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Hikma v. Amarin: Supreme Court Reins in Induced Infringement Claims Against Skinny Label Generic Drugs

Hikma Ruling Looms Large in House IP Subcommittee Hearing Debating Legislation Favoring Generic Drugmakers

At approximately the same moment that the U.S. Supreme Court handed down today’s landmark ruling in Hikma v. Amarin, the House Judiciary’s Subcommittee on Courts, Intellectual Prop...

Generics Cos. Get More Freedom In High Court Patent Ruling

The U.S. Supreme Court's decision Thursday shutting down a patent case involving a generic heart drug that uses a so-called skinny label establishes a road map for generics compani...

Generic drugmakers gain key victory in ‘skinny label’ patent case

The Supreme Court ruled that a knockoff version of Amarin’s Vascepa didn’t infringe on patents — a decision with far-reaching implications for the availability of generics.

Readers React: What to Expect After the Supreme Court’s Hikma Ruling

Thursday’s Supreme Court ruling in Hikma v. Amarin has been discussed as a definitive win for the generics industry and may have implications beyond pharmaceutical and Hatch-Waxman...

Supreme Court Hands Generics a Unanimous Win on Skinny Labels in Hikma v. Amarin

High Court's Hikma Decision Reshapes 'Skinny Label' Suits

The U.S. Supreme Court's decision in Hikma v. Amarin marks a significant victory for generic drug manufacturers, but rather than putting an end to so-called skinny label inducement...

Supreme Court Shuts Down 'Skinny Label' Drug Patent Suit

The U.S. Supreme Court on Thursday ended a patent suit over Hikma Pharmaceuticals USA Inc.'s generic version of a heart drug that uses a so-called skinny label, saying Amarin Pharm...

Pharmaceutical Method-of-Use Claims After Teva v. Eli Lilly and In re Xencor: Written Description, Enablement, and the K...

Orange You Glad You Used the Right Form?

By Sara W. Koblitz —

Long Live the Skinny Label

By Sara W. Koblitz —

Sen. Committee Clears Drug Disclosure, Biosimilar Bills

The U.S. Senate Committee on Health, Education, Labor and Pensions on Wednesday cleared two bills for full Senate review, tackling the gap between health and patent oversight agenc...

<![CDATA[Pharmaceutical Executive Daily: Supreme Court Unanimously Rules in Favor of Hikma Pharmaceuticals in Skinny...

A Bitter pH-ill to Swallow: Federal Circuit Affirms Mylan’s Win Over Actelion’s Epoprostenol Drug Patents

Last week in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., the Federal Circuit delivered generic drug maker Mylan Pharmaceuticals Inc. with a notable victory when it...

Old Drugs, New Tricks: FDA’s Drug Repurposing Initiative

By Charles D. Snow & Kalie E. Richardson —

The Supreme Court Just Made It Easier for You to Get Cheaper Generic Drugs—With 1 Major Catch

A ruling in favor of generic drugmaker Hikma will make it harder for brand-name manufacturers to block cheaper alternatives. A pharmaceutical patent lawyer says the legal battle is...

WuXi AppTec’s 1260H Listing Brings the BIOSECURE Act Back to Center Stage

By Steven J. Gonzalez —

Handa, Intas Face Patent Suits Over Exelixis Cancer Drug

Handa Pharmaceuticals and Intas Pharmaceuticals are wrongly trying to bring to market drugs that would compete with Exelixis Inc.'s blockbuster cancer pill Cabometyx before patents...

Fed. Circ. Backs Lupin Win In Generic Kidney Drug Case

The Federal Circuit on Thursday affirmed a Delaware federal judge's ruling that Indian generic-drug maker Lupin's version of the kidney disease drug Jynarque does not infringe two...

Federal Circuit Addresses Prosecution History Estoppel, Disclosure-Dedication Rule in Affirming ANDA Product Noninfringe...

Key Takeaways The Federal Circuit held that an ANDA product formulation did not infringe, literally or under the doctrine of equivalents, patent claims that require lyophilized ph...

Justices reject holding generic pharmaceutical manufacturers liable for decisions of pharmacists about prescribing their...

Among the three opinions arriving on Thursday from the April argument session was Hikma Pharmaceuticals USA v. Amarin Pharma. As the quick turnaround would suggest, Hikma is not a...

Hikma v. Amarin and a Clarified Standard for Induced Patent Infringement Under 35 U.S.C. § 271(b)

<![CDATA[The Pharma Patent Cliff Explained: What It Is and How Companies Navigate It]]>

Federal Circuit Affirms Ruling Blocking Generic Nuedexta

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today in Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited, affirming a preliminary...