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Genentech, Inc. v. Sandoz Inc.

Docket 22-1595, U.S. Court of Appeals, Federal Circuit (Apr. 5, 2022)
Patent - Abbreviated New Drug Application (ANDA)
Case Type835 Patent - Abbreviated New Drug Application (ANDA)
Tags835 Patent, Abbreviated New Drug Application, Anda, 835 Patent, Abbreviated New Drug Application, Anda
Plaintiff - Appellant GENENTECH, INC.
Plaintiff - Appellant INTERMUNE, INC.
Defendant - Appellee SANDOZ INC.
...
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No. 49 OPINION filed for the court by Newman, Circuit Judge; Lourie, Circuit Judge and Prost, Circuit ...

Document Genentech, Inc. v. Sandoz Inc., 22-1595, No. 49 (Fed. Cir. Dec. 22, 2022)
If a patient exhibits >3 but ≤5 x the upper limit of normal (ULN) ALT and/or AST with- out symptoms or hyperbilirubinemia after starting pirfenidone tablets therapy: • Discontinue confounding medications, ex- clude other causes, and monitor the pa- tient closely.
The district court began its analysis by noting that the parties “agree that Sandoz’s label recommends using pirfenidone for the treatment of IPF and includes treat- ment instructions for patients exhibiting Grade 2 eleva- tions in ALT and/or AST.” Decision at *7.
Lastly, Genentech asserts that objective indicia of nonobvi- ousness weighed in its favor because it showed skepticism regarding pirfenidone’s efficacy and safety, as well as evi- dence of a long-felt and unmet need of treating patients fol- lowing Grade 2 AST/ALT elevations.
In Eli Lilly, for ex- ample, we relied on “[t]he product labeling, combined with [] testimony [discussing physicians’ general practices]” to conclude that there was sufficient evidence “that physi- cians condition ... treatment on” the patients’ perfor- mance of the patented method, thereby satisfying the GENENTECH, INC. v. SANDOZ INC. requirements for proving direct infringement.
Weighing all the evidence, the district court did not clearly err in finding that Genentech had not met its bur- den to show that if Sandoz’s drug were put on the market, it would directly infringe the asserted claims of the DDI patents which require use of both pirfenidone and fluvox- amine.
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No. 24 ORDER granting parties' joint motion to voluntarily dismiss Appeal No. 2022-1714 [22]

Document Genentech, Inc. v. Sandoz Inc., 22-1595, No. 24 (Fed. Cir. Jun. 16, 2022)
Motion for Voluntary DismissalGranted
United States Court of Appeals for the Federal Circuit
2022-1714 GENENTECH, INC. v. SANDOZ INC. Appeal from the United States District Court for the District of Delaware in No. 1:19-cv-00078-RGA, Judge Richard G. Andrews.
Upon consideration of the parties’ joint motion to vol- untarily dismiss Appeal No. 2022-1714,
(3) The Clerk of Court shall transmit a copy of this or- der to the merits panel assigned to Appeal No. 2022-1595.
(4) Genentech, Inc. and InterMune, Inc.’s reply brief in Appeal No. 2022-1595 is due no later than July 5, 2022.
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No. 24 ORDER granting parties' joint motion to voluntarily dismiss Appeal No. 2022-1714 [22]

Document Genentech, Inc. v. Sandoz Inc., 22-1595, No. 24 (Fed. Cir. Jun. 16, 2022)
Motion for Voluntary DismissalGranted
United States Court of Appeals for the Federal Circuit
2022-1714 GENENTECH, INC. v. SANDOZ INC. Appeal from the United States District Court for the District of Delaware in No. 1:19-cv-00078-RGA, Judge Richard G. Andrews.
Upon consideration of the parties’ joint motion to vol- untarily dismiss Appeal No. 2022-1714,
(3) The Clerk of Court shall transmit a copy of this or- der to the merits panel assigned to Appeal No. 2022-1595.
(4) Genentech, Inc. and InterMune, Inc.’s reply brief in Appeal No. 2022-1595 is due no later than July 5, 2022.
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No. 19 ORDER filed denying the motion [10] filed by Genentech, Inc. and InterMune, Inc

Document Genentech, Inc. v. Sandoz Inc., 22-1595, No. 19 (Fed. Cir. May. 9, 2022)
United States Court of Appeals for the Federal Circuit
The appellants move to enjoin, pending appeal, the ap- pellees from marketing, selling, offering for sale, or import- ing into the United States the appellees’ pirfenidone product and request an interim injunction pending consid- eration of the motion.
GENENTECH, INC. v. SANDOZ INC. Rule 8(a)(2) of the Federal Rules of Appellate Proce- dure authorizes this court to grant an injunction pending appeal.
Our determination is governed by four factors: (1) whether the movant has made a strong showing of a likeli- hood of success on the merits; (2) whether the movant will be irreparably injured absent an injunction; (3) whether is- suance of the injunction will substantially injure the other parties interested in the proceeding; and (4) where the pub- lic interest lies.
Based on the papers submitted and without prejudic- ing the ultimate disposition of the appeal, we conclude that the appellants have not established that an injunction pending appeal is warranted here.
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No. 13 ORDER consolidating appeals (22-1595, 22-1714)

Document Genentech, Inc. v. Sandoz Inc., 22-1595, No. 13 (Fed. Cir. Apr. 25, 2022)
Motion to Consolidate Appeals
NOTE: This order is nonprecedential.
United States Court of Appeals for the Federal Circuit
Appeals from the United States District Court for the District of Delaware in No. 1:19-cv-00078-RGA, Judge Richard G. Andrews.
The revised official cap- tion is reflected above.
The briefing schedule GENENTECH, INC. v. SANDOZ INC. set forth in the court’s order of April 14, 2022 (22-1595, ecf 7) continues to apply.
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No. 12 ORDER filed directing the appellees to respond to the motion no later than April 27, 2022

Document Genentech, Inc. v. Sandoz Inc., 22-1595, No. 12 (Fed. Cir. Apr. 21, 2022)
United States Court of Appeals for the Federal Circuit
Appeal from the United States District Court for the District of Delaware in No. 1:19-cv-00078-RGA, Judge Richard G. Andrews.
The appellants submit a motion to enjoin, pending ap- peal, the appellees from marketing, selling, offering for sale, or importing into the United States its pirfenidone product and request an interim injunction pending consid- eration of the motion.
The appellants state that the appel- lees oppose the relief requested.
The appellees are directed to respond to the motion no later than April 27, 2022.
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No. 7 ORDER filed granting motion to expedite this appeal [6] filed by Appellants Genentech, Inc. ...

Document Genentech, Inc. v. Sandoz Inc., 22-1595, No. 7 (Fed. Cir. Apr. 14, 2022)
Motion to ExpediteGranted
United States Court of Appeals for the Federal Circuit
Appeal from the United States District Court for the District of Delaware in No. 1:19-cv-00078-RGA, Judge Richard G. Andrews.
Upon consideration of appellants’ unopposed motion to expedite this appeal,
The joint appendix is due no later than seven days from the date of service of the last-filed brief.
The case will be placed on the next available argument calendar after the date of service of the joint appendix.
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