Joint Statement of BIO, AAU, ACE, APLU, AUTM and COGR

Contributed by dbking

 Earlier today, the United States Supreme Court issued its opinion in the appeal of Stanford University against Roche Diagnostics. This case is of significant interest to the Biotechnology Industry Organization (BIO), Association of American Universities (AAU), American Council on Education (ACE), Association of Public and Land-grant Universities (APLU), Association of University Technology Managers (AUTM), and Council on Governmental Relations (COGR) because of its potential impact on university technology transfer, on development and commercialization of university-generated basic technology, and on scientific collaborations between university and private-sector scientists.

The biotechnology industry and the university community rely on effective collaborations to make the products of their research and development efforts available to the public.  The university’s mission of the discovery and dissemination of new knowledge is complementary to the biotechnology industry’s mission of translating basic science into products to benefit patients, farmers, and consumers. The discoveries arising from university research are most efficiently transformed into valuable new products with the participation of companies willing to invest in the long development process that is often necessary to bring new products to market.

By all accounts, the U.S. system of public-private technology transfer that was established under the 1980 Bayh-Dole Act has been extraordinarily successful in moving university discoveries from experimental laboratories to the marketplace through collaborations with private industry. This system has provided a rich return on public funding for basic research, in the form of countless innovative products that today benefit consumers, create jobs, and contribute to U.S. technological leadership internationally.  

Although BIO and the undersigned higher education associations held different views on the Stanford v. Roche case, the organizations are united in the desire to ensure that the U.S. technology transfer system continues to generate these public benefits through the robust provisions of the Bayh-Dole statute.  We are committed to working together in light of the Supreme Court’s decision to ensure the continued vibrancy of public-private partnerships and success of our shared objectives.

MEDIA CONTACTS

Biotechnology Industry Organization:

Stephanie Fischer, Director of Communications

(202) 312-9263

sfischer@bio.org

Association of American Universities:

Barry Toic, Vice President of Public Affairs

202-898-7847

barry_toiv@aau.edu

 

American Council on Education:

Erin Hennessy, Director of Public Affairs

202-939-9367

erin_hennessy@ace.nche.edu

Association of Public and Land-grant Universities:

Paul Hassen, Vice President of Public Affairs

202-478-6073

phassen@aplu.org

Association of University Technology Managers:

Jodi Talley, Marketing and Communications Manager

(847) 559-0846 x237

jtalley@autm.net

 

Council on Governmental Relations:

Robert Hardy, Director of Contracts and Intellectual Property

(202) 289-6655

rhardy@cogr.edu

BIO’s “What Every State Should Know About Bayh-Dole” Webinar

BIO’s “What Every State Should Know About Bayh-Dole” Webinar

The Biotechnology Industry Organization (BIO) recently hosted a webinar entitled: “What Every State Should Know About Bayh-Dole: Leveraging University Research to Create Jobs and Spur Economic Development Benefits.”

The Bayh-Dole Act, enacted in 1980, placed patent ownership of federally funded research at universities in the hands of the university and enabled universities to out-license technologies for commercialization.  As a result of the Act, more than 7200 companies were created (including nearly 600 last year despite the national recession) and 8818 new products were made available to patients and other consumers.   Since the Bayh-Dole Act, university start-ups have contributed at least $187 billion to the U.S. Gross National Product, and created a minimum of 279,000 jobs within a nine year period.

The webinar provides an overview of the Bayh-Dole Act and how the Act has allowed states to leverage university funded research to spur economic growth.  It also explores recent economic data and provides several examples of successful licensing agreements.  Finally, the webinar provides an overview of the challenges to the Bayh-Dole Act and how these challenges could negatively impact job creation and economic growth at the state level. 

Lila Feisee, Vice President for Global Intellectual Property Policy at BIO, acted as moderator with Dr. Ashley J. Stevens, Special Assistant to the Vice President of Research at Boston University, and Joe Allen, former staffer to Senator Birch Bayh, as panelists.

Please follow the following links to view the webinar.

Streaming recording link:

https://biotechnology.webex.com/biotechnology/ldr.php?AT=pb&SP=MC&rID=60992482&rKey=cb4322ff92c9c107

Download recording link:

https://biotechnology.webex.com/biotechnology/lsr.php?AT=dw&SP=MC&rID=60992482&rKey=12a4f24204098489

NIST Report: Federal Laboratory Technology Transfer Fiscal Year 2009

The National Institute of Standards and Technology in the U.S. Department of Commerce released a report in March discussing Federal Laboratory Technology Transfer for the fiscal year 2009.

The report concludes that from the years 2005-2009 the number of new inventions reported declined while new patent applications and issued patents increased.  Standard invention licensing declined while “other” licenses increased. 

The report cautions that the numbers do not tell the whole story and they are working to develop more accurate metrics to evaluate technology transfer of federal research and its role in economic growth.

BIO’s IP Priorities for 2011

As we start a new year, the BIO Intellectual Property Department has determined their 2011 priorities.  Intellectual Property remains a foundational priority for BIO and our 1100 biotechnology company members.

BIO’s IP department has approved the following priorities for 2011:

1) PTO reforms to improve efficient, timely and quality examination

2) Congressional patent reform legislation

3) Improving IP protection in key foreign markets

4) IP legal developments in the courts

5) Protecting the breadth and flexibility of the patent and technology transfer system.

AUTM U.S. Licensing Survey 2009

AUTM released their 2009 report for technology transfer licensing activities.  Of particular interest is the 596 start-up companies that were created in the middle of an economic recessision.  This Survey suggests that in 2009 Bayh-Dole contributed to growth in an otherwise declining economy, created jobs, and helped fund future research. 

Here are the U.S. Highlights:

Economic Impact

The number of licenses executed increased 5.6 percent, whereas the number of options decreased 3.4 percent. Total licenses and options increased 3.8 percent. The number of startups was essentially unchanged.

Products, startups and licenses/options:

• 658 new commercial products launched

• 5,328 total licenses and options executed, 4,374 of which were licenses

• 596 startup companies formed, 435 of which had their primary place of business in the licensing institution’s home state

• 3,423 startups still operating as of the end of 2009

 

Technology Transfer Pipeline

Research expenditures continued to increase: total research and development spending increased 4.7 percent, federal expenditures increased 1.9 percent, and given the financial downturn, an 8.2 percent surge in industrial research funding was especially significant.

Research expenditures:

• $53.9 billion total sponsored research expenditures

• $33.3 billion in federally funded sponsored research expenditures

• $4.0 billion in industry-sponsored research expenditures

 

Intellectual Property Management

The number of disclosures received increased 1 percent.

Disclosures:

• 20,309 disclosures

AUTM analyzed, in great depth — the areas within which the disclosures fell and was able to categorize 66 percent of the disclosures or 13,376.

Total U.S. patent applications filed decreased almost 4 percent, while new patent applications declined almost 1 percent. However, the number of foreign filings increased significantly, up almost 56 percent.

Patents filed:

• 18,214 total U.S. patent applications

• 12,109 new patent applications

• 1,322 non-U.S. patent applications

The number of patents issued increased nearly 4 percent.

Patents issued:

• 3,417 issued patents

 

License Income

Total license income decreased 32.5 percent in 2009. This decrease is largely due to 2008’s figures including substantial one time payments received by Northwestern University, City of Hope National Medical Center and Beckman Research Institute, Sloan Kettering Institute for Cancer Research and Children’s Hospital of Philadelphia. The decrease was across the board: Running royalties dropped 29.7 percent, cashed-in equity dropped 45 percent, and other income dropped 35.5 percent.

• Total income: $2.3 billion

• Running royalty: $1.6 billion

• Cashed-in equity: $24.4 million

• Other income: $362 million

IPWatchdog.com interview of Bayh-Dole insider

A great article from IPWatchdog.com giving Joe Allen’s (a Birch Bayh staffer) insider perspective on the passage of the Bayh-Dole Act. 

The Article’s Introduction:

William Shakespeare once wrote:

There is a tide in the affairs of men
Which taken at the flood, leads on to fortune;
Omitted, all the voyage of their life
Is bound in shallows and in miseries.

See Julius Caesar.

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

U.S. House passes Bayh-Dole 30th Anniversary Concurrent Resolution

On November 15th, the United States House of Representatives voted 385-1 for the Bayh-Dole 30th Anniversary Concurrent Resolution.  

Here are some interesting quotes from the Resolution on the need for and the successes of Bayh-Dole.

“the United States Government is one of the largest funders of research in the world, but that research does not fully benefit American taxpayers unless it contributes new products and processes to the marketplace, thereby creating new companies and jobs, and solving societal problems;”

“the commercial development of discoveries and inventions falls upon private sector entrepreneurs, often requiring millions of dollars in development funding over many years, and even then commercial success is uncertain at best”

“ before the enactment of that Act, few inventions arising from the billions of taxpayer dollars granted each year to American research universities, nonprofit organizations, and Federal laboratories were being translated into commercial products of benefit to the public and the United States economy;”

“a critical factor in developing federally funded inventions into commercial products is the continued involvement of the inventor in the process, and Government patent policies before the enactment of the Bayh-Dole Act chilled the intended incentives of the patent system in this regard;”

“the ability to obtain a reliable patent license for commercial development is needed to justify private sector investments, and Government patent policies before the enactment of the Bayh-Dole Act made negotiating and obtaining such licenses difficult, if not impossible;

“patent ownership of potentially important inventions is crucial in the formation of many start-up companies, which form vital parts of an innovation economy, and ownership rights were discouraged by Government patent policies before the enactment of the Bayh-Dole Act;”

“the success of the Bayh-Dole Act became apparent with the creation and dominance of the United States biotechnology and information technology industries, that remain largely dependent on university research;”

“the Bayh-Dole Act has been widely recognized as a best practice and is now being adopted by other countries (both developed and developing) around the world to better integrate their own research universities into their economies in order to be more competitive;”

“objective examples of how the Bayh-Dole Act has not only benefitted the United States but has also created a better world include the creation of over 150 new drugs, vaccines, or in vitro devices, including the hepatitis B vaccine, cisplatin, carboplatin and taxol anticancer therapeutics, laser eye surgery devices, the Palmaz balloon expandable stent, and many more; and

“economic activity spurred on by the Bayh-Dole Act include the formation of more than 6,500 new companies from the inventions created under the Act, an estimated contribution of $450,000,000,000 to United States gross industrial output, and the creation of 280,000 new high technology jobs between 1999 and 2007:”

“(1) it is the sense of the Congress that— (A) the Bayh-Dole Act (Public Law 96– 517), as amended by Public Law 98–620, has made substantial contributions to the advancement of scientific and technological knowledge, fostered dramatic improvements in public health and safety, strengthened the higher education system, led to the development of new domestic industries and hundreds of thousands of new private sector jobs, and benefitted the economic and trade policies of the United States;”

BIO’s take on the CBD Nagoya Protocol

After several years of negotiations, the 10th Conference of the Parties of the Convention on Biological Diversity (CBD) successfully adopted the Nagoya Protocol.  The Protocol provides benefits to the biotechnology industry by creating a legal framework to regulate access to genetic resources and provide fair and equitable sharing of benefits.  In addition, the Protocol does not apply retroactively or hinder regulation or a country’s intellectual property systems.  Assuming nations implement the Protocol appropriately, we can meet the joint goals of conservation and sustainable use of biodiversity. 

The biotechnology community recognizes several important aspects of the Protocol.

Mutually Agreed Terms

Article 4.1 creates the obligation to share benefits on mutually agreed terms between the provider and user of genetic resources.  Both parties will understand their rights and obligations regarding the transfer of genetic resources which will create a synergetic relationship.

Emergencies

The Protocol recognizes the need to access genetic resources to respond to imminent emergencies that threaten or damage human, animal or plant health.  Article 6(b) answers these needs by ensuring national access and benefit sharing (“ABS”) requirements do not impede a response to a public health crisis.

Transparency

Those Parties requiring prior informed consent must take legislative, administrative or other policy measures to provide legal clarity and transparency under the Protocol.  Article 5.2 requires a “clear and transparent written decision” in a reasonable time.  These requirements enable biotechnology companies to comply with national access and benefit sharing laws. 

Prospective

The Protocol appears to be prospective and applies only to genetic resources transferred after the entry into force of the Protocol.  This particular provision however, is a bit unclear and will require more study, particularly during the implementation phase.  Retroactive application would create widespread uncertainty and litigation and should be avoided.

Intellectual Property Laws/Marketing Approval

The Protocol does not create new rules or laws for intellectual property or for marketing approval for new products.  Article 13.1(a) provides for checkpoints which will help monitor the collection of information providing transparency and respect for mutually agreed terms. 

The Nagoya Protocol represents a series of compromises with many provisions in the text still unclear.  As a result, BIO will monitor the national implementation of the Protocol and the implementation of the “global multilateral benefit-sharing mechanism” used for genetic resources existing in transboundary situations or where no prior informed consent is obtainable. (Article 7 bis)  However, we believe that the successful implementation of the Protocol is likely to result in positive relationships between the biotechnology industry, governments, and other stakeholders.

BIO Press Release: BIO and AUTM file Amicus Brief in Myriad Case

The Biotechnology Industry Organization (BIO) filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit on Friday, October 29th, in an appeal of a lawsuit brought by the American Civil Liberties Union on behalf of a number of plaintiffs against Myriad Genetics, the U.S. Patent and Trademark Office, and others.

The brief, filed jointly with the Association of University Technology Managers (AUTM), supports the patentability of isolated DNA molecules, noting that invalidating the patentability of these molecules would discourage future biotechnological innovation.  DNA-based patents are a critical tool that help enable the fundamental research and development of new biotech products, therapies and technologies to fight deadly diseases, expand agricultural production, clean the environment, and reduce our dependence on foreign sources of oil. 

Isolating a DNA molecule, in addition to creating a new chemical molecule that does not exist in nature, imparts new utilities and functions that are not available from native DNA.  The utility of isolated DNA molecules derives from their chemical structure, which is developed by human ingenuity using complex scientific expertise and equipment. As a result, isolated DNA molecules are patentable subject matter based on decades of U.S. case law.

 “Unless reversed, the district court’s ruling will seriously harm the U.S. biotechnology industry, which consists largely of small firms that are engaged in foundational research and dependent on private investment to fund their work,” stated BIO President & CEO Jim Greenwood.  “Patent protection is critical for the ability of biotechnology firms to secure the private investment necessary for the research and development of innovative diagnostic, therapeutic, environmental and agricultural products. This innovation will lead to domestic job creation and help sustain our country’s global competitiveness.”

 If the Court of Appeals affirms the district court’s categorical rejection of the patentability of isolated DNA molecules, it would cast a cloud of uncertainty over thousands of similar patents and compromise the ability of biotechnology firms to pursue groundbreaking discoveries in human healthcare, renewable energy, and sustainable agriculture. 

 “Patentability of isolated DNA molecules is critical to the translation of university research discoveries for the public good. Without this, many promising discoveries would not make their way from the university research lab and into the hands of companies for development of products which improve the public health,” stated AUTM President Ashley J. Stevens.

“From the mass production of life-saving medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society,” concluded BIO President and CEO Jim Greenwood. 

The joint BIO-AUTM amicus brief is available at http://bio.org/ip/amicus/BIO_AUTM_Amicus_Brief_AMP_v_USPTO_2010-1406_FedCir.pdf.  Additional background materials are available at http://bio.org/ip/genepat

Secretary Sebelius speaks at biotech meeting

Secretary Sebelius delivered a speech in California yesterday which recognized the potential of biotechnology to address unmet needs in human health, agriculture and industrial and environmental applications.  In her remarks, Secretary Sebelius stated:

“[I]nvesting in each step of the process that starts with basic scientific discovery and ends with the development and provision of better diagnostics, treatments, and preventive strategies to significantly improve health care.  I know I don’t have to tell you that because these steps are often very complex, promising scientific discoveries can move incredibly slowly toward practical application, encountering significant hurdles along the way.”

The Secretary also recognized the challenges faced by emerging companies in raising the funds necessary for research and development and the approval process: 

“While many companies may have powerful new ideas, the fact is that when those companies are young and small, they may not have access to the capital they need to get those ideas off the ground.” 

The Secretary’s stated objective to “accelerate the process of scientific discovery, and improve the health of the American people” requires a strong and predictable intellectual property system together with an efficient and flexible technology transfer system.  It is equally important to foster partnerships and collaborations between the private and the public sector to translate basic research into new medical therapies and other products. 

Without strong intellectual property protection and an efficient technology transfer system, biotech companies may have trouble attracting investment into cutting-edge products and technologies.”

Below is a transcript of the Secretary’s speech.

The Biotech Meeting

Laguna Beach, CA
October 12, 2010

Thank you Brook for that very kind introduction.

I want to thank both Brook and Steven Burrill for convening this important discussion today and for all the work you have done to advance the life sciences.

Thank you as well to my colleague and friend Congresswoman Anna Eshoo, a true champion of science and technology in the House of Representatives.

I am delighted to be here. As you know, I came to the Department of Health and Human Services as a governor where I saw firsthand the potential of biotechnology – not just to create jobs and drive growth, but also to solve some of our biggest problems: to improve health and eradicate disease, to reduce our dependence on foreign oil and keep our water clean.

When we look back over the last century, we see that biotechnology is responsible for some of our greatest progress in public health, from the discovery of penicillin to the development of effective therapies for HIV infection.

Diseases that had once been a death sentence have been eradicated or cured.  Conditions that had once been disabling are now manageable.

Today, at the beginning of a new century, we can see even bigger opportunities ahead.

And our mission at HHS is to make good on those opportunities, accelerate the process of scientific discovery, and improve the health of the American people.

That means investing in each step of the process that starts with basic scientific discovery and ends with the development and provision of better diagnostics, treatments, and preventive strategies to significantly improve health care. 

I know I don’t have to tell you that  because these steps are often very complex, promising scientific discoveries can move incredibly slowly toward practical application, encountering significant hurdles along the way. 

But with so much to gain, we can’t afford to let any good idea go to waste. We must be able to realize tomorrow’s opportunities. And that means being able to count on a robust and streamlined process to translate and carry promising ideas forward, from the microscope to the medicine chest, from initial investment to the global market.

As you may know, this very challenge was recently highlighted in an HHS report examining our nation’s medical countermeasure enterprise.

With the President’s support, we conducted a first-of-its-kind, comprehensive analysis, and its conclusions ultimately confirmed what some of you have been saying for some time: that the pipeline we rely on to provide those critical countermeasures – diagnostics, vaccines, antivirals, antibiotics – is full of leaks, choke points, and dead ends.

In an age of new threats and persistent challenges, where delays cost lives, we simply aren’t developing and manufacturing new medical countermeasures fast enough. 

So, when the review was completed this August, HHS announced it would direct nearly $2 billion in preparedness funds to help us build a medical countermeasures enterprise that is modern, flexible, and equipped to respond quickly and effectively to any threats that arise.

What I want to share with you today is that:

One, we’re already moving forward on this plan.

And two, you need to be a part of it. We intend to call on your expertise and experience to make sure we get it right.

It was in this spirit last month that the Department’s Biomedical Advanced Research and Development Authority (BARDA) announced a solicitation for one or more new Centers of Innovation for Advanced Development and Manufacturing.

Despite tireless efforts on every front during the H1N1 influenza pandemic, we needed greater capacity and more flexibility to produce enough vaccine in a timely manner.

These new centers would serve as key platforms where flexible manufacturing can take place. They may be brand-new facilities, or existing facilities that are significantly refurbished. And they will have the potential to offer a dependable and robust domestic source of vaccines and other countermeasures for pandemic influenza, unknown pathogen outbreaks, and other evolving public health priorities.

But more than that, these Centers — established as public-private partnerships — will also serve as a resource so that small biotech companies with big ideas can get the regulatory, technical, and manufacturing know-how they need to demonstrate their product’s potential and bring it to market.

And they will provide manufacturing resources so those same small companies can produce these products without the heavy burden of capital investment into their own facilities.

Going forward, we are very interested in feedback and guidance from the community we hope these Centers will serve. Comments are due no later than October 29th, and will be used to develop a formal request for proposals that will potentially be awarded by the end of 2011. So please contribute your thoughts, so that we can make these facilities as responsive and effective as possible.

At the same time and in similar spirit, we are also initiating what we call the Concept Acceleration Program at the NIH, to ensure that discoveries with great potential do not die on the vine.

The program will create so-called “Sherpa” teams to guide these concepts through early stage development with partner agencies, academic researchers, biotechnology and pharmaceutical companies.

NIH is essentially scouting the emerging science that comes from its investments then leveraging its resources to take them further still.

Now, our comprehensive review identified another key challenge as well:

While many companies may have powerful new ideas, the fact is that when those companies are young and small, they may not have access to the capital they need to get those ideas off the ground.

Right now, there’s little financial incentive for private companies to explore rare conditions like the Ebola virus infection or exposure to non-medical radiation.

Yet in the event of an Ebola outbreak or a nuclear explosion, countermeasures for these conditions would be critical.

That’s why we’re exploring a strategic investment fund.

It may be a new entity entirely or a new initiative within an established government-sponsored fund.

But I can tell you it will be an independent, not-for-profit organization whose mission is to find and nurture those organizations that have the greatest chance of making good on the public’s early investment.

And we’re not just talking about money. A good venture capital organization does not just infuse capital into key projects; it brings in executive business expertise — the vision and the guidance to take something small with big potential and find the best path to reach the next level.

At the same time, we will continue, as always, to provide direct support for the advanced development of products that are important to the public health but often unattractive to investors in private industry.  Let me give you some examples:

In 2005, the National Institutes of Health established the Centers for Countermeasures Against Radiation, where investigators developed innovative methods and tools to measure radiation exposure and evaluate potential drugs to treat radiation injury.

The program funded 130 pilot studies, and attracted many new scientists to the field, bringing with them new ideas and new perspectives.

So this summer, we announced an additional five years of funding to extend the program — $105 million in support of further research at seven institutions nationwide, building on the advances of the last five years.

On August 31, BARDA awarded a contract of up to $64.5 million for the continued development of a promising new antibiotic that may be used to fight drug-resistant organisms, including serious biothreat agents like the one that causes bubonic plague.

And late last week, we announced three new contracts that could reach $68 million focusing on a dengue vaccine delivered by a needle-free device, an anthrax vaccine delivered orally, and an anthrax vaccine delivered in conjunction with a compound that stimulates the immune system.

Clinical trials of all three vaccine products should begin within three years.

All of these investments, like many of the new initiatives highlighted in our medical countermeasure review, are about addressing risk. 

By supporting facilities and resources at the new Centers of innovation, we’re addressing the technical risk that comes with taking on uncertain, but important public health projects.

By exploring a strategic investment fund, we are addressing the risk in terms of business development.

But there’s another kind of risk, and that’s regulatory risk.

So we’re addressing that too, by improving regulatory science at the FDA.

Last week, our terrific FDA Commissioner Margaret Hamburg unveiled the agency’s new Regulatory Science Initiative, laying out a strategic framework to modernize how we evaluate and regulate product development.

For too long, we’ve underinvested in the tools, models, methods and knowledge needed for making these assessments.

Because of this underinvestment, we’re often testing and producing cutting-edge products using science that’s decades-old.

We’re going to give our world-class FDA scientists the resources they need to create clear regulatory pathways, analyze promising new discoveries faster, and help identify and solve scientific problems as they occur. And we’re going to build capacity throughout the development process to support intensive and early interaction between FDA and sponsors as well as government partners.

In the end, if a product fails to make it into our national stockpiles, it should only be based on its failure to meet our stringent standards for safety, efficacy or quality, and not because we failed to provide the needed business, regulatory and technical support for success. 

To achieve that goal we will have to work together.

Last year, less than an hour after being sworn in as Secretary, I was in the Situation Room being briefed on the H1N1 flu by John Brennan, the President’s Advisor for Homeland Security and Counterterrorism.

I was so new I didn’t even know where the Situation Room was. Someone had to show me how to get there.

During last year’s flu season, we turned to medical countermeasures, of course. But they were just one part of a much larger response.

That response depended on the strength of our health care workforce. 

It depended on our ability to collaborate across the government and to execute a national strategy on the local level. And it depended on successful public-private communication and collaboration, as well as an informed and engaged public. 

With so many factors in play at once, coordination was key.

It was a good reminder that to be ready for the next public health crisis, we need to focus on our entire end-to-end response, from how we assess and identify threats to how we distribute and administer products to counter those threats across the country.

This was one of the goals we had in mind when we passed the Affordable Care Act six months ago.  And although it is not often referred to this way, it is one of the strongest public health bills our nation has ever seen. 

The Treasury Department has already received over 5,000 applications and will soon announce recipients of the $1 billion therapeutic discovery grant and tax credit program as part of the new law, helping small businesses that are developing new and cost-saving therapies for patients suffering from serious diseases.

Investments like these create jobs and help us stay competitive as a nation.

So, too, will the new $15 billion Prevention and Public Health Fund that recently distributed nearly $43 million in grants to state, local, and tribal governments to improve their public health services.

And at the heart of so much of our prevention efforts is an understanding that vaccination is absolutely critical.

That’s why under the new consumer protections that took effect last month, Medicare and new private health plans will offer flu vaccine and other critical vaccine coverage – without co-pays or deductibles.

The elimination of cost as a barrier comes at a key moment: This is the first year in which health officials are recommending that every American older than six months get a flu shot. And there should be ample supply; over 100 million doses have already been distributed. 

I want to thank you again for having me here today — and for your partnership. Together we’re going beyond scientific discovery, and bringing its possibilities to more people and more communities.

That is our shared responsibility — to make the very most of biotechnology’s great promise: to make it work for people’s families and communities, to strengthen our economy, and to improve our quality of life.

Francis Crick said that “Big questions get big answers.” 

By pushing science in powerful new directions, we can continue to answer some of today’s biggest, toughest questions with confidence and real hope for a brighter tomorrow.