News & Analysis as of

Pharmaceutical Patents

Mylan Institutional LLC v. Aurobindo Pharma Ltd. (Fed. Cir. 2017)

Last week, the Federal Circuit reviewed the rare event of a preliminary injunction being granted in a lawsuit over a chemical invention, made rarer still by the evidence of likelihood of success on the merits required for the...more

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

BPCIA Litigation Roundup (Spring 2017)

by Goodwin on

Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Supreme Court Limits Venue in Patent Litigation

In an 8-0 decision issued on May 22, 2017, the U.S. Supreme Court, in TC Heartland LLC v. Kraft Foods Group Brands LLC, restricted the available venues for patent litigation claims under 28 U.S.C. § 1400. Under Section...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

Changes coming soon for pharmaceutical patent litigation in Canada: key points

by DLA Piper on

As a result of the Comprehensive Economic Trade Agreement with the European Union, significant changes to the patent linkage provisions and patent litigation framework relating to generic and biosimilar drug approval in...more

Why Design Patents Are Surviving Post-Grant Challenges

As of January 2017, the institution rate for Patent Trial and Appeal Board trials involving design patents was 37 percent. That is significantly lower than every other technology area and makes design patents the only...more

Allergan, Inc. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....more

Changes to pharmaceutical/biopharmaceutical patent litigation in Canada

by DLA Piper on

As a result of the Comprehensive Economic Trade Agreement with the European Union, significant changes to the patent linkage provisions and patent litigation framework relating to generic and biosimilar drug approval in...more

Clarity on Doctrine of Equivalents Analysis for Chemical Claims

Mylan Institutional LLC v. Aurobindo Pharma Ltd, No. 2017-1645 (Fed. Cir. May 19, 2017) - On May 19, 2017, the Federal Circuit addressed and modified a rare grant of a preliminary injunction based on the doctrine of...more

Sanofi v. Lupin Atlantis Holdings SA

by Robins Kaplan LLP on

Case Name: Sanofi v. Lupin Atlantis Holdings SA, Civ. No. 15-415-RGA, 2017 U.S. Dist. LEXIS 10653 (D. Del. Jan. 26, 2017) (Andrews, J.). Drug Product and U.S. Patent: Multaq® (dronedarone tablets); U.S. Patent No....more

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more

PTAB Invalidates Patent for Blockbuster Drug HUMIRA®

The PTAB issued a Final Written Decision in Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., IPR2016-00172 (P.T.A.B. May 16, 2017) finding claims 1-5 of U.S. Patent No. 8,889,135 (“the ‘135 patent”) unpatentable....more

Pfizer Files Two Petitions for IPR of Chugai Pharmaceutical’s Protein Purification Patents

by Goodwin on

Pfizer, Inc. has filed two petitions for IPR of Chugai Pharmaceuticals’s patents: IPR2017-01357 on U.S. Patent 7,332,289 and IPR2017-01358 on U.S. Patent 7,927,815. According to the petitions, both patents are directed to...more

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

by Robins Kaplan LLP on

Case Name: Shire Development, LLC v. Mylan Pharms., Inc., No: 12-1190-T-36AEP, 2017 U.S. Dist. LEXIS 11441 (M.D. Fla. Jan. 27, 2017) (Honeywell, J.). Drug Product and Patent(s)-in-Suit: Lialda® (mesalamine); U.S. Patent...more

Coherus Responds to Apotex Citizen Petition Seeking Heightened Regulatory Requirements For Biosimilar Competition

by Goodwin on

We previously reported that Apotex filed a Citizen’s Petition requesting that FDA require biosimilar applicants to conduct comparative clinical efficacy studies in at least one intended patient population, rather than...more

Amgen v. Sandoz Jury Trial Pushed Off

by Goodwin on

A Stipulation and Scheduling Order for Trial (Order) entered on May 19, 2017 in the Amgen v. Sandoz litigation rescheduled trial for March 26, 2018 (from December 18, 2017), and pushed back other pre-trial deadlines....more

Update on Biosimilar Approvals and Pending Applications in Europe and the U.S.

Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more

New BPCIA Litigation: Janssen v. Samsung Bioepis (D.N.J.)

by Goodwin on

On May 17, 2017, Janssen filed a complaint under the BPCIA in the District of New Jersey against Samsung Bioepis Co., Ltd. regarding Renflexis® (infliximab-abda), Samsung Bioepis’s recently approved biosimilar of Remicade®....more

Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, Civ. No. 15-250-SLR, 2017 U.S. Dist. LEXIS 12165 (D. Del. Jan. 30, 2017) (Robinson, J.). Drug Product and U.S. Patent: Nasonex® (mometasone furoate nasal...more

5 Key Takeaways: Patent Strategies Applicable for Repurposing & Rescuing of Drugs

Kilpatrick Townsend Partner Ken Weber, Ph.D. recently presented “The Role of Patents in Repurposing and Rescuing Old Drugs” at the STC 2017 Spring Seminar Series in Albuquerque, New Mexico. This presentation defined the role...more

In re copaxone consolidated cases

by Robins Kaplan LLP on

Case Name: In re copaxone consolidated cases, No. 14-1171-GMS (consolidated) 2017 U.S. Dist. LEXIS 12168 (D. Del. Jan. 30, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Copaxone® (prefilled syringes of...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

PTAB Life Sciences Report -- Part II - May 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Alcon Research, Ltd. PTAB Petition: IPR2017-01053; filed...more

Amgen Sues Coherus Under BPCIA After Completing Patent Dance

On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S....more

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