The three tenets of a patent grant are possession, disclosure, and claims of invention. It is true that invention is by necessity the subject matter defined by patent claims, yet its support by written description and truthful representation to serve as proof of possession of the invention is essential to fetch a patent grant from the patent office. The inventions that cannot be defined clearly are not patent-eligible due to a lack of description. The description includes drawings in cases where the description is insufficient to explain the structure or working of the invention. There are still certain inventions that cannot be identified by description or even drawings. In such cases, inventors use functional claims to grant a patent where the invention is defined by the method of isolation or the characteristic of the claimed product.
Introduction of deposits as a requirement for patents in the US
In 1949, when the first patent application for the grant of a patent for Streptomyces strains was filed by Parke Davis Co. in the USPTO, the examiner insisted on the inventors deposit the pertinent micro-organism with a culture collection centre as words alone were found to be insufficient to micro-organism claimed. The examiner allowed the patent on the deposited culture of Streptomyces venezuelae in the American Type Culture Collection (ATCC) ATCC 10712 and US 2,483,892 patent for a process for manufacturing chloramphenicol in October 1949. Similarly, in August 1949, the American Cyanamid Company deposited a culture of Streptomyces aureofaciens with the Agricultural Research Service Culture Collection known as the Northern Regional Research Laboratory (NRRL). NRRL 2209, the U.S. Patent 2,482,055(for the production of aureomycin), which was allowed in September 1949.
These two cases of the historical requirement for the patent office marked the beginning of deposits for patent purposes worldwide. In fact, they are seen as forerunners to the existing practice of the patent offices around the world with respect to applications for inventions involving micro-organisms, plasmids, vectors, cells, plant tissues, seeds, and other biological materials that are newly isolated, novel, manmade, that cannot be defined or described in words in the specification. A deposit in a recognised patent depository serves the purpose of making the invention available to the public. This practice is now formally accepted by countries members (89 countries now including India ) to the Budapest treaty on the International Recognition of the Deposit of Micro-organisms for the purposes of Patent Procedure done at Budapest in April 1977.
Position of patenting living entities before 2005
In India, the Patent Act, 1970 sets the standards for disclosure and the written description requirement under section 10(4)(a), which says that every complete specification shall- fully and particularly describe the invention and its operation or use and the method it is to be performed. The patent law in India was understood to specifically bar patents on living entities or material of natural or artificial origin, including those genetically engineered, like animals and plants and plants or parts thereof or micro-organisms and biological materials like plants and animal cells, viruses, cultures, altered genes, DNA fragments, plasmids, vectors, replicons including methods or processes of their production/creation, like gene therapy, tissue culture cell fusion and hybridoma technology as they do not fall under erstwhile section 2 (1) (j) and section 3(h) and 3(i).
However, processes or methods of production of tangible and non-living substances like enzymes, antibiotics, insulin, hormones, interferons, alcohols, etc., by bioconversion utilising micro-organisms, etc., as well as chemical substances produced by using genetically engineered organisms or of such exiting made more economically by the use of biotechnology and/or microbiology were considered patentable. The Controller General, through the instructions in July 1991, made it clear that in case of deposit of specimen/s of biological materials, including micro-organisms in any depository institutions and reference thereto in the patent specification by way of any depository number, such depository number is not allowable unless such reference to the deposit number is accompanied by relevant description of the concerned deposit in the complete specification because a sample cannot form part of the of a patent specification in accordance with section 10(3) of the Patents Act.
Therefore, the specification does not furnish complete details of the micro-organism and/or biological material and satisfies provisions of section 10(4) of the Patents Act, 1970. This Indian position perhaps finds its support from the necessity of possession of an identifiable subject matter of the patentable invention. The 1991 opinion in Vas-Cath Inc. v. Mahurkar Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1560 (Fed. Cir. 1991) US Federal court provides a leading authority on the written description requirement and its relation to possession of the invention. The possession test had its roots in the decision of the US Federal court in the Vas-Cath case, where the court declared that the purpose of the written description requirement "is broader than to merely explain how to 'make and use'; the applicant must also convey ... that, as of the filing date sought, he or she was in possession of the invention."
The court explained that possession was shown if the disclosure reasonably conveyed to a person of ordinary skill in the art that the applicant possessed the claimed invention when the patent application was filed. It created an anomalous situation for inventions in the field of emerging biotechnology, where the identification of subject invention remained the subject matter of debate. The inventors looking for patents on biological materials found different ways to prove possession. For instance, written descriptions of chemical and biotechnological compounds could be described in terms of their function, properties, method of making, or any other manner sufficient to convey possession by the inventor.
Emergency ‘Deposit in lieu of description’ provision in India
The concept of deposits in lieu of description under section 10(4)(d)(ii) in Indian patent law now allows an inventor to deposit biological material in a recognised depository institution instead of providing a detailed written description of the material in the patent application. This provision was introduced in May 2003 to address the challenges of describing biological materials in a patent application, which can be difficult due to their complex nature and the lack of adequate vocabulary to describe them. India also joined the Budapest treaty in September 2001 to recognise the institutions as authorised institutions for the purposes of section 10((d)(ii). Section 10 relates to the requirement of the content of the complete specification of all the patent applications irrespective of the field of technology, which reads as
“10. Contents of specifications.—(1) Every specification, whether provisional of complete, shall describe the invention and shall begin with a title sufficiently indicating the subject-matter to which the invention relates.
(2) Subject to any rules that may be made in this behalf under this Act, drawings may, and shall, if the Controller so requires, be supplied for the purposes of any specification, whether complete or provisional; and any drawings so supplied shall, unless the Controller otherwise directs, be deemed to form part of the specification, and references in this Act to a specification shall be construed accordingly.
(3) If, in any particular case, the Controller considers that an application should be further supplemented by a model or sample of anything illustrating the invention or alleged to constitute an invention, such model or sample as he may require shall be furnished before the application is found in order for grant of a patent, but such model or sample shall not be deemed to form part of the specification.
(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;
(b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and
(c) end with a claim or claims defining the scope of the invention for which protection is claimed;
(d) be accompanied by an abstract to provide technical information on the invention: Provided that—
(i) the Controller may amend the abstract for providing better information to third parties; and
(ii) if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be completed by depositing the material to an international depository authority under the Budapest Treaty and by fulfilling the following conditions, namely:
(A) the deposit of the material shall be made not later than the date of filing the patent application in India, and a reference thereof shall be made in the specification within the prescribed period;
(B) all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification, including the name, address of the depository institution and the date and number of the deposit of the material at the institution;
(C) access to the material is available in the depository institution only after the date of the application of the patent in India or if a priority is claimed after the date of the priority;
(D) disclose the source and geographical origin of the biological material in the specification when used in an invention.
The new provision under section 10((d)(ii) is deemed to be satisfied if the name, address of the depository institution and the date and number of the deposit of the material at the institution are given in the specification. The Indian patent office also now allows deposit numbers of biological material in claims. In addition to this, the Indian patent office also insists on the disclosure of the source of the origin of the biological material used in the invention. In case the biological material used in the invention is from India, the necessary permission from a competent authority is also required to be obtained and submitted before the grant of the patent. There is no statuary bar on the grant of product patents in India now.
Guidelines for biological material and deposits: Para 11.2
As the Patent Office Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals of October 2014 para 11.2
“11.2 Sufficiency of disclosure with respect to biological material and deposits: If the invention relates to a biological material which is not possible to be described in a sufficient manner and which is not available to the public, the application shall be completed by depositing the material to an International Depository Authority (IDA) under the Budapest Treaty. The deposit of the material shall be made not later than the date of filing of the application in India, and a reference of the deposit shall be given in the specification within three months from the date of filing of the patent application in India. All the available characteristics of the material required for it to be correctly identified or indicated are to be included in the specification, including the name, address of the depository institute and the date and number of the deposit."
Definition of ‘Biological Material’
The term 'biological Material' used in section 10 of the Indian Patents Act is not defined. The term 'micro-organism' is not defined in the Budapest Treaty; therefore, it allows a broad interpretation of this term. Accordingly, this term includes unicellular and multicellular organisms, bacteria, fungi, plant, animal and human cell cultures, murine embryos, plasmids, DNA sequences, enzymes, seeds, etc. Today, the term biological material is more commonly used in the context of deposits under the Budapest treaty.
Definition of 'biological Material' in the US
In the United States, regulations pertaining to the deposit of biological material for purposes of patents state that:
[t]he term biological material shall include material that is capable of self-replication either directly or indirectly. Representative examples include bacteria, fungi including yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Viruses, vectors, cell organelles, and other non-living material existing in and reproducible from a living cell may be deposited by the host cell capable of reproducing the non-living material. 37 C.F.R. § 1.801 (1989).”
This US definition is quite wide to cover even non-living biological materials like Viruses, vectors, cell organelles, and other non-living material existing in and reproducible from a living cell that may be deposited by deposit of the host cell capable of reproducing the non-living material. Since the definition of biological material is not given in Indian law, we may assume that it may take wider coverage, like USPTO.
Changing Trends in Written Description Requirements in the US
The written description jurisprudence in US Patent Law kept on changing with new parameters for ascertaining the adequacy of written description under the patent law. Earlier, in In re Ruschig 379 F.2d 990 (C.C.P.A. 1967), the federal circuit made it clear that the manner in which a claimed invention is described in the specification is not critical, so long as that description is capable of conveying to readers whether the inventor had actually invented the claimed subject matter as of the application filing date. In this case, the court observed that the inquiry is whether "the specification convey[s] clearly to those skilled in the art, to whom it is addressed, in any way, the information that the applicants have invented that specific compound.”
Again, the CCPA in re Smith (481 F.2d 910 (C.C.P.A. 1973). ) described the "essential goal" of the description requirement as "convey[ing] clearly to those skilled in the art the information that the applicant has invented the specific subject matter later claimed. Therefore, when the complete specification accomplishes this goal, the written description requirement is satisfied regardless of how the specification accomplishes it.
Thus, the written description requirement shares a mixed "subjective/objective" approach to dealing with the sufficiency of description under patent law. However, the adequate written description of chemical and biotechnological compounds had not been restricted to disclosures of physical structure. In certain situations, such compounds could be described in terms of their function, properties, method of making, or any other manner sufficient in the context of the claimed invention to convey possession by the inventor as of the application filing date. At the root of this is the ability of the inventor to prove possession of the invention to the public.
Higher level of Written Description for biological materials in the US
The Federal Circuit developed a higher parameter for written description standards for biotechnology patents involving DNA. For instance, in Amgen Inc. v. Chugai Pharmaceutical Co. (1991), the court held that proof of conception required the provision of a gene sequence in patents involving DNA. Later, in 1993 in Fiers v. Revel the court used Amgen standard for conception into the written description requirement, reasoning that since "a conception of a DNA requires a precise definition and held that the written "description also requires that degree of specificity." Again, in Regents of the University of California v. Eli Lilly. 119 F.3d 1559, 1568 (Fed. Cir. 1997) the court held that an adequate written description of "a DNA requires in addition to a mere statement that it is part of the invention and reference to a potential method for isolating it," a description of the DNA itself also.
The practice of depositing micro-organisms in lieu of a description of an invention micro-organism has been in place in USPTO since 1949. The judicial acceptability of the ability to patent novel life forms, as held in the Chakrabarty case, opened the gates for the patentability of novel biotechnology-generated products. The acceptability of deposits of new biotech products increased patenting in these areas. The role of the Budapest treaty in laying standards for the storage and public use of deposits facilitated and opened new vistas for biomedicines.
However, whether a deposit is necessary is a decision made on a case-by-case basis by the examiner. Of course, such a decision is guided by considering the reproducibility of the invention based upon a written description alone, the level of skill in the art, the teaching of the prior art, and the availability of starting materials. It means a deposit is not automatically required. Only when the examiner is convinced that the written description is insufficient is the requirement of deposit of biological material used in the invention enforced to meet the requirement sufficiency of description for practising an invention.
In India, section 10 (4)(d)(ii) clearly manifests and supports this approach to meet the requirements of section 10(4)(a)(b). The patent eligibility of novel biological material had many ups and downs in USPTO. When the US Federal Circuit in Regents of the Eli Lilly case applied the written description requirement to claims originally filed in a pioneering patent application directed to the recombinant production of insulin and held that the written description requirement is not satisfied for claims to DNA absent an express disclosure of nucleotide sequence, it introduced new parameter to be applied to cases where invention claims a DNA.
Though we have not encountered cases like Lilly in India so far, we may face such requirements from Indian examiners in DNA-related inventions as well. Expert advice would be useful for filing patents relating to biological material in India to meet all requirements of adequacy of description under the Indian Patent Law.