Category Archives: MassBio
Guest Post: The Myriad Ruling: 6 Points Every Biotech CEO Must Consider
Written by Konstantin Linnik, Ph.D., J.D., a practicing patent attorney and partner in the Boston office of Nutter McClennen & Fish LLP and a Co-Chair of MassBio’s Legal & Regulatory Group. Konstantin will also speak on tomorrow’s Member Briefing: The Supreme Court Decision on Myriad Case conference call at 3pm. Click here to register.
Last week, the US Supreme Court issued a long-awaited decision in Myriad Genetics, which sent shockwaves through the very foundation of the biotech industry. The decision invalidated one of Myriad’s patents on mutated BRCA-gene sequences associated with increased risk of breast cancer. Though widely referred to as “a gene patent,” Myriad’s patent, in fact, did not claim genes per se, but instead claimed the sequences in their “isolated” form. Such claims –“isolated XYZ substance”–have long been widely accepted as a valid approach for claiming purified or isolated substances extracted from nature (e.g., insulin, antibiotics, blood coagulation factors, to name a few). The Federal Circuit has twice considered these claims and upheld them both times. Nevertheless, the Supreme Court held that for genomic sequences “isolation” does not go far enough in distinguishing them from the genomic DNA. According to the Court, such claims are merely trying to protect “natural phenomena.”
Many questions arise. How will this decision affect the biotech industry? Will it promote or impede innovation? Will it reduce the cost or increase access to medicines? Which sector of the industry will it impact the most? How large is the impact on the existing patents? How should a biotech company react to this decision?
Commentary and confusion both abound, but here are the six most salient points that every biotech executive should bear in mind in the post-Myriad world.
1. A Myriad-type decision was anticipated, and in many cases, backup positions had already been put in place. “Isolated” sequence claims are just one of many various types of claims that are typically drafted into a patent application or a patent portfolio. For example, Myriad itself announced shortly after the decision that it has about 500 other claims covering the BRCA test that were unscathed by the Supreme Court’s decision. Industry-wide, only a small fraction of patents will turn out completely unsalvageable.
Welcome New Members!
The Japan External Trade Organization (JETRO) is a non-profit, Japanesegovernment-supported organization dedicated to promoting mutually beneficial investment and trade relations between Japan and other nations. JETRO was established in 1958, and has a worldwide network of 38 offices in Japan and 96 offices overseas. Website.
MaxCyte is a leader in cell transfection, bringing to market its patented flow electroporation technology. MaxCyte is focused in applying its significant capabilities in the discovery, development, and manufacturing of virtually all classes of innovative therapeutics targeting a broad range of chronic and acute diseases. MaxCyte’s customers and partners utilize its technologies in the development and commercialization of cell-based therapies in regenerative medicineand active cell immunotherapies and in the discovery and development of protein drugs, monoclonal antibodies, vaccines, and small molecule drugs. This clinical-grade cell loading technology is fully developed and well validated and has received Master File designation with the CBER Division of the U.S. FDA, has been cleared by NIH’s RAC and Health Canada, and is commercialized in Japan. Considerable energy is devoted to R&D on new applications. These efforts have lead to the expanded application of our technology in pharmaceutical and biotherapeutic drug discovery pipelines. Our instrumentation is currently placed in most of the major global pharmaceutical companies and is used for high throughput/high content screening and preclinical protein production. MaxCyte’s technology uniquely fulfills the needs for high quality, fully scalable cell modification in both the clinical and R&D arenas. MaxCyte’s technology is protected by U.S. patents issued and allowed, with over 40 U.S. and international pending patents. Website.
Neurotech Pharmaceuticals is a biotechnology company developing sight saving therapies for retinal diseases.
We are ophthalmic scientists, engineers, technologists, and clinical – all working together, inventing new treatments against blindness. Our patented core technology platform, Encapsulated Cell Technology (ECT), is a genetically engineered implant that enables the continuous delivery of protein drugs directly into the vitreous of the eye. The living ECT implants continuously treat diseased retinas for over 2 years – superior to conventional approaches requiring monthly eye injections. Website.
XRpro provides the first significant data point in 180 hours, rather than the typical 180 days.
The technology uses label-free, non-destructive X-ray fluorescence.
Dried samples can be re-analyzed months later. Specialties include: analyze poorly-soluble ion channel inhibitors, rapidly identify substrates, and screen inhibitors using label-free, non-distructive, high-throughput X-ray fluorescence. Website.
Top 5 News Stories: 6/8-6/14
1) Supreme Court says genes can’t be patented; patient advocates and researchers cheer - NBC News – 6/13/2013
The Supreme Court ruled unanimously Thursday that companies cannot patent human genes, a decision that patient advocates said would increase competition and lower the cost of screenings for cancer risk and other genetic tests. Link
2) Allies, adversaries gather for farewell to Paul Cellucci - The Boston Globe – 6/13/2013
A striking constellation of political figures, including rivals and allies past and present, shared these memories of Paul Cellucci at an emotional State House memorial service for the former governor on Thursday. The farewell was both a reunion for a graying generation of Republicans who ruled Beacon Hill in the 1990s and a heartfelt tribute to a governor who was remembered for his decency, compassion, and humility. Link
Read MassBio’s story about the late Paul Cellucci: Champion Among Us: Former Gov. Paul Cellucci goes to bat for ALS Research
3) CEO calls being in Mass. crucial for Shire to innovate - The Boston Globe – 6/12/2013
Danish doctor-turned-businessman Flemming Ornskov’s first decision after taking over as chief executive of Shire PLC April 30 was to move himself to Massachusetts, about 3,000 miles and an ocean away from the Irish drug company’s headquarters. Link
4) FDA approves Sanofi Pasteur influenza vaccine - Reuters – 6/10/2013
Sanofi SA said on Monday that its Sanofi Pasteur vaccines division has won clearance from the U.S. Food and Drug Administration to market its four-strain influenza vaccine, Fluzone Quadrivalent. Link
5) Pembroke High School students participate in job shadowing program – Wicked Local Pembroke – 6/14/2013
Twenty-seven Pembroke High School students closed their textbooks for the day Tuesday and put their science-based passion in motion during the fourth annual biotechnology Job Shadow Day hosted by the Massachusetts Biotechnology Education Foundation (MassBioEd). Link
Adventures in Biotech Kicks Off with Dreams to Reality
Today, part one of the Adventures in Biotech six-part series kicked off at the MassBio offices with a full house anxious to learn from experienced life sciences founders and CEOs. These industry leaders shared stories of their successes – and challenges – in starting companies, each representing a different business model. Panelists shared what motivated them to establish their companies and their initial goals. They revealed their strategies for achieving these goals, overcoming hurdles along the way, and how they adjusted their preconceived notions of success.
Panelists Included:
Mark Benjamin, DSc, President & CEO, Galenea (Partnership with big pharma model and grant & foundation funded)
Barbara Fox, PhD, Founder & CEO, Avaxia Biologics (Angel & non-dilutive funding model)
Roger Frechette, PhD Founder, MaxThera, Inc. (Grant funded, semi-virtual model)
Jeff Saunders, PhD, VP, Small Molecule Drug Discovery, Ember Therapeutics (VC model, 3rd Rock)
Roger Tung, PhD, Co-Founder, President and CEO, Concert Pharmaceuticals (Partnerships with big pharma model)
Attendees listen in for insight and advice from panelists.
Barbara Fox, CEO of Avaxia Biologics, said she started her company “ to make an impact in the world, with that combination of naivete and arrogance I think is needed to start a company.”
Top 5 News Stories: 6/1-6/7
1) Cubist, others open doors to learning during MassBioEd Job Shadow Day - Mass High Tech- 6/5/2013
Local biotech and life sciences companies throughought the state will open their doors Thursday in hopes of inspiring students to start a career in the industry. Link
2) North Shore InnoVentures Adds Six New Companies to its Technology Incubator - The Wall Street Journal – 6/5/2013
North Shore InnoVentures, (NSIV) one of New England’s leading technology incubators and business accelerators, announced today that six new startup companies in the cleantech and life sciences sectors have joined as members since March 2013, for a total of 21 companies now in the program. Link
3) UMass Amherst gets $95m life sciences grant - Boston Globe – 6/6/2013
Two Western Massachusetts projects have won state grants totaling $100.5 million, including a $95 million award to the University of Massachusetts Amherst that is the largest so far under the $1 billion life sciences initiative launched by Governor Deval Patrick six years ago. Link
4) Researchers identify protein that may predict cancer response therapy - Mass High Tech – 5/3o/2013
Researchers at the Whitehead Institute have identified a protein that, when mutated, sends a pathway found in 50 to 80 percent of cancers, known as mTORC1, into hyperactivity. Link
5) Bristol-Myers and AstraZeneca Get Priority Review for Lipodystrophy Treatment - The Wall Street Journal – 6/4/2013
Bristol-Myers Squibb Co. (BMY) and AstraZeneca PLC (AZN, AZN.LN) have received Priority Review designation from the U.S. Food and Drug Administration for the biologics license application for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy. Link
