Tuesday, October 25, 2011

Speaker Spotlight: Marc Boutin, Executive Vice President & COO, National Health Council

Marc Boutin
The National Health Council brings together all segments of the healthcare community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers.
Boutin has been actively involved in health advocacy, policy, and both federal and state legislation throughout his career. He has designed and directed advocacy strategies for legislative initiatives, which have included issues ranging from access to healthcare to cancer prevention. Before joining the Council, Boutin served as the vice president of government relations and advocacy at the American Cancer Society for New England. In addition, he was a faculty member at Tufts University Medical School, where he lectured on healthcare policy.

At the CHI 2011 Annual Meeting, to be held Nov. 3 in San Francisco, Boutin will discuss the Moddern Cures Solution, a proposal to update the U.S. regulatory system to remove barriers to innovation and provide greater predictability in the search for answers to the nation’s unmet medical needs. It is not too late to register.

Let’s talk about the impetus for the National Health Council. What was the driving need behind its formation?

A: The National Health Council was formed in 1920, so we have a long history. We were formed by a group of about 20 patient organizations that was looking for a trade association.

Q: Were there any other large trade associations of its kind in existence?
A: No, and there currently is nothing out there. We still serve in that function, so half our work is really directed at member services. Our work includes anything from board management, governance, corporate structures, volunteers, income development and benchmarking studies. We still maintain what is called the standards of excellence. The standards are a set of nonprofit standards, essentially, that the patient groups have to meet in order to be in membership. They are actually the most strident nonprofit standards in the industry.

Q: How is your organization funded?
A: We are a dues-based organization so about half our income comes from dues and the other half comes from sponsorships.

Q: Can you give me an example of some of the leading patient advocacy groups that make up your membership?
A: Some of the original founders include American Cancer Society, American Heart, American Diabetes and we run the gamut from those very large groups such as Easter Seals to small groups that represent various disorders like Sj√∂gren’s disease or Alpha-1.

Q: What unique function does your group serve?
A: We are able, through our process, to engage the community, create a common understanding and then a common platform from which to advocate on systemic issues. And when they come together, they tend to have a great deal of impact.

Q: What are some of those messages you are working to convey through this organized effort?
A: In terms of public policy, we really are focused on two different things. One would be access to care, so we’ve been heavily involved with the implementation of health reform in a variety of different initiatives right down to the level of helping craft part of the regulatory language, as well as the legislative language, that created the Affordable Care Act. So, for example, we worked on defining the essential health benefits the Secretary of Health and Human Services is working on. We did our own actuarial analysis of what it would mean to put certain benefits into the design. We did recommendations on regulatory language.

On the other hand, we are extremely interested in development of new treatments, and so there is the dual focus.

Q: Tell me a little about your latest effort, the Moddern Cures Solution, which stands for Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network?
A: We are promoting legislative language that will do two things. It will, one, allow a company to bring a medicine to market without a patent, and that is significant. A lot of people don’t understand, but when somebody identifies a new potential medicine in the early pre-clinical phases, it typically will go to a company that could develop and commercialize that product and bring it to U.S. Food and Drug Administration approval. In 80 percent to 90 percent of those cases, new potential treatments are dismissed not because the science is not good, but because they have weak patents.

It just makes no sense from a patient perspective, and this legislation corrects that. It says if you’ve got good science, you can bring it to market, receive a return on your investment, and still allow a generic to enter at a predetermined time.

Q: Does this proposed change include medical devices?
A: That is the second half of the legislation. There are mechanisms that address specific issues such as creating the incentives to invest in the device/diagnostic arena.

Q: Is this modeled after any other country’s system?
A: No, and actually these initiatives were identified by the chief medical officers of the patient groups. In other words, they came to the council about five years ago and said, “We’ve doubled the investment in the development of new treatments, and we are not getting double the output of new treatments.” And they start to look at the lifecycles of the development of treatments and diagnostics and identify barriers.

And then asked us to look at possible solutions and we settled on these four major issues and developed solutions that we think could work, but are not actually modeled on existing solutions. We are, however, already seeing Europe and other countries look at this as a potential metric that they would copy.

Q: What has the reception been like so far from the policy side?
A: Extremely positive. It has been described by some as one of the few major health policies that has bipartisan support and the current Congress and administration could actually enact. It is exciting.

Q: What kind of dialogue do you hope to get out of the 2011 CHI Annual Meeting?
A: I am hoping, given the audience that will be at that meeting, that there will be a great deal of synergy on what we are doing on the development of new treatments and how it will positively impact the environment that your audience is working and living in.

I figured it is an incredible event, and I was really pleased to be invited to participate.

CHI-Advancing California biomedical research and innovation

Bookmark and Share

Tuesday, October 18, 2011

Event Spotlight: CHI Co-Hosts Congressional Briefing on Infection Prevention

On Oct. 12, CHI and MassBio co-hosted a congressional briefing in Washington D.C. titled, “Infection Control: Detection, Prevention, and Treatment.” Participants were joined by Reps. Jackie Speier (D-CA) and Edward Markey (D-MA). The partnership was hailed as a powerful combination of two of the most significant state powers in the biotech industry. As a father of a child suffering from cystic fibrosis, MassBio President and CEO Bob Coughlin said passionately, “I don’t care if [cystic fibrosis] is cured in California or Massachusetts. All boats rise.”

Coughlin and CHI President and CEO, David L. Gollaher, Ph.D, made opening remarks and introduced Reps. Speier and Markey, who each made their own comments. Next, a panel of experts provided educational presentations on challenges and advances in combating healthcare-associated infections (HAIs). The program, held in the Gold Room of the Rayburn House Office Building, attracted more than 50 congressional staffers, patient advocates, and industry representatives.

Speakers outlined the scope and effect of HAIs. Estimates show that HAIs take the lives of 100,000 patients a year – patients who enter healthcare facilities in good health, or without such infections yet die from exposure in healthcare settings. As Speier noted, “That’s the equivalent of 333 [Boeing] 747 airplanes crashing every year.” This makes HAIs the 10th leading cause of death, and the No. 1 cause of death in non-cardiac intensive care units. In the U.S. alone, antibiotic-resistant infections are responsible for $20 billion in excess healthcare costs, $35 billion in societal costs and $8 million in additional hospital days.

Despite these numbers, HAIs remain a dangerously under-recognized threat. Continuing her airplane metaphor, Speier said, “If that many planes were crashing every year, we’d expect the FAA to do something about it.” Dr. Arnold Huang, Ph.D., of Thermo Fisher Scientific, later polled the audience to demonstrate the high degree of recognition of October as breast cancer awareness month. He juxtaposed those numbers with the audience’s lack of knowledge about sepsis – a condition that causes four to five times as many deaths each year.

Despite the high death rate and the continued appearance of new strains of antibiotic-resistant bacterium (such as MRSA), the number of new antibiotics in the development pipeline has been shrinking during the past several decades. Rick Winningham, CEO of Theravance, described the trends that have led to diminished approvals of new antibiotics. Overall, “antibiotic drug development is dying,” he said. He attributed this to market dynamics which have led large pharmaceutical firms to exit the market entirely, leaving small firms to overcome tremendous obstacles. These dynamics include: decreases in expected returns on investment; rising costs of clinical trials and the number of required patients; and regulatory challenges and delays from the FDA. Winningham laid responsibility for these on both Congress – for having taken the FDA to task over past high-profile safety issues – and industry itself, for problems in effectively pricing previous products.

Speakers ended the day by noting the promising introduction of the Generating Antibiotic Incentives Now Act (GAIN), and giving a call to action. The GAIN Act would give developers of select antibiotic products five or more years of additional data exclusivity and provide for priority review of their products by the FDA among other provisions. Despite this positive development, participants like Kathy Warye of Becton Dickinson stressed a fundamental challenge to inspiring advocacy to address HAIs: Because they strike and kill patients relatively quickly and are not long-term chronic diseases, it’s impossible to put a face on the problem in the way that advocates for other diseases and conditions have succeeded in doing. Further, the public fails to relate deaths from these sorts of HAIs to our lack of effective antibiotics. As Winningham said, “Leadership has to drive this change.”

CHI-Advancing California biomedical research and innovation

Bookmark and Share

Monday, October 10, 2011

Guest Blog: Fish & Richardson Attorneys Explore European Patent System

Steven Carlson
Germany is a top country for patent enforcement. Knowing the German system is fundamental for technology companies that sell products in Europe, both for patentees and for companies pulled into German courts as defendants.
Alexander Harguth
In Germany, patent cases frequently take less than a year, at a fraction of the cost of U.S. cases.

A tremendous advantage to patentees is that infringement cases are tried separately from challenges to the validity of a patent. Likewise, many of the procedural “outs” that defendants enjoy in the United States (such as motions to dismiss, early claim construction rulings, and summary judgment proceedings) are unavailable in Germany — accordingly, the first time the parties appear in court is typically for the trial on the merits. Defendants, therefore, must be ready to act quickly to develop their case, to prepare their validity challenge, and to pursue other available defenses.

Customs actions provide another way to enforce patents. Customs authorities may seize goods upon the patentee’s request, after which the case may be referred to the trial courts. Therefore, potential infringers must be aware, for example, when presenting goods at a trade show, there could be a seizure action carried out on the floor of the exhibition.

German damages awards are typically lower than in the United States. Nonetheless, there may be nowhere better for winning an injunction if the patentee has strong patent rights. Although infringement relief will be limited to Germany’s borders, being enjoined from selling in Europe’s biggest market may be intolerable for many companies. A German enforcement strategy, or a parallel strategy of enforcement in Germany and the United States, may, therefore, result in a global settlement of disputes.

We have written a new book on the German IP system: “Patents in Germany and Europe: Procurement, Enforcement and Defense.” As native attorneys of Germany and the United States, we have tried to present Germany’s system to the U.S. audience in an accessible and authoritative handbook, including chapters on:
• Sources of law in Germany;
• The German court system;
• Procurement of IP rights in the German and European patent offices;
• Invalidity challenges through oppositions and nullity actions;
• Enforcement actions through infringement trials and customs proceedings; and
• Employee rights in inventions.

Moreover, key provisions of German and European law are provided in the appendices, as well as sample pleadings, ending with a list of key distinctions between U.S. and German/European law.

The book is available on Amazon.com. If your company has particular interest in the German system, we will be happy to provide a complimentary copy along with an in-person seminar where feasible. Please feel free to us contact directly, at Harguth@fr.com or Carlson@fr.com.

CHI-Advancing California biomedical research and innovation

Bookmark and Share