ANDA Patents

News & Analysis as of

Court Report - May 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Pharma, Inc. et al. v. Actavis Laboratories FL., Inc. et al. 3:15-cv-03322; filed May 13, 2015 in the District...more

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more

Lessons in Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

An emerging issue in Hatch-Waxman litigation – and potentially under the Biologics Price Competition and Innovation Act (BPCIA) – is the impact of the Supreme Court’s decision in Daimler AG v. Bauman, 134 S. Ct.746 (2014), on...more

Declaratory Judgment of Non-Infringement of a Disclaimed Patent Warranted in Hatch-Waxman - Apotex Inc. v. Daiichi Sankyo, Inc.

Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...more

Judgment On The Pleadings Is Granted Barring DOE Claims

This is an ANDA case involving the generic version of Treanda®. The two disputed patents claim compositions and preparations that include tertiary-butyl alcohol (“TBA”), which is absent in the defendants’ ANDA products. ...more

Court Report - April 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicis Pharmaceutical Corp. v. Taro Pharmaceuticals U.S.A., Inc. et el. 3:15-cv-02841; filed April 22, 2015 in the...more

Magistrate Recommends Dismissing Certain Induced Infringement Claims

The disputed technology relates to carvedilol, initially patented 20 years ago for the treatment of hypertension, and now for the treatment of chronic heart failure. Defendants filed ANDAs for generic versions of the drug...more

Apotex Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex Inc. v. Daiichi Sankyo, Inc., 2014-1282, -1291 2015 U.S. App. LEXIS 5134 (Fed. Cir. Mar. 31, 2015) (Circuit Judges Taranto, Mayer, and Clevenger presiding; Opinion by Taranto, J.) (Appeal from N.D. Ill.,...more

AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

InSite Vision Inc. v. Sandoz, Inc. (Fed. Cir. 2015)

The Federal Circuit showed once again the importance of a district court's factual findings (and the deference the appellate court gives those findings, particularly when supported by expert testimony), in InSite Vision Inc....more

Exela Pharma Sciences LLC v. Lee (Fed. Cir. 2015)

Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences...more

Claim Construction Opinion Issues In ANDA Case

Andrews, J. Court issues a claim construction opinion in ANDA case regarding terms from nine patents. The disputed technology relates to the administration of testosterone. The following terms were construed...more

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

Threshold Issues: IPR Not Derailed by Unidentified D/B/A Name or Prior ANDA Certification - Metrics, Inc. v. Senju Pharmaceutical...

Addressing threshold jurisdictional issues of a petition for inter partes review (IPR), the U.S. Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (PTAB or Board) determined that a d/b/a name does not create...more

FDA Denies Amgen’s Citizen’s Petition Awaiting Guidance from the Courts

As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more

Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. (Fed. Cir. 2015)

Senju PharmaceuticalEarlier this month, the Federal Circuit affirmed a District Court judgment of obviousness in ANDA litigation under the Hatch Waxman Act having a long provenance of earlier litigation, in Senju...more

Claim Construction Opinion Issues In ANDA Rufinamide Litigation

Stark, C. J. The court issues claim constructions regarding 7 terms from 3 patents. The following terms were construed...more

Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds

On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss...more

Glenmark Generics Ltd. v. Ferring B.V.,

Case Name: Civ. No. 3:14-cv-422-HEH, 2014 U.S. Dist. LEXIS 146528 (E.D. Va. Oct. 14, 2014) (Hudson, J.) (Where patent holder disclaims patent and asks FDA to delist, but patent remains in Orange Book, declaratory judgment...more

Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp.,

Case Name: Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp., Civ. No. 14-1268-SLR, 2014 U.S. Dist. LEXIS 155981 (D. Del. Nov. 4, 2014) (Robinson, J.) (Given statements made in the accused product’s proposed labeling,...more

Allergan, Inc. v. Actavis, Inc.

Case Name: Allergan, Inc. v. Actavis, Inc., Nos. 14-cv-638, 14-cv-188, 2014 U.S. Dist. LEXIS 176551 (E.D. Tex. Dec. 23, 2014) (Gilstrap, J.) (Only an ANDA “received” by the FDA can form the basis for a patent infringement...more

Spectrum Pharms., Inc. v. Sandoz Inc.,

Case Name: Spectrum Pharms., Inc. v. Sandoz Inc., No. 2:12-cv-111-GMN-NJK, 2014 U.S. Dist. LEXIS 179755 (D. Nev. Dec. 29, 2014) (Navarro, J.) (Because the ANDA product did not meet the claimed dosage strength,...more

Orange Book Patent Listing and Patent Certifications: Key Provisions in FDA’s Proposed Regulations Implementing the Medicare...

On February 6, 2015, the United States Food and Drug Administration (FDA) issued long-awaited proposed regulations to implement portions of the Medicare Modernization Act of 2003 (MMA). Consisting of almost one hundred pages...more

Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc

Case Name: Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc., Nos. 2014-1439, 2014-1441, 2014-1444, 2014-1445, 2014-1446, 2014 U.S. App. LEXIS 21946 (Fed. Cir. Nov. 18, 2014) (Circuit Judges Lourie, Reyna and Taranto...more

Court Report - January 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Par Pharmaceutical Inc. et al. 1:15-cv-00068; filed January 21, 2015 in the District Court of...more

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