Life Science IP

Federal Circuit Summaries

Subscribe
Visit Blog
By: Patrick J. Halloran, Ph.D., J.D.

Blog Authors

Patrick Halloran

Latest from Life Science IP

Sony Corporation v. Andrei Iancu (USPTO as intervenor) Docket No. 2018-1172 (IPR2016-00834) PROST, NEWMAN (D), DYK May 22, 2019 Brief summary: IPR FWD obviousness finding reversed and remanded as disputed means-plus-function limitation is computer-implemented and requires an algorithm and Board did not determine whether prior art disclosed the algorithm. Summary: Sony appealed USPTO (“Board”) IPR final decision finding claims 5 and 8 of (expired) US 6,097,676 “directed to ‘an information recording medium’ (e.g., a compact disk…)…and ‘a reproducing device’ that can select which channel to play based on a default code or value stored in nonvolatile memory” unpatentable as obvious…
Quest Integrity USA, LLC v. Cokebusters USA Inc. Docket No. 2017-2423 DYK, TARANTO, HUGHES May 21, 2019 Brief summary: DC grant of SJ based on § 102(b) on-sale bar defense (e.g., inventor declarations not “sham affidavits”) reversed. Summary: Quest appealed DC grant of SJ of invalidity of certain claims of US 7,542,874 relating to commercial furnace inspection systems under § 102(b) (on-sale bar (Pfaff, US 1998; Medicines Co., FC 2016)) to Cokebusters. The claims are directed to “computer-readable medium having computer-executable instructions for” detecting problems with furnace tubes and “system[s] for displaying inspection data”. Cokebusters defended Quest’s infringement allegations “on…
Nuvo Pharmaceuticals, Horizon Medicines LLC v. Dr. Reddy’s Labs. et al. Docket No. 2017-2473, -2481, -2484, -2486, -2489, -2491-93 PROST, CLEVENGER, WALLACH May 15, 2019 Brief summary: DC reversed as FC panel found found Nuvo/Horizon’s ‘907 and ‘285 claims to be invalid for lack of WD. Summary: Dr. Reddy’s, Mylan, and Lupin (ANDA filers, “the Generics”) appealed DC final judgment finding Nuvo’s US 6,926,907 and 8,557,285 (shared specifications; two of ten Orange Book patents for the non-steroidal anti-inflammatory (NSAID) / proton pump inhibitor (PPI) combination product Vimovo®) non-obvious (§ 103), enabled (§ 112 enablement), and described (§ 112 written description…
BTG Int. Ltd. and Janssen Biotech, Inc. et al. v. Amneal Pharmaceuticals LLC, et al. Docket Nos. 2019-1147, -1148. -1323, -1324, -1325 MOORE, WALLACH, CHEN May 14, 2019 Brief summary: PTAB IPR decision finding BTGs’s ZYTIGA® (abiratone) Orange Book ‘438 method of treatment patent invalid for obviousness affirmed. Summary: This appeal relates to ANDAs filed regarding BTGs’s ZYTIGA® product (abiratone) filed by Amneal, Amerigen, Mylan, Teva, and Wockhardt. Amerigen, Mylan, and Wockhardt filed three IPRs (IPR2016-00286. -01332, and -01582), for which the USPTO issued final written decisions (FWDs) finding the Asserted Claims of BTG’s pre-AIA US 8,882,438 (the only patent…
Docket Nos. 2018-1247 and 2018-114 PROST, WALLACH (D), HUGHES May 1, 2019 Brief summary: ITC decision “that Amarin’s allegations are precluded by the FDCA” affirmed since, e.g., “[p]rivate parties may not bring [FDCA] enforcement suits.” Summary: Amarin, which markets Vascepa fish oil capsules (“the only purified ethyl ester E-EPA product sold in the [US] as an FDA-approved drug” (E-EPA being the ethyl ester form of eicosapentaenoic acid)), appealed the ITC decision not to institute an unfair competition or unfair act investigation under 19 USC § 1337(a)(1)(A). Amarin filed a complaint under § 337 of the Tariff Act of 1930 alleging…
Docket No. 2018-1434 STOLL, PLAGER, CLEVENGER May 13, 2019 Brief summary: DC’s “ultimate determination that the challenged claims would not have been obvious” due to no reasonable expectation of success affirmed. Summary: WW (which filed ANDA 207486 for generic Afinitor®) appealed DC holding that claims 1-3 Novartis’s US 8,410,131 claiming methods for using the mTOR (the mammalian target of rapamycin) inhibitor everolimus (the active ingredient in Novartis’s Afinitor® product; the ‘131 patent being one of seven Orange Book-listed patents) to treat “solid excretory system tumors” (e.g., advanced renal cell carcinoma (“RCC”)) were not shown to be obvious by clear and…
Docket Nos. 2018-1551 and -1552 LOURIE, O’MALLEY, REYNA May 8, 2019 Brief summary: DC claim construction findings and grant of SJ of non-infringement to Sandoz regarding its Neupogen® and Neulasta® biosimilars affirmed. Summary: Amgen appealed two DC decisions finding Sandoz’s biosimilars to Amgen’s Neupogen® and Neulasta® (filgrastim (a recombinant analog of granulocyte-colony stimulating factor (“G-CSF”) and pegfilgrastim (polyethylene glycol (“PEG”)-conjugated filgrastim) do not infringe claim 7 of Amgen’s US 8,940,878 (by Summary Judgment (“SJ”)) directed to “[a] method of purifying a protein” by particular steps and using a non-affinity separation matrix. In 2014, Sandoz submitted an abbreviated Biologics License Application…
PGR2018-00001 (US 9,539,268 B2) Final Written Decision April 29, 2019 Brief summary: GG found to have demonstrated by a preponderance of the evidence that Antecip’s claims related to zoledronic acid and methods for using the same to treat arthritis are unpatentable for lack of enablement. Summary: Grünenthal GmbH (GG) requested post-grant review (PGR) of Antecip’s claims 3-30 (claims 1 and 2 were statutorily disclaimed) of US 9,539,268 B2 relating to “[a] method of treating arthritis comprising orally administering a dosage form” of zoledronic acid, as well as pharmaceutical oral dosage forms thereof. The FWD explains that FWDs also issued regarding…
Docket No. 2018-1054 WALLACH, CLEVENGER, STOLL May 3, 2019 Brief summary: DC holding that Endo’s claims to low “ABUK” oxymorphone were not shown to be invalid for obviousness affirmed. Summary: Actavis appealed DC holding that claims 1-6 of Endo’s US 8,871,779 claiming “[a] hydrochloride salt of oxymorphone comprising less than 0.001% of 14-hydroxymorphinone” (see FN3 explaining that this is an oxymorphone impurity/precursory, aka “oxymorphone ABUK”; and 14-hydroxycodeinone is an ABUK impurity in oxycodone, aka “oxycodone ABUK”). Actavis argued that the DC erred by “misconstruing the claim term 14-hydroxymorphinone” and in the obviousness determination. The FC panel explained that in a…
Docket No. 2018-1054 WALLACH, CLEVENGER, STOLL May 3, 2019 Brief summary: DC holding that Endo’s claims to low “ABUK” oxymorphone were not shown to be invalid for obviousness affirmed. Summary: Actavis appealed DC holding that claims 1-6 of Endo’s US 8,871,779 claiming “[a] hydrochloride salt of oxymorphone comprising less than 0.001% of 14-hydroxymorphinone” (see FN3 explaining that this is an oxymorphone impurity/precursory, aka “oxymorphone ABUK”; and 14-hydroxycodeinone is an ABUK impurity in oxycodone, aka “oxycodone ABUK”). Actavis argued that the DC erred by “misconstruing the claim term 14-hydroxymorphinone” and in the obviousness determination. The FC panel explained that in a…
PGR2018-00001 (US 9,539,268 B2) Final Written Decision April 29, 2019 Brief summary: GG found to have demonstrated by a preponderance of the evidence that Antecip’s claims related to zoledronic acid and methods for using the same to treat arthritis are unpatentable for lack of enablement. Summary: Grünenthal GmbH (GG) requested post-grant review (PGR) of Antecip’s claims 3-30 (claims 1 and 2 were statutorily disclaimed) of US 9,539,268 B2 relating to “[a] method of treating arthritis comprising orally administering a dosage form” of zoledronic acid, as well as pharmaceutical oral dosage forms thereof. The FWD explains that FWDs also issued regarding…
Docket Nos. 2018-1247 and 2018-114 PROST, WALLACH (D), HUGHES May 1, 2019 Brief summary: ITC decision “that Amarin’s allegations are precluded by the FDCA” affirmed since, e.g., “[p]rivate parties may not bring [FDCA] enforcement suits.” Summary: Amarin, which markets Vascepa(TM) fish oil capsules (“the only purified ethyl ester E-EPA product sold in the [US] as an FDA-approved drug” (E-EPA being the ethyl ester form of eicosapentaenoic acid)), appealed the ITC decision not to institute an unfair competition or unfair act investigation under 19 USC § 1337(a)(1)(A). Amarin filed a complaint under § 337 of the Tariff Act of 1930 alleging…
Docket No. 2018-1257-8, -1288, -1290 (multiple IPRs) Moore, WALLACH, HUGHES April 26, 2019 Brief summary: Board IPR decisions finding Lilly’s claims relating to administration of vitamin B12 with pemetrexed were not shown to be obvious affirmed. Summary: Neptune Genetics (NG) appealed Board holding that claims 1-22 of Lilly’s US 7,772,209 relating to administering pemetrexed disodium with folic acid and a “methylmalonic acid lowering agent” (MMA; e.g., vitamin B12) were not shown to be unpatentable for obviousness. Claim 12 relates to a similar method but as “[a]n improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment”.…
Derivation Proceeding DER2017-00007 Petitioner Appln. No. 15/058,862; Respondent Pat. No. 9,428,953 B2 Final Written Decision (March 20, 2019) Brief summary: In this AIA derivation proceeding, the PTAB found that “Andersen has not demonstrated’ derivation “by a preponderance of the evidence”. Summary: Andersen requested a derivation proceeding under 35 USC § 135 regarding its ‘862 application relating to window frames, alleging that “an inventor named in the ‘953 patent derived” an invention “recited in claims 1-22 from an inventor named in Andersen’s ‘862 application.” The PTAB’s FWD explains that “[t]o prove derivation, the party asserting derivation must establish (1) prior conception…
Docket No. 2017-2257, -2621, 2018-1063 CBM Nos. 2015-00179, 2016-00051, 2016-00032 MOORE, MAYER, LINN April 18, 2019 Brief summary: Board finding that TT’s patents are CBM eligible (e.g., claims are not “for technological inventions”) and patent ineligible (§ 101) affirmed. Summary: TT appealed Board findings that each of US 7,533,056; 7,212,999; and 7,904,374 are eligible for covered business method (CBM) review and ineligible under § 101, and that the ‘056 claims are invalid for obviousness. The FC panel explained that under § 18(a)(1)(E) of the AIA a patent eligible for CBM review do not include those “for technological inventions” and that…
Docket No. 2015-1950, -1967 WALLACH, HUGHES, STOLL December 15, 2016 Update (April 19, 2019 (non-precedential)): On remand of this decision (“US Water I”), the jury found no inherent anticipation and awarded damages of about $7.5 million. But the DC partially granted JMOL in favor of Novozymes and found the Asserted Claims invalid as inherently anticipated. FC panel reversed and remanded because, e.g., “[t]here is…substantial evidence to support the jury finding that [the prior art] only discloses the possibility of reducing phytic acid concentration below detection levels, which is not legally sufficient to demonstrate inherent anticipation” and “Novozymes, therefore, did not…