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Momenta Pharms., Inc. et al. v. Amphastar Pharms., Inc. et al., nos. 2012-1062, -1103, -1104 (Fed. Cir. Aug. 3, 2012)
- Winston & Strawn LLP
- -
- USA
- -
- August 9 2012
Post-approval studies of generic drugs that are “reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs,” fall within the scope of the Hatch-Waxman Act safe harbor, 35 U.S.C. 271(e)(1
Sciele Pharma Inc. v. Lupin Ltd., No. 2012-1228 (Fed. Cir. July 2, 2012)
- Winston & Strawn LLP
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- USA
- -
- July 26 2012
Defendants’ burden of proof for invalidity is not raised because a reference was previously before the PTO; statements made during prosecution to rebut enablement rejections under Section 112 may be used as proof of motivation to combine references under Section 103
Medeva
- Winston & Strawn LLP
- -
- United Kingdom
- -
- July 25 2012
Much has been said about the meaning of “specified in the wording of the claims”, a phrase which the Court of Justice of the European Union used when describing products which can be protected by a Supplementary Protection Certificate (“SPC”
In re Hugh Edward Montgomery, John Francis Martin, and Jorge Daniel Erusalimsky, No. 2011-1376 (Fed. Cir. May 8, 2012)
- Winston & Strawn LLP
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- USA
- -
- May 31 2012
Prior art describing an unexecuted process or protocol may inherently anticipate claims when the result at issue inevitably flows from its disclosures
District courts have jurisdiction over declaratory judgment actions by second ANDA filers when the first filer has not yet triggered its exclusivity period, so long as other pending litigation could remove the other barriers to the second filer’s launch
- Winston & Strawn LLP
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- USA
- -
- May 31 2012
A generic pharmaceutical manufacturer filed a second ANDA with paragraph IV certifications as to all three patents listed in the Orange Book for the NDA product
U.S. Supreme Court unanimously upholds generic drug makers’ right to correct inaccurate brand patent descriptions
- Winston & Strawn LLP
- -
- USA
- -
- April 18 2012
In its first-ever case construing the Hatch-Waxman Act’s provisions governing competition between generic and brand-name drug makers, the United States Supreme Court on Tuesday handed a major victory to the generic drug industry
Pharma corner
- Winston & Strawn LLP
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- European Union
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- April 3 2012
Whilst the decisions relating to the manner in which the English courts approach the question of the obviousness of patents are of particular interest to those working in the pharmaceutical industry, perhaps the most significant judgment handed down over the last few months has been the SPC case relating to the litigation between Novartis and Medimmune on the Cambridge Antibody Technology’s (CAT) phage display technology
Pharma corner
- Winston & Strawn LLP
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- European Union
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- November 7 2011
In this edition we report on mixed fortunes for pharmaceutical patent holders in EU litigation
Will Ireland outstrip UK’s reputation as a patent “graveyard”?
- Winston & Strawn LLP
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- Ireland, United Kingdom
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- September 1 2011
In November 2010, Mr Justice Arnold, one of the three specialist judges in the Patents Court in London, held three Medinol patents not to be infringed by Abbott Laboratories’ coronary stents
Pharma focus
- Winston & Strawn LLP
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- United Kingdom
- -
- September 1 2011
Mr Justice Kitchin recently considered the scope of Swiss form claims in the context of the proton pump inhibitor esomeprazole
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