Generic Drugs

News & Analysis as of

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election

On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election. We believe that, for all practical purposes, this means that...more

CAFC Affirms Finacea Gel Infringement Under Doctrine of Equivalents

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more

Court Report - May 2016 #2 (Part II)

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amgen Inc. et al. v. Sandoz Inc. et al. 3:16-cv-02581; filed May 12, 2016 in the Northern District of California - .....more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

FDA Talks Generic Drugs: A Look at the Generic Drug Approval Process from the Agency’s Perspective

So you’re preparing an abbreviated new drug application submission… what could possibly go wrong? The Food and Drug Administration responds: Let us count the ways… However, much of it can be avoided if one merely knows where...more

Court Report - May 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Endo Pharmaceuticals Inc. v. Impax Laboratories, Inc. 2:16-cv-02526; filed May 6, 2016 in the District Court of New Jersey...more

Yet Another Failure-To-Update Claim Bites the Dust

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts,...more

Judgment Issues For Plaintiffs In ANDA Case

Sleet, J. The court issues findings of fact and conclusions of law and rules on post-trial motions. A 4-day trial took place between November 9-13, 2015. The disputed product is generic forms of plerixafor, which is...more

The right policy prescription for pharmaceutical patents? The Australian Productivity Commission proposes a new formula

As mentioned in our earlier article Australia’s Productivity Commission has released a draft report (Report) regarding intellectual property (IP) in Australia. The Report covers various IP rights and provides the Commission’s...more

Are Drug Prices Really Too High?

Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more

Judge Griesa Grants Endo an Injunction Against Generic Manufacturers of Opioid Opana ER

On April 29, 2016, S.D.N.Y. District Judge Thomas P. Griesa granted Defendants Actavis, Inc., Actavis South Atlantic LLC (together “Actavis”) and Roxane Laboratories, Inc.’s motion to correct the court’s August 14, 2015...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

Supernus Pharms., Inc. v. Actavis Inc.

Case Name: Supernus Pharms., Inc. v. Actavis Inc., Civil Nos. 13-4740 (RMB/JS), 14-1981 (RMB/JS), 2016 U.S. Dist. LEXIS 14111 (D.N.J. Feb 5, 2016) (Bumb, J.)... Drug Product and Patent(s)-in-Suit: Oxtellar XR®...more

Legislative Developments in Post-Grant Proceedings

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd.

Case Name: Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd., Civ. No. 11-3962 (MLC), 2016 U.S. Dist. LEXIS 27477 (D.N.J. Mar. 3, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more

TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really...more

Braintree Labs. Inc. v. Breckenridge Pharm., Inc.

Case Name: Braintree Labs. Inc. v. Breckenridge Pharm., Inc., C.A. No 12-cv-6851 (AJN), 2016 U.S. Dist. LEXIS 33336 (S.D.N.Y. Mar. 15, 2016) (Nathan, J.)... Drug Product and Patent(s)-in-Suit: Suprep® (sodium sulfate /...more

Shire Development, LLC v. Watson Pharms., Inc.

Case Name: Shire Development, LLC v. Watson Pharms., Inc., Civ. No. 12-60862-CIV-MIDDLEBROOKS/BRANNON, 2016 U.S. Dist. LEXIS 40360 (S.D. Fla. Mar. 25, 2016) (Middlebrooks, J.)... Drug Product and Patent(s)-in-Suit:...more

Jazz Xyrem + Valproate Patent Claims Avoid IPR

The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute...more

Purdue Pharma L.P. v. Epic Pharma, LLC

Case Name: Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir. Feb. 1, 2016) (Circuit Judges Prost, Reyna, and Stark [sitting by designation] presiding; Opinion by Prost, C.J.) (Appeal from S.D.N.Y., Stein,...more

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

Case Name: Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., 2015-1588, 2016 U.S. App. LEXIS 4945 (Fed. Cir. March 18, 2016) (Circuit Judges Lourie, Dyk, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D.N.J.,...more

April Antitrust Bulletin

FTC Files No-AG Suit Against Pharmaceutical Companies - On March 30, 2016, the Federal Trade Commission (FTC) filed a complaintin the U.S. District Court for the Eastern District of Pennsylvania against several drug...more

The Next Move in the Name Game: FDA Provides Long-Awaited Draft Guidance on Biosimilar Labeling

On March 31, 2016, the U.S. Food and Drug Administration (FDA) released its long-awaited Draft Guidance on labeling for biosimilar products (the “Draft Guidance”) and is currently soliciting comments on its proposals. The...more

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