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Review – U.S. Patent and Trademark Office Subject Matter Eligibility Guidelines
On March 4, 2014 the USPTO issued new patent subject matter eligibility guidelines in an attempt to provide examiners and patent practitioners with some guidance on which claims improperly encompass...
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Proposed health IT strategy aims to promote innovation
On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission...
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Sham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential...
Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even...
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Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical...
Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere,...
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Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge...
In our blog post of November 18, 2013 (“No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Before Biosimilars Application is Filed”), we discussed the decision of the U.S. District Court...
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Update: Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars...
In our previous blog post of November 11, 2014, we noted that Celltrion had filed a declaratory judgment action against Kennedy Trust for Rheumatology Research for invalidity of certain patents...
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U.S. Patent and Trademark Office Clarifies “Patent Eligible Subject” Matter...
Summary On December 15, 2014, the U.S. Patent and Trademark Office (PTO) released its updated 2014 Interim Guidance on Patent Subject Matter Eligibility (the “Interim Eligibility Guidance”) in light of...
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New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure...
Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the...
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FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to...
On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing...
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What’s in a Name? That Which We Call a Biological Product…
The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on...
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HHS Recognizes Changing Environment of Research: Still Time to Comment
Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy...
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Day One Notes – JP Morgan Healthcare Conference, San Francisco
Someone asked me last week what it was like to attend the JP Morgan Healthcare Conference in San Francisco, which started its annual run today. Outside the conference hotel right now is the obligatory...
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Day Two Notes – JP Morgan Healthcare Conference, San Francisco
It was another interesting day at JP Morgan, the healthcare conference that never disappoints. Surprising declarations of war and peace, partnering that really works and strong growth stories all were...
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Day Three Notes – JP Morgan Healthcare Conference, San Francisco
Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more...
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Extending the Patentable Life of 3D Printers: A Lesson From the...
Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’...
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PTO Cancer Immunotherapy Fast Track
In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated...
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New EU Rules for Medical Devices
After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and...
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En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to...
Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create...
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Looking Forward/Looking Backward – Day 1 Notes from the JPMorgan Healthcare...
A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the...
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Food for Thought (and Health): Day 2 Notes from the JP Morgan Healthcare...
Addressing the Social Determinants of Health: Is the healthcare industry pushing a rock up a hill? We collectively are trying to provide healthcare with improved quality and reduced cost, but the...
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