IP Professors: 12-Year Data Exclusivity a Win-Win for Patient Access & Biotech Innovation

David E. Adelman of the University of Texas School of Law and Christopher M. Holman of the University of Missouri – Kansas City School of Law recently published analysis on the “sideshow” of the data exclusivity debate in Washington.

Adelman and Holman use a cost-benefit analysis that incorporates the most important legal precedents and case law today in concluding that “policymakers should focus on mitigating the systematic barriers to entry that pose much greater and longer-term obstacles to lower-cost biotech drugs.”  Specifically, the draft paper provides solid analysis of the need for 12-year data exclusivity, which the authors describe as a right balance between providing access to important medicines to patients, and creating the incentives needed for investors and companies to prepare (and survive) the regulatory approval process for follow-on biologics.

Much like tort reform, the debate over pending legislation on biotech drugs—and particularly regulatory supplements to patent protection—has taken on a significance that dwarfs its impact on overall health care expenditures. Under the pending Health Care Reform legislation, Congress would enact two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics, which are the analogues of generics for conventional drugs. Second, establishment of a twelve-year “data exclusivity” period during which clinical testing data collected by brand-name producers could not be used by competitors to satisfy FDA testing requirements. While the abbreviated FDA approval process enjoys broad support, the data-exclusivity provision has been hotly contested, including strong opposition from the Federal Trade Commission.  (Paper Abstract)

The paper flies through data that’s been collected for over 20 years on intellectual property and biotechnology in a clear way as to make the longer data-exclusivity proposal an obvious non-issue for Congress in the health care debate. That is to say:

The economic studies used by critics of supplemental patent protection conclude that a twelve-year period of data exclusivity is essential to the profitability [and thus investment and research likelihood] of biotech drugs… data exclusivity could encourage development of clinically important biologics that would otherwise be abandoned because robust patents on the active ingredient are unavailable… the health care savings would be nominal, as drugs account for only about ten percent of total health care expenditures in the United States.

It’s important to understand the connection between health care and biotechnology, without “killing the goose” that lays the golden (innovation) egg. The authors note that “the successes of biomedical innovation are paradoxically  at the root of the health care crisis… limiting the term of data exclusivity could also be counterproductive for everyone…. safeguarding high short-term profits through a twelve-year data exclusivity term stands to mitigate the difficulties of balancing innovation and patient access.”

You can visit Chris Holman’s blog at http://holmansbiotechipblog.blogspot.com.

BIO CEO: Patient Groups Join Call for Data Protection

“Biomedical innovation is not only key to our industry’s future, but more importantly, continued medical breakthroughs are vital to patients living with debilitating diseases and their families. Without ongoing progress in our industry, patients of today and tomorrow have limited hope for future cures and therapies.

“Many patient groups have entered the debate on Capitol Hill over establishing a pathway for approval of biosimilars because they know how critical continued innovation is to finding new therapies and cures for diseases. A number of these groups are asking Congress to ensure biotechnology companies are able to continue to innovate, with many joining BIO in asking for a minimum of 12 years of data exclusivity, the amount of time during which the Food and Drug Administration (FDA) may not rely on an innovator’s proprietary safety and efficacy data to approve a competitor’s product.

“As the AIDS Institute, Community Access National Network, CAEAR Foundation and National Minority AIDS Council noted in a July 13th letter to Senator Ted Kennedy (D-MA), “innovations have turned what was once a terminal illness into a potentially chronic, manageable condition.” They added, “We believe health care reform should improve quality and reduce costs, but it must be crafted in such a way as to strongly support continued medical innovation. That is why we strongly urge you to include a period of data exclusivity relative to biologics of 12 years.”

“In a July 16th letter to Rep. Anna Eshoo (D-CA), the ALS Association noted that there is no effective treatment for people with ALS, which is a terrible neurodegenerative disease that erodes a person’s ability to control muscle movement. According to the group, “legislation that reduces costs without promoting new technologies will be of little help to people with ALS whose lives depend on the development of new treatments.” Likewise, the Alliance for Aging Research noted in a letter to Rep. Eshoo that, “The creation of a well-defined process for approving biosimilars will help sustain investment in this vital area of therapy development and allow for these treatments to one day be made widely available to patients who otherwise could not have access to them.”

“Thanks to billions of dollars in research and development, we are getting closer to discovering cures to diseases we once thought uncurable. HIV/AIDS was once seen as a death sentence. Today, people with HIV/AIDS are living longer, healthier lives – something we didn’t think was possible when the disease was first beginning to spread just a few short decades ago. According to the American Cancer Society, between 1991 and 2006, the cancer death rate decreased by 16 percent.

“The progress shouldn’t stop here. Biotech companies across the nation have more than 600 new products in the pipeline, and the future is wide open. Let’s hope Congress keeps it that way.

(reposted from BIOtech Now blog)

For July 4: Let’s Thank the Inventors

For this week’s IP News Weekly, I emphasized stories about research breakthroughs and U.S. healthcare reform. In honor of this July 4, I’m taking a moment thank the researchers, business entrepreneurs and investors, and inventors who, as encouraged and protected by the U.S. Constitution, work tirelessly to create solutions to global health and environmental needs.

While I watched “The Fashion Show” on Bravo last night, one of the contestants proclaimed that “a designer is only as good as his last fashion show.” Its easy to forget that the United States’ economy (read = our jobs and homes) is only as strong as our last innovation. Further, everyone (from artists like clothing designers to high-technology workers) understands that it takes a long time to create the next “masterpiece.”

The complexity of creating biotechnology products is especially investment and time-consuming, and both the research process and the final product have a fragile relationship with human health and the environment. The intellectual property framework protects biotechnology innovators when they need it most, during the research and development process and the period of time the patent holder uses to recoop the investors funding. This protection creates a safe environment for investors that increases the possibility of the inventor producing a sustainable, high-quality product.  Americans do not prefer low-quality, high-risk solutions to the biggest problems of our time.

I hope that the current members of Congress will take it upon themselves to appreciate the need for data and patent protection for follow-on biologics, intellectual property rights and enforcement in international trade agreements, and increased funding for the NIH, FDA and PTO. No government can force innovation that comes out of the natural creative capabilities of its citizens, even in times of need.

My hope for America this July 4? I hope, in 100 years, the response time to human and environmental suffering will be immediate. Until that day arrives (thanks to scientific breakthroughs funded  by individual citizens) — let’s thank the scientists, investors, and inventors around us.

Finally, let’s also thank the founding fathers for knowing America’s innovative potential without seeing it for themselves.

For U.S. Healthcare Reform and Global Health Crises, Both Public and Private Efforts Needed

This morning Laura and I attended 2 sessions about the benefits of collaborative public-private partnerships at the International Convention.

The first was the super session “Global Biotechnology Innovation: Connecting the Laboratory, the Field, and the Marketplace” with speakers from the Food & Drug Administration, National Cancer Institute, the Centers for Disease Control and Prevention – moderated by former U.S. Secretary of Health & Human Services, Louis Sullivan. The speakers discussed how discoveries created through collaborative initiatives have accelerated biotechnology innovation to address global health disparities. The second session, “Time for Action: A prescription for Health-Care Reform” was moderated by BIO’s President & CEO and included speakers from the American Cancer Society, Regence BlueCross BlueShield, and the American Medical Association. The speakers presented their association’s perspectives on how U.S. healthcare reform could become a reality under the Obama Administration after decades of Congressional failures to comprehensively address rising costs and limited access to care.

The two panels addressed what are seemingly different topics: one global heath, and the second national healthcare reform. What struck me was the need to sustain new, complex collaborations between all stakeholders in order to encourage finding solutions to “old” problems.

The old view of global health programs states that logistical issues, including a lack of needed resources and capacity, require a top-down strategy with governments leading the efforts. Yesterday’s idea about healthcare reform, taken up by many a Congress the past 20 years, asserts that only the grassroots efforts of individual Americans can encourage permanent, sustainable solutions in communities where the government is unable to keep up (and often times hurts innovation rather than helping).

The truth is, for both global health goals and national healthcare reform, innovation requires both a “grass-top” and a “grass-roots” approach. I stole that phrase from the CEO of the American Cancer Society, John Seffrin. Seffrin is also CEO of the ACS Action Network. Both branches of the ACS facilitate efforts at the individual level (encouraging prevention and wellness efforts, for example) and the national level (analyzing Congressional proposals for reform). Both entities working together help solidify the foundation upon which the war on cancer can be won.

Indeed, the driving factor of encouraging biotechnology innovation to meet health care goals comes from the individual human beings who suffer, manage, and cure their own or another’s illness. Individuals collectively bring their unique experience and knowledge as patients, physicians, researchers, venture capitalists, university administrators, and government policymakers to public discourse, and by working together, benefit each other and accelerate finding a solution to health needs.

Some examples taken from the 2 sessions:

1. Gardasil, the blockbuster cervical cancer vaccine appeared under the guidance of collaborative efforts via the CDC.

2. The hope of collaboration helped the FDA form the basis for what would become the Critical Path Initiative for clinical trials.

2. Collaboration was the key for the American Medical Association’s work to address streamlining patient care by studying inefficiencies inequalities in the healthcare system, as Dr. Patrice Harris described this morning.

3. AMA, BIO, and ACS joined together to create the “Health Economy Now” website, which puts the focus of U.S. healthcare reform efforts on the need to lower costs through health information technology, changes in the reimbursement system, and encouragement of prevention & wellness. Jason Daughn of Regence remarked that “real reform lets innovators innovate, and preserves competition through public-private partnerships.”

4. James Curran, Dean of the Rollins School of Public Health at Emory University described that when the HIV/AIDS epidemic first emerged in 1981, it was thought that we would never find the cause or be fully able to characterize the disease. Since then, we can now screen the blood supply, extend the lives of those infected with HIV with antiretroviral therapy, prevent pregnant women from passing the virus to their unborn children, and measure the viral load of an infected individual’s blood.

 Both public and private entities are needed at the table of public discourse, not one or the other. We can address health needs in both the United States and developing countries at the same time by working together via open, fair, and collaborative partnerships. It saves money, time, effort and – most important of all – lives.

This post was co-written by Margarita Noriega and Laura Sambataro at BIO.

BIO Home Video: The Promise of Personalized Medicine

I recently interviewed Dr. Daryl Pritchard, Director, Research Programs Advocacy at BIO about how personalized medicine provides opportunities for sustainable healthcare reform. Its my first in a series of interviews with BIO staff meant to help connect the biotechnology community to what we’re up to at BIO, but more importantly, to talk about what the biotechnology community is up to during this current economic climate. 

While the ongoing economic recession has decreased funding opportunities for biotechnology research and development, thanks to previous funding and the continued success of researchers, personalized medicine is and will continue to be a key arena for economic growth.

You can watch the interview at www.bio.org/bioethics.