Private Equity's Inversion Excursion: Pepper Hamilton Talks Tax With the Deal
On July 11, 2022, the United States District Court for the District of Kansas approved a $264 million settlement against Mylan and certain of its subsidiaries in the case In Re EpiPen (Epinephrine Injection, USP) Marketing,...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more
Recent notable industry transactions. The Alan Turing Institute, the Royal Statistical Society and the UK Department of Health and Social Care's Joint Biosecurity Centre finalised a partnership agreement in relation to the...more
We have previously reported that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, are combining to form a new company. We also reported that although the planned integration has been delayed because of the...more
COVID-19 Delays Proposed Combination of Mylan and Upjohn - Mylan N.V. and Pfizer Inc. have announced that unprecedented circumstances surrounding the COVID-19 pandemic will delay the proposed integration of Mylan and...more
The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware...more
Drug giants Pfizer and Mylan have inked a deal that will merge the former’s off-patent drugs with the latter’s generics business, a tie-up that creates a mammoth global seller of lower-priced medicines....more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
About the PTAB Life Sciences Report: periodically, we will report on developments at the PTAB involving life sciences patents. Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH - PTAB Petition: ...more
Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more
Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more
Below are IPR updates from this week. LANTUS - On December 13, 2017, the Board instituted two IPRs on Mylan’s petitions (IPR2017-01526 and IPR2017-01528) challenging Sanofi’s U.S. Patent Nos. 7,713,930 and 7,476,652,...more
Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more
Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories, LLC et al. v. Amerigen Pharmaceuticals, Inc. et al. 1:15-cv-00966; filed October 23, 2015 in the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals, LLC et al. v. Amneal Pharmaceuticals, LLC 1:15-cv-00964; filed October 22, 2016 in the District...more
Case Name: Pfizer Inc. v. Mylan Pharms. Inc., Civ. No. 10-528-GMS, 2014 U.S. Dist. LEXIS 150283 (D. Del. Oct. 22, 2014) (Sleet, J.) (When a POSA would have to undertake significant guesswork to vary the parameters of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co. Ltd. v. Apotex Inc. et al. 1:15-cv-00109; filed January 29, 2015 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Par Pharmaceutical Inc. et al. 1:15-cv-00068; filed January 21, 2015 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Sanofi-Aventis U.S. LLC et al. v. Breckenridge Pharmaceutical, Inc. 9:15-cv-80056; filed January 15, 2015 in the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Pfizer Inc. et al. v. Mylan Inc. et al. 1:15-cv-00026; filed January 8, 2015 in the District Court of Delaware. •...more
What is an inversion? An inversion is a transaction that results in an existing U.S. company becoming a foreign company or becoming a subsidiary of a foreign parent. Historically, inversions involved U.S. companies...more