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Acting Solicitor General gives government’s position on generic-pharma preemption to U.S. Supreme Court

Duane Morris LLP
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USA
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November 4 2010

In a brief filed in the U.S. Supreme Court on November 2, 2010, Acting U.S. Solicitor General Neal Katyal provided the federal government's position on federal preemption of state laws regarding the labeling of generic drugs

FDA proposes pre-marketing user fees for biosimilar product manufacturers comparable to fees for branded manufacturers

Duane Morris LLP
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USA
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May 11 2011

In its next step toward implementing a pathway for biosimilar product approval under the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), the U.S. Food and Drug Administration (FDA) released a Notice and Request for Comments on "Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Year 2013 Through 2017," ("User Fee Notice")published in the Federal Register on May 10, 2011

Pennsylvania District Court prevents disclosure of hundreds of confidential settlement agreements

Duane Morris LLP
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USA
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March 24 2011

In a scrimmage over the legality of settlement agreements relating to only one drug, the U.S. District Court for the Eastern District of Pennsylvaniain FTC v. Cephalonprovided what may be considered a win-win scenario for much of the pharmaceutical industry and for the Federal Trade Commission (FTC

Federal Circuit reverses N.Y. district court: claims to "isolated" DNA are eligible for patent protection

Duane Morris LLP
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USA
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August 2 2011

On July 29, 2011, the U.S. Court of Appeals for the Federal Circuit reversed in part the U.S. District Court for the Southern District of New York's ruling in Association for Molecular Pathology v. USPTO, Myriad Genetics, et al. ("Myriad") and held that claims to "isolated" DNA molecules were patent-eligible

FDA issues proposed rule regarding citizen petitions and psas related to Section 505(b)(2) applications or ANDAs

Duane Morris LLP
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USA
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January 4 2012

As part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) enacted on September 27, 2007, Congress added Section 505(q) to the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. 355(q

Federal Circuit addresses infringement of method-of-use patents by generics in YASMIN case

Duane Morris LLP
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USA
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April 18 2012

The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz, Inc., Nos. 2011-1143, -1228 (YASMIN), affirmed a district court's holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of an FDA-approved drug where the U.S. Food and Drug Administration had not approved the drug for the claimed uses, and where the FDA-approved labeling did not indicate instructions or intent to encourage the claimed use

U.S. Supreme Court restores generic pharma's ability to challenge Orange Book use code information

Duane Morris LLP
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USA
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April 19 2012

The U.S. Supreme Court's unanimous ruling on April 17, 2012, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk AS was a resounding win for both Caraco and the generic pharmaceutical industry as a whole

Addressing breach of method-of-use patents by generics

Duane Morris LLP
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USA
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May 2 2012

The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz Inc., Nos. 2011-1143, -1228 (Yasmin), affirmed a district court's holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of a U.S. Food and Drug Administration (FDA)-approved drug where the FDA had not approved the drug for the claimed uses, and where the FDA-approved labeling did not indicate instructions or intent to encourage the claimed use

Third Circuit holds that settlement agreements containing payments from the innovator to the generic challenger may violate antitrust laws

Duane Morris LLP
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USA
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July 23 2012

On July 16, 2012, the U.S. Court of Appeals for the Third Circuit, which includes Delaware, New Jersey and Pennsylvania, issued a long-anticipated decision in In re K-Dur Antitrust Litigation, finding that settlement agreements in which payments are made to the generic manufacturers challenging the patents to settle the litigation may be unreasonable restraints on trade and unenforceable under federal antitrust laws

FTC proposes new HSR rules for exclusive patent licenses in the pharmaceutical industry

Duane Morris LLP
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USA
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August 15 2012

On August 13, 2012, the U.S. Federal Trade Commission (FTC) announced it is seeking public comment to proposed changes to the premerger notification rules under the Hart Scott Rodino Act (HSR) relating to acquisitions of exclusive patent rights in the pharmaceutical industry

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