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Gene Patenting : Legality & current trend analysis

By Ashrujit Basu
Founder
AskLegalMart Consultancy



While most of us think of patents covering things like toasters, tractors and turntables, the fact is
that since 1982, the U.S. Patent and Trade office has been issuing patents on genetic material as
well. In fact, there are currently 3,000 to 5,000 patents on human genes in the United States alone
with another 47,000 on inventions involving genetic material [source: Cook-Deagan]. On June 13,
2013, though, the U.S. Supreme Court ruled that human genes could not be patented -- but that
brand new inventions that used or replicated DNA could.
DNA mapping can override History of Mankind therefore while Myriad Genetics a company based in
US, owns intellectual property protection for BRACAnalysis (a Breast cancer identification process )
granted by USTPO. According to Supreme Court of US patenting of Gene is only possible in case of
cDNA or Synthetic Gene which means not biologically or naturally mutation process.
Meanwhile; China does not allow companies or research institutes to patent life forms; however
patenting genes is permissible. Indeed, in 2001, Shanghai Joint Gene Technology Co. Ltd, the largest
gene technology company in China, applied for more than 3700 gene patents, including patents for
genes dealing with cancer, obesity, high blood pressure and senile dementia, which are expected to
be of high value for clinical diagnosis and the development of new medicines.



India's patent law, until 2005, did not permit product patents. Consequently, composition of matter
patents on genes did not exist. However, India's patent law recently underwent amendments to
bring it into line with TRIPS. ( source: WHO).
In order to have a paten, the invention must satisfy four criteria:
It must be useful, novel, non-obvious, and must meet what is known as the enablement
criterion, meaning that it should have a detailed enough description that anyone working in
the appropriate field should be able to make use of it. When a patent is issued, though, it
gives the owner 20 years during which no one else can make, use or sell the invention.
In order to receive patent right over genes that involve altered products of nature, the inventor
must deposit a sample of their product into one of 26 worldwide culture depositories as stipulated
by the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the
purpose of Patent Procedure. Genes can count as altered products of nature only if they have been
removed from the body and processed in some way. The patent applies to that processed end
product. In furtherance there were a significant rush of DNA patenting application after the
completion of Human Genome Project in the year of 2003 as USs Patent Law follows First to
Invent model- therefore, everyone wanted to be first.
Its far beyond the question of ethics of Human Gene Patent which might undermine the dignity,
others disagree saying that Patenting in some bodypart cannot undermine human dignity as a
whole.
But the collection of sample of DNA from any person should follow adequate legal steps in order to
obtain prior consent in order to safeguard violation of individuals right to privacy. Its also
observable that the patenting in this arena will hold companies accountable for disclosing
information to the public which is broadly acceptable. Agreements such as the Agreement on Trade-
related Aspects of Intellectual Property Rights (TRIPS) require members of the World Trade
Organization (WTO) to have intellectual property protection laws in place for most biological
innovation.




Sources & References:
Wikipedia
Association for Molecular Pathology v. Myriad Genetics ( Case Law)
Howstuffsworks.com

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