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Health Intellectual Property

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

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On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application.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

IP and healthcare in South East Asia: “Bigger than BRIC”. So why aren’t you filing your patent applications there?

by FPA Patent Attorneys on

The South East Asian healthcare market is emerging as one of great importance, expected to experience faster rates of healthcare spending growth over the next 5 years than the BRIC (Brazil, Russia, India, China) countries...more

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

by Foley & Lardner LLP on

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

Rx IP Update - September 2017

by Smart & Biggar on

Federal Court of Appeal Applies Supreme Court’s Utility Test to SPRYCEL Patent - In its first decision to consider the Supreme Court of Canada’s landmark decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36...more

THE LATEST: Integra Forced to Divest Neurosurgical Tools to Gain FTC Clearance

by McDermott Will & Emery on

WHAT HAPPENED - On February 14, 2017, Integra agreed to purchase Johnson & Johnson’s Codman neurosurgery business (excluding Codman’s neurovascular and drug deliver businesses) for $1.045 billion.... ...more

Samsung Bioepis Biosimilar Updates

by Goodwin on

We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab...more

Building a Health App? Part 2: Protecting Your Intellectual Property

This post is the second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful...more

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

Judge Talwani Dismisses Diagnostic Patent Infringement Case under Section 101

In a recent patent infringement case relating to a method for diagnosing a neuro-muscular disorder, Judge Indira Talwani in the District of Massachusetts found the asserted patent claims to be patent ineligible because the...more

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

by Knobbe Martens on

On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio,...more

Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

by Goodwin on

At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of...more

FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market

by Knobbe Martens on

Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Publication of Final Regulations on Patent Linkage and Term Restoration

by Smart & Biggar on

On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more

Rx IP Update - August 2017

by Smart & Biggar on

Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more

K2M Obtains Exclusive License to Patent Portfolio

by Knobbe Martens on

K2M Group Holdings, Inc. recently announced its acquisition of a portfolio of 17 issued and pending patents for expandable interbody technology. According to K2M, the company is a global leader in the medical device industry...more

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