News & Analysis as of

Reversal Generic Drugs

Mintz - Intellectual Property Viewpoints

Federal Circuit Cautions Against Rigid Approach to Prosecution History Estoppel in Fourth Appeal from ALIMTA® Litigations

On August 9, 2019, the United States Court of Appeals for the Federal Circuit, in Eli Lilly & Co. v. Hospira, Inc., Nos. 2018-2126, 2127, 2128, reversed in-part and affirmed in-part a district court’s determination of...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

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Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Bradley Arant Boult Cummings LLP

First Circuit Restricts Class Certification of Classes Containing Uninjured Persons

In recent years, courts have reached divergent conclusions about the circumstances in which a damages class containing uninjured persons can be certified. Although there is some room to debate what constitutes injury, it is...more

Knobbe Martens

Orexo AB, Orexo US Inc., v. Actavis Elizabeth LLC

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Federal Circuit Summary - Before Newman, Hughes, and Stoll. Appeal from the United States District Court for the District of Delaware Summary: Objective indicia of nonobviousness cannot be dismissed merely because all...more

Knobbe Martens

Federal Circuit Review - March 2018

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Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more

Knobbe Martens

The Medicines Company v. Hospira, Inc.

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Federal Circuit Summaries - Before Dyk, Wallach, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: A distribution agreement qualifies as an invalidating “offer for sale”...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too heavily on the commercial availability of the prior art. The panel...more

Knobbe Martens

Federal Circuit upholds Millennium’s Patent on Velcade®

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MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more

Smart & Biggar

Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Smart & Biggar

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent...

Smart & Biggar on

On February 2, 2017, the Federal Court of Appeal released a significant decision on accounting for profits, a remedy for patent infringement in Canada: Apotex Inc v ADIR, 2017 FCA 23. The appeal concerned two defences raised...more

Patterson Belknap Webb & Tyler LLP

Third Circuit says sunk discovery costs not a proper factor in class certification analysis

It is not every day that antitrust plaintiff classes fail to win certification due to lack of numerosity under Federal Rule of Civil Procedure 23(a)(1). Yet this week, absence of numerosity was the reason a Third Circuit...more

Foley & Lardner LLP

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

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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

McDonnell Boehnen Hulbert & Berghoff LLP

The Medicines Company v. Hospira (Fed. Cir. 2015)

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

McDonnell Boehnen Hulbert & Berghoff LLP

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

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