The Sherley v. Sebelius lawsuit challenging U.S. funding for human embryonic stem-cell studies was dismissed by a federal judge after an appeals court found the government-backed research is probably lawful.

U.S. District Judge Royce Lamberth, chief of the federal court in Washington, last year said the lawsuit was likely to succeed and ordered a stop to the research while the case was pending. But, the injunction was yanked by the U.S. Circuit Court of Appeals who thought the case was likely to fail.

The original suit was brought by two doctors who sought to block the U.S. Health and Human Services Department and the National Institutes of Health from spending federal funds on research involving human embryonic stem-cells.  The plaintiffs in this case, Dr. Sherley and Dr. Deisher, are scientists who conduct research using only adult stem cells. They assert that the NIH violated the Dickey-Wicker Amendment by funding ESC research projects.

Lamberth last year temporarily barred the government from funding the research, finding it probably violated the so-called Dickey-Wicker Amendment. The 1996 law bars government spending on research that damages or destroys a human embryo. Now, the United States Court of Appeals for the District of Columbia overruled, by 2-1, the district court judge’s preliminary injunction on federal funding of research using embryonic stem cells (ESCs).

The Dickey-Wicker Amendment is an appropriations rider that bars the NIH from funding:

  1. The creation of a human embryo or embryos for research purposes; or
  2. research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

The court’s analysis turned on the ambiguity of the Dickey-Wicker Amendment, specifically, a lack of definition for the word “research.” The court determined that the present tense of the Amendment, with no reference to embryos that “were destroyed,” implied that the Amendment did not ban ESC research on stem cell lines in existence at the time of the Amendments enactment.

Judge Ginsburg also pointed out that Congress has continued to leave the Dickey-Wicker Amendment unchanged every year since 1996 even though Congress has had “full knowledge” that the Department of Health and Human Services has been funding ESC research since 2001.

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The Indian patents system, having its seeds laid in the British era (1852) and undergoing sporadic replantations (the 1912, 1970, 2005 Patents Act & amendments), was appearing to grow tall and bear fruits until a noticeable downfall last year. It was surprising and interesting to note the sudden decline in the patents filed, examined and granted with the Indian Patent Office as highlighted in the Annual Report 2009-10 of the Intellectual Property Office India.

In hindsight, we had a heavy backlog of pending examination cases, need for transparency in the system, controversies over pharmaceuticals and software patents and a longer list to deliberate upon.

On the other side of the coin, we could use a periscope to notice some of the positive changes that have happened over the last couple of years. A significant one would be the drive to digitalize the patent documents to a respectable extent, because of which patent practitioners worldwide can easily access Indian patent data on a click, instead of waiting for weeks together. Another feather in the cap was the appointment of the IPO as an International Search Authority, for which of course the IPO will have to use all their muscles.

It was also noteworthy to have the IPO initiate the drive to increase the pool of their patent examiners, which will be a significant step in filling the gaps of the years gone behind. The man leading the ship for most of these positive crusades, Mr. Khurian, in a sudden turn of events resigned as the Controller General of Patents, Designs & Trademark, only to keep us all guessing on his decision’s implications.

In light and support of the above comments, closer2patents, an India based patent services firm would like to share, an analysis conducted on the Annual Report (’09-‘10) of the IPO. The analysis aims to summarize the key points and statistics highlighted in the Annual Report, and make a few comparisons with other countries on those lines. The analysis can be accessed at the closer2patents blog.

Comments and questions are always welcome.

Today’s post is by guest barista Abhishek Pandurangi, Founder at closer2patents, B.Tech (Chem), LL.B, Patent Agent-India

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The India-US Business Network (IUSBN) was created in April, 2010 as a non-profit, membership-based entity, and is based in Cincinnati, Ohio.

The vision of the IUSBN is to create profitable and sustainable commercial alliances, and to foster business transactions between socially responsible enterprises in India and the United States.  Please visit our website www.iusbn.org to learn more.

The IUSBN has an opening for an Executive Director.  The job responsibilities and qualifications are described be.

Interested applicants are requested to email a cover letter delineating why you would be perfect as the IUSBN Executive Director, and a current CV to information@iusbn.org.

Closing Date:  August 15th, 2011

More Info:  Executive Director Job Opening

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A Practitioner from a Leading U.S. Law Firm sent in a screen capture of the U.S. Patent and Trademark Office’s login screen for Patent Application Information Retrieval (PAIR) system.

I find some interest that the site shows a bit of an international flavor in the use of Arabic characters.  The full image is here:  PAIR reCAPTCHA.

Thinking this might be a spoof, I contacted the Electronic Business Center and inquired about the alternate characters.  I received the following reply:

Hello,

ReCAPTCHA images are generated automatically from scanned documents.  It is possible that a CAPTCHA could contain non-English characters, such as Arabic letters or mathematical symbols. 

If you receive an unreadable CAPTCHA on the Public PAIR site, simply click the refresh button next to the CAPTCHA text box.

If you have additional questions about the reCAPTCHA system, please contact Google using the following page:  http://www.google.com/recaptcha/contact

If you have any other questions or concerns about the PAIR system, please let us know.

Thank you,

EBC

I also looked at the function of reCAPTCHA.  A CAPTCHA is a program that can tell whether its user is a human or a computer. You’ve probably seen them — colorful images with distorted text at the bottom of Web registration forms. CAPTCHAs are used by many websites to prevent abuse from “bots,” or automated programs usually written to generate spam. No computer program can read distorted text as well as humans can, so bots cannot navigate sites protected by CAPTCHAs.

reCAPTCHA is a free CAPTCHA service that helps to digitize books, newspapers and old time radio shows at the same time! To archive written information, physical books are being photographically scanned, and then transformed into text using Optical Character Recognition (OCR).

reCAPTCHA improves the process of digitizing books by sending words that cannot be read by computers to the Web in the form of CAPTCHAs for humans to decipher. More specifically, each word that cannot be read correctly by OCR is placed on an image and used as a CAPTCHA.

Each new word that cannot be read correctly by OCR is given to a user in conjunction with another word for which the answer is already known. The user is then asked to read both words. If they solve the one for which the answer is known, the system assumes their answer is correct for the new one. The system then gives the new image to a number of other people to determine, with higher confidence, whether the original answer was correct.

About 200 million CAPTCHAs are solved by humans around the world every day, representing more than 150,000 hours of free work each day for Google Inc. (GOOG).

Hmmmmm…perhaps lawyers should join in the lawsuit against Google by the Authors Guild and the Association of American Publishers over the company’s digital reproduction of books.

The company’s plan to digitize every book ever published and make them widely available was derailed when a federal judge in New York rejected a $125 million legal settlement the company had worked out with groups representing authors and publishers. Google has already scanned some 15 million books.

See:  Authors Guild v. Google Inc., 05-CV-8136, U.S. District Court, Southern District of New York (Manhattan)

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At an event co-sponsored by the US Patent and Trademark Office, The Biotechnology Industry Organization and the Biojudiciary Project,  David J. Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office gave a speech on “From Chakrabarty to Today.

Kappos remarked that there is no question that the Chakrabarty pivotal decision had a seismic effect on US patent policy, giving birth to a new mode of thinking at the United States Patent and Trademark Office.

In part, Kappos connected the past changes to the patent system with the now proposed patent reform act:

And while we gather here in the light of this case’s 30th Anniversary and reflect on its history to infer guidance for the road ahead—

Today, we also stand at the precipice of a new history.  One that, through Congressional patent reform legislation, will historically redefine the nexus of patenting and innovation.

Just last week the U.S. House of Representatives demonstrated significant leadership in passing the American Invents Act—representing a major step towards transforming our patent laws to account for the modern stresses and expectations of a fast-moving 21st century global economy.

While we are diligently working to reconcile the bill with a version passed earlier this Spring in the Senate—we are stand at the threshold of major change and a truly “Jeffersonian moment.”

Recognizing that innovation is at the heart of human progress and patents are how we drive that progress forward, Kappos believes that changing the patenting process, small and independent inventors to move their ideas to the market place faster and enable all of you to do your jobs more easily.

And if we get this right, we can foresee resolutions to post-grant review processes that take shape in less than one year.

If we get this right, we can equip our agency with the thousands of additional examiners it will require to tackle the backlog—which for far too long as been an enemy of progress.

If we get this right, we can confirm the strength of patents efficiently or even promptly let businesses know that their claims are in fact not strong enough.

Either way, efficient processing grants independent inventors and large biotech firms alike the assurances you need to move your technologies and services forward. That way, if we get this right, business can conduct business…without constant speculation or endless arbitration.

Let me be clear—should patent reform be signed into law, implementing a robust IP infrastructure around it will not be easy—but we are up for the challenge.

30 June 2011

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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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