Patenting in Biotechnology-What does the experts say?
Patenting in all fields of technology follows the same criteria for all inventions like Novelty, non-obviousness and industrial applicability. As researches and inventions in biotechnology domain revolves around living organisms and genetic engineering, the criteria for getting patent i.e., novelty, utility, inventiveness and non-obviousness have been opening up new challenges. Identifying the characteristics of novelty and/or patentability in living beings is a mammoth tough task.
According to the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), patents are available for any invention in all fields of technology. However, the issue related patentability of the biological materials, isolated or derived from living organisms, has triggered extensive discussions. Some argue that such biological materials are mere “discoveries”, and therefore cannot be patented, while others argue that they are man-made “inventions”.
What are the issues and challenges in filing patents in biotech domain?
For an invention to be patentable, it has to be novel, unique, non-obvious and have an industrial applicability. The biotechnological processes and the products do not deal with anything that is not already existing. Further, in the case of biotechnology, there are different exclusions that are exempted from getting patents a few of which are given below:
- An invention would not be patentable if it is immoral or against public order, harmful to human, animal, or plant life, or harmful to the environment 
- Discovery of living things or non-living substances in nature 
- Plants and animals in whole or any parts thereof other than micro-organisms but including seeds, varieties, and species 
- Essentially biological processes for the production or propagation of plants and animals. 
- Any Process for the medicinal, surgical, curative, prophylactic, diagnostic or therapeutic, or other treatment of human beings or animals to render them free of disease or to increase their economic value or that of their products. 
- New use or new property of the known substance. 
- Methods of agriculture or horticulture. 
- Traditional knowledge. 
Changes in case laws that allowed patenting in biotechnology- a case study
- Diamond v. Chakrabarty, 1980 case has opened many gates to various applications in biotechnology.
Chakrabarty filed a patent application relating to his invention of a human-made, genetically engineered bacterium capable of breaking down crude oil, a property that is possessed by no naturally occurring bacteria. The application was rejected and affirmed by the Patent Office Board of Appeals on the ground that living things are not patentable subject matter under § 101. The Patent Office, in the name of its Commissioner, Sidney A. Diamond, appealed this decision to the Supreme Court. The Supreme Court heard oral arguments from the parties on March 17, 1980, and issued its decision in favour of Chakrabarty and affirmed the decision of the Court of Customs and Patent Appeals.
Are all the rules same all over the world?
While modern biotechnology is growing really fast with various opportunities, on the other hand it is also, posing new challenges to the national and international community. International law on biotechnology is a typical example of how the international community creates regulatory responses to problems and challenges arising from scientific innovation and technological change.
Taking an example, a patent was given for novel yeast strain suitable for use in the brewing of beer to Louis Pasteur in France, Italy, in US in 1873. The patenting of life forms emerged as an important issue only after the 1970s when there was a boom in biotechnology with the emergence of Recombinant DNA Technology, Tissue culturing, Hybridoma Technology, etc. By using these technologies, it is possible for researchers and industries to exploit the biological resources and produce large-scale commercially viable products in the field of pharmaceuticals, agriculture, etc.
There is no such thing as an international patent or international patent law, as patents are restricted to a specific territory and no single patent presents protection for inventions globally. Patent law is specific to each country; although regional agreements exist, there is no global patent law. There are some different procedures and criteria that are uniquely followed in EPO, USPTO, IPO, and other patent offices.
What are the possibilities in Biotech domain?
Biotechnology firms can potentially change the face of the healthcare and food industry. These firms have various possibilities and ideas to revolutionize patient care and desired products and amass significant profits. That’s why protecting the ideas, research and technologies contributing to breakthroughs is essential. Biotechnology is a very broad domain and finds applications in several domains.
Green technology (Agriculture process and products)
Black technology (Industrial technology)
Blue technology (Marine and aquatic application)
Red technology (Manufacturing pharmaceutical and genetic
What falls under biological inventions?
A standard patent can be obtained for isolated bacteria, cell lines, hybridomas, some related biological materials and their use, and genetically manipulated organisms. A few examples of patentable inventions include:
- Isolated bacteria and other prokaryotes, fungi (including yeast), algae, protozoa,
plasmids, viruses, prionsCell lines, cell organelles, hybridomas
- Genetic vectors and expression systems
- Apparatus or processes for enzymology or microbiology
- Compositions of micro-organisms or enzymes
- Propagating, preserving, or maintaining micro-organisms
- Mutagenesis or genetic engineering
- Fermentation or enzyme using processes to synthesize a desired compound or composition
- Measuring or testing processes involving enzymes or micro-organisms
- Processes using enzymes or micro-organisms to liberate, separate, purify, or clean
- The use of micro-organisms to produce food or beverages.
Patents are vital to protect commercial interests and intellectual property rights in biotechnology. They are limited rights based on a claim that a new technological invention has been created and fully communicated to the public. Patents can cover new products, processes that create these new products, new processes for producing existing products, and new processes generally.
Most modern medicines are based on biotechnology. Many anti-cancer drugs based on patented human gene sequences are prolonging the lives of cancer patients, such as Herceptin for breast cancer and Avastin, for colon and other cancer. Humira, a patented medicament based on human gene sequences used to treat auto-immune diseases such as arthritis, was the world’s best-selling medicine in 2014. Eight out of the top 10 best-selling medicaments were biological in origin and covered by patents.
How MCRPL can help?
MCRPL is 20-year-old company undertakes all kind of prior art search including scientific and technical information that exist. Biotechnology is one of our company’s most specialised practice areas with professional experts (Patent attorneys and technical experts). Our team is a collaboration of expertise in Biotech searching with experts such as Masters and PhDs with a tremendous amount of knowledge in the biotech domain and patent searching work on such complex biotech cases. We use the Human-plus-Machine approach (MCRANK) to ensure quality is immaculate throughout the search process, well-maintained SOPs and internal manuals for working on typical biotech searches, etc. We have many patent agents that give us an edge in performing complex searches.
Some of our key areas that are pertinent to the biotechnology industry are recombinant DNA technology, immuno technology, antibody, vaccine, plant biotechnology, natural bioremediation, Bioanalytical techniques, Cosmetics preparations, Reactor design, Formulation development, peptides, natural product, FMCG etc.