BIO Hosts U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office and China’s State Intellectual Property Office

Press Release:

 
WASHINGTON, D.C. (Tuesday, April 05, 2011) – The Biotechnology Industry Organization (BIO) hosted a U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office (PTO) and China’s State Intellectual Property Office (SIPO) on March 28, 2011 in Beijing, China. The workshop which was organized by BIO for SIPO examiners, focused on biotechnology patenting and encouraged bilateral cooperation between SIPO and the USPTO.“BIO recognizes the commitment on behalf of the Chinese Government and SIPO to spur innovation in the biotech industry and, together with the PTO, we pledge to partner with Chinese leaders to move the industry forward to benefit patients and other consumers worldwide,” said Jim Greenwood, CEO and President of BIO.The workshop was the first of a series of meetings intended to open communication and establish a relationship between the two groups. BIO will work with the SIPO to strengthen China’s regulatory system to encourage innovation and protect intellectual property within the country. The commitment of SIPO will be critical for sending a message to companies that want to do business in China.

“Robust development of the biotech industry in China depends on an advanced intellectual property and patent system,” said Scott Sindelar, Minister Counselor of Agricultural Affairs. “Today’s workshop is timely in sharing experience and regulations of patenting and IP both in the U.S. and China, and establishing greater understanding of each other.”

“Since most Chinese attendees are examiners of intellectual property, [the workshop] provides an opportunity to share experiences and ideas with our American counterparts,” said Yang Xiaowei, deputy Director General of International Cooperation Department of SIPO.

In each of three panels, USPTO and SIPO speakers discussed how each issue is handled by the pertinent provisions in their current patent law and rules. They also addressed office practice and shared practical experiences with the different technical arts in biotech.  Industry and academic speakers provided user perspectives in their interaction with the patent law and practice in each country.

The workshop featured the following panels:

·         The first panel focused on taking a balanced approach to written description and enablement requirements, which are necessary for preventing impediments to patenting activity. Panelists also discussed the type of information that is required for an invention to satisfy the written description and enablement requirements.

·         The second panel focused on issues arising from claims with sequence homology. Panelists discussed the scope of claims using homology or percent of sequence identity language and issues that often arise during examination.

·         The third panel addressed meeting discussed China’s new requirements for patent disclosure for genetic resources, stakeholders’ experiences with China’s new genetic disclosure requirement, and alternative ways to ensure appropriate access and benefit sharing.

The three groups (BIO, PTO and SIPO) are looking forward to future opportunities to work together on issues of common interest.  

Upcoming BIO Events 

BIO Intellectual Property Counsels Committee Spring Conference and Committee Meeting
April 13-15, 2011
Seattle, WA

World Congress on Industrial Biotechnology & Bioprocessing
May 8-11, 2011
Toronto, Ontario, Canada

Partnering for Global Health Forum 2011
June 27, 2011
Washington, DC

BIO International Convention
June 27-30, 2011
Washington, DC

2011 BIO Human Resources Conference
June 26-28, 2011
Washington, DC

The Business Forum at the BIO International Convention
June 28-30, 2011
Washington, DC

BIO India International Partnering Conference
September 21-22, 2011
Hyderabad, India

BIO China International Conference
October 12-13, 2011
Shanghai, China

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtech Now, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtech Now.

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Innovation Alliance Event “Patents, Innovation and Job Creation: A Virtuous Circle”

An event is coming up on patents, innovation and job creation at the Newseum on Friday January 21.  The keynote speakers are  PTO Director David Kappos and Retired Chief Judge of the Federal Circuit Paul Michel. 

Other industry experts and executives will participate in panel discussions.  Below is the news release.

As the U.S. economy struggles with high unemployment, the Innovation Alliance hosts a half-day discussion with inventors, entrepreneurs, business leaders, and industry experts on the economic value of patents and a vigorous USPTO. The conference features remarks from David Kappos, Director of the U.S. Patent and Trademark Office, and Paul Michel, U.S. Court of Appeals for the Federal Circuit, Retired Chief Judge. Gene Quinn, founder of IPWatchdog, Inc and Kim Hart, reporter at Politico will moderate morning panels on creating jobs and the impact of patents on the modern innovation economy. Email Innovation Alliance to RSVP

Here is the advertisement with further details.

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.

Getting to Market: The Challenges of Technology Transfer

An article about BIO’s recent Technology Transfer Symposium.

Getting to Market: The Challenges of Technology Transfer
Attendees at special symposium focus on issues of commercializing and licensing biotech discoveries

Read the post on BIOtech NOW

New Blogger

Patently Biotech has a new writer.  My name is Roy Zwahlen and I am the new Intellectual Property manager at BIO.  I am an attorney and political science undergraduate and fascinated with intellectual property policy.  I am excited about this opportunity to enter the IP blogosphere.

My hope is to provide information about BIO’s IP activities including conferences and amicus briefs.  I also hope to reintroduce our IP staff and spotlight our BIO company members.  Finally, I plan on featuring guest writers from around the Biotech industry on IP issues. 

I am heading to Boston for BIO’s Intellectual Property Counsels Committee Fall Conference and Committee Meeting from Monday October 18th to Wednesday the 20th.  I plan on posting summaries of our panel discussions on the following topics:

  • Evolving patent-eligibility standards for genes, biomarkers, diagnostics, and cell-based therapies;
  • Valuation of IP when selling, licensing, or acquiring biotech patent rights;
  • Present and impending changes to the way you practice before the PTO;
  • How to defend your patent in an inter partes reexam;
  • Whether inequitable conduct reform is close or elusive;
  • Inducement, divided infringement, “abstract idea” exceptions, and other things that go “bump” in the dark if you own Biotech method patents;
  • Tales from the edge and beyond: accounts of biotech investment in emerging market countries.  

Don’t Forget:

Follow us on Twitter @petepatentagent which will display our new blog posts.  Alternatively, the blog has a sign up mechanism to notify you by email when a new blog is posted.

IPWatchdog Blog: “In Search of Technology Transfer Best Practices”

Gene Quinn of IPWatchdog.com covered the BIO-AUTM Technology Transfer Symposium this past week, on May 4, 2010 at the 2010 BIO International Convention.

The Symposium attendees were high-level experts on technology transfer policy looking to get to the “brass tacks” of issues concerning innovation, federally funded research, and creative licensing schemes for product development in the United States.

Below is a quotation from IPWatchdog’s coverage:

Last week while at the 2010 BIO International Convention, I attended the Tech Transfer Symposium, which was held on Tuesday, May 4, 2010 at the Hyatt Regency Ballroom at McCormick Place. I had previously arranged an interview with Linda Katehi, Chancellor of the University of California (Davis), a transcript of that conversation appears below. At the outset of the Tech Transfer Symposium Katehi gave an introductory presentation on technology transfer that lead into a panel discussion.  As an Electrical Engineer, Professor and now Chancellor in the UC system, Katehi has a lot of experience with technology transfer, and for those Universities struggling to figure out how to license out technology in a successful manner they could learn an awful lot from Katehi. Her presentation and the time I spent thereafter with her continued to facilitate my understanding of why some Universities succeed and others fail.

Katehi also has some interesting suggestions regarding what the Patent Office could do to help Universities, both in speeding up the patent process and in keeping costs lower.  I learned a lot from speaking with Katehi, which supplemented my knowledge based on my experiences at Syracuse University.  What I am continually piecing together suggests that there is no great surprise why most Universities do not do a better job with respect to technology transfer.  There are things that are clearly considered best practices in the private sector that seem to elude Universities for the most part.  The University of California system seems to be out in front and trying to bring the best practices of the private sector into Universities.  It is no wonder they do a better job than most with technology transfer.

Full summary of the BIO-AUTM Technology Transfer Symposium:

Today’s Technology Transfer Symposium’s panel on The Role of Universities, Biotechnology Companies and Technology Transfer in the Innovation Economy included an active debate on issues ranging from increasing the odds for a successful partnership and the pros and cons of the Bayh-Dole Act.  Andrew Cittadine, Co-founder & CEO of American BioOptics, Linda P.B. Katehi, Chancellor of the University of California (Davis), Steve Mento, President and CEO of Conatus Pharmaceuticals, Inc., and Tom Skalak, Vice President for Research, University of Virginia, all participated in the conversation, moderated by Robin A. Chadwick of Schwegman, Lundberg & Woessner.

Skalak noted during the panel that one of the keys to a successful partnership is “diverse eyeballs on the project,” which can help in making good decisions.  As an example, he pointed to a deal his university is involved in with AstraZeneca.  Cittadine underscored the importance of finding a good fit between the university and the biotech firm.

In discussing Bayh-Dole, all the panelists agreed that the Act has brought a lot of benefit to the industry, although there is room for improvement.  The Act “provides incentives to institutions to bring research to the marketplace,” explained Katehi.  Under Bayh-Dole, “ideas can emerge,” she added.  While she acknowledged that changes are needed, Katehi explained that if the Act is eliminated “there will be millions of good ideas, but no process for bringing them forward.”

Mento agreed, stating, “Bayh-Dole made the biotech industry possible.”  He noted that the system worked in the beginning, but it has now “evolved into a system where the focus is on short term return.”  It’s “impossible” to make the economics work, Mento said.

Cittadine added, the framework in Bayh-Dole is what enables new ideas to get funding.  Skalak, meanwhile, noted that without Bayh-Dole, discovery-oriented research would not happen.

Did you attend the Symposium? Interested in materials, or in joining the BIO Technology Transfer Committee? Email me at mnoriega@bio.org.

Sharing & Promoting Innovative Technology in Public-Private Global Development Partnerships

Sharing and Promoting Innovative Technology in Public-Private Global Development Partnerships

World Trade Organization (WTO) Public Forum, Geneva

September 29, 2009

The World Trade Organization Public Forum has become one of the most important platforms for dialogue among stakeholders of the multilateral trading system. Each year representatives from key international agricultural and development agencies attended the Public Forum as panellists and participants. The Public Forum draws significant attention from governments, non-government organizations, academics, businesses and the mass media.

This year, CropLife International is assembling a diverse panel with substantial experience to offer their views on innovative solutions to critical global agricultural problems on Tuesday, September 29 (16:30-18:30) in Geneva.

Panelists will discuss:

  1. The increasing importance of public-private partnerships for development;
  2. How such partnerships stimulate, protect, and share innovation, and
  3. The case of agricultural innovation as an example of the role of public-private global development partnerships in stimulating, protecting, and sharing innovation

Technological advances can play a particularly central role in addressing agricultural challenges such as drought and destructive pests. Meeting these challenges sustainably will require new ideas, tools and technologies. The WTO Public Forum is an excellent opportunity to have a productive discussion on these important topics; we look forward to your participation.

Invited Panelists:

  • Mr. Grant D. Aldonas – Senior Associate, Center for Strategic and International Studies (Invited)
  • Dr. Gerard F. Barry – Head, IPMU and Program 4 Leader, Golden Rice Network Coordinator, International Rice Research Institute (Invited)
  • Professor Sir Gordon Conway – Chair in International Development, Imperial College London, Imperial College (Confirmed)
  • Mr. Gavin Power – Deputy Director and Head of Financial Markets, UN Global Compact (Invited)

For more information, visit Croplife’s website.