U.S. Rep. Diana DeGette , D-CO, and Rep. Charlie Dent, R-Pa, reintroduced legislation to support embryonic stem cell research.  The representatives are co-sponsoring the Stem Cell Research Advancement Act of 2011, H.R. 2376.

The bill would codify the National Institutes of Health’s guidelines for carrying out all stem-cell research and require the NIH to review its guidelines every three years and make updates as science warrants.  Furthermore, the bill would give legislative enforcement to the president’s 2009 decree allowing federal funding for medical research performed on abandoned embryos from fertility clinics.

SEC. 498E. HUMAN STEM CELL RESEARCH.

(a) In General.–Notwithstanding any other provision of law, the
Secretary shall conduct and support research that utilizes human stem
cells, including human embryonic stem cells.

(b) Eligibility.–Human embryonic stem cells eligible for use in
research under subsection (a) shall include stem cells that meet each
of the following:

(1) The stem cells were derived from human embryos that
have been donated from in vitro fertilization clinics, were
created for the purposes of reproductive treatment, and were in
excess of the clinical need of the individuals seeking such
treatment.

(2) It was determined through consultation with the
individuals seeking reproductive treatment that the embryos to
be donated would never be implanted in a woman and would
otherwise be discarded.

(3) The individuals seeking reproductive treatment
donated the embryos with written informed consent and without
receiving any financial or other inducements to make the
donation.

SEC. 498G. PROHIBITION AGAINST FUNDING FOR HUMAN CLONING.

(a) Prohibition.–The Secretary shall not use any funds for the
conduct or support of human cloning.

(b) Guidelines.–The Secretary shall update the guidelines
maintained under section 498F for consistency with subsection (a).

(c) Definitions.–In this section, the term `human cloning’ means
the implantation of the product of transferring the nuclear material of
a human somatic cell into an egg cell from which the nuclear material
has been removed or rendered inert into a uterus or the functional
equivalent of a uterus.”

Critics of the bill site religious and moral reasons for their opposition, contending that the research will destroy possible embryos to harvest the stem cells.  Rep. Doug Lamborn, a Colorado Springs Republican, has been among those opposed to embryonic stem cell research on the grounds that it’s unethical and immoral to use human embryos for scientific research.

Backers of the bill point out that bill provides a basis for protecting the NIH’s ability to continue to support the important scientific work that gives hope to millions of patients and their families. Currently, companies support research in Central and South America where there are fewer restrictions on stem cell research. Stem cell cures could produce billions of dollars of revenue for the companies that develop these cures and bring them to market, making federal support for stem-cell research in the U.S. crucial to maintaining the nation’s competitive edge.

Earlier versions of the Act were passed by both the House and the Senate but ultimately vetoed by then President George Bush.

Urge your representative and senators to pass the Stem Cell Research Advancement Act this year. The U.S. must continue to invest in embryonic stem cell research and a legislative solution is necessary to ensure that federal funding for this important research is no longer vulnerable to political or ideological challenge.

http://www.house.gov/house/MemberWWW_by_State.shtml

http://www.senate.gov/general/contact_information/senators_cfm.cfm

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The Biotechnology Industry Organization (BIO) announced its endorsement of the “Joint Declaration on Cooperation in the Fight against Doping in Sport” between the World Anti-Doping Agency (WADA) and the International Federation of Pharmaceutical Manufactures and Associations (IFPMA).

“This endorsement adds credence to the declaration between WADA and the IFPMA and is further evidence that the fight against doping in sport is becoming more unified”

A resolution to endorse the declaration, which was signed last year, was approved during the 2011 BIO International Convention being held in Washington D.C., from June 27-30 at the Walter E. Washington Convention Center.

The declaration between WADA and the IFPMA outlined a voluntary cooperation to identify medical compounds with doping potential, restrict misuse of medicines still in development, improve the flow of relevant information, and facilitate development of detection methods in the context of the fight against doping sport.

“It is of high importance to BIO’s members that their medicines are used for what they were intended – to save lives and improve the quality of life of patients suffering from serious disease,” said BIO President and CEO Jim Greenwood. “Our members have continually demonstrated their commitment to the anti-doping cause. Our endorsement of this joint declaration is a natural step in this long-standing tradition and enables us to further reach the goal of eradicating doping in sports.”

“It is not only sport that is cheated by the misuse of medicines, the manufacturers are also being cheated, and WADA is delighted with the growing spirit of cooperation in the fight against doping sport.”

As part of their endorsement, BIO will encourage its member organizations to collaborate with WADA and the IFPMA as outlined in the declaration.

This year’s BIO International Convention includes a breakout educational session addressing the issue of anti-doping in sport entitled, “How Dare they Dope with our Medicines,” being held Thursday, June 30.

Ironically, the discussion will be led by Steve Elliott, Scientific Executive Director for Amgen.

See the 60 Minutes interview with Tyler Hamilton on doping in cycling.

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Celebrating 30 years of Biotechnology Innovation: From Diamond v. Chakrabarty to Today

Thursday June 30, 2011 9:00-11:00AM

Walter E. Washington Convention Center Room 102AB

This event co-sponsored by the US Patent and Trademark Office, The Biotechnology Industry Organization and the Biojudiciary Project  will  celebrate the 30th anniversary of the issuance of the patent from the Supreme Court case, Diamond v. Chakrabarty, which held that subject matter derived from nature is eligible for patenting.

This decision has led to numerous breakthroughs in medical therapies, increased crop yields and renewable fuels.  The event will trace the journey of a biotechnology invention from the university to the USPTO and the marketplace and will highlight breakthrough biotechnology inventions of the past 30 years.

Registration                                                                                                                                                       8:00-9:00AM

Opening Remarks 9:00-9:15AM

David J. Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office

Technology Showcase                                                                                                                                   9:15-9:55AM

  1. Toby Horn, Carnegie Institution-A History of Biotechnology
  2. Ananda Chakrabarty, Distinguished Uni. Professor, University of Illinois at Chicago-30 years after Diamond v. Chakrabarty:  Looking back and moving forward
  3. Jerry Steiner, Exec. VP, Sustainability & Corporate Affairs, Monsanto Company
  4. Dr. David Fischhoff, Inventor, Monsanto Company-Synthetic Bt Genes for Insect-protected Plants
  5. Jason Ferrone, VP, Patents and Senior Patent Counsel Isis Pharmaceuticals-Chemically Optimized Antisense Compounds

Panel: From Discovery to Market: The Journey of a Biotechnology Invention                     9:55-10:55AM

Moderator:

Teresa Stanek Rea, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office

Panelists:

  1. Ananda Chakrabarty, Distinguished Uni. Professor, University of Illinois at Chicago
  2. George Elliott, Technology Center Director, USPTO
  3. Christine Bellon, Vice President for Intellectual Property and Legal Affairs, HydraBiosciences

Q&A for reminder of time

Closing Remarks                                                                                                                                              10:55-11:00AM

James C. Greenwood , President and CEO of the Biotechnology Industry Organization

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You can keep up with what’s happening at BIO 2011 on BIOTechNOW (@BIOTechNOW) plus all the BIO Official Bloggers hitting the floor at the convention.

I’ll be in attendance as well as participating in the BIO Official Blogger network throughout the week.   If you’d like to meet up during the conference, drop me a note and we’ll schedule some time to have coffee together. email the Baristas

If you have anything you’d like to bring attention to, track me down at the convention and let me know. Feel free to talk up your own company or product, or just vent.

Besides Patent Baristas, here are some BIO Convention 2011 bloggers:

John Carroll at Fierce Biotech – follow John at @JohnCFierce
About John: John is a biotech analyst with 32 years of prize-winning experience in journalism. Appointed editor of FierceBiotech in 2003, he has covered genomics, biotechnology, healthcare and more.

Angie Drakulich and Amy Ritter at PharmTech Talk
About Angie: Angie joined Pharmaceutical Technology in 2007, where she covers global health, biopharmaceutical, academic, government, and donor communities in support of bio/pharmaceutical research and development, among other pharma topics.

Yali Friedman at Biotech Blog – follow Yali at @thinkbiotech
About Yali: Yali Friedman, Ph.D., is founder of thinkBiotech and chief editor of the Journal of Commercial Biotechnology. His book, Building Biotechnology, is used as a course text in dozens of biotechnology programs.

Brady Huggett at Trade Secrets – follow Brady at @naturebiotech
About Brady: Brady is the Business Editor for Nature Biotechnology. Since 1998, Nature Biotechnology’s Bioentrepreneur has been capturing key insights and advice for those directly involved in shaping the innovative biotech sector.

Kevin Noonan at Patent Docs – follow Kevin at @patentdocs
About Kevin: Kevin combines his JD and PhD in molecular biology to represent pharmaceutical and biotechnology companies both large and small in all aspects of patent prosecution, interference, litigation, and client counseling on validity, infringement, and patenting strategy matters.

Steven Overly at Capitol Business – follow Steven at @StevenOverly
About Steven: Steven Overly covers local business, specifically technology, entrepreneurship and venture capital, for The Washington Post and its weekly Capital Business section.

Gene Quinn at IP Watchdog – follow Gene at @ipwatchdog
About Gene: Gene is a US Patent Attorney who runs one of the top intellectual property blogs on the Internet.

Mike Spear at Genome Alberta – follow Mike at @mikesgene
About Mike: Mike is the Director of Corporate Communications at Genome Alberta, where he covers Agriculture/Forestry/Environment/Byproducts, Biomedical/Health, Life Sciences Technologies, and last but not least Genomics Ethical, Economic, Environmental and Legal Studies (GE³LS).

Betsy Raymond Stevenson at Snapshot – follow Betsy at @Betsy_RSHC
About Betsy: Betsy knows that most of us are involved in the healthcare industry because we want to contribute in a meaningful way to improve public health. She founded RaymondStevenson Healthcare Communications in 2007, to strengthen relationships between the pharmaceutical and biotechnology industries. Betsy speaks and writes frequently on healthcare communications, industry reputation, and the changing media landscape.

Don Zuhn at Patent Docs – follow Don at @patentdocs
About Don: Don has more than a decade of experience in all aspects of patent prosecution, litigation, counseling, and licensing. He represents a variety of clients, including biotechnology and pharmaceutical companies both large and small, and universities.

If you are a blogger in attendence — or know someone who is — send me a note and I’ll add them to the list.

See you there!  @PatentBaristas

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If you’re attending the BIO International Convention in Washington, DC on June 27-30th here are some of the sessions covering issues in biotech patenting and technology transfer:

Drug Patent Linkage and Compulsory Licensing – Challenges of Working Patented Inventions in India for Pharma Sector Monday, June 27, 2:00 pm – 3:15 pm.  The session deals with hot and highly debated topics -Patented drug regulatory approval (BMS vs Hetero &Bayer Vs UOI 2010), Patent vs. pricing debate (Roche vs Cipla), Compulsory Licensing: Export of patented drugs (Pfizer/ Roche vs Natco), Linkages in Indian Patent System (Custom enforcement, Biopharmaceuticals, Marketing –Approval and EMR, Efficacy testing, Competition, Working).

A Brave New World: Patent Litigation Tactics and Strategies for Biosimilars Monday, June 27, 3:45 pm – 5:00 pm.  This session will educate attendees on the requirements of a new biosimilar patent litigation pathway.

IP Issues Affecting Biomarker-Based Diagnostics.  Monday, June 27, 3:45-5pm, Speakers will discuss challenges for securing IP protection for biomarker diagnostics and discuss important cases before the Federal Circuit.

The Myriad Case and the Patentability of Isolated DNA Molecules.  Tuesday, June 28, 8:30 am – 9:45 am.  This panel will discuss high-profile patent cases and address recent developments in the Myriad case and BIO’s leadership role as an amicus.

Patents in the Supreme Court.  Tuesday, June 28, 10-11:30am.  Several of the country’s most experienced Supreme Court litigators, among them former Solicitor General of the United States, will discuss the direction of patent law in the nation’s highest court and its implications for the biotechnology industry.

Counterfeiting – How Corporations and the Government Can Work Together.  Tuesday, June 28, 2:00-3:30pm.  A panel of experts representing BIO companies, government, and law enforcement will address the role of each entity in identifying, arresting, and prosecuting counterfeiters. Victoria Espinel, the first U.S. IP Enforcement Coordinator, will serve on the panel.

Navigating the New Law on Licensing Biosimilars.  Tuesday, June 28, 3:45-5pm.  This panel discussion will address FDA’s structure and approach to biosimilar reviews and guidance, the meaning of terms such as “highly similar” and “interchangeability,” whether the new pathway may be used for products presenting advances over existing products (“biobetters”), and the complex and fast-moving patent dispute framework incorporated into the new law.

Technology Transfer: New Methods, New Media, New Models for Improving Interactions with Industry.  Wednesday, June 29, 8:30-9:45am.  With increased pressure to do more with less resources, business development as well as technology transfer offices have the task of efficiently moving inventions and research materials through product development and ultimately into the hands of consumers. This session will focus on traditional and new methods in streamlining internal processes and technologies to accomplish this goal.

Lessons From In-Licensing Partnership: Biotech Company Partners With Global Pharma to Deliver Cutting-Edge Follow-On Biologics.  Wednesday, June 29, 10:00 am – 11:30 am.  Panelists from the pharmaceutical and biotech industry will provide exclusive insight on how global pharma and biotech can collaborate to develop, gain authorization and globally commercialize a cutting edge follow-on biologics.

Collaborative R&D From the Perspective of Large Multinationals, Universities and Start-ups.  Wednesday, June 29, 2:00 pm – 3:30 pm.  Panelists will teach participants how to approach technology owners and attract sponsors for research and licensing revenues. The session will also address key aspects of collaboration and licensing agreements.

IP Challenges for Personalized Medicine: Navigating Bilski, Myriad, and Prometheus. Wednesday, June 29, 2-3:30pm.  This session will outline the intersection of personalized medicine and gene patents and will highlight how current cases, e.g., Bilski, Myriad and Prometheus, are affecting biotechnology. The session will also explore how companies can deliver on the promise of personalized medicine in such an environment.

The Trans-Pacific Partnership and the Importance of Intellectual Property Rights: Attracting Investment in Biotechnology. Wednesday, June 29, 2-3:30pm.  TPP represents a unique opportunity for the US and other TPP party governments to set a high standard and example for the region for improved intellectual property rights, including a 21st century data protection and patent regime that will foster greater collaboration, innovation, investment and economic growth in biotechnology.

Innovative Collaborations: Deal Structures for Nonprofit/For-Profit Collaborations.   Thursday, June 30, 8:30 am – 9:45 am.   The panel will provide examples of productive collaborations and discuss the elements of those deals that contributed to their success.

European patent and unitary EU patent: the changes ahead. Thursday, June 30, 10-11:30am.  This session will focus on the recent and expected changes in EU, national and EPO laws and try to determine their impact on patenting, licensing and global business development strategies.

See you there!  @PatentBaristas

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bio_intl_con.jpegSee how biotech innovations help heal, fuel, and feed the world. The Biotechnology Industry Organization (BIO) will be holding its annual BIO International Convention on June 27-30, 2011 in Washington, DC.

Not a small, intimate affair, the BIO International Convention draws approximately 20,000 industry leaders from 60 countries. This year, the Convention program will feature 16 tracks with 125+ Sessions, 1,000+ speakers.   An electronic version of the brochure for the 2011 Convention can be obtained here.

The 2011 BIO International Convention will feature leading industry experts and government officials from around the world debating key issues that dramatically influence the biotechnology industry including follow-on biologics/biosimilars, biomarker research, genomics and the ever-changing global biotechnology business landscape.

In addition, more than 2,000 biotech companies, organizations, and institutions will participate in the BIO Exhibition.  A searchable list of exhibitors can be found here.  Information regarding registration and pricing can be obtained here.

I’ll be in attendance as well as participating in BIO’s blogger network throughout the week. If you’d like to meet up during the conference, drop me a note and we’ll schedule some time to have coffee together. email the Baristas

You can follow Patent Baristas here or @PatentBaristas.  You can get BIO updates from BIOtechNOW, an online portal and newsletter produced by BIO or @BIOConvention.

See you in DC!

 

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Today is Take Your Dog to Work Day.  Apparently, businesses worldwide have been opening their workplaces to employees’ four-legged friends since 1999, according to Pet Sitters International’s Take Your Dog to Work Day website.

It’s not just the small places like mom and pop stores or pet stores that are allowing this.  In fact, large companies such as Amazon and Google are two of the places where your dog is just as welcome as you are (maybe more so)! According to a recent survey by American Pet Products Manufacturers Association, about one in five companies now allows pets, and three percent of dog owners have brought theirs to work a couple dozen times.

Why should an employer want to be a part of this dog day? Studies show that pets in the workplace boost employee morale, productivity and even sales! TYDTWDay is touted as a great public relations opportunity as well as an opportunity to raise awareness of helping save the lives of homeless shelter animals in your area and around the world!

While my dog is laid up with a back injury, I hope others were able to spend some quality time with their pet.

~Ed.

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There’s more reaction to the passage of The Leahy-Smith America Invents Act, H.R. 1249, by the House of Representatives.

The Biotechnology Industry Organization (BIO) came out in support of the bill.  President and CEO Jim Greenwood said:

“The Leahy-Smith America Invents Act will bring our patent system into the 21st century.  The improvements made by the bill will benefit all sectors of the national economy by enhancing patent quality and the efficiency, objectivity, predictability and transparency of the U.S. patent system.”

But, Greenwood indicated that the issue isn’t final just yet saying:

“BIO will continue to work with House and Senate leaders to ensure that final patent reform legislation addresses any remaining concerns and is enacted into law this year.”

The U.S. Chamber of Commerce applauded passage of H.R. 1249 as  an important piece of legislation that would help ensure the U.S. Patent and Trademark Office (USPTO) has the necessary resources to revitalize America’s patent system:

“Businesses’ ability to innovate and create quality jobs should not be hindered by stalled patent applications,” said Bruce Josten, Chamber’s executive vice president for Government Affairs.  “This bill, which makes long over-due and needed reforms, is a critical tool to ensure that the PTO is adequately staffed, efficiently operated, and fully funded to process patent and trademark applications in a high-quality and expeditious fashion.”

 

The  American Innovators for Patent Reform (AIPR), an  advocacy group for inventors, opposed the legislation saying:

“We are very concerned that the change to a first-to-file regime and post-grant opposition will stifle innovation in the U.S., and because the House version of the bill fails to provide full funding for the U.S. Patent and Trademark Office (USPTO),” says Alexander Poltorak, AIPR’s founder and president. “This legislation was bought and paid for by large corporations which see being forced to pay royalties for technology invented by others as an unfair business practice. Faced with the escalating costs of defending their patent validity when challenged by post-grant oppositions, I fear that many inventors and small businesses will keep their inventions as trade secrets instead of patenting them, contrary to the intent of the Founding Fathers who envisioned the patent system as a mechanism to encourage disclosure of inventions to stimulate the progress of science and technology as they enshrined it in the Constitution.”

Others were also disappointed that the Act still contains the controversial Section 18 of the bill, which many argue was designed solely to make it easier for financial institutions to challenge business method patents:

(a) Transitional Program- (1) ESTABLISHMENT- Not later than the date that is 1 year after the date of the enactment of this Act, the Director shall issue regulations establishing and implementing a transitional post-grant review proceeding for review of the validity of covered business method patents. The transitional proceeding implemented pursuant to this subsection shall be regarded as, and shall employ the standards and procedures of, a post-grant review under chapter 32 of title 35, United States Code, subject to the following:

(d) Definition-(1) IN GENERAL- For purposes of this section, the term ‘covered business method patent’ means a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions.

Note:  The House approved several amendments to the bill, and because it differs from the version passed by the Senate on March 8, it now must go back to the Senate for reconsideration.

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