Mohr Davidow’s Siegel tapped to run $6B GE health tech initiative

Posted under affymetrix, Blog, Companies, Diagnostics, Funding, GE, healthymagination, Medical Devices, Medical Supply, Mohr Davidow Ventures, personalized medicine, Pharmaceuticals, R&D, Startups, Sue Siegel, Universities, Videos by John Carroll

Mohr Davidow Ventures' Sue Siegel, the former president of Affymetrix ($AFFX), is leaving the venture group to take the reins at GE's $6 billion healthymagination project. An expert in tech platforms and molecular diagnostics, Siegel brings considerable experience in the personalized medicine field to the task. Mohr Davidow, Kleiner Perkins and other VC groups have been working with GE to identify new technologies that can cut healthcare costs by 2015. Release

Mayo v. Prometheus: Thought Leaders Express Concern and Evaluate the Impact

Posted under Blog, Companies, Diagnostics, Funding, Mayo v. Prometheus, Medical Devices, Medical Supply, Patently BIOtech, personalized medicine, Pharmaceuticals, Public Policy, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The Mayo v. Prometheus event hosted at George Washington School of Law with the Biotechnology Industry Organization created an opportunity for a panel of thought leaders to distill meaning from the case, the impact on personalized medicine, and possible solutions to the Court created problem.*

Is the decision a game-changer?

Judge Paul R. Michel, former Chief Judge of the Court of Appeals for the Federal Circuit handling patent cases, concluded that the Mayo v. Prometheus represents a “shift in attitude between the Supreme Court and Federal Circuit.  There’s a certain amount of trust, a certain amount of respect, a certain amount of suspicion that there might be some deeper immersion, deeper familiarity, harder thinking and greater exposure [to patent law] at the Federal Circuit than the Supreme Court itself can offer,” he said. “The game changer I see here is the Supreme Court is effectively saying ‘We’re done with the Federal Circuit.’ They don’t get any credit for greater immersion, greater expertise, harder thinking or anything of the sort.”  While many of the panelists disagreed on what exactly the Supreme Court concluded in the Mayo v. Prometheus decision, it was clear that all the panelists shared in the concern expressed by Judge Michel.

Some might think that a 9-0 decision represents a shared consensus of opinion on how to handle the “law of nature” exemption for patents.  Not so according to former Solicitor General to the United States, Seth Waxman.  Waxman asserted that when this Supreme Court rules unanimously “its language cannot be taken at face value.”  This court rarely suggests edits or withholds their votes unless certain language is included.  “But in the end, there is no way that all nine justices thought that this opinion has the broad consequences that people are catastrophizing.  I do not believe that every single justice on the Supreme Court thought that the entire field of molecular diagnostics, everything in personalized medicine, that’s over. There’s just no way that there was that level of consensus about how the patent laws have to be reasonably read.”

How will Prometheus affect the Myriad case?

The panelists expressed disagreement over how Prometheus would impact Myriad with some asserting a clear difference between the abstract idea claims in Mayo versus the tangible molecules in Myriad.  However, Donald Dunner from Finnegan indicated that future litigants are going to take Prometheus to the ultimate extreme until district courts agree and the federal circuits have to disagree and until the Supreme Court disagrees again.

However, all panelists agreed that the Courts and the Department of Justice were unclear on the science.  Professor Christopher Holman stated that no rigorous claim construction had occurred in the District Court.  As a result, there is as lot of misperception of what exactly the patent covers in the Myriad case.  Professor Holman argued that the Court created distinctions between isolated cDNA and gDNA that do not make any scientific sense.  Seth Waxman added that the considerable challenge for articulating the science and what the patent covers in the remand of Myriad is to correct the “unfortunate formulation conceived immaculately.”

How will these decisions affect businesses?

Paul Yasger, head of IP for Abbott Laboratories, stated that while the Prometheus decision may be good for litigators and patent office fees, it is not good for business because of the uncertainty it creates.  Phil Johnson, Chief Intellectual Property Counsel at Johnson & Johnson, pointed out that “capital is hard to come by these days and people are reluctant.”  Johnson and Johnson can invest money in R&D projects involving shampoo instead of biomarker research.  He said investors “have other things they can invest in but I don’t think we, and I mean mankind, can afford it.”

Michael Walker, Chief Intellectual Property Counsel at Dupont pointed out that these decisions have an impact beyond personalized medicine.  60% of Dupont’s R&D is in Ag and Food research and industrial biosciences such as biofuels.  Mr. Walker concluded that businesses have large settled business expectations in this technology and they look at Prometheus and Myriad and wonder if their technologies are just natural phenomena.

What are the solutions going forward?

Phil Johnson at J&J concluded that making it hard to get patent protection cannot help innovation because who will fund that work.  In this day and age, government sources of additional money are unlikely.  Chief Judge Michel pointed out that this is exactly the problem when the Court makes assumptions about patents stifling innovation without providing any convincing evidence that it was so.  Michel pointed out that the articles cited “don’t prove the point that the Court is assuming.  The preemption problem is all hypothesized as far as I can tell.”  Finally, Michel concluded it is dangerous to have unelected judges with no expertise in measuring the retarding effects compared to the beneficial effects make these kinds of decisions.

Hal Wagner, partner at Foley & Lardner, argued that in spite of the lack of evidence of the stifling effect of patents on research, the rest of the world allows for an exemption for experimental use.  It does not hurt the patent owners and it gets rid of the stifling argument.  Dr. Sauer pointed out that Judge Newman, among other Judges on the Federal Circuit has expressed frustration on the lack of cases on this issue as researchers are not being sued and so the court cannot explore the U.S. exemption.

Chief Judge Michel closed the meeting by suggesting that participants focus their energy and attention on the federal circuit panels and district courts dealing with 101 issues over the next 12 months.  If at the end of the year it is a terrible mess then go to Congress for a solution.

 

*Comments by the panelists should not be taken to bind the clients, companies, law firms, or other organizations with which they are affiliated.

GSK lands one-two punch in melanoma trial

Posted under ASCO, Blog, BRAF inhibitor, Companies, dabrafenib, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Melanoma, personalized medicine, Pharmaceuticals, R&D, Roche, skin cancer, Startups, targeted therapies, trametinib, Universities, Videos, Zelboraf by rmcbride

GlaxoSmithKline ($GSK) is rushing to start a late-stage trial of an experimental cocktail therapy against deadly skin cancer after a mid-stage study produced impressive results. And data from the small trial provide early evidence that GSK's two-drug combo could have an edge over Roche's ($RHHBY) approved melanoma drug Zelboraf.

In the 77-patient study, those who took the combo of GSK's BRAF inhibitor dabrafenib and MEK-targeting agent trametinib lived for 7.4 months without their melanoma getting worse. Also, there were data to support that the combo could reduce a patient's risk of developing a separate cancer known as squamous-cell carcinoma while taking BRAF blockers, which are linked to growth of the tumors, Bloomberg reported.

Roche's Zelboraf is the first BRAF inhibitor approved for treating melanoma. GSK aims to stymie mutated forms of BRAF with dabrafenib, and pack the added punch of the MET-blocking trametinib to close an escape route that melanomas travel to skirt attacks from BRAF inhibitors. And despite the advance in care that Zelboraf has provided, about a third of patients on the drug develop cutaneous squamous-cell carcinoma and most patients' tumors eventually build up resistance to the targeted drug, Reuters reported.   

"We know that cancers are smart," said ASCO president-elect Dr. Sandra Swain, as quoted by Reuters. "They find work-around pathways. We are seeing a very innovative approach that ostensibly blocks off some of this pathway."

The results of GSK's study were revealed Wednesday as part of an avalanche of cancer trial news tied to next month's ASCO meeting, where the London-based drug giant will present the study and feed a frenzy in the oncology world for targeted treatments that are tailored for cancer patients based on the specific molecular drivers of their tumors.

Not surprisingly, GSK's combo is already drawing comparisons to Zelboraf. And Bloomberg noted that, while the London-based giant's study showed that its two-drug combo provided longer profession-free survival than Roche's BRAF inhibitor in similar studies, Roche pointed out to the news service that such comparisons are premature.

- check out Bloomberg's article
- see Reuters' report

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Cancer drug experts brace for ASCO abstract dump tonight

Posted under ASCO, Blog, Bristol-Myers Squibb, Companies, dabrafenib, Diagnostics, Funding, GlaxoSmithKline, Johnson & Johnson, Medical Devices, Medical Supply, personalized medicine, Pfizer, Pharmaceuticals, Pipeline, Roche, Startups, trametinib, Universities, Videos, Xalkori, Zytiga by john

Tonight's the big night for cancer drug watchers. ASCO is releasing a mountain of data on cancer studies, and some of the biggest names in the business will be angling for star billing on some closely watched therapies.

Peter Loftus at Dow Jones lists Pfizer ($PFE), GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ) among the big names that will be featured tonight. But Bristol-Myers Squibb ($BMY) and Roche (T-DM1) plan to hold back on the headlines until the confab in Chicago gets under way.

For GSK, dabrafenib and trametinib are slated for top billing. Together, the two therapies could earn more than $700 million a year, Cowen reports. Pfizer, meanwhile, will be looking to make a case to expand the approval for Xalkori while J&J will make a case for Zytiga.

As Loftus notes in his report, one of the big themes this year will be the continued focus on personalized medicine, as investigators look for better results from cancer therapies targeted to specific patient populations.

- here's the story from Dow Jones

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