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Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

Takeda Pharm. Co., Ltd. v. Mylan Inc.

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more

Depomed, Inc. v. Actavis Elizabeth LLC

Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more

Apotex Inc. v. UCB, Inc.

Nature of the Case and Issue(s) Presented: Apotex appealed the district court’s finding that the ’556 patent was unenforceable due to inequitable conduct. The ’556 patent describes a method for making moexipril tablets used...more

Silence of ANDA with Respect to a Claim Limitation Does Not Constitute Infringement

Ferring B.V. v. Watson Labs., Inc. - In Hatch-Waxman litigation that involved Abbreviated New Drug Applications (ANDAs) that were silent as to certain claimed limitations, the U.S. Court of Appeals for the Federal...more

Emerging Impact of Inter Partes Review on Hatch Waxman Litigation – A Primer

Hatch-Waxman Litigation in a Nutshell - Hatch-Waxman litigation refers to pharmaceutical patent litigation between a brand drug manufacturer and a generic drug manufacturer under the Hatch-Waxman Act (“Act”). The Act...more

Sham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?

Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

After Actavis: Crafting Pharmaceutical Settlements that Avoid Antitrust Scrutiny

Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

GENERICally Speaking - Vol. 4, No. 1

The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more

Galderma Laboratories, L.P. v. Tolmar, Inc. (Fed. Cir. 2013)

When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more

Supreme Court corner - Q3 2013

RECENT DECISIONS - Federal Trade Commission v. Actavis - Decided: 6/17/2013 Patent Holding: (5-3) reverse payment settlement agreements should be reviewed based on a “rule of reason. In a split...more

Hatch-Waxman Watch: Safe Harbor Edition

Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute. Both of the cases relied heavily on the Federal Circuit case Momenta Pharm....more

Mutual Pharmaceutical Co. v. Bartlett (2013)

The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...more

Reverse Payment Schemes Risk Antitrust Liability: U.S. Supreme Court Declines to Adopt Bright Line Test

A divided Supreme Court recently held in an opinion by Justice Breyer that “reverse payment” or “pay for delay” agreements between patent holders and potential competitors are not immune from scrutiny under antitrust laws....more

Supreme Court Rules That Pay-For-Delay Settlements Subject To Antitrust Challenges

Antitrust challenges to so-called “pay-for-delay” settlements in drug patent suits are allowed under the U.S. Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc....more

Supreme Court Applies Rule of Reason in Antitrust Challenges to Reverse-Payment Patent Settlements

One of the most controversial antitrust issues for the pharmaceutical industry during the last decade has been the treatment of patent settlements in which a patent-holding branded manufacturer made payments to its generic...more

FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?

On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation....more

U.S. Supreme Court Rejection of the “Scope of the Patent” Test in FTC v. Actavis Has Wide-Ranging Implications

Key Points: - Patent settlements must be analyzed under the rule of reason, requiring a full analysis of the net competitive effects - Payments to an alleged infringer may be permissible if justified by, for...more

Supreme Court Applies Antitrust Scrutiny to ANDA Reverse Payment Settlement Agreements

In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust...more

Reverse Payment Settlements Now Subject to Antitrust Scrutiny, But Lower Courts Left to Fill in the Blanks

Earlier this week in FTC v. Actavis, No. 12-416 (U.S. Jun. 17, 2013), the Supreme Court handed down its long-anticipated ruling on “reverse payment” or “pay-for-delay” agreements, holding that these agreements—while not...more

Supreme Court Rules That “Pay for Delay” Generic Drug Patent Settlements Are Not Shielded From Antitrust Liability

The Supreme Court has held that the antitrust laws may forbid patent settlements that delay the market entry of generic drugs in return for large payments from manufacturers of competing branded drugs....more

Reverse-Payment Patent Settlements Subject to Antitrust Analysis

The Supreme Court today decided FTC v. Actavis, Inc. and held, in a 5-3 decision authored by Justice Breyer, that so-called reverse-payment patent settlements are subject to full antitrust Rule of Reason analysis....more

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