Friday, February 5, 2010

Genetic Privacy : Genetic Testing in New York : Newborn DNA Samples in Texas : German Genetic Diagnosis Act Went Into Effect on February 1, 2010

As reported in numerous German-language sources, the German Genetic Diagnosis Act (Gendiagnostikgesetz, GenDG) - English translation at eurogentest.org - took force on February 1, 2010. This law is of interest for many disciplines, especially in view of the recent "genetic privacy" decision in Texas and the pending passage of Katie's Law in New York.

A summary of the German law is found at DRZE - Predictive Genetic Testing - this is an excerpt:
"1. The German Genetic Diagnostics Act (GenDG)

... The German Genetic Diagnostics Act will come into effect on 1st February 2010 (§ 27).

The Act explicitly aims at defining the prerequisites for genetic testing and genetic analysis performed in the context of genetic testing, as well as for the use of genetic samples and data, and at preventing discrimination on grounds of genetic predisposition, in order to ensure the state's commitment to respect and to protect human dignity and the right to informational self-determination. (§ 1)

The scope of the Act is not limited to predictive genetic testing: it extends, in fact, to genetic testing carried out on (born) human beings (i.e. postnatal) as well as to genetic examination of embryos and foetuses (prenatal; see special provisions in § 15), covering different contexts and purposes of application (§ 2 para. 1). Besides the use of genetic testing for medical purposes, the Act regulates the use in the field of insurance (§ 18) and in working life (§§ 19-22), as well as genetic screenings (§ 16), and also covers tests to determine parentage ('paternity tests', §17). However, it does not address the use of genetic testing and analysis or the handling of genetic samples and data for research purposes (§ 2 para. 2 no. 1). Moreover, the Act does not apply to measures carried out under provisions relating to criminal proceedings, international mutual assistance in criminal matters, and the Federal Criminal Police Office Act (BKA-Gesetz) (§ 2 para. 2 no. 2 letter a), or relating to the Protection against Infection Act (IfSG) (§ 2 para. 2 no. 2 letter b)."
Read the full summary here and the full English translation of the text of the law here.

EuroGentest - What is EuroGentest?

EuroGentest - What is EuroGentest?
"EuroGentest is an EU-funded Network of Excellence (NoE) with 5 Units looking at all aspects of genetic testing - Quality Management, Information Databases, Public Health, New Technologies and Education. Through a series of initiatives EuroGentest encourages the harmonization of standards and practice in all these areas throughout the EU and beyond."

Friday, January 29, 2010

Biogen Idec, Genzyme and the Struggles of Big Biotech - Health Blog - WSJ

Biogen Idec, Genzyme and the Struggles of Big Biotech - Health Blog - WSJ

Friday, January 22, 2010

Venture Funding Moves from Clean Energy to Efficient Lighting and Energy-Management Software : Biotech Leads the Pack

Venture Funding Stabilizes, Shifts to Biotech, Shuns Energy - BusinessWeek

Biotech is on the rise as drug companies seek to offset expiring patents and as investments are being made in new technologies such as genome and cancer research. Less money is going into clean energy and more into projects for efficient lighting and energy-management software.

Tim Mullaney, January 22, 2010 (Bloomberg) , writes:
"Venture-capital funding for startup companies stabilized in the fourth quarter, with investor interest shifting toward drug development and away from clean energy....

Biotech was the largest industry for the quarter."

Wednesday, November 11, 2009

What is Patentable? Bilski Patent Case Oral Argument Heard at the United States Supreme Court : We Hope for Adoption of the Transformative Standard

On Monday, November 9, 2009, the U.S. Supreme Court heard oral argument in the Bilski patent case, the judicial resolution of which is bound to have far-reaching consequences on the way that the United States and the rest of the world view and treat patents (see the original transcript of the arguments here - hat tip to Kevin E. Noonan at PatentDocs in Supreme Court Bilski Argument).

Although the Supreme Court may decide the case narrowly with respect to the particular facts of the Bilski business method patent case, the reasons which the Supreme Court sets out as the basis for its decision will nevertheless have broad application in law, for the Supreme Court can not duck the pressing legal patent issues and must provide a flexible standard NOW, inserting stability into a system currently ruled by chaos.

Joe Mullin at The American Lawyer in Supreme Skepticism Over Bilski Claims Puts Method Patents on Shaky Ground writes in this regard that:
"For the first time in almost 30 years, the U.S. Supreme Court on Monday considered the issue of what types of technology should be eligible for patent protection when it heard oral arguments in Bilski v. Kappos.

Across the board, the justices indicated a deep skepticism toward the invention described in the patent application at issue, which was rejected by the U.S. Patent and Trademark Office and describes a method for trading commodities. Some of the justices went even further--expressing both a fair amount of disdain for the idea of granting broad "method" patents and a concern that ruling in favor of the petitioners would lead to patent grants on fundamental ways of conducting business or organizing human behavior. "
We have posted about the landmark Bilski case from the very beginning and our line of reasoning - prior to the court decisions - anticipated what the courts decided:

In re Kubin : Hitting the NAIL on the Head : Sequencing Poor Federal Circuit Court Decisions out of the Biotechnology Patent Genome via KSR and/or Bilski Reasoning

In re Bilski : Patentable Subject Matter : Federal Circuit Overturns Pure Business Method Patents : Requires Machine Process / Physical Transformation

Federal Circuit to Review Business Method Patents for Future Viability : There is a Great Likelihood of a New Upcoming Legal Standard

The Patentability of Business Methods and the Upcoming Federal Circuit Hearing en banc in Ex parte Bilski

For our part, we hope that the standard adopted is the transformative one. Transformation is the operative element that is common not only to patents but also to copyright law, for it is "transformation" which is the inventive step.

A copyrighted work is after all - in most cases - simply a unique transformation of commonly used words of the language or languages written. Since nearly every word is in a sense "copied" from prior art, and since many elements of any written work are common to many works due to the linguistically identifiable rules of grammar and syntax, almost any truly transformative work still necessarily contains many copied "elements". It is therefore the transformative nature of a work as a whole which must be judged and not its individual parts per se.

As far as patents are concerned, the same reasoning applies. Any transformation of "matter" or of a more abstract element of technology such as software or medical knowledge necessarily "copies", i.e. it relies on many elements of prior art to reach a new discovery. An inventive step is never taken in a vacuum and can therefore as good as never be divorced from the environment in which it takes place.

An invention is the whole work and it is entirely conceivable to imagine a fantastic new written work or invention made up totally of otherwise copyrighted or patented parts - for which the copyright or patent holders of those parts should in the case of such an invention nevertheless get nothing, because a transformation has taken place in the new whole.

A transformative standard can also be equally applied to software products (as a whole) or to new medical advances (as products), i.e. the transformative software (as a product) should be patentable, but NOT elements of the software code, and similarly, transformative medical discoveries should be patentable, but NOT the methods used to achieve them, e.g. transformative new ways to synthesize a gene should be patentable, but not the gene itself.

In the case of business methods, a transformative software product implementing a particular business method should be patentable - but NOT the business method itself. Until a business method is APPLIED, no transformation has occurred. Therefore, only a product which performs such a transformation can be patented.

We see no serious problems with a transformative standard - which need not be tied to machines or any other technology. The inventive step should be universally recognizable as a reproducible transformation.

The view voiced by some commentators and also expressed by some judges and also U.S. Supreme Court Justices that the Bilski patent might be rejected as being merely "an abstract idea" is an intellectual cop-out and begs the question of drawing the necessary line between "an abstract idea" and "an inventive step". WHERE that line is to be drawn is the job of the U.S. Supreme Court to determine and the Supremes therefore can not avoid the establishment of a standard simply by rejecting Bilski's business method as "an abstract idea".

The question is, when does a non-obvious abstract idea become an invention? And that question, the Court must answer. They have little choice.

We suggest that the only viable answer is the transformative standard.

Wednesday, October 21, 2009

Pharma and Biotech Twitter at @LaxPatLawMan

@LaxPatLawMan twitters about biotech and the pharmaceutical business, including patents and regulatory issues.

A Biotechnology Blog at Patently BIOtech

Patently BIOtech is a biotechnology blog at WordPress.com which covers "intellectual property, technology transfer, biotechnology, gene patenting, global health, economic growth, sustainability, green jobs...."

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