Patents & Biotechnology

by Shikha Chaturvedi

Abstract

Each country has set its own standards for granting patents to biotechnological inventions.  This article focuses on biotechnological inventions -- what is patentable, where and how, with focus on patentability of biotechnology inventions in India.

Author

The author is a patent attorney in the Biotechnology Division of Surana & Surana International Attorneys, India.  She is a commerce graduate from the University of Madras and a law graduate from the Banaras Hindu University, India.

Article

Patenting of biotechnology inventions has become front-page news with each big breakthrough in this burgeoning field, elevating the patenting of inventions to a higher profile.  Biotechnological research and developments involve an increasing amount of time, money and energy.  Patent protection encourages research, allowing inventors to profit from their inventions.  This economic and intellectual investment has made the relationship between intellectual property and biotechnological inventions an issue of immediate interest. 

The rules and regulations governing biotechnology patents are country-specific.  Each country has set its own standards for granting biotechnological patents.  Some countries place stricter standards than others regarding the patentability of biotechnological inventions.  Given the great potential value of such inventions, these country-specific nuances need to be understood if inventors are to profit from their inventions. 

Exciting inventions in the field of biotechnology have been made in recent years. Following the examples of the owners of the biotech patents, companies with high investments in the field of biotechnology now recognize the advantages of protecting and enforcing their intellectual property rights.  

Specific patent needs in the case of biotechnology inventions:

The current controversy in biotechnology is what is patentable and what is not.  Generally, an invention is patentable while a discovery is not.  While this rule may, in other areas, appear well defined, in biotechnology, it is often the cause of differences in regulations between countries. 

Discovery is merely making available what already exists in nature.  A substance freely occurring in nature, if merely found or discovered, is not patentable.  However, if the substance found in nature has first to be isolated from its surroundings, and a process for obtaining it is developed, that process is patentable.   

The granting of patent is subject to strict criteria of novelty, inventiveness and industrial application. In the case of biotechnology, often involving living entities like microorganisms, there is an additional requirement of sufficient disclosure, for which the invention is required to be deposited at an authorized Depository Authority.  

Biotech patents in Australia, USA & Europe

Even given these broad guidelines, across the globe, each country has taken a different approach to biotech patent regulation.  As mentioned, countries differ even in the subject matter they view as “inventable” and “discoverable.” 

Australia’s approach to biotech patents is one of the most liberal.  In 1976, the Australian Patent Office (APO), in Rank Hovis McDougall Ltd.’s Application, held that living organisms are patentable, implying that they are inventable.  The Australian Patent Act contains no express prohibition against the patenting of life forms (aside from human beings).  The APO considers all living organisms excluding human beings as potentially patentable subject matter. 

The US Patent Law has followed Australia’s liberal approach towards biotech patents.  The US Supreme Court decision in Diamond vs Chakraborty (1980) opened the way for inventions relating to genetic engineering and living organisms, declaring them as inventable.  The United States Patent Office (USPTO) has since issued patents for over 6,000 genes, and about 1,000 of these relate to human genes.  Currently, there are more than 20,000 patent applications related to genes pending in the US.  However, in response to criticism that their gene patents are too liberal in defining what is invented, the US recently issued “utility guidelines” requiring stricter applicability standards. 

In contrast, Europe adopts a more cautious approach towards granting biotech patents, which is addressed by the European Union Directive on the Legal Protection of Biotechnological Inventions.  The Directives include a non-exclusive list of unpatentable processes, for example, cloning, germ-line modifications, embryo processes, transgenic processes, etc.  The discovery/invention distinction, also referred to as “attack of obviousness,” has been one which has featured strongly in biotech patents in Europe.  In Genetech Inc.’s patent, a claim to an isolated and characteristic protein produced by r-DNA technology was held by the English Court of Appeal to lack this required “attack of obviousness.”   

Indian Perspective

India is a storehouse of biological resources and one of the world’s richest biodiversity countries.  In the past two years, there has been a rise in the investment in the biotech-oriented industries.  It is estimated that over the next five years, biotechnology can offer opportunities for fresh investment of Rs 7-8 billion in India.   Biotechnology is poised to take India to a different playing field where it can dominate the world market.  However, to achieve its full potential, the biotech sector requires a facilitative environment.  The government needs to make a concerted effort to amend its Patent Laws, strengthen its IPR regime, so as to protect the economic interests of those who innovate.  Additionally, India needs to sign the “Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure” to assist in the standardization process of biotechnology patenting.   

What is patentable in biotechnology?

This is the question that India must decide in regards to new biotechnology (read genomics, proteomics, bioinformatics, genetic engineering).  As per the Indian Patent Act, the following are patentable: 

Ø      Microorganisms: under the Indian Patent Act, microbiological processes can be patented.  Also patentable are processes for producing new-microorganisms through genetic engineering and the products that result out of this process, such as microorganisms including plasmids and viruses if they are non-living. 

Ø      Cell lines-A cell line is patentable if artificially produced.

Ø      R-DNA, RNA, AMINO ACID: if the end result is non-living, it is patentable.

Ø      Hybridoma technology: patents are also allowed on hybridoma technology, but not on protoplast fusion.

Ø      Expressed sequence tag’s, or ESTs, are small fragments of genetic material obtained by reverse transcriptions of messenger RNA (mRNA) from expressed genes.  The gene sequence, or expressed sequence tags (ESTs), can be patented if it has a use, such as if it works as a probe.

 What is not patentable in biotechnology?

Additionally, the Indian Patent Act defines what is not patentable biotechnology: inventability does not apply to plant or animals.  Accordingly, a method of producing a new form of a known plant or tissue culture method for production of plant variety is not patentable, nor is a method of treatment of a human body by surgery or operation for diagnosis.  Nor is a method of improving or changing the appearance of the human body or parts of it patentable.   

Still, these categories are not as clear-cut as they appear.  Skilful wording may decide whether a finding is an “invention” or a “discovery.”  Thus, it is best to consult a patent attorney prior to filing a patent.  

To compete worldwide, India must decide whether to remain with the more conservative European approach, or if the Australia/US or some other approach better suits the needs of its emerging economy.  In either case, Indian companies, inventors, and investors venturing into the biotech sector must be well-informed and well-aware of Indian laws, as well as the laws of other countries as they seek to join the biotechnology headlines.  More importantly and immediately, these companies and investors venturing into the biotech sector need to fully realize the significant role intellectual property plays in the commercialization process for biotechnological innovation.


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