President of the EPO says Unitary Patent Still on Track

Before answering this question, I must say that one thing has always astonished me: while Europe, or at least quite a number of EU Member States, was able to adopt a common currency after a relatively short period of negotiation considering the importance and sensitivity of the issue, it seems much more difficult to obtain a common patent with a single litigation system even though this is an absolute economic and legal necessity.

First came the opinion of the European Court of Justice regarding the patent litigation system on 8 March. One could have been disappointed that the Court concluded that the project was incompatible with the EU Treaty and have feared this result could negatively impact the discussions about the further Unitary Patent. But happily this has not been the case as the EU Council, with a group of 25 Member States, took a landmark decision pushing the enhanced cooperation for the Unitary Patent, on 10 March.

This decision represents a major step forward for European innovative industry, particularly the SME’s! Of course, to respond to the ECJ concerns, policy makers will have to be creative and a transitory solution for the litigation system will certainly have to be found. From the EPO side, I can assure you that all the necessary steps will be duly prepared in order to allow the rapid implementation of the Unitary Patent.

Benoît Battistelli

President

Full EPO Blog Post

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U.S. Inter-Agency Group takes on Counterfeit Pharmaceuticals

The Office of the Intellectual Property Enforcement Coordinator released an Inter-Agency report partnering with the Food and Drug Administration, U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, and the Departments of Justice, State, and Commerce and USAID.

The report highlights the Administration’s efforts to combat counterfeit pharmaceuticals listing various Department initiatives and in some cases providing actual budget numbers (State Department budgets $1.3 million in 2011 to combat counterfeit pharmaceuticals). 

Finally, the report provides the Vice President and Congress some legislative fixes they deem appropriate to help combat counterfeit pharmaceuticals.  Recommendations include mandatory disclosure by importers and manufacturers when they discover counterfeit drugs or medical products, the adoption of a “Track-and-Trace” system, and the group recommends increasing penalties for counterfeiters.

BIO Hails Senate Passage of America Invents Act

BIO Hails Senate Passage of America Invents Act

Bipartisan, consensus-oriented approach will strengthen nation’s patent system and spur innovation, job creation

Washington, D.C. (March 8, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the passage today of the America Invents Act (S. 23) by the U.S. Senate:

“BIO commends the Senate for its overwhelming passage of the America Invents Act by a vote of 95-5.  We appreciate the dedication of Senate Judiciary Chairman Patrick Leahy (D-VT), Ranking Member Charles Grassley (R-IA) and the bill’s other cosponsors for their tireless efforts to build bipartisan consensus on the legislation.  Once enacted into law, it will strengthen and improve our nation’s patent system, spurring innovation and job creation.

“Patents are often the main assets of small biotech companies, and they rely on this intellectual property to attract investors to fund the lengthy and expensive research and development process necessary to bring breakthrough new therapies and other biotech products to patients and consumers.

“The improvements made by the America Invents Act would benefit all sectors of the U.S. economy by enhancing patent quality and the efficiency, objectivity, predictability, and transparency of the patent system. 

“BIO encourages the House of Representatives to consider patent reform without delay, and we look forward to working with Chairman Lamar Smith (R-TX) and the members of the House Committee on the Judiciary.  We are committed to ensuring that patent reform legislation preserves and enhances the incentives necessary to sustain our nation’s global leadership in biotechnology innovation and to spur the creation of high-wage, high-value jobs throughout the country.”

IP Position Critical to Biotech Investment

A great article from Genetic Engineering and Biotechnology News written by Lisa Haile reviewing the Myriad case and its implications for future medical advances.

Interesting Quotes:

“While it is unfortunate, I have seen quite a few technologies over the years that would be of potential great benefit to patients, but the intellectual property was simply not there to support protecting the product from fast followers in the market place,” explains Robert More, a general partner at Frazier Healthcare Ventures.

“Unfortunately, because of the enormous sums of money required to discover, develop, test, and approve anything in the healthcare sector, quite aside from the time it takes, IP is critical.” More further states that since “patents have definitive lifetimes, 20 years or less of exclusivity, and then an infinite time in the public domain, I think that is a small price for us to pay for innovation.”

“When evaluating opportunities to determine whether we will come in and underwrite the deal, we look at the IP position as one of the key questions,” explains Robert Dentice, head of life sciences investment banking at Cantor Fitzgerald. “We know that if the IP position is not strong, it is unlikely that we will pursue the opportunity further, knowing that the IP strategy and position will be one of the top three questions that the investors will ask about.”

Takeaways: The Case for Gene Patents

     Gene patents are the foundation of the biotech industry and precluding them would halt forward progress.

The patent system promotes innovation and stimulates investment in R&D.

If there were no exclusive rights in the final product, there would be little incentive to invest time and money into developing it.

Without the incentives offered by the issuance of patents, the industry and, ultimately, patients would suffer. 

2011 BIO International Convention Super Sessions

2011 BIO International Convention Super Sessions Focus on State of the Industry

C-Level speakers lead broad conversations on global biotech, industry forecast, and key trends

WASHINGTON, D.C. (March 2, 2011) — The 2011 BIO International Convention will feature six high-level super sessions focused on the state of the industry, global biotech advancements and the outlook on the future of the industry. Hosted by the Biotechnology Industry Organization (BIO), the global event for biotechnology will take place June 27-30, 2011 at the Walter E. Washington Convention Center in Washington D.C.

“The last few years have presented significant economic challenges for emerging biotech companies trying to raise investment capital, which has had a global impact on the industry. Despite recent positive signs, it is still a tough market,” said BIO CEO and President Jim Greenwood. “These Super Sessions feature high-level speakers sharing their long-term outlook on the industry, and suggested strategies for successfully rebounding from the financial challenges and moving innovation forward to help heal, fuel and feed the world.”

Super Sessions include:

Ernst & Young’s 25th Annual Biotechnology Industry Report

Ernst & Young will present highlights from its 25th annual industry report. The session will discuss implications for biotech companies as they face a more uncertain future in the current business climate. As always, Ernst & Young will also summarize the sector’s performance using key metrics – financial performance, financing, deals and pipeline productivity.

Sponsored by: Ernst & Young 
Tuesday, June 28, Time: 10:00 am – 11:30 am
Confirmed Speakers: Glen Giovannetti, Partner and Global Biotech Leader, Ernst & Young LLP; Gautam Jaggi, Senior Manager and Editor, Beyond Borders and Progressions, Ernst & Young LLP

Burrill State-of-the-Industry Report
This presentation will look back over 25 years and describe some of the critical events that have shaped the industry into the global enterprise it is today and discuss what companies will need to do in order to remain competitive in a world being influenced by a tougher financial climate, rapidly evolving technology, globalization and new emerging markets.

Sponsored by: Burrill & Company
Tuesday, June 28, Time: 2:00 pm – 3:30 pm
Confirmed Speaker: G. Steven Burrill, Chief Executive Officer, Burrill & Company  

It Takes a Village– The Biotechnology Innovation Ecosystem

This session will detail the roles, relationships and interplay among government research labs, universities, and large and small biotechnology firms in the continuum from basic research to FDA-approved products and ultimately to the patient.

Sponsored by: Eli Lilly and Company
Tuesday, June 28, Time: 3:45 pm – 5:15 pm
Confirmed Speaker: John Lechleiter, Ph.D., Chairman, President & Chief Executive Officer, Eli Lilly & Company

Emerging Markets: The Future of Growth for Biologics?

This panel will bring together leading business executives with senior government officials to talk about how Emerging Markets are shaping business thinking and what impact they will have on the future of the biotech sector.

Sponsored by: Merck
Wednesday June 29, Time: 10:00 – 11:30 am
Confirmed Speaker: Richard T. Clark, Chairman, Merck

Campbell Alliance 2011 Dealmakers’ Intentions

Campbell Alliance and BIO present updated findings from two unique forward-looking measures of deal-making in the industry – the Campbell Alliance Dealmakers’ Intentions Survey and the BIO One-on-One Partnering Forecast.  New analysis in 2011 will include year-over-year trends and the first assessment of the predictive value of these instruments.

Sponsored by: Campbell Alliance
Wednesday June 29, Time: 2:00 – 3:30 pm
Speakers to be announced. 

Worldview 2011: Scientific American’s Regional Bio-Innovation Scorecard

Worldview 2011 will feature the third annual Scientific American’s Regional Bio-Innovation Scorecard, a review of individual country programs and policies aimed at growing local innovative biotechnology sectors. 

Wednesday June 29, Time: 3:45 – 5:15 pm
Confirmed Speaker: Fareed Zakaria, CNN host, Editor-at-Large of TIME Magazine, Washington Post columnist, former Editor, Newsweek International

The 2011 BIO International Convention is expected to draw more than 15,000 industry leaders from 49 states and 65 countries.  This year, the Convention program will feature more than 125 sessions in 16 tracks.  In addition, this year’s BIO Exhibition will cover an estimated 180,000 net sq. ft. and host more than 1,700 exhibitors.

The BIO International Convention also includes the BIO Business Forum, which offers attendees an unparalleled opportunity for large and small biotech companies to gather in one place, at one time to engage in partnering discussions. The ability to schedule up to 80 one-on-one meetings within just a few short days with biotech leaders from around the world enables companies to maximize their ROI for the registration and travel investment for this event. In 2010, the BIO Business Forum hosted more than 17,000 partnering meetings with more than 2,000 companies participating.

The BIO International Convention helps to support the association’s programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation.  For additional attendee and exhibitor information, please visit http://convention.bio.org.

For detailed descriptions and a full program, please visit http://convention.bio.org.

Advance media registration for the 2011 BIO International Convention is now open and will be available online through June 17, 2011. To register in advance, please visit http://convention.bio.org/media.

BIO submits comments on Australian Senate Patent Amendment

The Australian Senate has proposed the Patent Amendment (Human Genes and Biological Materials) Bill 2010 that aims to ban ‘gene patents’

From the BIO Submission to Australian Senate Legal Committee on Patent Amendment:

This amendment would exclude from patent protection “any” biological material, whether a human gene or otherwise, that is substantially identical to a naturally-occuring biological material.  Specifically, the amendment states that the following materials would be catergorically declared unpatentable:

            “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.”

“Biological materials” broadly “include,” but apparently not limited to, such fundamental biotechnology building blocks as “DNA, RNA, proteins, cells and fluids.”

As almost any biological material can be said to be “substantially identical” to some other natural biological material, this change would have the effect of banning large swaths of previously patentable innovative biological discoveries – thus, removing the protection needed to incentivize investment in biotechnology-related innovation in drugs and biological therapies, preventative treatments such as vaccines, animal healthcare products, renewable energy production and other “green” technologies, environmental mitigation and remediation, biodiversity, farming, food, nutrition, household cleaners, and industrial fermentation for food and fuel production.
BIO and its members believe that excluding biological inventions from patent protection is inconsistent with the demonstrated evidence of social benefit from isolating and purifying active compounds from previously ineffective mixtures occurring in nature. For example, the invention of isolated polymerase from certain thermophilic bacteria has provided valuable methods for amplifying DNA that enables forensic DNA analysis to establish guilt or innocence of crimes, the development of life-saving medical diagnostics, and molecular breeding for improved plants. If the amendment had been law, it would have prevented the patenting – and thus development – of significant advances in human health, like purified insulin, adrenaline, and antibiotics; vitamin D and B-12 compositions; human growth hormone; erythropoietin, and numerous vaccines and anti-cancer treatments on the market today.

Accordingly, BIO believes that this amendment, if adopted, would fail to affect its intended purpose of advancing medical and scientific research and the diagnosis and cure of human illness and disease. Indeed, it would slow such progress immeasurably. The public demands continuing the patent incentive for such biologic innovation.