News & Analysis as of

Pharmaceutical Industry

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

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

by Goodwin on

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer,...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

SEC Disclosure Trends Related to Brexit and the Trump Administration

The Brexit vote and President Donald Trump’s election and proposed regulatory and other reforms have led to worldwide geopolitical uncertainty. We expect reporting companies will continue to disclose risk factors relating to...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

Cinfa Biotech Announces Positive Clinical Trial Results for Neulasta Biosimilar

by Goodwin on

Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the...more

Public Comment Period Closes for FDA’s Draft Interchangeability Guidance

by Goodwin on

On May 19, 2017, the period for submitting public comments on the FDA draft guidance on biosimilar interchangeability closed (for a discussion of the FDA draft guidance click here). The draft guidance was published on...more

Picking Up the Post-Preemption Pieces

by Reed Smith on

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying a ruling on in limines from one case to another can be a dicey proposition...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

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

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Materials Available for May 25, 2017 ODAC Meeting Regarding Hospira’s Epoetin Alfa Biosimilar Application

by Goodwin on

As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit®...more

Excessive pricing in pharmaceutical products attracts the European Commission's attention

by Hogan Lovells on

In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a...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

Congress members buy, sell sector stocks even as they make health care law

The U.S. Congress, based on its members’ legally required financial disclosures, fares far better than most. Senators and representatives are worth a net $1 million on average. But is it seemly for so many of our crucial...more

FDA Approves Expanded Use of Small Molecule Drug Kalydeco on the Basis of In Vitro Data

On May 17, 2017, Vertex Pharmaceuticals small molecule drug Kalydeco® (ivacaftor) was approved by the U.S. Food and Drug Administration (FDA) for use in treating an expanded population of cystic fibrosis patients with...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability

by Goodwin on

The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product...more

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

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...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

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