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Read Intellectual Property Law updates, alerts, news, and legal analysis from leading lawyers and law firms:

Generic drugs taking hold in the Asian marketplace: STAT News interview

by Hogan Lovells on

Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Microbot Medical to Acquire CardioSert's Technology

by Knobbe Martens on

Microbot Medical Inc. announced that it entered into an agreement with CardioSert Ltd. to acquire CardioSert’s patented guidewire technology, including R&D information, technical know-how, and intellectual property....more

View of Venture Capital and Emerging Companies From New England Venture Summit

by Pepper Hamilton LLP on

Pepper Hamilton was the coaching sponsor of the 2017 New England Venture Summit at the end of last year. Pepper had a nice team at the conference over the two days, and we are joined by most of them for this podcast. Pepper...more

Momenta and Mylan Collaborating to Develop Biosimilar of Eylea® (aflibercept)

by Goodwin on

Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Rx IP Update - December 2017

by Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Cannabis Podcast — A New Jersey Update

by Pepper Hamilton LLP on

The New Jersey Compassionate Use Medical Marijuana Act was passed in 2010, legalizing marijuana use for patients with certain approved debilitating medical conditions. In the 2017 election for New Jersey’s next governor,...more

Update on Biosimilars

by Smart & Biggar on

The following provides an update on biosimilars in Canada. Health Canada’s guidance on biosimilars - In November 2016, Health Canada issued a Guidance Document: Information and Submission Requirements for Biosimilar...more

FDA Includes Patent Submission Date Updates In Orange Book

by Tarter Krinsky & Drogin LLP on

The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent...more

Canada releases proposed amendments to Regulations governing patented medicines pricing

by Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

Cannabis Industry FAQ - December 2017

by Pepper Hamilton LLP on

In July of 2017 Pepper Hamilton formalized our cannabis industry group by drawing together attorneys from a variety of practice areas to make a multidisciplinary team. Those practices included attorneys with experience in...more

Rx IP Update - November 2017

by Smart & Biggar on

Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman - The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...more

Biocon Ltd Launches Bevacizumab Biosimilar in India

by Goodwin on

Biocon Ltd., a biopharmaceutical company based in India, develops, manufactures and supplies products to treat diabetes, cancer, and autoimmune conditions. Last week, Biocon launched KRABEVA®, a bevacizumab biosimilar for the...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

PTAB Life Sciences Report - November 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Sawai USA, Inc. v. Astellas Pharma Inc. PTAB Petition: IPR2018-00079; filed October 16,...more

Digital Health Report - Fall 2017

Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more

Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application. The purpose...more

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

by Knobbe Martens on

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

Building a Health App? Part 7: Commercialization and Strategic Partners

Given the uncertainty in reimbursement from private insurance and government programs such as Medicare and Medicaid, it is important early on to consider how best to land and leverage relationships with key customers and...more

Rx IP Update - October 2017

by Smart & Biggar on

Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

Building a Health App? Part 5: Contracting for Health App Construction

As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties. For...more

PTAB Declines Request to Review Method of Treating Lymphoma Claim

A Patent Trial and Appeal Board (PTAB) panel declined to institute an inter partes review (IPR) of a claim directed to a method for treating low grade B-cell non-Hodgkin’s lymphoma. The challenged method required patients to...more

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more

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