 2011 (“based on an incorrect understanding of the claim[s])). The Board decision was reversed.

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

Enzo Biochem Inc et al. v. Applera Corp. et al.


Docket No. 2016-1881

PROST, O’MALLEY, WALLACH
August 2, 2017

Non-precedential

Brief summary: DC grant of SJ to Applera on remand following Applera’s appeal of a $48.6 million adverse judgment affirmed since, e.g., the DOE “cannot embrace a structure that is specifically excluded from the scope of the claims” (the claims do not include direct detection).

Summary: Enzo appealed DC entry of SJ favoring Applera regarding Enzo’s US 5,449,767 relating to detecting DNA and RNA sequences in samples without using radioisotopes. A jury originally found that Applera infringed the asserted ‘767 claims and awarded Enzo $48.6 million in damages (Enzo I, FC 2010; Enzo II, FC 2015). That decision was appealed and that FC panel agreed with Applera, concluding claim 1 was limited to indirect detection. On remand, the DC “agreed with Applera that [the FC panel’s] decision in Enzo II covered all claims of the ‘767 patent, not just claim 1 as argued by Enzo, and rejected Enzo’s doctrine of equivalents argument relating to claims 1 and 8” and granted Applera’s motion for SJ. The disputed language of claim 1 (upon which the other asserted claims depend) in this appeal “involves the following limitation: ‘wherein A comprises at least three carbon atoms and represents at least one component of a signaling moiety capable of producing a detectable signal’”. Enzo argued the DC erred in its construction of the claims and that “the previously-construed scope of claims 67, 68, and 70, cover[] both direct and indirect detection.” The FC panel determined that Enzo II “consistently refers to the ‘claims’ at issue in that appeal, which extend beyond claim 1 to include claims 8, 67, 68, and 70”, and therefore affirmed this part of the DC’s decision. The DC also granted Applera’s motion for SJ that it did not infringe claims 1 and 8 under the doctrine of equivalents (DOE) (Warner-Jenkinson, US 1997; Graver Tank, US 1950), which Enzo argued was improper “because there is a genuine dispute of material fact” on this point. Infringement under the DOE can be shown “if every limitation of the asserted claim, including a limitation’s ‘equivalent.’ Is found in the accused product, ‘where an ‘equivalent’ differs from the claimed limitation only insubstantially” (e.g., “[w]hether a component in the accused subject matter performs substantially the same function as the claimed limitation in substantially the same way to achieve substantially the same result” (Ethicon, FC 1998)). The FC panel explained that the DOE “cannot embrace a structure that is specifically excluded from the scope of the claims” (Dolly, FC 1994) and “cannot ‘render[] a claim limitation inconsequential or ineffective’” (Akzo Nobel, FC 2016; Warner-Jenkinson). The FC, however, found that Enzo’s DOE argument “runs headfirst into our decision in Enzo II” which found “the inventors were claiming only indirect detection” (“the asserted claims do not include direct detection in part because they excluded direct detection…direct detection cannot be an equivalent of indirect detection” in the ‘767 claims). Thus, the DC decision was affirmed.

Posted in Claim Construction, Doctrine of equivalents | Leave a comment

Honeywell International Inc. v. Mexichem Amanco Holdings S.A. et al.


Docket No. 2016-1996

LOURIE, REYNA, WALLACH
August 1, 2017

Brief summary: Board affirmance of obviousness rejections vacated and remanded because, e.g., it erred “in dismissing properties of the claimed invention as merely inherent, without further consideration as to unpredictability and unexpectedness.”

Summary: Honeywell appealed PTAB in a merged inter partes reexamination of Honeywell’s US 7,534,366 relating to a heat transfer equipment (e.g., air conditioner) fluid (“at least about 50% by weight of 1,1,1,2-tetrafluoropropene (HFO-1234yf) [an unsaturated hydrofluorocarbon (“HFC”) compound] having no substantial acute toxicity” and “at least one polyalkylene glycol lubricant” (“PAF”)). Durign the reexamination, the Examiner rejected the claims as obvious under § 103 in view of three references (“Inagaki” (for expressly disclosing HFO-1234yf), and “Magid” and “Acura” (for teaching the use of PAG lubricants with HFC refrigerants). In its appeal to the Board, Honeywell argued Inagaki does not teach HFO-1234yf and a PAG lubricant (only “disfavored” immiscible lubricants), and that the secondary references only refer to “saturated HFC refrigerants, not unsaturated (i.e., HFO) refrigerants” and that the “stability of HFO-1234yf in combination with PAG over other similar refrigerants with PAGs” was unexpected, there was a long-felt need for the claimed combination, and “skepticism that such an environmentally-friendly composition existed”. The Board, however, affirmed the Examiner’s rejection because, e.g., “the stability and miscibility of HFO-1234yf with a PAG lubricant are ‘inherent properties of an otherwise known refrigerant’ that could not confer patentable weight to the claimed mixture” and Honeywell did not show a nexus between the secondary considerations evidence and the claimed composition. “The Board acknowledged that ‘[e]ven inherent properties, to the extent that they demonstrate results beyond what would have been expected…particularly superior results that demonstrate more than a mere improvement in a property, are evidence that the invention is non-obvious and must be considered accordingly” (In re Geisler, FC 1997) but “found Honeywell’s evidence to be unpersuasive because Omure” (a reference presented by Mexichem but not addressed by the Examiner) shows the skilled artisan “would no more have expected failure…than would have expected success.” The Board also “found that, due to the ‘overall unpredictability as to stability in the art,’ one of ordinary skill would have arrived at the claimed combination by mere routine testing.” Thus, the Board affirmed the Examiner’s finding of obviousness.

The FC panel reviewed the Board’s legal determinations de novo (In re Elsner, FC 2004) and its factual findings underlying those conclusions for substantial evidence (In re Gartside, FC 2000; Consol. Edison (“substantial evidence if a reasonable mind might accept” it)). And obviousness, it explained, “is a question of law, based on underlying factual findings, including what a reference teaches, whether a person of ordinary skill in the art would have been motivated to combine references, and any relevant objective indicia of nonobviousness” (Apple, FC 2016, en banc). The FC panel found “[t]he Board committed legal error by improperly relying on inherency to find obviousness” (an “internally inconsistent analysis”) and erred “in its analysis of the motivation to combine references.” Regarding inherency, the FC panel explained “that the use of inherency in the context of obviousness must be carefully circumscribed because ‘[t]hat which may be inherent is not necessarily known’ and that which is unknown cannot be obvious” (In re Rijckaert, FC 1993; PAR Pharm., FC 2014 (distinguishing a prior case finding obviousness based on inherency because, in that case, ‘neither party disputed that the [claimed features] were expected in light of the dosages disclosed in the prior art’”)). Further, “[w]hat is important regarding properties that may be inherent, but unknown, is whether they are unexpected”; “unexpected properties may cause what may appear to be an obvious composition to be nonobvious” (In re Papesch, CCPA 1963). It found that “the Board here, in dismissing properties of the claimed invention as merely inherent, without further consideration as to unpredictability and unexpectedness, erred as a matter of law.” It also found error with the Board’s “burden-shifting argument that Honeywell did not persuasively establish that one of ordinary skill in the art would have expected failure” since in an inter partes reexamination “the burden is on the Examiner to show…a motivation to combine the references with a reasonable expectation of success” (Redline Detection, FC 2015; Rambus, FC 2013; Leo Pharm., FC 2013). The FC panel also disagreed with the Board’s position on “routine testing” since, e.g., “patentability shall not be negatived by the manner in which the invention was made” (In re Fay, CCPA 1965). Thus, the motivation question was remanded to the Board. The FC panel also found the Board improperly raised a new ground of rejection with its reliance on the Omure reference (Judge Wallach’s dissent disagreed with this point). The Board decision was therefore vacated and remanded.

Posted in Inherency, Obviousness, Reexamination | Leave a comment

Eli Lilly and Company v. The Trustees of The University of Pennsylvania

IPR2016-00458 (US 7,625,558)
Final Written Decision
July 13, 2017

Brief summary: PTAB FWD found claims of Penn’s ‘558 patent allegedly relating to Lilly’s Erbitux® (centuximab) to be invalid for obviousness.

Summary: IPR as to claims 1-7, 9-12, 14, 16, 17, and 19-31 of the ‘558 patent was instituted on July 14, 2016 for obviousness over the combination of the “Saleh”, “DeNardo”, and “Balaban” prior art documents. Litigation (ED PA) regarding the ‘558 patent in which Penn alleged infringement by Lilly’s Erbitux® (centuximab) is currently stayed pending any motions for reconsideration or appeals of this FWD. At least one application related to the ‘558 patent (15/442,046 filed Feb. 1, 2017) is currently pending at the USPTO. The challenged claims (for obviousness in view of a combination of the “Saleh”, “DeNardo”, and “Balaban” references) are directed to “[a] method of treating an individual who has an erbB protein mediated tumor” by “administering to said individual an antibody which inhibits formation of erbB protein dimers that produce elevated tyrosine kinase activity in a tumor cells, said inhibition having a cytostatic effect on the tumor cell; and (b) thereafter exposing said individual to a therapeutically effective amount of anti-cancer radiation.” In its Decision to Insitute, the PTAB construed “anti-cancer radiation” and “gamma radiation” (ind. claim 5) to mean “any of the protocols and parameters” described “in the Perez & Brady textbook”. In this FWD, the PTAB agreed with Lilly that under the broadest reasonable construction (Cuozzo, US 2016) “anti-cancer” and “gamma irradiation” are not limited to “conventional external beam radiation” as argued by Penn (“neither standard nor conventional in the art at the time of the invention”, relying on, e.g., the specification’s incorporation by reference (Zenon, FC 2007) and expert witness testimony) and do not exclude radio immunotherapy (“RIT”) (Glaxo, FC 2003 (“When a claim term has an accepted scientific meaning, that meaning is generally not subject to restriction to the specific examples in the specification.”); and “there was no prosecution history disavowel” (SAS Inst., FC 2016)). The PTAB also concluded that “[a] showing in the prior art of an antibody that disrupts tyrosine kinase activity, such as by inhibiting dimer formation, is sufficient to satisfy the claimed inhibition having a ‘cytostatic effect’.” The FWD discussed but did not construe “‘multimeric receptor ensembles’ because both parties agree” it “includes EGFR-p185 heterodimers.” The PTAB found “that the cited prior art is representative of the level of ordinary skill in the art” (Okajima, FC 2001). It also allowed Penn’s motion to amend and its arguments regarding a fourth reference since it was mentioned in Lilly’s Petition, and disagreed with Penn regarding the propriety of Lilly’s expert witnesses.

Regarding the combination of references, the PTAB first concluded that Saleh’s disclosure of the C225 anti-EGFR antibody showed a “cytostatic effect” (as opposed to a cytotoxic effect as argued by Penn) on erbB protein mediated tumor cells. Interestingly, a second Saleh reference, “Saleh II”, having a post-‘558 filing date publication date, was also relied on as evidence to show an inherent property, see FN10 (Schering, FC 2003 (rejecting the contention that inherent anticipation requires recognition in the prior art before the critical date)). The claimed requirement that radiation be administered after antibody was found to be disclosed by the combination of the three references. The PTAB also found the references provided “a reasonable expectation of inhibiting, the formation or of kinase activity mediate by, ‘a heterodimer of p185 and EGFR’”, as in claims 5, 10, 14, 17 and 20. It also found Lilly had shown a skilled artisan would have had reason to combine the references since, e.g., according to Lilly’s expert, “DeNardo indicates that cancer patients will have better outcomes if they receive radiation after the treated with C225” and “it is of no matter that the prior art might not have recognized the mechanism of operation” (In re Litner, CCPA 1972 (reason to combine taught by the references differing from applicant’s reason to combine did not alter the conclusion of prima facie obviousness); Senji, FC 2015 (affirming DC decision that even statistically insignificant data can serve as motivation to combine)). Penn argued the art taught away (Tec Air, FC 1999) from the claimed subject matter since cytotstatic cancer therapies would have been thought to decrease radiation sensitivity, but the PTAB disagreed. The PTAB also disagreed with Penn’s unexpected results argument, finding those to be “unsupported by evidence, such as expert testimony, and amount[ing] to attorney argument.”

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

Regeneron Pharmaceuticals, Inc. v. Merus N.V.


Docket No. 2016-1346

PROST, NEWMAN, WALLACH
July 27, 2017

Brief summary: DC finding of inequitable conduct based on “adverse inference of specific intent to deceive the PTO”, perhaps due in part to litigation misconduct, affirmed.

Summary: Regneron appealed DC holding that US 8,502,018 claiming “[a] genetically modified mouse, comprising in its germline human unrearranged variable region gene segments inserted at an endogenous mouse immunoglobulin locus” is unenforceable for inequitable conduct. The DC held a first bench trial on the materiality of the “Withheld References” (Bruggemann, Taki, Zou and Wood) and scheduled but never held a second bench trial on specific intent to deceive (Therasense, FC 2011). The DC “drew an adverse inference of specific intent to deceive the PTO” against Regeneron, discussing “Regneron’s repeated violations of the [DC’s] discovery orders and improper secreting of relevant and non-privileged documents.” The ‘018 patent issued from the “‘176 application” which was filed one of several continuations of a divisional of US 6,596,541 (the ‘541 patent). During prosecution, Regeneron argued the cited art only taught “random and not targeted insertion”, amended the claims to require insertion at “an endogenous” mouse immunoglobulin locus, and submitted “a presentation” asserting “that it had developed a commercial embodiment of the claimed mouse with surprising results”, an assertion found to be undisputably false (“Regeneron had not developed any such mouse at the time.”) Regeneron also intereviewed the case with the Examiner in March 2013 and “relied on the misleading presentation” at that meeting. The Examiner then issued a Notice of Allowance, stating “[t]he prior art does not teach or suggest” insertion “at an endogenous mouse immunoglobulin locus.” Prior to issuance of the Notice of Allowance, “a third-party filed a submission in the parent application of the ‘018 patent, describing three” of the Withheld References (Wood is a PCT application not included in that submission). A Wood co-inventor (Dr. Alt) an author on Taki and Zou (Dr. Rajewsky) were on Regeneron’s scientific advisory board before the ‘018 patent was filed. “During prosecution, these individuals corresponded with Dr. Murphy, an ‘018 patent inventor, expressing concerns about his characterizations of the prior art in related publications.” And Regeneron’s in-house counsel was aware of but did not disclose the Withheld References, but Regneron did subsequently disclose the same “in every related application having the same specification and similar claims.” Regneron argued it was under no obligation to disclose the Withheld References because “they were not but-for material.”

Under Therasense, “materiality” must be “but-for materiality”, meaning “the PTO would not have allowed a claim had it been aware of the undisclosed prior art” provided it is not “merely cumulative” (Dig. Control, FC 2006). A “specific intent to deceive the PTO” (“a deliberate decision to withhold a known material reference” must also be shown, and may be inferred from circumstantial evidence (Star Scientific, FC 2008; Molins, FC 1995; Apotex, FC 2014). The FC panel opinion explains that DC findings of materiality are reviewed for clear error and a finding of inequitable conduct based on those facts for an abuse of discretion. In reviewing materiality, the FC panel first concluded that “under the broadest reasonable construction” of the claims, the DC “correctly found that the claims are not limited to mice that solely comprise mouse constant region gene segments” (“Claim 1 encompasses humanized, fully human, and reverse chimeric mice”) and that, based on this construction, “the Withheld References were but-for material and were not cumulative.” The FC panel also found the DC did not abuse its discretion “by drawing an adverse inference of specific intent” against Regeneron based on litigation misconduct (detailed in the FC panel opinion). Unlike in Aptix (FC 2001 (“courts may not punish a party’s post-prosecution misconduct by declaring the patent unenforceable”), relied on in Judge Newman’s dissent (the “absence of trial and trial findings on” intent “cannot be substituted by inference”)), the FC panel wrote, “[h]ere, Regneron is accused not only of post-prosecution misconduct but also of engaging in inequitable conduct during prosecution” and it was “[o]nly after Merus proved the remaining elements of inequitable conduct” that the DC held the patent unenforceable.” Thus, the DC decision was affirmed.

Posted in Inequitable Conduct | Leave a comment

Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc.


Docket No. 2016-1814, -1815, -1051

PROST, BRYSON, HUGHES
July 26, 2017

Brief summary: Board decision of obviousness following inter partes reexamination affirmed (e.g., “absolute predictability” not required, no teaching away).

Summary: Soft Gel appealed PTAB inter partes reexamination decision invalidating claims in three related patents (US 8,124,072; 8,105,583; and 8,147,826) relating to a method for dissolving coenzyme Q10 (CoQ10, ubiquinone) in solvents (monoterpenes), as well as a composition, a soft gelatin capsule, and a method for making the soft gelatin capsule. The FC panel opinion explains that the patents note that “at the time of the inventions most solvents that were used to administer CoQ10 in liquid form could dissolve, at most, only about 5 to 10 percent of the CoQ10” and “[f]or that reason, CoQ10 was generally administered in solid form, such as in a tablet or powder” (or “as a suspension, in which the CoQ10 is partially dissolved in a solvent”). These formulations, however, delivered “only a small fraction of the CoQ10” to the bloodstream. According to the patents, monoterpenes (e.g., the claimed d-limonene) were identified as CoQ10 solvents (“about 30 to about 45% of the CoQ10…is solubilized [dissolved] in the monoterpene”). Representative ‘583 claim 1 claims “coenzyme Q-10; a sufficient quantity of d-limonene suitable to solubilize said coenzyme Q-10…with the proviso that said solution is not part of an emulsion, suspension, or elixir.” Representative ‘826 claim 1 claims a method for preparing a soft gel capsule encapsulating that composition. During inter partes reexamination, the examiner rejected the claims in view of “five key references”. The “Motoyama” reference is described as disclosing capsules containing CoQ10 in the monoterpene 1-carvone (found in the spearmint and peppermint oils (“essential oils”) derived from plants), and showing high bioavailability in dogs. The “Khan ‘786 patent” and the “Nazzal” dissertation were described as showing CoQ10/essential oil (peppermint, spearmint, lemon) mixtures that “facilitate[e] absorption by the body” by, e.g., lowering CoQ10’s melting temperature. “Fenaroli” was described as “not[ing] that lemon essential oil has many different components, but ‘contains approximately 90% limonene (by weight).” The fifth reference, a WHO cancer-related document (“IARC”), was described as stating “that limonene is ‘the most frequently occurring natural monoterpene” which “occurs naturally in the d- and l- forms, and that ‘the d form comprises 98-100% of the limonene in most citrus oils.’” The Board concluded “that the combination of those references suggest the invention claimed in the Soft Gel patents” and that one of ordinary skill in the art would have been motivated to combine the same with a reasonable expectation of success. Soft Gel argued in this appeal that the Board erred in finding “that d-limonene is the main constituent of lemon oil”, that the Khan ‘786 patent does not teach away from the claimed invention, and that there would have been a reasonable expectation of success. The FC panel agreed with the Board on each of these points. Regarding the teaching away argument, the FC panel found Khan ‘786 “merely notes the difficulty of dissolving CoQ10 in many solvents other than essential oils”, “teaches the use of essential oils to make CoQ10 more available” (“precisely what is claimed”), and that “lemon oild provided the best performance…not that it behaved in an entirely different manner from the other oils” (“Khan’s focused attack on the Khan ‘786 patent does not undermine the Board’s decision” (In re Merck, FC 1986 (“in the context to teaching away, “[n]on-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references”))). The FC panel also agreed with the Board regarding the reasonable expectation of success since, e.g., Nazzal suggestion of “future research show[ing] that a person of skill in the art would have recognized-and at least one (Nazzal) did recognize-that the monoterpenes limonene and carvone are of interest in the essential oil-CoQ10 mixtures” (“absolute predictability” not required (Noelle, FC 2004)). The fact that the Board’s ‘072 decision “ignored the fact that the claims were amended to recite ‘d-limonene’ instead of ‘limonene’” was found to have “no material effect on its obviousness decision”. The Board decision was therefore affirmed.

Posted in Obviousness, Obviousness-Teaching Away, Reexamination | Leave a comment