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Health Intellectual Property Science, Computers & Technology

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

Cancer Moonshot: USPTO Extends Cancer Immunotherapy Pilot Program Initiative

by Morrison & Foerster LLP on

The United States Patent and Trademark Office (PTO) issued a Notice today extending the Cancer Immunotherapy Pilot Program (Pilot Program), also known as “Patents 4 Patients.” The Pilot Program, which accelerates the...more

Federal Court reaffirms and reissues section 8 venlafaxine judgments overturned by the Court of Appeal for hearsay

by Smart & Biggar on

As previously reported, in 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations...more

USPTO Extends Cancer Immunotherapy Pilot Program

by Foley & Lardner LLP on

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO...more

Chief Judge Stark Denies Defendants’ Motion For Reargument Of Court’s Order Holding Defendants Liable For Costs Of ANDA Litigation...

by Fox Rothschild LLP on

By Memorandum Order entered by The Honorable Leonard P. Stark in UCB, Inc., et al. v. Watson Laboratories, Inc. et al., Civil Action No. 14-1083-LPS-SRF (D.Del., May 19, 2017), the Court denied Defendants’ motion for...more

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

by Dorsey & Whitney LLP on

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

Determination on Indirect Infringement Requires Factual Record, Warranting Denial of Motion to Dismiss

by Orrick - NorCal IP Group on

Ever since the abolition of form complaints in patent cases, patent defendants have been incentivized to file motions to dismiss, and many have succeeded. But as Judge Gonzalez Rogers’ recent Order in this case reminds us,...more

Biosimilar Development Updates: Infliximab, Ranibizumab, Etanercept, Filgrastim & Trastuzumab

by Goodwin on

According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab (“CT-P13 SC”) with its currently...more

FDA Approves Keytruda as First Cancer Treatment Based on a Genetic Biomarker

by Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more

Rx IP Update - May 2017

by Smart & Biggar on

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

[Webinar] Medical Device Connectivity: HIPAA, FDA and IP Considerations - June 14th, 2pm ET

by BakerHostetler on

Please join us for this complimentary CLE webinar. With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the...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

Some Cardiac Monitoring Patents Beat Alice Challenge, While Others Fail to Survive

In the time since Alice changed the landscape of patent eligibility for certain types of inventions, the Federal Circuit has begun pumping out opinions interpreting this landmark Supreme Court case. The expanding body of law...more

The Pricing of Patented Drugs in Canada: Stakeholder Consultation Period Open Until June 28, 2017

by Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more

Cyber Hot Topics: Data Security Strategies Suited to Small Physician Practices

In our recent webinar, “Data Security Strategies Suited to Small Physician Practices,” we discussed several technical and administrative controls that are essential to keeping your patient information secure, and also easy...more

CFDA’s New Draft Policy Introduces the Chinese Version of Patent Linkage

by Allen & Overy LLP on

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more

Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc. (D.N.J. 2017)

Last month, in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Senior District Judge William H. Walls of the U.S. District Court for the District of New Jersey issued an amended opinion granting the motion for...more

Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc. (Fed. Cir. 2017)

The Federal Circuit's decision on Friday, in Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc., illustrates the risks a litigant can take when agreeing to stipulation in an effort at least to reduce litigation...more

JAMA Article: Obstacles to the Adoption of Biosimilars for Chronic Diseases

by Goodwin on

Generic drugs currently account for 88% of all U.S. prescriptions, yielding 10-year cost savings in excess of $1.5 trillion. There is some optimism that biosimilars will offer a similar low-cost therapeutic alternative to...more

Teva awarded section 8 damages regarding pregabalin and olanzapine

by Smart & Biggar on

On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) regarding pregabalin (Pfizer’s LYRICA)...more

Sandoz v. Amgen—Biosimilars at the Supreme Court—Decisions Forthcoming?

by K&L Gates LLP on

All nine Supreme Court Justices heard argument on Wednesday, April 26, in Sandoz Inc., v. Amgen Inc. The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (“BPCIA”) made by the...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Testing of Jenex TherOZap™ Device Set to Begin

by Knobbe Martens on

Luminar Media Group recently announced that, after completing development of a working prototype device, the Jenex Corporation has signed an agreement with the Techna Institute at the University Health Network to begin...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more

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