Chloroquine and COVID, a real possibility?

Interesting research:

1) An Effective Treatment for Coronavirus (Todaro and Rigano)

https://docs.google.com/document/d/e/2PACX-1vTi-g18ftNZUMRAj2SwRPodtscFio7bJ7GdNgbJAGbdfF67WuRJB3ZsidgpidB2eocFHAVjIL-7deJ7/pub#ftnt6

2) Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia (Zhonghua, et al.)

https://pubmed.ncbi.nlm.nih.gov/32164085/?fbclid=IwAR0ZNk2JXMGYCDLKHwB5kykkLUviE03JqNRWGH8P8lt1NRKVJLk6cOIfjv8

3) In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (Yao, et al.)

href=”https://pubmed.ncbi.nlm.nih.gov/32150618/

4) Coronavirus Covid-19: Chloroquine data; Japan to trial HIV drug (https://www.clinicaltrialsarena.com/news/coronavirus-covid-19-choroquine-data/)

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Method of treatment claims eligible under 101 (DC reversed); DC obviousness findings affirmed


Boehringer Ingelheim Pharm. et al. v. Mylan Pharmaceuticals Inc.

Docket No. 2019-1172
DYK, MOORE, HUGHES
March 16, 2020
Non-precedential

Brief Summary: DC decision of ineligibility under 101 for method of treatment claims reversed; invalidity for double-patenting and obviousness affirmed.

Summary: Boehringer appealed DC judgement that certain claims of US 8,853,156 are directed to ineligible subject matter under section 101, and the other claims of US 9,173,859 and 8,673,927 are invalid for obviousness-type double patenting and obviousness over the prior art. The patents relate to treatment of type 2 diabetes using DPP-IV inhibitors (e.g., linagliptin).

The ‘156 claims, directed to “[a] method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate…comprising orally administering to the patient a DPP-IV inhibitor” were found ineligible for being “directed to an ‘abstract idea,’ namely ‘the act of administering the DPP-IV inhibitor to the target patient population” and did not “recite an inventive concept”. The FC panel reviewed the DC ineligibility decision de novo (SAP, FC 2018) and explained that “the Supreme Court has cautioned…we must be careful in this analysis as ‘too broad an interpretation of this exclusionary principle could eviscerate patent law’” (Natural Alternatives, FC 2019). Boehringer argued “that the claims are directed to a ‘method of treating a specific disease…for specific patients…using a specific compound…at specific doses…to achieve a specific outcome” and were therefore patent eligible. The FC panel agreed since “the claims are directed to a particular method of treatment under step one” (of Alice, US 2014) “and are therefore patent eligible” (Vanda, FC 2018 (Patent eligible since “[b]ased on the results of that test, a particular dose of iloperidone was selected and internally administered….While we acknowledged that the inventors had recognized the underlying relationships, we explained that those were not what was claimed.”); CellzDirect, FC 2016 (the “natural ability of the subject matter to undergo the process does not make the claim ‘directed to’ that natural ability”)). This part of the DC’s decision was therefore reversed.

The ‘859 and ‘927 patents were held invalid for obviousness-type double patenting over Boehringer’s earlier expiring US 8,178,541, and obvious in view of the PCT ‘510 publication (the ‘541 patent priority document). The DC “determined that because ‘the claimed invention’s doses of linagliptin in 2.5 mg and 5 mg fall within the ‘510 publication[’]s disclosed range of 1-100 mg,’ there is a presumption of obviousness” and “a skilled artisan would ‘have a reasonable expectation of arriving at the claimed 2.5 mg and 5 mg dosages’ through routine experimentation”, citing Tyco (FC 2011) and based on expert testimony (e.g., “one would be guided through that information of looking at the lowest end of the dose range for the most potent compound”). The FC panel found no clear error with this conclusion or with the DC’s secondary consideration analysis, and affirmed these obviousness conclusions.

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Board CBM decisions of patent ineligibility affirmed (no improved computer functionality)


Customedia Technologies, LLC v. Dish Network Corp. et al.

Docket No. 2018-2239 (CBM2017-00023), 2019-1000 (CBM2017-00032)
PROST, DYK, MOORE
March 6, 2020

Brief Summary: PTAB CBM decisions of patent ineligibility under 101 affirmed (e.g., “computers are invoked merely as a tool”, not to improve functionality)

Summary: Customedia appealed PTAB (“Board”) CBM final written decisions (FWDs) finding certain claims of US 8,719,090 and 9,053,494 relating to “data delivery system[s] for providing automatic delivery of multimedia data products” ineligible under section 101 and certain ‘090 claims invalid for anticipation or obviousness. The FC panel applied the two-step Alice test (US 2014; step 1: whether the claims are directed to an abstract idea, step 2: “whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application”) to the DC’s section 101 patent ineligibility decision. The FC panel explained the claimed technology to be “ensur[ing] memory is available for at least some advertising” “by dedicating a section of the computer’s memory to advertising data”. Under Alice step one, the FC panel concluded that the claims are directed to an “‘abstract idea’ for which computers are invoked merely as a tool”, (“at most an improvement to the abstract concept of targeted advertising wherein a computer is merely used as a tool”) and “not an improvement in the functioning of the computer itself” (citing Enfish, FC 2016 (“claims did not invoke a computer merely as a tool, but rather improved the way the computer itself operated and handled data, allowing more efficient launching and adaptation of databases…not on economic or other tasks for which a computer is used in its ordinary capacity”) and similarly not abstract: Visual Memory, FC 2017 (“the accommodation of different types of processors without compromising performance”), Koninklijke, FC 2019 (“improve[d] the functioning of the overall technological process of detecting systematic errors in data transmissions”), Ancora Techs., FC 2018 (“storing a verification structure in computer memory…a non-abstract improvement in computer functionality because they improved computer security”), Finjan, FC 2018 (“‘behavior-based virus scan’…improvement in computer functionality”, not abstract), Data Engine Techs., FC 2018 (non-abstract “tool able to instantly access all parts of complex three-dimensional electronic spreadsheets”), and Core Wireless, FC 2018 (“improved user interface”, not abstract); SRI Int’l (FC 2019) (“using network monitors to detect suspicious network activity” not abstract); abstract: Affinity Labs., FC 2016 (“providing out-of-region access to regional broadcasts”), TLI Comm., FC 2016 (“storing digital images in an organized manner”), Intell. Vent. (FC 2015) (“providing web pages tailored to an individual user”), Ultramercial, FC 2014 (“displaying an advertisement in exchange for access to copyrighted material”), SAP Am., FC 2018 (analyzing and displaying information), Trading Techs. I and II, FC 2019 (improving a user’s experience, process information more quickly)). Under Alice’s step two, the FC panel found no “inventive concept” since “the claims recite only generic computer components” that is “insufficient to render eligible claims to an abstract idea”. The Board decision was therefore affirmed without discussing the anticipation/obviousness issues.

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Board IPR decision of no obviousness reversed as claim construction excluded preferred embodiment


Uber Technologies, Inc. v. X One, Inc.

Docket No. 2019-1165 (IPR2017-01264)
PROST, DYK, WALLACH
March 3, 2020
Non-precedential

Brief Summary: Board IPR decision of no obviousness of certain mapping-related claims reversed as claim construction would exclude the preferred embodiment; obviousness of another claim affirmed.

Summary: Uber appealed Board IPR decision findings certain claims of X One’s US 8,798,647 regarding methods for “displaying a map of the positions of a ‘first wireless device’ and a ‘second wireless device’ on the first wireless device, and updating that map based on ‘positional update[s]’ as to the location of the second wireless device”, each step in the method being “in some way tied to the ‘launch’ of an ‘application’” not unpatentable as obvious. The FC panel reviewed the Board’s claim construction “based on evidence intrinsic to the patent” and since this “IPR stems from a petition filed before November 13, 2018” under “the ‘broadest reasonable interpretation’ consistent with the specification” (Williamson, FC 2015; Game & Tech., FC 2019). It found “that the Board’s ‘during or near’ requirement is generally correct” but “that the Board’s claim construction is imprecise and that some refinement…is necessary in light of the specification” as it “would exclude the specification’s preferred embodiment” (e.g., “the Board’s ‘during or near’ requirement must allow for method invocation minutes or hours after application launch”; Medrad, FC 2005). And under the revised construction, the FC panel concluded that the Board erred in finding the prior art (Konishi and Mitsouka) “do not teach or suggest the ‘responsive to’ limitations” (e.g., “[t]he very purpose of Konishi is to start mapping shortly after the launch of the vehicle allocation service”) and therefor concluded certain claims would have been obvious in view of Konishi or Misuoka. Claim 22 includes the limitation “that a ‘second wireless device’ (whose location is to be mapped) is ‘selected in association with launch of the application’” which the Board found to be disclosed by Konishi and Mitsuoka, and the FC panel agreed. The Board’s decision was therefore reversed-in-part and affirmed-in-part.

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Failure to disclose pre-critical date offer for sale was inequitable conduct, DC decision affirmed


GS Cleantech, Cantor Colburn LLP v. Adkins Energy LLC, Big River Resources et al.

Docket No. 2016-2231, -1838, 2017-1832
REYNA, WALLACH, HUGHES
March 2, 2020

Brief Summary: DC finding of inequitable conduct for failure to disclose pre-critical date offer for sale affirmed.

Summary: GS Cleantech (“Cleantech”) appealed DC finding the Patents-in-Suit (US 7,601,858; 8,008,516; 8,008,517; and 8,283,484 (shared specification)) directed to methods for recovering oil from a dry mill ethanol plant’s byproduct (“thin sillage”) unenforceable due to inequitable conduct. The inequitable conduct (IC) issue related “to whether the patentee failed to disclose information regarding the on-sale bar under 35 U.S.C. § 102(b)” which renders a patent invalid “if, before the critical date, the invention was: (1) the subject of a commercial sale or offer for sale; and (2) ‘ready for patenting’” (Pfaff, XXXX). The FC panel explained that “[t]o prevail on a claim of [IC]…the accused infringer must prove by clear and convincing evidence that the patentee: (1) ‘knew of the reference’ or prior commercial sale; (2) ‘knew of the reference’ or prior commercial sale; and (3) ‘made a deliberate decision to withhold it’” with a “specific intent to deceive” which “must be the single most reasonable inference able to be drawn from the evidence” (Therasense, FC 2011). Assessment of a commercial sale “involves an assessment of whether the circumstances surrounding the transaction show [it] was not primarily for purposes of experimentation” (Allen Eng’g, FC 2002 (“(1) the necessity for public testing…(3) the nature of the invention, [and]…(10) whether the invention reasonable requires evaluation under actual conditions of use”); Clock Spring, FC 2009 (“experimental only if it is designed to (1) test claimed features of the invention or (2)…determine whether an invention will work for its intended purpose”); Therasense, FC 2011 (“preponderance of the evidence standard”)). And “[a]n invention is ‘ready for patenting’ when prior to the critical date: (1) the invention is reduced to practice; or (2) the invention is depicted in drawings or described in writings of sufficient nature to enable a [PHOSITA] to practice the invention” (Hamilton Beach, FC 2013). The DC concluded that a “July 2003 Proposal” made by Cleantech to another company (Agri-Energy) was a pre-critical date offer for sale as it was a “sale on approval” under the UCC. The FC panel agreed with the DC’s analysis, and would not consider Cleantech’s Plumtree (FC 2006) argument that a patentee must have “either: (i) made a commercial offer to perform the patented method[]’[;] or (ii) in fact performed the patented method for a promise of future compensation” because it was not raised until this appeal. The FC panel also agreed with the DC that the claimed invention was ready for patenting before the critical date since “tests conducted…in the summer of 2003…support its determination” (i.e., “reduced to practice”), “the Inventors themselves made statements contemporaneously…that the claimed invention was reduced to practice”, the DC “considered the Allen factors and concluded that the offer…was an offer for sale and not for purposes of experimentation”, and “the claimed invention…had been depicted and described in such a way that a PHOSITA would be able to practice it.” The DC also also concluded that CleanTech and its lawyers made a deliberate decision to withhold material information with the specific intent to deceive the USPTO during prosecution, i.e., committed inequitable conduct, and the FC panel agreed (e.g., “evidenced by documents belatedly or not turned over to the USPTO”, letter filed with USPTO mentioned later testing “with no mention of the documents dated over a year earlier” (Molins, FC 1995 (“[P]atentees who are not ‘up front’ with the [US]PTO run the risk that, years later, a fact-finder might concluded they intended to deceive.”); “Cantor Colburn ‘threatened’ Argi-Energy to coerce its support regarding the critical date”; “the Inventors and Cantor Colburn made a ‘patently false’ statement” in a declaration “by claiming the July 2003 Proposal…was delivered after the critical date”, and CC failed to correct the false declaration). The DC decision was therefore affirmed.

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Acoustic’s IPR time-bar arguments waived; anticipation and obviousness findings affirmed


Acoustic Technology, Inc. v. Itron Networked Solutions, Inc.
Docket No. 2019-1061 (IPR2017-1061) (see also FC Docket Nos. 2019-1059, -1060)

MOORE, REYNA, TARANTO
February 13, 2020

Brief Summary: Appeal based on time-bar arguments not presented to the Board were waived; anticipation and obviousness conclusions affirmed.

Summary: Acoustic appealed PTAB finding the challenged claim of US 6,509,841 relating to remote monitoring of utility meters unpatentable. Acoustic argued that that merger of Petitioner Silver Spring Networks, Inc. (SSN) with “undisputably time-barred” Itron, Inc. during the IPR proceeding created a time-bar against SSN. The FC panel opinion explains that Acoustic sued Itron in March 2010 for infringement of the ‘841 patent which it licensed to Itron as part of a settlement agreement. As a result, “Itron was time-barred from seeking…IPR…as of March 26, 2011” under 35 USC § 315(b). Acoustic sued SSN for infringement of the ‘841 patent in 2016 and SSN filed the IPR petition on March 3, 2017. “Several weeks before” SSN filed the petition, the FC panel explains that SSN and Itron had begun “privately discussing ‘a potential business combination’”, that nine days after the Board instituted IPR review on Sept. 8, 2017 SSN and Itron agreed to merge which was completed on Jan. 5, 2018, while the IPR was in progress, and that “Acoustic never raised a time-bar challenge to the Board.” The FC panel held that “Acoustic waived its time-bar challenge to the IPR because it failed to present those arguments before the Board”, explaining that it “retain[s] case-by-case discretion over whether to apply waiver” (Monsanto, FC 2018; In re Watts, FC 2004) as that failure “deprives the court of the benefit of the [Board’s] informed judgment” (In re NuVasive, FC 2016; Freytag, US 1991 (to allow time-bar challenges for the first time on appeal would encourage…‘sandbagging’”); would afford Acoustic “a significant and unfair advantage” by allowing to “appeal only if the Board finds the claims obvious”)). Because the issue was not raised in front of the Board, the FC panel did not “resolve whether Itron’s pre-merger activities made it a real-party-in-interest, or whether the Board has any authority or obligation to reevaluate § 315(b) post institution.”

Acoustic also appealed the Board’s anticipation and obviousness findings. The FC panel affirmed the Board’s anticipation conclusion because expert testimony showed “a skilled artisan would reasonably understand that NetComm’s disclosure of radio wave communication was the same as CDMA” (“substantial evidence”; Koito Mfg., FC 2004) and “the same structure in Gastouniotis [meets] the ‘control’ and ‘relay’ limitations of claim 8.” The FC panel also disagreed with Acoustic that “the Board erroneously mapped Nelson onto the elements of claim 8” and its “motivation-to-combine finding is not supported by substantial evidence”. On the first argument, the FC panel found the “same electronic meter reader in Nelson” satisfies “both the ‘metering device’ and ‘relay’ limitations”. The FC panel also found the Board properly found SSN’s “arguments ‘supported by a sufficient rational underpinning’” and supported by expert testimony that was “not conclusory or otherwise defective” (In re Am. Acad. Sci., FC 2004; Unwired Planet, FC 2016). Thus, the Board’s anticipation and obviousness conclusions were affirmed.

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

Horizon’s petition for en banc rehearing regarding indefiniteness denied (four judges dissented regarding “consisting essentially of”))


HZNP Medicines LLC et al. v. Actavis Laboratories UT, Inc.

Docket No. 2017-2149, -2152-53, -2202-3, -2206
PROST, NEWMAN, REYNA
October 10, 2019 (update Feb. 25, 2020)

Update (2/25/20): Petition for en banc hearing denied. Judges Lourie, Newman, O’Malley and Stoll dissented, arguing that the majority “erroneously construed the ‘consisting essentially of’ language” of claim 49 “in evaluating the definiteness requirement of 35 U.S.C. § 112” because “better drying time is not in the claim, and it is the claims that the stature requires be definite” and “[t]he possibility of inclusion of other[]” ingredients “implied by the language at issue here, does not make what is recited and essential indefinite” (“[T]he advantages of an invention and disclosure of how to make and use an invention are not incorporated into claims for purposes of evaluating their indefiniteness…the meaning of the ‘consisting essentially of’ language should boil down to…whether the presence of an unrecited material in an accused product is in fact inconsistent with, or defeats the purpose of, the claimed composition…the principle of importing an uncertainty in measuring an advantage of an invention could have unintended potential effects well beyond this particular case” and “should not be sound precedent.”)

Brief Summary: DC findings of indefiniteness, no induced infringement, and no invalidity for obviousness regarding Horizon’s OB patents for Pennsaid® affirmed.

Summary: Horizon appealed DC judgment of invalidity and noninfringement of certain Orange Book (OB) patents relating to methods and compositions for treating osteoarthritis (Pennsaid®, topical 2% diclofenac sodium, “the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees”), and Actavis (which filed ANDA 207238) cross-appealed the DC’s judgment of non-obviousness regarding other patents. The FC panel opinion split the OB patents into methods-of-use (e.g., “method for applying topical agents to a knee of a patient with pain”) and formulation groups (“topical formulation consisting essentially of’).

The DC found indefiniteness for the identity of the claimed “impurity A” (“identity…is unknowable”), “the formulation degrades by less than 1% over 6 months” (“neither the claims nor the specification disclose the means to evaluable degradation”), and the “consisting essentially of” limitation in the formulation patents (no identification of “basic and novel properties” that would not be “materially affect[ed]” by “unlisted ingredients”). The FC panel agreed with the DC that “impurity A” and the “degrades” term are indefinite (e.g., “[t]he claims do not make clear that ‘impurity A’ refers to an impurity of diclofenac sodium” as opposed to the “several other excipients” in “the entire topical formulation”, “written description provides no clue”, no supporting extrinsic evidence). Regarding “consisting essentially of”, the FC panel agreed that “the basic and novel properties of the formulation patents…are implicated” by the phrase, and agreed with the DC’s application of the Nautilus definiteness standard (US 2014, “inform, with reasonable certainty”), and that it was “indefinite based on its finding that the basic and novel property of ‘better drying time’ was indefinite” (detailed analysis of the specification and relevant case law is included in the FC panel opinion). Judge Newman dissented on this point.

The DC also granted summary judgment (SJ) to Actavis since Horizon did not “show that Actavis’s label induced infringement of the method-of-use patents.” The FC panel explained that “[i]t is undisputed that Actavis’s label is substantially similar to Horizon’s”, but that Actavis’s “instructions…only require the first step of” Horizon’s “patented method”, and “is broader than step three of Horizon’s claimed method” (e.g., “Actavis’s label also warns about clothing, cosmetics…and other substance” that “operates in an ‘if/then’ manner” and “does not encourage infringement” (e.g., AstraZeneca, FC 2010)).

Actavis’s ‘913 claim 12 patent obviousness theory (the only claim appealed on this point) was that the 2% formulation would have been obvious in view of a prior art 1.5% formulation, which Horizon argued “were not routine optimizations, and that the results of the various changes could not be predicted by the prior art” (e.g., “the field is…complex and unpredictable”). The FC panel found no error with the DC’s findings (e.g., “the variables involved in this case, including the inventive formulation, interact in an unpredictable or unexpected way, such that the results emanating into [the 2% formulation] were not obvious.”) Accordingly, the DC decision was affirmed.

Posted in comprising, consisting of, Generics / ANDA, Indefiniteness | Leave a comment