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Introduction

Biotechnology comprises any technology that uses living entities, in particular animals, plants or microorganisms. According to the Organisation for Economic Cooperation and Development (OECD)  biotechnology includes any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses.

The biotechnological inventions can be classified broadly into the following categories:

(a)inventions relating to an organism or material such as living entities of natural or artificial origin (animals, plants, and microorganisms), biological material (plasmids, viruses and replicas, and parts of organs, tissues, cells, and organelles), and naturally occurring substances from living entities, biological material and parts thereof;

(b)inventions relating to the process for the creation of a living organism or production of other biological materials; and

(c)inventions relating to the use of such organisms or biological materials.

Recent development in patent system

Recent developments in the field of patent law have been diversified in nature in India. The Indian patent system is continually evolving to provide seamless services to its users by utilizing and implementing digital technology. Significant efforts like reduced examination timelines and other improvement steps such as an efficient filing system for applicants show the patent system is improving in relation to both prosecution and enforcement. As the patent office is also trying to simplify and clarify various procedures, this is an exciting time to witness the many more significant and positive developments in the near future for the Indian IP ecosystem.

Modifications in Indian patent laws have been made in accordance with TRIPS by widening the list of inventions not patentable, incorporating greater rights of the patentee, reversing the burden of proof in an infringement suit on process patents and creating a uniform period of patent protection of twenty years for all categories of invention.

During 2014, the Indian Patent Office released guidelines pertaining to issuance of pharmaceutical patents. These guidelines primarily incorporate features of various court decisions so as to assist the Patent Office in establishing uniform standards of patent grant/examination. These guidelines are expected to bring in uniformity with regard to examinations of the patent applications across all Patent Offices in India and by different responsible officers, in addition to giving to the inventors and corporates much desired certainty on how their application will be examined by the Indian Patent Office. Furthermore, in the recent past, various administrative and procedural mechanisms have been improved in the field of intellectual property law. The infrastructure of the Indian Patent Office has been improved greatly, so as to develop facilities for proper management of International Searching Authority/International Preliminary Examining Authority operation under the Patent Cooperation Treaty.

Indian Patent (Amendment) Rules 2014 recently introduced a third category of applicant being of “small entity”, and provided procedural rules for governing the same. Furthermore, the fee for basic patent filing have been revised due to the introduction of the e-filing system of patents wherein the rates for e-filing are lower than those involved in physical filing.

Patentable biotechnological inventions:

•Methods for producing or analyzing proteins and their use in an analysis method or in a medicinal product.

•Proteins, DNA sequences, microorganisms and constituents of the human body (for example, cells) which already exist in nature, if they are isolated from their natural environment or produced by a technical procedure, and have not been described previously.

•A gene, which is isolated and given a new task as a medicinal product or diagnostic tool.

•Genetically modified products, such as plants and animals.

Non-patentable biotechnological inventions:

•Pure discoveries, such as discovered but not isolated or further described parts of animals, plants or microorganisms.

•Plant varieties and animal breeds. For a definition of plant variety, the Act on the Protection of Plant Breeders’ Rights.

•Inventions that are contrary to public order or morality, which society regards as unethical and unacceptable. For example, it is not possible to patent a method for reproductive human cloning as it is contrary to public order and morality.

Invention or discovery?

•Something that is only a discovery, such as the identification of a new gene, is not patentable. But if you have studied further what the gene’s function is if it is used as a medicinal product or diagnostic tool, then it is an invention that can be patent protected. The protection is often defined as “isolated DNA molecules with (a certain) nucleotide sequence”. In other words, the protection cannot be said to cover DNA in nature, only artificial DNA molecules or DNA which is isolated from the human body and cut down to the piece you are interested in.

Plants and animals?

•An invention relating to plants and animals can be patented, if the implementability of the invention is not limited to a certain plant variety or animal breed. Even a microbiological procedure and products of such a procedure, for example plants and animals, can be patented. However, methods consisting of biological procedures, such as cross-breeding and selection, for producing plants and animals cannot be patented.

Biotechnology involves the production of a large number of commercial products of economic importance. Broadly, biotechnology inventions can be categorized into two forms — products and processes.

Biotechnology Products:

•1. Living entities:

•The various forms of life- existing and life-supporting systems derived from living organisms are regarded as living entities. These include microorganism, animals and plants, cell lines, organelles, plasmids and genes.

•2. Naturally occurring products:

•The primary and secondary metabolites produced by living systems e.g. alcohol, antibiotics.

Biotechnology Processes:

•Biotechnology involves development of several processes — isolation, purification, cultivation, bioconversion etc. Novel, innovative, simple and cost-effective processes are developed for the isolation and creation of the above products. Some examples are listed:

•i. Production of monoclonal antibodies

•ii. Bioconversion of sugar to alcohol

•iii. Microbial production of antibiotics.

PATENTING OF BIOTECHNOLOGICAL INVENTIONS

Patenting in different countries:

Patenting laws are very complex and vary between different countries. It is interesting to note that a patent application rejected in one country may be given patent in other country. The best example is the production of recombinant human tissue plasminogen activator (tPA) in E. coli. Genentech Company was awarded patent for tPA production in USA, while it was first rejected in UK. After appeals and legal battles, patent was finally granted in UK also.

Patenting microorganisms:

A genetically engineered strain of the bacterium Pseudomonas called superbug was the first micro­organism to be patented. Superbug is capable of breaking down the multiple impurity of crude oil. It took almost 10 years of procedural delays, and legal battles to get the superbug patented. Now, many microorganisms are patented.

Patenting multicellular organisms:

A genetically manipulated mouse namely the oncomouse was the first and probably, to date the only animal to be patented in both USA and UK. This transgenic mouse carries a gene that makes it susceptible to tumor formation.

Patenting genes?

The human genome projects (HGPs) have elucidated almost the entire sequence of human genome, besides identifying the genes. Patenting of DNA sequences and genes has become a controversial and debatable issue. Some researchers and institutions in fact have approached the patent offices for grant of patents. So far, patents have not been granted for genes. The most important reason being that the genes are natural, universal and inherent biological functional units of all individuals.

Patenting and cell/tissue donor’s rights:

While dealing with human tissues/cells, the involvement of the donor of source material becomes very important. John Moore was a victim of hairy-cell leukemia, a rare form of cancer. His spleen was removed, and Mo cell lines developed. These cell lines were patented by the researchers and their associated organizations. Moore however was not involved in the patenting. Moore filed a suit in the court on the ground that he should also be a party to the profits derived by using his tissue. The court allowed his claim to share the profits.

Plant Breeders’ Rights:

•Agriculture for the first time was included (in 1994) in the trade-related intellectual property rights (TRIPS). TRIPS is a major concern for developing countries. The plant varieties in many countries (not in India) are protected through plant breeders’ rights (PBR) or plant variety rights (PVR).

•PVR provides legal protection to the original breeder or owner of the plant variety. It is believed that PBR will encourage innovative research and plant breeding programmes, in view of the expected financial returns.

•Plant breeders’ rights are comparable to the patent rights. Under TRIPS agreement, plant breeder possesses the exclusive rights over the plant developed. It prevents the third parties from using the plant without the owner’s consent.

•Although PBR will increase competition and development of good plant varieties, the owner’s motto would be profit making. Therefore, PBR will prohibit the free exchange of plant materials, besides threatening the farmer’s rights. It is feared that PBR will benefit rich farmers and developed countries only.

•Patenting and Biotechnology Research:

•In the earlier years, research used to be mostly for academic interest and worthwhile scientific contributions. And researchers were purely academic-oriented with not much interest in financial gains from what they do. Further, unlike now, the research used to be supported mostly by Governments/Universities.

•There used to be no secrecy in research. Academic recognition and outstanding research publications (open to all) were adequate to satisfy the researchers. Watson and Crick who discovered DNA structure never had a thought of patenting!

•The situation has now changed. A good proportion of research is either being conducted or financially supported by private companies/ universities. It is quite natural for these companies to expect returns for their investments. There is a lot of change in the attitude of researchers also. For many scientists, financial gains have become more important than academic recognition. Consequently, some people carry out research secretly and opt for patenting of their discoveries rather than publishing.

•We have to accept the fact that the progress of research is usually much faster in private companies compared to many government organizations. This may be due to the higher financial returns and efficient administration. Probably, the biotechnological research might not have progressed to the same extent as it is today without the dreams of getting the patents by scientists and research funding organizations.

Some of the biotechnological domains being patented today

A.Genetic engineering process;

B.Method of producing organisms;

C.Method of isolation of microorganisms from culture medium;

D.Method of mutation;

E.Biologically pure cultures;

F.Mixed cultures;

G.Eukaryotic cells;

H.Tissue or organ cultures; mutants; transformants; plasmids;

I.Process for making monoclonal antibodies;

J.Cell lines for making monoclonal antibodies

Patenting has also raised important issues

1.A number of very basic inventions, fundamental methods, research techniques and tools significant for product development, have been made and granted patents.

2.In many cases, there were initial doubt about patentability, but the doubts have regularly been resolved in favour of patentability [at least by the US Patent and Trademark Office (USPTO)].

3.The transgenic research mouse designed as a laboratory model for cancer studies at Harvard under NIH funding was patented, and licensed to DuPont, which further sought strong controls over it and other forms of modified mice.

4.Concentrated stem cells, which are undifferentiated or partially differentiated cells, which can be developed into a number of other cell types, have been patented in the US.

5.Partial gene sequences including ‘expressed sequence tags’ (EST’s), which are components of genes being expressed at a particular time, can now be sequenced by machine.