Category: Intellectual Property
You can’t put a price tag on Sovaldi (unless it’s over $84K)
Gilead Sciences has developed a new drug (Sovaldi) that cures hepatitis C.
This is a huge deal: about 150 million people world wide are chronically infected with the hepatitis C virus (HCV); according to the CDC 60-70% of people with chronic HCV will go on to develop chronic liver disease, 5-20% will develop cirrhosis over 20-30 years, and 1-5% will eventually die from the direct consequences of chronic infection (liver cancer or cirrhosis).
Sovaldi, which cures patients about 90% of the time with minimal side effects, could change all of this. John Castellani, President of Pharmaceutical Research and Manufacturers of America says that this breakthrough is so valuable, that “you just can’t put a price tag on it.”
But of course, a price tag has been put on it: $84,000 for the 12-week course of treatment (or $1,000) per day.
Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls
In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.
In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.
Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part IV
Finishing up the event today is Tom Kowalski from Vedder Price, giving a US perspective on section 101 on patentable subject matter. This post will encompass his presentation and general questions afterward.
Kowalski starts with a brief review of patentable subject matter, and states his view that after Prometheus and Myriad, “the fabric of the patent system has been torn.” His view is that isolated DNA is a separate chemical entity, and that the Supreme Court simply got it wrong. Read More
Liveblog of 4/2 panel in European Bio-patent Law, Part III
Third up is Dr. Maaike van der Kooij, discussing medical use claims at the EPO.
In general, methods of medical treatment aren’t patentable under Art. 53(c) of the EPC, but the way around is to claim a relevant product either for medical use (if the substance is known but not medically used (Art. 54(4)) or for a specific medical use (Art. 54(5)). (From my point of view, this seems like another way that the EPO is trying to address its innovation mandate by working around what appears to be pretty clear language in the EPC, a pattern which we certainly see in the US in both PTO and Federal Circuit practice). Read More
Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part II
Next up is Dr. Anja Schmitt, comparing Myriad and Mayo to EPO practice, and describing gene patents and diagnostic method patents in the EPO.
Human gene patents
The basic question of human gene patents–as will be familiar to those who followed the Myriad litigation–is whether isolated DNA is a product of nature/mere discovery, or a man-made product with technical character. In the Myriad case, claims covered isolated DNAs for the BRCA1 and BRCA2 genes which are useful for identifying a predisposition to breast cancer.
At the EPO, on the other hand–using the same sources of law as Dr. Nichogiannopoulou mentioned before–genes are patentable as long as they disclose the industrial applicability and the function of the gene and/or its encoded protein. Read More
Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part I
I’ll be liveblogging today’s panel on Hot Topics in European Bio-Patent Law (co-sponsored by the Broad Institute), with several guest speakers from the European Patent Office (EPO).
Ben Roin, Heiken Assistant Professor of Patent Law here at HLS, is moderating. Speakers will be Dr. Aliki Nichogiannopoulou on stem cells, and Dr. Anja Schmitt on gene patents, Dr. Maiake van der Kooij, all of the EPO, followed by Tom Kowalski of VedderPrice.
Dr. Nichogiannopolou begins by talking about stem cells, and opens with a few background points about the EPO. The agency has its own implementing legislation separate from the EU, and includes 38 member states – 10 more than the EU itself, including industry-important Switzerland. The EPO supports innovation, competitiveness, and economic growth for the benefits of European citizens, and has the mandate to grant European patents for inventions. Read More
TOMORROW: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More
Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More
April 2, 2014, 12:00 PM
Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA
Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.
Panelists:
- Aliki Nichogiannopoulou, Director, Biotechnology, EPO
- Anja Schmitt, Examiner, EPO
- Maaike van der Kooij, Examiner, EPO
- Tom Kowalski, US Patent Attorney
- Moderator: Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute
This event is free and open to the public, but space is limited and registration is required. Register here.
Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.
Cosponsored by the Broad Institute of MIT and Harvard.
New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives
By Timo Minssen
Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard. The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.
I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.
Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.
4/2: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More
Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More
April 2, 2014, 12:00 PM
Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA
Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.
Panelists:
- Aliki Nichogiannopoulou, Director, Biotechnology, EPO
- Anja Schmitt, Examiner, EPO
- Maaike van der Kooij, Examiner, EPO
- Tom Kowalski, US Patent Attorney
- Moderator: Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute
This event is free and open to the public, but space is limited and registration is required. Register here.
Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.
Cosponsored by the Broad Institute of MIT and Harvard.
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