Supreme Court Ruling on Patentability of Human Genes
The Supreme Court has declared that naturally occurring human genes can’t be patented but that cDNA, synthetically produced genetic material, can. PhRMA is negative about the impact of the ruling as they see broad implications for the pharmaceutical, biotech and gene-testing industries. The article “The Sky Isn’t Falling” appearing in BioCentury’s June 17th issue raises concern about need for clarity about the distinction between isolated DNA and cDNA going forward.
“Critics said the ruling would not only hurt Myriad Genetics, but also the bottom line of companies that sell genetic tests. It could also discourage investment in genetic sequencing research.” But those interested in developing products in the human gene area formerly blocked by patent holders like Myriad are delighted. Previously there was no possibility for competition with Myriad’s BRCA1 and BRCA2-based products.
The court’s ruling was unanimous which was welcome in this world of strong bipartisanship. The downside of the ruling is balanced by clearing up this contentious issue that has impacted life science investment negatively. The opinion written by Justice Clarence Thomas declares while isolated human genes are not patentable, forms of DNA that have been manipulated in the lab in a way that alters their natural state can be patented. BioCentury also notes that the Thomas writing reinforces the patentability of “method” and “use” claims involving human DNA. The lawyer for Myriad was happy about the final ruling because Myriad has already moved to develop manipulated genes for future products. They warn potential competitors that they are many patents they hold that will stand in this newly revised world.
In summary, we expect that opinions will vary about the real impact but agree with BioCentury that the sky isn’t falling.
Upcoming Life Science Meetings
Please send in July announcements to me at firstname.lastname@example.org prior to June 20th so they can be included in my month overview of July to be published Saturday, June 22nd.
I have listed this coming week’s picks for meetings below:
- BioCentury This Week, See new program Webcast Starting Sunday, June 16, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Six Years of Avandia: What Did We Learn;” Speakers: Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research; Dr. Murray Stewart, SVP and head of the cardiovascular unit at GSK; Dr. Kenneth Mahaffey at the Duke Clinical Research Institute; Dr. Robert Califf, Professor of Cardiology and Vice Chancellor for Clinical Research at Duke
- BioDesign, Monday Evening, June 17, 2013; Event: “From the Innovators Workbench;” Speaker: John Dineen, Chief Executive Officer and President of GE Healthcare Ltd. and GE Medical Systems, Inc.
- Palo Alto AWIS, Monday Evening, June 17, 2013; Event: Volunteer Meeting
- Bio2Device Group, Tuesday Morning, June 18, 2013; Topic: “Hypertension: A historical and philosophical perspective;” Speaker: Michel Accad. M.D., Physician, UCSF
- EMBS, Wednesday Evening, June 19, 2013, 7:30 PM; Topic: “The Magellan Robotic Catheter System;” Speaker: Francis Macnamara, Vice President, Hansen Medical, Inc.
- WIB, Wednesday Evening, June 19, 2013; Topic: “Fireside Chat with Gail Maderis”
- Reimbursement Intelligence, Wednesday Morning, June 19, 2013; Topic: “Reimbursement Intelligence P&T Advisor™: Can You Identify Physicians Standing Between Your Brand and Millions of Lives?” Speakers: John Whang, MD, FACC, COO, President of Market Research, Reimbursement Intelligence; Jessica DiPaolo, MPH, VP, Business Development, Reimbursement Intelligence
- UC Berkeley Extension Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development,” (formerly known as Biotechnology Business Development); Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA; Cost: Fall term—fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html
Not Too Late To Enroll
It’s not too late to sign up for my business development course taking place this coming Thursday and Friday. You can enroll as late as the start of the class on Thursday morning. The two days of intensive provide expert guest speakers in the trenches who influence the alliances, deals and collaborations process that is now critical to the funding of new and ongoing biomedical companies. Individuals have the opportunity to work on projects of their choice over two subsequent months which qualify the attendance for credit toward a certificate but also provide valuable work to include in their career portfolio.
Students will receive a printed reader with copies of speaker slides and lists of online resources developed by instructor as well as gratis access to subscription database resources graciously provided by BioCentury and Thomson Reuters (formerly Deloitte) Recap. I preach the value of hands on work to really incorporate the skills taught in the classroom into one’s own skill set or otherwise risk forgetting most of the knowledge conveyed. We know from adult learning theory that passive learning is not very effective versus active involvement this course provides.
You can download the list of Audreys picks June 16, 2013 which includes all the details for upcoming meetings through next January 2014 of which I’m aware and Jobs That Crossed My Desk Through June 16 2013 which includes the latest plus previous two weeks’ jobs for your information. Just right click on the highlighted titles. Share with colleagues who might find these useful. You can also download these lists found in my blog at my website www.AudreysNetwork.com at any time.