News & Analysis as of

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Dorsey & Whitney LLP

UGG, Is it Finally Over?

Dorsey & Whitney LLP on

A long-running battle between Deckers Outdoor Corp., the makers of UGG boots, and Australian Leather PTY Ltd. may finally be over after a May 7 ruling by the United States Court of Appeals for the Federal Circuit. The battle...more

Kilpatrick Townsend & Stockton LLP

Two Bipartisan Bills Aim to Encourage Competition in the Biopharma Industry

Drug pricing and innovation are hot topics in Washington right now with several bills making their way through the legislative process, many in a bipartisan fashion. On April 23, 2021, two of these bills were signed into law...more

Robins Kaplan LLP

Financial Daily Dose 5.20.2021 | Top Story: Cryptos Whipsaw and Close Down, Dragging Markets With Them

Robins Kaplan LLP on

A weeks long slide for Bitcoin and other cryptos turned into a “frenzied selloff” on Wednesday, crashing the digital currencies back to earth after what had been a pandemic year of impressive gains....more

Skadden, Arps, Slate, Meagher & Flom LLP

The Tax Court Offers a Mixed Bag in the Mylan Case

In Mylan, Inc. & Subsidiaries v. Commissioner, 156 T.C. No. 10 (April 27, 2021), the Tax Court held that legal expenses incurred by a manufacturer of generic pharmaceutical drugs for the preparation, assembly and transmittal...more

White & Case LLP

President Biden Signs Legislation Boosting Generic and Biosimilar Drugs to Help Foster Price Competition

White & Case LLP on

On April 23, 2021, President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices by supporting generic and biosimilar alternatives to branded drugs. The Ensuring Innovation Act supports...more

Locke Lord LLP

Tax Court Finds Legal Fees Incurred in Defending Hatch-Waxman Lawsuits are ‎Deductible Expenses

Locke Lord LLP on

On April 27, 2021, the U.S. Tax Court issued its decision in Mylan, Inc. v. Comm’r of Internal Revenue regarding which legal fees that a generic-drug manufacturer incurs in connection with its Abbreviated New Drug Application...more

Pullman & Comley - Connecticut Health Law

Post-Public Health Emergency – Connecticut Pharmacy Limitation Changes

Connecticut has recently notified pharmacies and prescribing providers that various quantity limits and refill criteria will revert back to pre-COVID 19 requirements come May 21, 2021. The reinstatement of pre-COVID 19...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Drugs Losing Patent Exclusivity in 2021

Earlier this month, Eric Sagonowsky reviewed the top ten drugs in the U.S. (in terms of sales) losing patent exclusivity in an article published by Fierce Pharma....more

Robins Kaplan LLP

Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc.

Robins Kaplan LLP on

Vimovo® (naproxen and esomeprazole magnesium) - Case Name: Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc., No. 15-3324 (SRC), 2021 WL 616067 (D.N.J. Feb. 17, 2021) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Vimovo®...more

Vicente Sederberg LLP

Cannabis Trademarks 101

Vicente Sederberg LLP on

In an industry that runs on innovation and differentiation, a cannabis brand’s identity is among its most valuable—and most prone to copying—assets. It’s a common myth that cannabis industry brands cannot get trademark...more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

Robins Kaplan LLP on

Symbicort® (budesonide and formoterol fumarate dihydrate) - Case Name: AstraZeneca AB v. Mylan Pharms. Inc., No. 1:18CV193, 2021 WL 798856 (N.D.W.V. Mar. 2, 2021) (Keeley, J.) - Drug Product and Patent(s)-in-Suit: Symbicort®...more

Husch Blackwell LLP

Tax Court Rules In Favor Of Generic Drug Manufacturer On Deductibility Of Patent Litigation Expenses In Connection With ANDAs

Husch Blackwell LLP on

On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need...more

Troutman Pepper

Second Circuit: Nonspecific Fraud Allegations Aren't Enough

Troutman Pepper on

On April 20, in Frei v. Taro Pharmaceutical U.S.A., Inc., the U.S. Court of Appeals for the Second Circuit affirmed a Southern District of New York opinion from U.S. District Court Judge Vincent Briccetti, which dismissed,...more

Smart & Biggar

Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations would expand definition of “claim for the...

Smart & Biggar on

On April 24, 2021, proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations were published (proposed PMNOC amendments). The proposed PMNOC amendments relate to the 2019 proposed Regulations...more

Robins Kaplan LLP

Takeda Pharm. Co. Ltd. v. Torrent Pharms. Ltd.

Robins Kaplan LLP on

Case Name: Takeda Pharm. Co. Ltd. v. Torrent Pharms. Ltd., No. 2020-1552, -1598, 2021 WL 560763 (Fed. Cir. Feb. 16, 2021) (Circuit Judges Dyk, Mayer, and Chen presiding; Opinion by Chen, J.) (Appeal from D.N.J., Chesler, J.) ...more

Allen & Overy LLP

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

Allen & Overy LLP on

On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more

Robins Kaplan LLP

New ANDA Cases - Spring 2021

Robins Kaplan LLP on

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Robins Kaplan LLP

Generic Launches - Spring 2021

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

McDermott Will & Emery

Fourth Circuit Breathes New Life into Monopolization Suit

McDermott Will & Emery on

The US Court of Appeals for the Fourth Circuit revived an antitrust suit alleging that a pharmaceutical manufacturer illegally maintained its monopoly for its innovator drug by precluding competition beyond the expiration...more

McDermott Will & Emery

‘Pay-for-Delay’ Agreements can be Restrictions of Competition by their very Nature

McDermott Will & Emery on

On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...more

Robins Kaplan LLP

ANDA Litigation Settlements - Spring 2021

Robins Kaplan LLP on

This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Hogan Lovells

Pay for delay and document retention - The ECJ‘s Lundbeck decision

Hogan Lovells on

In the much-anticipated Lundbeck case (i.a. C-591/16 P), the European Court of Justice (“ECJ”) on 25th March 2021 confirmed the decision of the European Commission (“Commission”) to impose fines on Lundbeck and several...more

Robins Kaplan LLP

ANDA Approvals - Spring 2021

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

MoFo Life Sciences

Pay-For-Delay Has A Tough (Antitrust) Time At EU Top Court

MoFo Life Sciences on

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts. In two recent rulings – “Lundbeck and...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Prevails in Reverse Payment Case

The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more

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Updated: Apr 27, 2021:

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Information for EU and Swiss Residents

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Changes in Our Privacy Policy

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Contacting JD Supra

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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