Prerequisite for Comprehensive Revelations in Biotechnology Patent Application

PREREQUISITE FOR COMPREHENSIVE REVELATIONS IN BIOTECHNOLOGY PATENT APPLICATION INTRODUCTION A patent is a monopoly right that has been granted to a person who has invented a new and useful article; or an improvement to an existing one or a new process of making an article. The patent consists of an exclusive right to manufacture the new invented or manufactured article according to the invented procedure for a period of limited period that is a period of 20 years in accordance to Indian Patent Act of 1970. An invention may be granted patents only when its core pre-requites of novelty, inventive step and capability of the invention in industrial applicability is met. The variance and disputes in the process of patenting products related to biotechnology ascend because the conception of patent law was made to placate the requirements of industrial technology.

However, the initiation of biotechnology compelled the patent laws to be more aptly reformed to match the prerequisites of science and technology. The traditional concepts with regards to application for patents and other formalities were reformed to accommodate to the innovations made in the field of biotechnology. The three universally criteria of patentability are novelty, non – obviousness and industrial application or utility. These apply to all inventions including biotechnological inventions.

[1] Nevertheless, patenting life or living beings is challenging because it is doubtful whether the patent protection will be granted to living matters. Bio technology inventions are difficult to describe.

There is an ambiguity in considering biotechnology as an invention or as a discovery.

[2] Hence it was realized that the requirements of the traditional patent law are not enough to test the patentability of the bio technological inventions due to the inherent complexities and technicalities. To overcome these issues, a solution was formulated in the form of deposits of the invention in any recognized depositories. The Budapest treaty recognizes international depositories where inventions relating to living matters may be deposited and maintained for the purpose of patent protection, and further it may be accompanied for patent application for further approval.

The essential requirements that bio technological inventions for being granted patent require the subject matter to be patentable. The invention must have novelty and it must be non-obvious. Along with the above criteria, the parent must have some industrial utility. In addition to the above, in cases of biotechnological patents, there must be a written description of disclosure of the invention and the invention must be deposited in any recognized depositories.

[3] NEED FOR COMPLETE DISCLOSURE The crucial document in the whole process of securing and relying upon a patent is the specification.

[4] The description must be such that it must clearly allow the persons of ordinary skill in the art to recognize that the inventor invented what it has claimed.

[5] Enablement i.e., how to be made and how to be used is a need for the patent practisers. The method of making an enabling disclosure is amply illustrated by the Indian Patent Act which provides that every specification shall fully and particularly describe the invention and is operation or use and the method by which it is to be performed.

Section 64 of the Indian Patent Act, 1970 deals with revocation of a patent application on grounds of incomplete disclosure. Determining the insufficiency of the disclosure requires consideration of the particular invention, nature and state of development of the prior art, knowledge, kinds and degree of skills and experience of one killed in the art.

[6] Best Mode: the Indian parent law requires an applicant for patent to set forth the best mode which beans the best experiments with the best conditions giving the best possible yield.

[7] This disclosure is directed to those skilled in the art and once must consider the level of skill in the relavant art in determining whether a specification discloses the best mode or not. Budapest Treatyof 1977: this treaty was entered by states for the international recognition of the deposit of micro organisms for patent procedure.

[8] Subsequent to the requirement of the TRIPS agreement, the indian patent act has been amended providing that, in the case of a mentioning of a biological material in the specification which may not be described in such a way as to satisfy the requirements for a specification, the application shall be completed by depositing the material in an International Depository Authority under the Budapest Treaty. The same has been mentioned as a proviso (ii) to Section 10 sub clause (4). WRITTEN FORM OF DESCRIPTION An invention must be described in a written form. This is a necessary condition to be satisfied for the grant of patent. In addition to fulfilling the requirements such as novelty, non – obviousness and industrial application, an inventor must sufficiently disclose the invention known to the inventor.

[9] The written description shall provide for details of the invention, in a complete, clear and concise manner and shall disclose the best mode of processing, making and using the invention to enable a person skilled in the art to utilize the invention. In general terms, the requirement is to disclose ‘how to make’ the invention and ‘how to use the invention’.[10] The requirement of written description of the invention serves the purpose of evaluating the inventor whether he does possess the invention at the time of filing the patent application. Written description is a public notice that the inventor possesses the invention. [11] The development of law relating to written description requirement is of recent origin.

The requirement of written description was historically not well delineated. ***** It has recently come to represent a heightening of the patentability bar with respect to bio technology inventions. For many years the requirement was interpreted to mean description to enable a person skilled in the art to practice. With the advent of bio technology, patent offices and law courts started interpreting the requirement of written description stringently to check the scope of inventions of biotechnology. The requirement of written description is strictly imposed in order to confine and limit the scope of the invention to what is described in the application.[12] APPLICABILITY OF INDIAN PATENT ACT India is no different as far as written description of biotechnology inventions is concerned.

The patents act states that the patent application shall be accompanied by the complete specification or provisional specification of the invention. The application must be accompanied by provisional or complete specification.[13]The patent act of 1970 deals with the patents that are claimed within the territory of India. Section 10[14] of the Patents Act, 1970 deals with clear and complete disclosure of the product or invention. Section 10(4) (a)[15] of the Act exemplifies the enablement and the requirements for written descriptions and on the other hand, section 10(4) (b)[16] emphasis that the applicant shall disclose the invention on the basis of the best mode of performing of the invention. The specification must describe the invention, its operation or use with the help of drawings if necessary. If the applicant does not give complete specification of the invention at the time of filing the application, he can file the complete specification within 12 months there after filing of the application.

Further, the specification must disclose the best mode performing the invention, which is known to the applicant[17]. In case of claiming the priority of an application filed earlier, priority shall be given only when the earlier application does not give the complete specification of the invention to enable a person skilled in the art to practice the invention in the best possible way. [18] Further, the specification shall define the scope of the claimed invention with claim or claims on the invention. The patent act was amended latest by 2005 keeping in mind the necessity of deposit of invention in case of biotechnology patents. The amendment recognized Budapest treaty of 1977for facilitating the deposit of biotechnology inventions for the sake of patent procedure. [19] A biotechnology patent application must be accompanied by a deposit of the invention in any recognized depository as recognized by the government of India through notification in the official gazette.

The name and address of the depository and the date of deposit shall be mentioned in the application. Further, the access number issues to the deposited invention shall also be mentioned in the application. There is no case law development with regard to the fulfilment of written description requirement by biotechnology inventions in India. Since the biotechnology industry is an infant stage in India and only since 2005 India is granting patents on biotechnology invention, there is no substantiate development of law in this regard.

However, the disclosure of the invention through specification while making the patent application is a prerequisite for the grant of patent. In contrast to the patent law of the United States of America and of the European Union, the Indian Patents Act mandates the disclosure of source and geographic origin of the biological material used in producing the claimed biotechnology invention. The bio diversity act, 2001 read the claimed biotechnology invention shall be disclosed and mentioned in the patent protection application to share the benefits of the patents to the geographical regions which conserved the resource. The TRIPS agreement does not require the mentioning of the origin of the resources. However, the convention on the biological diversity states that the origin of the biological resources used shall be acknowledged and the geographical regions shall be given a share in the benefits of such usage. In fact, it is a crucial issue where the CBD and the TRIPS do contradict. However, having ratified both the agreement, India does provide in its patents laws that the patent application claiming a biotechnology invention is complete only when it discloses the source of the resourced used. Written description of the invention is a core principle of patent law. An invention shall be described in a clear and comprehensive manner in order to enable a killed person in the art to practise the invention.

The requirement of written description has been applied to biotechnological invention in varied forms. In case of biotechnological invention the written description has to furnish the chemical and physical properties of the invention along with its structure and sequences. However, in every case, it is not possible to describe a biotechnological invention in a clear and comprehensive manner. Due to the fact that biotechnological inventions are living beings it may not always be possible to describe the invention as required under the patent laws. So the practice of depositing the claimed invention has been adopted to satisfy the written description requirement. It is accepted that the deposit of deposit of the invention fulfils the requirement of a written description. A deposit of the invention serves as an additional security to the inventor in claiming the patent and also helps in rebutting claims of invalidity against the patent. A biotechnology invention, which satisfies the requirements of novelty, non-obviousness, utility and written description is patentable provided that the invention falls within the range of matters which are patentable. The patent law states that a biotechnology invention, which is not a patentable subject matter, cannot be patented though it may satisfy the requirements of patentability. It is a settled principle in the patent law that a bio technology invention is patentable only when it does fall within the purview of patentable subject matter.

Difficulties arise in determining the novelty and non-obviousness of biotechnology inventions. The fact that biotechnology inventions are living beings which are manipulated from their earlier position of natural existence to possess certain desired characteristics to give rise to certain difficulties. As per the present patent law it is believed that things or living beings existing in nature are products of nature, which are not patentable. It is also believed that addition of human ingenuity to these products of nature renders then product of man. Therefore, the difference between products of nature and products of man and the point from where a product of nature becomes a product of man are very significant in deciding the novelty and non-obviousness of biotechnology inventions. However, the utility of biotechnology inventions is undisputed. Further, the satisfaction of the requirement of written description is also problematic in case of biotechnology inventions. It is felt that it may not be possible to describe a biotechnology invention in a clear and complete manner.

Therefore, difficulty arises in satisfying the requirement of written description. CONCLUSION In order to compensate the non-fulfilment of written description requirement deposit of the invention is recommended. It is believed that deposit of the invention serves the purpose of describing the invention in order to enable the person skilled in the art to practice the invention in the best possible way[20]. With the coming into being of the TRIPS agreement throughout the world patent laws have been harmonized. Now in all the member states of the TRIPS agreement, the requirements of patentability of biotechnology inventions are uniform.

Therefore, a biotechnology invention satisfying the requirements of novelty, non – obviousness, industrial application and written description or deposit of the invention is patentable throughout the world. REFERENCES:

1. Dr. Sreenivasulu, N.S. and Dr. Raju C.B.; Biotechnology and Patent Law – Patenting of Living Beings; 1st Edition 2008; Manupatra
2. Albany Law Journa of science and technology; David Kelly; ‘ The federal circuit transforms the written description requirement into a biotech – specific hurdle to obtaining patent protection for bio technology patents;” 2002
3. TRIPS Agreement
4. Elizabeth Verkey; Law of Patent; 2nd Edition; eastern book company.

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[1] Jayashree Watal, Intellectual Property Rights in the World Trade Organization and Developing countries, New Delhi; Oxford University Press; Published on 2001, 3rd Impression 2002; Page No. 132.

[2] M.S. Swaminathan. An introduction to guiding principles in the decisions on patent law, Delhi; Bhari Brothers, 2000 pg: 331

[3] Budapest Treaty of 1977 provides for the establishment and recognition of international depositories to deposit inventions of life forms and other bio technological inventions for the grant of patent along with patent application.

[4] Lord Hatherley in Arnold vs. Bradbury (1871) 6 Ch App 706

[5] Vas-cath inc. vs. D. Mahukar (935 F 2d 1555) (Fed Cir 1991)

[6] A.B. Dick Co. vs. Barnett [288 Fed 799(2nd Cir 1923)]

[7] Supra Note 9

[8] Art 1, Budapest treaty [9]TRIPS agreement: Article 29 – Conditions on patent applicant. [10] Albany Law Journa of science and technology; David Kelly; ‘ The federal circuit transforms the written description requirement into a biotech – specific hurdle to obtaining patent protection for bio technology patents;” 2002 [11] Patentability of Bio technology Pg. 105 [12] The later claim over and above the earlier claim will not receive the benefit of the earlier filing date. [13] The patent act stands amended latest by 2005. Section 9: Provisional and complete specification. [14] Section 10 of Indian Patent Act, 1970 – Contents of Specifications. [15] 10.Contents of specifications (4) Every complete specification shall- (a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed; [16] 10.Contents of specifications (4) Every complete specification shall- (b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; [17] ibid [18] Section 11 [19] Patent Amendment Act 2002 [20] Electric and Musical Industries Ltd. Vs. Lissen Ltd. (1939) 56 RPC 23

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