University of Utah v. Max-Planck et al.


Docket No. 2016-1336

O’MALLEY, REYNA, WALLACH
March 23, 2017

Brief Summary: DC finding that this case was not “exceptional” under § 285 and thus denying Max-Planck’s motion for attorney fees of about $8 million affirmed since there is no “precise Octane Fitness framework”. While the DC agreed the case “was weak and based on insufficient evidentiary support, it properly provided a detailed explanation as to why it disagreed”.

Summary: Max Planck appealed DC finding that this case was not “exceptional” under § 285 and thus denied it’s motion for attorney fees of about $8 million. The dispute is centered upon the ten RNA interference (RNAi) Tuschl II patents owned by Max Planck and whether Utah’s Dr. Bass should be named as a sole or joint inventor on those patents. In a Cell mini-review published before the application that led to the Tuschl II patents was filed, Utah’s Dr. Bass hypothesized about “3’ overhangs” on dsRNA. According to the opinion, Dr. Tuschl recognized this hypothesis may be relevant to RNAi, and later successfully produced and tested constructs including 3’ overhangs. Max Planck then filed a patent application that led to the Tuschl II patents. Dr. Bass’ mini-review was cited as prior art during prosecution of the Tuschl II patents. Utah argued that Dr. Bass was an inventor based on her Cell mini-review and “alleged collaboration between [her] and the Tuschl II inventors that occurred over several conversations at various academic conferences.” Max Planck moved to dismiss the complaint the DC found Utah “sufficiently alleged the facts necessary to” state its claims and the case proceeded to discovery. “During her deposition, Dr. Bass made several admissions undermining UUtah’s allegation that [she] reduced the Tuschl II invention to practice”, including statements that she did not do “any of the experiments or generate[d] any of the data” of the patents and her lab never “studied how to put siRNAs on cells and make them work”. Dr. Bass had also acted as a journal referee regarding publications of the Tuschl II data and “was asked whether she suggested to anyone that she was not being properly credited as the discoverer of the 3’ overhangs” to which “she responded: ‘I don’t think it would have ever crossed my mind to say that.’” Utah withdrew its sole inventorship claims with prejudice “[o]n the eve of the deadline for dispositive motions” in the DC. The DC “reasoned there was no evidence to support a finding of collaboration” or that joint inventorship had been established. Max Planck then argued the case was “exceptional” under § 285 because UTah “lacked any meaningful basis for filing its” suit “in light of Dr. Bass’ testimony”, Utah’s “delay in withdrawing it sole inventorship claim until the even of [SJ] indicates [it] knew its claim was meritless”, and Utah’s “claimed damages were extorionately high.” The DC disagreed “when all reasonable inferences were drawn” in Utah’s favor and “its inventorship claim was predicated on a valid interpretation of Kimberly-Clark” (FC 1992 (“one inventor seeing a relevant report and building upon it might be an element of joint behavior supporting collaboration”)), although it acknowledged the “sole inventorship argument had little factual support” (and crediting Utah for withdrawing that claim). The FC panel explained it reviews § 285 decisions for an abuse of discretion (“clearly erroneous assessment of the evidence” (Highmark, US 2014; Insite Vision, FC 2015). In the appeal, Max-Planck argued the DC disregarded Octane Fitness (US 2014). The FC panel explained that “there is ‘no precise rule or formula for making these determinations’” (there is no “precise Octane Fitness framework”). It noted that while the DC agreed the case “was weak and based on insufficient evidentiary support, it provided a detailed explanation as to why it disagreed” with Max-Planck, and “[t]he trial judge was in the best position to understand and weigh [the] issues” with “no obligation to…reveal[] her assessement of every consideration.” The DC decision was therefore affirmed.

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Intellectual Ventures I LLC, et al. v. Capital One Financial Company et al.


Docket No. 2016-1077

PROST, WALLACH, CHEN
March 7, 2017

Brief Summary: DC grant of SJ for collateral estoppel (issue preclusion) affirmed under Fourth Circuit law and finding of ineligibility under under § 101 affirmed under the two-step Alice/Mayo “abstract idea” / “inventive concept” test.

Summary: IV appealed DC grant of SJ finding all claims of two patents (US 7,984,081; 6,546,002) ineligible under § 101, and barring IV from pursuing infringement claims regarding US 6,715,084 under a collateral estoppel (issue preclusion) theory. IV also appealed DC certification of its judgment under FRCP 54(b) (“the court may direct entry of a final judgment as to one or more, but fewer than all, claims or parties only if the court expressly determines that there is no just reason for delay”) so this appeal could proceed concurrently with Capital One’s antitrust counterclaims in MD. The FC panel opinion first addressed the certification issue, concluding the DC did not abuse its discretion since its reasoning was sufficient and “the mere existence of some factual overlap between the parties’ claims and counterclaims does not necessarily lead to the conclusion that the [DC] abused its discretion” (W.L. Gore, FC 1992). The issue preclusion issue was reviewed “de novo, applying the law of the regional circuit” (here the Fourth Circuit; Aspex, FC 2013; DDR, FC 2014). The Fourth Circuit “has established five requirements for collateral estoppel” but “[h]ere, the parties only dispute the finality requirement” (“a ‘final and valid’ judgment”) which the FC panel found was met “in light of the [related JPMC matter (see FN2)] court’s partial [SJ] order” (“IV’s reliance on Vardon is misplaced because in that case, we applied the law of the Seventh Circuit”, a more rigid test). The Fourth Circuit “neither demands final judgment, nor requires a party’s appeal” and describes “finality for the purposes of collateral estoppel [as] a flexible concept and ‘may mean little more than that the litigation of a particular issue has reached such a stage that a court sees no really good reason for permitting it to be litigated again” (Swentek, 4th Cir. 1987). Regarding ineligibility under § 101, the FC panel explained that this “is an issue of law that we review without deference” (OIP Techs., FC 2015) and applied the two-step Alice/Mayo test (Alice, US 2014; Mayo, US 2012) (1) the “abstract idea” step: is the “character” of the claim “as a whole” directed to a patent-ineligible concept (law of nature, natural phenomenon, abstract idea)? 2) the “inventive concept” test: do the claim elements “add enough to ‘transform the nature of the claim’ into a patent-eligible application” (“must be more than ‘well-understood, routine, conventional activity”)?). The FC panel found that “the ‘081 patent concerns a system and method for editing XML document”, the claims of which it found to be “at their core, directed to the abstract idea of collecting, displaying, and manipulating data” (Content Extraction, FC 2014; Intell. Vent., FC 2015; Elec. Power Grp., FC 2016). And it found no “inventive concept” transforming that abstract idea into patent-eligible subject matter (claim elements “merely describe the functions of the abstract idea itself”, “only a result-orientated solution, with insufficient detail on how a computer accomplishes it”). Finally, it notes the ineligibility of the ‘002 patent was addressed in the Erie opinion. Thus, the DC decision was affirmed.

Posted in Appeal, Collateral estoppel, Issue Preclusion, Patentability | Leave a comment

Coalition for Affordable Drugs V LLC, et al. v. Biogen MA Inc.

Case No. IPR2015-01993 (US 8,339,514 B2)
Final Written Decision
March 21, 2017

Brief Summary: Board found CAD V failed to show obviousness by a preponderance of the evidence as Biogen presented persuasive evidence of unexpected results (“the magnitude of the clinical efficacy” of the claimed dose “would have been unexpected”).

Summary: CAD V’s petition for IPR of Biogen’s US 8,399,514 (relating to Biogen’s multiple sclerosis (MS) drug Tecfidera® (dimethyl fumarate (“DMF”))) claiming methods for treating MS on the basis of a reasonable likelihood that it would prevail on obviousness grounds was granted based on three different combinations of prior art (Kappos, Clinical Trials, Joshi ‘999 and ICH for claims 1-6, 8-16 and 20; the same four references plus Joshi ‘992 for claim 7; and the initial four references plus Begleiter for claims 17-19). “Claim 20, the broadest” includes the limitation “wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day”. The Decision explained that “[t]he parties disagree on the level of skill of the person ordinarily skilled in the art” but the Board wrote that that person “is a hypothetical person that is presumed to be aware of all the relevant prior art” (Custom Accessories, FC 1986) and that “[g]eneralities that the person of ordinary skill in, for example, an M.D. with three years experience in some field or another, provides little help in establishing what that person knows or doesn’t know” (“As long as the art relied upon is from the same or analogous fields the hypothetical person is presumed to be aware of it.” In re Gorman, FC 1991). It held “that the cited references are representative of the level of ordinary skill in the art.” Kappos describes results of a MS Phase II trial using 120, 360 and 720 mg/day of DMF. Joshi ‘999 is a US patent publication describing methods of treating MS using an effective amount of DMF. “Clinical Trials” describes a clinical study using DMF for MS. “ICH” is a technical publication presenting general guidance for determining drug doses. Biogen argued that even in view of these references, “[t]he magnitude of the clinical efficacy exhibited by administering the 480 mg/day dose was unexpected”, relying on “post-filing date Phase III trials” (the “DEFINE study” and the “CONFIRM study” (480 and 720 mg/day DMF)) to show “‘surprisingly-that a 480 mg/day dose of DMF proved to have similar efficacy’ to the 720 mg/day taught by Kappos”. Expert testimony of Dr. Thisted, Dr. Brundage and Dr. Rudick was also submitted as evidence of unexpected results. The Board reviewed their backgrounds and found them to be “qualified by knowledge, skill, experience, training and education that is sufficiently related to the claimed invention that they may provide opinion testimony”. The Decision explains that “[a]ll three experts testif[ied] that one skilled in the art would have expected the efficacy of 480 mg/day to be closer to that of 360 mg/day, a dose which did not have a statistically significant effect, than to 720 mg/day dose described by Kappos” and “Drs. Thisted and Rudick further testif[ied] that the reported similar efficacy…would have been unexpected.” The Board found that “the degree of efficacy of the 480 mg/day dose of DMF would have been unexpected” (“the magnitude of the clinical efficacy…would have been unexpected”). This was found to be so even though “one having ordinary skill in the art would have had ample reason to use routine experimentation, including appropriate clinical trials, to determine the optimum doses for MS treatment” since “obviousness is not established when the results of optimization are shown to result in a propery or benefit that a person of ordinary skill in the relevant art would have found to be unexpected” (Antonie, CCPA 1977; Proctor & Gamble, FC 2009). Thus, the Board concluded the claims were not shown to be unpatentable by a preponderance of the evidence. It is also noted that FN1 of the Decision explains that Biogen was allowed to file a motion to antedate the Kappos reference and argued that another (Joshi) was not eligible prior art under § 103(c), but “[b]ecause post-filing date evidence demonstrates unexpected results, [it] did not reach” those issues.

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

Intellectual Ventures I LLC, et al. v. Erie Indemnity Company et al.


Docket No. 2016-1128, -1132

PROST, WALLACH, CHEN
March 7, 2017

Brief Summary: DC finding the IV lacked standing affirmed because assigning rights “‘in and to’ a particular patent” does not “automatically include[s] its child applications” (must explicitly refer to continuations and/or “invention” vs. “patents”). DC invalidity findings regarding ‘434 and ‘002 patents under § 101 affirmed.

Summary: IV appealed DC finding that all claims of the asserted patents (US 6,510,434; 6,519,581; and 6,456,002) are ineligible under § 101 and dismissing the ‘581 patent infringement claims for lack of standing because, the DC determined, IV does not own the patent. Regarding dismissal of the ‘581 patent, the FC explained that the review is de novo and under California law. The ‘581 ownership issue was whether an assignment assigning rights “‘in and to’ a particular patent automatically include[s] its child applications”. The first assignment considered “expressly assigned the [‘581 parent patent US 6,236,983] patent and any continuation of that patent” to AllAdvantage.com. AllAdvantage then executed an assignment that “expressly identified the various patents and pending applications subject to assignment”, without “explicitly list[ing] the ‘581 patent’s then pending application”, to Alset using the “in and to” language. Alset recorded the assignment as including the ‘581 patent, filed POAs and paid the issue fee. It later assigned its patents to IV. The FC panel concluded the “in and to” language did not support IV’s position that the ‘581 patent was assigned to Alset since that assignment did “not disclose that continuation applications or other family members of the enumerated patents [were] assigned” (“[I]f AllAdvantage intended to convey the application leading to the ‘581 patent to Alset, it knew how to do so…IV seems to conflate the meaning of the word ‘patent,’ as used in the agreement, with ‘invention’; the latter of which we held conveyed rights to continuation applications.” (DDB Techs., FC 2008 and § 261 (“must be assigned by an instrument in writing”)). As IV was found not to own the ‘581 patent and therefore to lack standing, the DC finding of invalidity of the ‘581 patent was vacated. Under the two step “abstract idea” (“determine if the claim’s ‘character as a whole’ is directed to excluded subject matter”) / “inventive concept” § 101 analysis (Alice, US 2014; Mayo, US 2012; Affinity Labs, FC 2016; Ultramercial, FC 2014), the FC panel agreed with the DC that the ‘434 patent is ineligible under § 101 since the “claimed elements either individually or as an ordered combination…recite no more than routine steps involving generic computer components and conventional computer data processing activities to accomplish the well-known concept of creating and index and using that index to search for and retrieve data.” The FC panel also affirmed the DC’s decision that the ‘002 patent is ineligible under § 101 because, e.g., “[t]he claimed mobile interface is so lacking in implementation details that it amounts to merely a generic component (software, hardware, or firmware) that permits the performance of the abstract idea, i.e., to retrieved the user-specific resources” and “provides no more than similar user interfaces recited in claims that we have previously held ineligible” (Intell. Vent. I, FC 2015; Enfish, FC 2016).

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Allergan, Inc. and Duke University v. Sandoz, Inc. (Akorn, Hi-Tech Pharm., Apotex)


Docket No. 2016-1085, -1160

REYNA, WALLACH, CHEN
March 17, 2017

Non-precedential

Brief Summary: DC finding of collateral estoppel and obviousness for asserted claims affirmed but reversed as to the unasserted claims of the Allergan’s ‘953 patent (“Sandoz, Inc. has not shown a continuing case or controversy….”) The FC panel also explained it “did not change the applicable legal standard” with Allergan II (FC 2014) but only “repeated” and applied that of In re Katz (CCPA 1982) (see FN2: “This court has not determined whether the Katz standard applies to reviews of prior art under the AIA’s § 102, nor does either party ask us to do so here.”).

Summary: Allergan appealed DC dismissal of its infringement case against Sandoz (“Allergan IV”) with prejudice based on collateral estoppel and obviousness determination. Six patents are involved, all generally relating to “a topical solution to treat hair loss or reduction” using bimatoprost (US 7,388,029; 7,351,404; 8,263,054; 8,038,988; 8,101,161; and 8,926,953 (all CONs of the ‘404 patent)). In “Allergan I”, the DC found in favor of Allergan regarding the ‘029 and ‘404 patents. In “Allergan II”, the FC reversed the DC, invalidated the ‘404 patent as obvious, and vacated the injunction against Sandoz. Following Allergan II, the DC granted Apotex’s motion for judgment on the pleadings and Allergan moved to dismiss its claims against the other defendants (Allergan III). While these suits were pending, Allergan’s application for the ‘953 patent was pending at the PTO and it submitted “ex parte declarations to the Examiner related to two prior art references used to invalidate the ‘404 patent.” These were “intended to show that one of the inventors…was an author oof the prior art references such that the references were no longer prior art under” § 102(a) and the ‘953 patent issued afterward (“one’s own work is not prior art under § 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under § 102(a)” (citing In re Katz (CCPA 1982) and § 3(b)(1) of the AIA (enacted in 2011; ‘953 effective filing date in 2013) but noting in FN2: “This court has not determined whether the Katz standard applies to reviews of prior art under the AIA’s § 102, nor does either party ask us to do so here.”) The FC panel explained that the law of the regional circuit is applied to collateral estoppel (CE) reviews as these “are not unique to patent issues” (Soverain Software, FC 2015) and, therefore, the decision was reviewed de novo (Tuttle, 4th Cir. 1999) in view of the 4th Circuit’s definition of the five elements of CE (Sedlack, 4th Cir. 1998; Collins, 4th Cir. 2006) and FC precedent (Aspex Eyewear, FC 2013). Allergan argued CE should not apply here because “the issue sought to be precluded is [not] identical to one previously litigated”, “the issue was [not] actually determined in the prior proceeding”, and it did not have “a full and fair opportunity to litigation the issue in the previous forum.” The FC panel agreed with the DC that the asserted claims “are substantially similar to the invalidated claims” and “any differences…do not materially alter the question of invalidity” (Ohio Willow Wood, FC 2013). The FC panel also found the issue of “darkness” in the claims “was actually determined in Allergan I and Allergan II” (e.g., “discussed in the claim construction proceedings for the ‘404 patent” (Brain Life, FC 2014 (not discussed where “[n]either party request that any terms off the…method claims…be construed”)). Regarding a fair opportunity to litigate, Allergan argued it did not since the FC, with Allergan II, “changed the legal standard under § 102(a) by adding a requirement that the inventor be ‘responsible for directing the production of the publication’” but the FC panel disagreed (Allergan did not explain why it did not address this alleged change with the DC and the FC “did not change the applicable legal standard” but only “repeated” and applied that of Katz (CCPA 1982)). However, the FC panel also reversed the DC’s order granting CE and finding the entire ‘953 patent invalid, incuding unasserted claims since “Sandoz, Inc. has not shown a continuing case or controversy” regarding those claims (“[a]s in prior cases in which we have found unasserted claims not invalidated”, citing MedImmune, US 2007 and Carroll Touch, FC 1993).

Posted in Anticipation (35 USC 102), Article III disputes, Collateral estoppel, Issue Preclusion, Obviousness | Leave a comment

Michael Meiresonne v. Google, Inc.


Docket No. 2016-1755 (IPR2014-01188)
PROST, LOURIE, MOORE
March 7, 2017

Brief Summary: PTAB’s finding of no teaching away “supported by substantial evidence” (e.g., “nothing in either reference indicates that descriptive text would render Finseth’s rollover area inoperative for its intended purpose”) and therefore affirmed the decision.

Summary: Mr. Meiresonne appealed PTAB final IPR decision that claims 16, 17, 19 and 20 of US 8,156,096 relating to a computer system with at least one website including “related subject matter links” and “a rollover viewing area that individually displays information corresponding to more than one of the related subject matter links in the same rollover viewing area” stored thereupon are unpatentable for obviousness in view of a book (World Wide Web Searching for Dummies (“Hill”)) and US 6,271,840 (“Finseth”). The PTAB “found that Hill discloses all the limitations of claim 19 except for the ‘rollover viewing area’ limitation, which it found disclosed by Finseth” and “that a person of ordinary skill in the art would not have read Finseth to teach away from the [claimed] solution.” The FC panel explained that it reviews the Board’s legal determinations de novo (In re Elsner, FC 2004) and the “factual findings underlying those determinations for substantial evidence” (Consol. Edison, US 1938 (“a reasonable mind might accept” it supports the finding); Apple, FC 2016 (“Obviousness is a question of law based on underlying facts.”); In re Mouttet, FC 2012 (“What the prior art teaches, whether a person of ordinary skill in the art would have been motivated to combine the references, and whether a reference teaches away from the claimed invention are questions of fact.”)). It also explained that “[a] combination of known elements is likely to be obvious when it yields predictable results” (KSR, US 2007), “[o]bviousness may be defeated if the prior art indicates that the invention would not have worked for its intended purpose or otherwise teaches away from the invention” (DePuy Spine, FC 2009), and that “[a] reference teaches away ‘when a person of ordinary skill…would be discouraged from following the path set out” (not shown by the expression of a “general preference” without “criticiz[ing], discredit[ing], or otherwise discourage[ing] investigation into’ the claimed invention” (Galderma, FC 2013). The “sole issue” on appeal is “whether Hill and Finseth teach away from the invention of the ‘096 patent, which combines descriptive text with a rollover viewing area.” The FC panel found that Finseth, e.g., “never…advocates abandoning text descriptions wholesale” and that its description of “descriptive text as ‘[o]ten[]…cursory, if not cryptic’ does not automatically convert the reference to one that teaches away” (“Finseth does not say or imply that text descriptions are ‘unreliable,’ ‘misleading,’ ‘wrong,’ or ‘inaccurate,’ which might lead of ordinary skill in the art to discard text descriptions completely.”) And “Hill’s description of website abtracts as ‘[s]ometimes…as informative as a paragraph of gibberish’” was found not to “amount to promoting abandonment of text descriptions.” Thus, “nothing in either reference indicates that descriptive text would render Finseth’s rollover area inoperative for its intended purpose.” It therefore concluded the PTAB’s finding of no teaching away “is supported by substantial evidence” and therefore affirmed the decision.

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

In Re: Ethicon, Inc.


Docket No. 2015-1696

NEWMAN (D), LOURIE, DYK
January 3, 2017

Brief Summary: The FC panel concluded that the “teaching of all of the required components of the claims” by the cited art “support the Board’s combination” of the same “to address the problem regarding elasticity taught by Tuch” which did not teach away and Ethicon’s objective indicia arguments were insufficient (e.g., it “did not establish that any success, praise or unexpected results were due to the 85:15 VDF:HFP coating”).

Summary: Ethicon appealed from PTAB decision in an inter partes reexamination that claims 1-17 and 19-23 of US 7,591,844 (claims 18 and 24 were cancelled by Ethicon) relating to drug-eluting balloon-expandable stents with a specific coating “that remains adhered to the device upon expansion” (“copolymer…compris[ing] about [85] weight percent vinylidinefluoride [VDF] copolymerized with about [15] weight percent hexafluoropropylene [HFP] and at least one pharmaceutical agent intermixed with said copolymer, wherein said coating has not been subjected to a maximum temperature of greater than 60o C [sic] during the coating process or afterward”) are invalid as obvious over three US patents (“Tuch”, “Tu”, and “Lo”) and one FR patent (“Le Morel”). Ethicon appealed the examiner’s rejection to the Board, “arguing that the examiner erred in combining the prior art references and by discounting the objective indicia.” But the Board affirmed the examiner’s conclusions (e.g., “a skilled artisan would have been motivated to use 85:15 VDF:HFP, possessing the[] advantageous properties [of Lo], as the polymer in Tuch’s stent because ‘Tuch teaches a problem with coatings with low elasticity” and “the ‘normal desire of scientists or artisans to improve upon what is already generally known’”; “Ethicon did not submit factual evidence or analysis to support its copying allegations….”) The FC panel explained that it reviews the Board’s legal determinations de novo (In re Elsner, FC 2004) and the “factual findings underlying those determinations for substantial evidence” (In re Gartside, FC 2000; Consol. Edison, US 1938 (“a reasonable mind might accept” it supports the finding)). It also noted Graham’s “guard against slipping into the use of hindsight” (US 1966), a patentable invention must be “more than the predictable use of prior elements according to their established functions” (KSR, US 2007), and that “a skilled artisan only would have been motivated to combine analogous art” (In re Clay, FC 1992). The FC panel concluded that the “teaching of all of the required components of the claims” by the cited art “support the Board’s combination” of the same “to address the problem regarding elasticity taught by Tuch” which did not teach away (e.g., while “Tuch stats that a ‘bioabsorbable polymer is probably more desirable,’…this statement, absent a clear discouragement from use” is not a teaching away (Tyco, FC 2014; Santarus, FC 2012). It also found no error with the Board’s reliance of Lo as the reference is “reasonably pertinent” (i.e., analogous) and “[t]he normal desire of artisans to improve upon what is already generally known can provide the motivation to optimize variables such as the percentage of known polymer for use in a known device” (In re Peterson and KSR). And it found no reversible error in the Board’s rejection of Ethicon’s arguments regarding objective indicia of nonobviousness (e.g., “Ethicon’s expert never even opined that the results pointed to would have been unexpected” and “did not establish that any success, praise or unexpected results were due to the 85:15 VDF:HFP coating”.) Thus, the Board decision was affirmed. Judge Newman’s dissent argued the references, “or any common knowledge or common sense” did not “tecach[] or suggest[] or motivate[] the claimed stent.”

Posted in Analgous Art, Obviousness | Leave a comment