The requirements for patentability of inventions can be considered as one of the most important parts of patent law. They form the basis for grant of a patent, scope of protection, and patent validity, among others. At a general level, they influence the efficiency of the patent system in achieving its objectives of promoting scientific and technological progress, economic/industrial growth and public benefit. Owing to their value, they may be termed as essential parts of the patent machinery. If they fail, the patent machine also fails.
Under the Indian Patents Act (“Act”), patentability requirements and their elements have not been laid out in an organised manner. Though the definitions capture the requirements at a general level, finding specifics of some of the requirements requires more effort than expected. Like in many other countries, there are five (5) patentability requirements under the Indian patent law.
An invention will be eligible for a patent grant in India only if it satisfies the patentability requirements. To be patentable, the invention must satisfy all of the requirements, which check worthiness of the invention for patent grant from different perspectives. Some of the requirements are relatively easy to satisfy when compared to others, but all of them are equally important for purposes of patentability assessment.
The five (5) requirements for patentability of inventions in India are:
A. Patentable Subject Matter;
B. Industrial Applicability;
D. Inventive Step; and
Patentability requirements may be viewed as filters arranged in succession for purposes of analysing patentability of inventions. Only inventions that pass through all the filters will be eligible for patent grant, and those that get filtered out will be refused. The picture below provides a view of the patent filter model.
Under Section 2(1)(j) of the Patents Act, inventions are defined as those that are either products or processes, are novel, have an inventive step, and are industrially applicable. When seen through the lens of patent law, inventions are only those products and processes that satisfy patentability requirements. The definition of invention however includes only three of the patentability requirements, and inventions must satisfy two additional requirements to be eligible for patent grant. One of them relates to the list of subjects that are not patentable even if they are inventions, and the other reviews the description and workability of the invention.
A. PATENTABLE SUBJECT MATTER
The Patents Act does not use the phrase patentable subject matter anywhere, and this phrase has been borrowed from the US Patent Code. The TRIPS Agreement uses the phrase ‘Patentable Subject Matter’ in a context broader than that of this chapter. For purposes of this chapter, patentable subject matter refers to subjects that are considered patentable, and those that are excluded from patentability.
Patentable subjects are provided in broad terms in the definition of invention, which states that an invention under the Act must either be a product or process. In other words, in order to be considered for patentability an invention must either be a product or process. Patent eligible subjects are therefore products and processes without any limitation of field, technology, or any other. At a general level, every invention is either a product and/or process, and patentability objections at this level are not very common. However, the Patents Act provides a long list of inventions not patentable, which form material part of the patentable subject matter requirement.
Sections 3 and 4 of the Patents Act provide a list of inventions that are not patentable. While Section 3 deals with a general list of subjects not considered as inventions, Section 4 excludes inventions relating to atomic energy from the scope of patentability. If the subject matter of an invention falls within the list provided in the said sections, the invention will not satisfy the patentable subject matter requirement.
The interplay between Section 2(1)(j), which defines ‘invention’ and Section 3, which provides a list of subjects that are not inventions can sometimes get very complicated. For several subjects not considered as inventions under Section 3, the analysis of their scope and coverage overlaps with analysis of invention assessment criteria under Section 2(1)(j). Having said that, the Supreme Court in the Novartis case stated that determination of Section 2(1)(j) and Section 3 are independent of each other and must be conducted separately. The demarcation of assessment by the Supreme Court means that the determination of one should not have a bearing on the other, but that is more theoretical than practical with respect to many excluded subjects.
Section 3 has sixteen (16) clauses each of which list multiple subjects that are not considered inventions. By one count, around forty-six (46) subjects form part of the sixteen (16) clauses. On its face, the long listing of non-patentable inventions restricts the scope of patentable subject matter in India. However, the statutory language of the subjects leaves scope for interpretation, which has been, and will continue to be employed by applicants to carve out patentable inventions from the scope of unpatentable ones.
To elucidate the applicability and analysis of Section 3, the following important exclusions to patentability in the section have been discussed in this chapter:
- New Forms (Section 3(d));
- Computer Programs Per Se (Section 3(k));
- Plants and Animals (Section 3(j)); and
- Traditional Knowledge (Section 3(p)).
Section 3(d) that deals with new forms reads as follows:
“3. What are not inventions.
The following are not inventions within the meaning of this Act, –
(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation. —For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;”
The clause excludes new forms, new uses and new properties from the scope of patentability. With respect to new forms, the explanation provides an illustrative list of forms that are considered as the same substance as the known substance. An exception is provided in the clause based on efficacy, satisfying which a new form will be patentable. If the new form has enhanced efficacy when compared with the known efficacy of the known substance, the new form will be patentable. This is a narrow exception to exclusion from patentability, but is nevertheless an invaluable opening to satisfy the patentable subject matter requirement.
Section 3(d) has been a hotly contested clause, and has by far been the most reported and publicized provision of the Indian Patents Act. This clause was the subject of discussions and debates, many of them led by Shamnad Basheer, a distinguished IP professor, who made significant contributions with respect to the provision’s scope, and its role in enabling access to medicines. Analysis of whether a new form is patentable involves the following steps:
- Identifying the known substance;
- Identifying the known substance’s purpose and efficacy;
- Checking if the invention being claimed is a new form of the known substance;
- Identifying the efficacy of the new form; and
- Comparing the efficacy of the new form with the efficacy of the known substance with respect to the purpose.
If the efficacy of the new form for the purpose for which the patent is claimed is higher than the efficacy of the known substance for the same purpose, than the new form is considered to have enhanced efficacy, which makes it patentable subject matter. Advantages provided by the new form, which are unrelated to the purpose of the substance in question will have no value in proving enhancement of efficacy. In the Novartis case, the Supreme Court held that attributes of a new form such as enhanced bio-availability and stability, and reduced hygroscopicity are not sufficient to prove enhanced efficacy because the said advantages are not related to the purpose of the invention.
Novartis Case Brief
The Appellant in the case, Novartis AG, filed an application for patent in 1998 for a crystalline salt form of Imatinib and its use in cancer treatment. It specifically claimed the methanesulfonic acid addition salt form of the compound, Imatinib, called as Imatinib Mesylate (commonly referred to as Glivac or Glivec), in its beta crystalline form, which is non-needle shaped, having better flow properties, thus better processible, less hygroscopic and more thermodynamically stable, thus better storable than its needle shaped, alpha crystalline form, characterized by the differences in the melting points and the X-ray diffraction diagrams. It also claimed that the Beta crystalline form of Imatinib Mesylate has higher bio-availability when compared to the free base form of Imatinib by thirty percent.
The application was rejected by the patent office and later by the Intellectual Property Appellate Board on the ground that the compound did not meet the requirements of Section 3(d), which excludes new forms of a known substance with known efficacy from the scope of patentability unless enhanced efficacy is shown. The Appellate Board relied on the decision of the Madras High court, which held that enhanced efficacy means enhanced therapeutic effect and stated that the compound in question lacked efficacy and therefore fell within the scope of Section 3(d). It however agreed that the compound satisfied the other patentability requirements such as industrial applicability, novelty and inventive step. Novartis challenged the decision of the Appellate Board before the Supreme Court of India, which led to this decision.
Reiterating its prior decisions stating that the text of a statute must be seen in the light of its context, which is understood from internal and external sources, the Supreme Court reviewed the history of the patent law in India from 1911 to 2005, with specific emphasis on Agreement on TRIPs and changes brought about for its compliance. Stating that patent systems are not created for inventors but in the interests of national economy, the Court pointed out how the patent law in India impacted the pharmaceutical industry. Noting that the growth of Indian pharmaceutical and chemical industry was propelled by the 1970 Patents Act, which enabled effective health care in India and many other countries, the Supreme Court observed that the changes in patent provisions to comply with TRIPs agreement were brought about bearing in mind the context of health care as served by the Indian pharmaceutical companies. Though the Court cited discussions about Section 3(d) in the parliament and its perceived role in safeguarding access to health, it did not delve into the role of public health and public interest in interpreting Section 3(d).
Talking about patentability, the Court pointed out that an invention would be patentable only if it satisfies the twin tests of invention, which tests novelty, industrial applicability and inventive step, and patentability, which is provided under sections 3 and 4. Though certain products or processes are inventions in the general sense, the Court observed that they may not be eligible inventions under the patent law. Discussing the backdrop of Section 3(d), the Court pointed out that the section primarily deals with pharmaceutical and chemical inventions and that its objective was to prevent abuse of product patents in medicines. According to the Court, the amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, checks any attempt at repetitive patenting or extension of the patent term on spurious grounds.
With respect to Imatinib Mesylate, pre-cursor of the invention in question, the Supreme Court after analyzing the scope of a prior patent filed by the Appellant on Imatinib, infringement action initiated by the Appellant against NATCO, an Indian pharma company, and articles published by the inventor, came to the conclusion that Imatinib Mesylate was not new and lacked inventive step. It pointed out that the salt form was covered in the US Patent, which claimed Imatinib and all its pharmaceutically acceptable salt forms. While coming to the said conclusion, the Court pointed out that the scope of claims in a patent cannot go beyond the disclosure and teaching in the patent. It stressed that it did not want the law of patents to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.
Having established that Imatinib Mesylate formed part of prior disclosure, the Supreme Court compared its efficacy with that of Beta Crystalline form of Imatinib Mesylate, which was its polymorph, for purposes of Section 3(d). Stating that efficacy under Section 3(d) for pharmaceutical substances, meant therapeutic efficacy, the Court reviewed the data with respect to enhanced flow properties, increased thermodynamic stability, reduced hygroscopicity and enhanced bioavailability, submitted by the Appellant, and concluded that the Beta Crystalline form of Imatinib Mesylate did not have enhanced efficacy. The said properties, according to the court, did not contribute towards enhancing the efficacy in treatment of cancer when compared to the free base Imatinib or its Mesylate salt.
Discussing the meaning of efficacy, the Court stated that therapeutic efficacy of a medicine must be judged strictly and narrowly. It came to this conclusion based on the fact that the text added to section 3(d) by the 2005 amendment, which laid down the condition of “enhancement of the known efficacy” and the fact that the explanation required the derivative to “differ significantly in properties with regard to efficacy”. According to the Court, not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of a medicine, is its therapeutic efficacy. The mere change of form with properties inherent to that form would, as per the Court, not qualify as “enhancement of efficacy” of a known substance. As a precautionary measure with respect to interpretation of the judgment, the Court stated at the end that Section 3(d) does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances.
Following the Supreme Court’s judgment, several patents have been granted with respect to new forms as applicants were able to show enhancement of efficacy related to the purpose of the invention. Section 3(d) sets higher standards for new forms based on showing of enhanced efficacy by way of enabling data and information, which calls for a change in strategy with respect to disclosures made in patent documents as well as timing of filings. It places higher standards for patentability of new forms, which are to be tested by the extent of their efficacy, and does not completely bar their patentability.
i) Computer Programs Per Se
Section 3(k), which excludes mathematical algorithms, mathematical methods, business methods and computer programs per se from patentability reads as follows:
“3. What are not inventions.
The following are not inventions within the meaning of this Act,—
(k) a mathematical or business method or a computer programme per se or algorithms;”
‘Computer programs per se’ are excluded under Section 3(k), but other computer program inventions are patentable. The general dictionary meaning of “per se” is “by itself” or “in itself” or “as such” or “intrinsically.” The said definition has been cited in the Guidelines with respect to computer related inventions (CRI) that form part of the Manual of Patent Office Practice and Procedure. (MPPP), 2017.As per the CRI guidelines, any invention that includes only a computer program that covers instructions to a computer is not patentable. Representing the computer program in the form of a process, system, apparatus, device, computer readable medium, product, or otherwise will not give rise to patentability if what is being claimed is in substance a computer program per se. However, if the invention being claimed includes something more than a computer program, it will not be covered under the exclusion.
As of date, no court has clearly expounded the meaning of what amounts to a ‘computer program per se’ and what does not amount to such a program. In the Ericsson case, the Delhi High Court observed in an interim order that the existence of technical contribution or technical effect may be used to differentiate computer programs that are per se from those that are not. But the Court did not delve into the question of whether the computer program in the case was patentable or not, and the applicability of the technical contribution/effect test that is followed in Europe to determine patentability of computer programs in India is still open. Having said that, the MPPP uses language similar to that of the technical contribution test and decisions of the patent office based on the said test are not uncommon.
To add to the confusion, the Intellectual Property Appellate Board (IPAB) has not followed a specific approach in assessing patentability of computer programs under Section 3(k). In a case relating to a system for analyzing speech voice signal, the IPAB held that technical advance is not sufficient to make excluded subjects under Section 3(k) patentable. In another case involving a patent application relating to a software application service provider, the IPAB stated that the requirement of novel hardware for patentability of computer programs is not valid. In another case, IPAB held that a computer operated or computer controlled technical instrumentation processing of the utilities to achieve the target in a wind machine is a process that produces technical effect and result, and is not excluded from patentability under Section 3(k). It is well accepted that computer programs embedded in hardware are patentable subject matter and that novelty of hardware is not material to computer program patentability, but the specific test that will determine whether a computer program is ‘per se’ or not is still undefined.
As it stands today, the Indian Patent Office (IPO) rejects patents that merely claim computer programs irrespective of the way in which they are claimed as a general practice. It accepts patent applications that claim computer programs as part of hardware, programs that form part of special purpose devices, programs that interact with networks, and programs that give instructions to devices outside the computer as patentable subject matter. In such inventions, a computer program is considered as just one part of the whole inventive concept, and therefore, not computer program per se. Patentability of computer program inventions that claim more than a computer program but less than those that form part of, or interact with external hardware is fraught with uncertainty.
For illustration, a computer program for making a playlist on a computer is considered as ‘per se’ and excluded, but a computer program to make a playlist on a mobile phone is patentable subject matter. However, it is not certain if a computer program that collects data from a few websites and prepares a playlist on a computer is patentable subject matter or not. All the computer programs may be rejected based on novelty or inventive step requirements, but the analysis of those requirements do not play a role in assessing patentable subject matter.
ii) Plants, Animals and Parts
Section 3(j) of the Patents Act that excludes plants, animals and their parts from patentability reads as follows:
“3. What are not inventions.
The following are not inventions within the meaning of this Act, —
(j) plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;”
The clause excludes the following subjects:
- Plants as a whole and their parts;
- Animals as a whole and their parts;
- Plant and animal varieties;
- Plant and animal species; and
- Essential biological processes for production and propagation of plants and animals.
On its face, Section 3(j) excludes plants and animals without any limitations. It excludes all kinds of plants and animals including those that are the result of breeding and genetic modification. The words ‘varieties’ and ‘species further qualify the general exclusion from patentability. Seeds are also not patentable, and the same applies to biological processes for creating and spreading plants and animals, which are essential for the said purposes. Microorganisms are excepted from the scope of the exclusion, and are patentable subject matter.
With a basic interpretation of the language used in the clause, it may be concluded that the exclusion from patentability extends to multi-cellular organisms and essential processes for their production and propagation. The caveat however is that the multi-cellular organisms must be considered as either plants or animals. As microorganisms are unicellular, it may be concluded that subject matter at the cellular level and lower is not excluded under Section 3(j). At the genetic level, complementary DNA is considered patentable, and so are biotechnological inventions that are cellular or sub-cellular. However, in the Monsanto case, the Delhi High Court came to the conclusion that gene constructs are parts of plants, and are therefore, not patentable.
Monsanto Case Brief and Comment
Monsanto (Monsanto Technology LLC.) holds an Indian Patent (Patent No. 214436, hereinafter referred to as “BT Patent”) with respect to gene sequences and methods for inserting such gene sequences into plant cells to express Bacillus thuringiensis (BT) Delta-endotoxin to provide Bollworm resistance in plants. The final granted patent has two sets of claims: one set claiming the isolated, purified and modified gene sequences, and the second set claiming methods of inserting the gene sequences into plant cells. Claims with respect to transgenic plants, hybrid varieties and seeds that formed part of the patent application were rejected during prosecution by the Indian Patent Office.
Nuziveedu (Nuziveedu Seeds Ltd.), a licensee of Monsanto’s BT Patent, initially challenged the ‘trait fee’ charged by Monsanto, and later challenged the license validity based on claims of patent invalidity. Nuziveedu contended that Monsanto’s BT Patent is not valid because the subject matter of the invention falls within the scope of excluded inventions under Section 3(j) of the Patents Act.
BT Patent Claims
Independent claims of BT Patent read as follows:
“1. A method of producing a transgenic plant comprising incorporating into its genome a nucleic acid sequence comprising a plant functional promoter sequence operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis d- endotoxin protein, within said plastid transmit peptide functions to localize said d- endotoxin protein to a subcellular organelle or compartment.”
“25. A nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis d- endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said d- endotoxin protein, and wherein said fusion protein functions to localize said d- endotoxin protein to a subcellular organelle or compartment.”
Analysis and Comment
The Court started its analysis of patentability by constructing Section 3(j) of the Patents Act. It stated that the mechanism adopted by Parliament was to spell out what was not patentable i.e., plants, seeds, plant varieties, – whole or part and then exclude micro-organisms, but clarify that the exclusion would not apply to “seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.” In the Court’s words, “the expression ‘includes’ is used as a legislative device to enlarge the meaning of words or phrases “occurring in the body of the statute; and, when it is so used, these words or phrases must be construed as comprehending, not only such things as they signify according to their natural import, but also those things which the interpretation clause declares that they shall include (Ref. Dilworth v. Stamps Commissioners (1899) A.C. 99) which the Supreme Court of India consistently followed.”
Based on the aforestated, the Court looked at dictionary definitions to define the meaning of the term “microorganism” as the term was not defined in the Patents Act or any other related statute. Citing meanings from Cambridge, Oxford and Black’s Law dictionaries, the Court stated that gene sequences in the BT Patent are not microorganisms because they have no existence of their own, and that they are useful only after their introgression at a particular place, and because seed materials must undergo hybridization to suit local conditions. While arriving at the conclusion, the Court did not explain how the aforestated reasons excluded gene sequences that are present in Bacillus thuringiensis, a microorganism, from the scope of patentability, and how the meaning in dictionaries was relevant for this analysis. Neither did the Court feel the need to elaborate why parts of microorganisms are not patentable while microorganisms themselves are patentable. Instead, it went on to point out that Monsanto failed to deposit the biological material and that it did not disclose the source and geographical origin of the material, which is not only irrelevant with respect to the subject matter of the invention, but is also not required if the invention can be described without the deposit.
Inexplicably, the Court then went on to elaborate the meaning of the phrase “essentially biological process” in Section 3(j) by citing the European Patent Convention, EU Directive, and several European decisions to conclude the well-known fact that creating hybrid plants through breeding amounts to an essentially biological process despite the human intervention. It discounted and did not address the fact that introducing a gene through genetic engineering through human intervention makes the process not essentially biological. The Court then went on to conclude that transgenic plants are not patentable in India, and therefore, gene sequences that form part of transgenic plants are also not patentable because the gene sequences can be propagated through breeding, which is an essentially biological process. The reasoning may make some sense from the infringement perspective, but the relevance of patentability of transgenic plants and the process of breeding for determining gene sequence patentability is legally and scientifically absurd because they are independent, unconnected subjects for purposes of patent analysis.
Thereafter, the Court went on to point out that gene sequences are inert and inanimate, and that they are relevant only as parts of seeds and plants. Once a gene sequence is introduced into seeds and/or plants, what follows is an essentially biological process, which, according to the Court, makes the gene sequences and processes of introducing them unpatentable under Section 3(j). In other words, the Court stated that because plants, seeds and breeding processes are not patentable, gene sequences and processes related to them are also not patentable. Here, the Court has wrongfully combined different inventions to analyze patentability of one based on patentability of another.
Contrary to reason, the Court finally concluded that gene sequences are not patentable because plant variety protection and patent protection are mutually exclusive and not complementary. By the said logic, gene sequences must be patentable because plant variety protection statute does not protect gene sequences. the Court then went ahead and gave an opportunity to Monsanto to acquire plant variety protection if it so desires by claiming the priority of the patent filing. Leaving aside the question of whether the Court can grant such a permission, there may not be any term left for plant variety protection to subsist from the patent priority date unless the Court wishes to grant protection from the plant variety filing date.
As of the date of this publication, the decision of the Delhi High Court has been overruled by the Supreme Court, and the case has been remanded for a full trial on the patentable subject matter issue. On full trial, the Court will hopefully arrive at a conclusion that makes legal and scientific sense.
iii) Traditional Knowledge
`Section 3(p) that excludes subject matter relating to traditional knowledge reads as follows:
“3. What are not inventions.
The following are not inventions within the meaning of this Act –
(p) an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.”
Three types of inventions are excluded from patentability under the clause:
Inventions that are in effect traditional knowledge;
Aggregation of known properties of traditional knowledge components; and
Duplication of known properties of traditional knowledge components.
Section 3(p) excludes inventions that claim traditional knowledge and its components, but does not bar inventions that are based on traditional knowledge. In other words, an invention is not excluded under the clause merely because it relates to traditional knowledge. Specific phrases such as “in effect traditional knowledge” and “aggregation or duplication of known properties,” provide sufficient scope for interpreting inventions out of the scope of the exclusion. For example, use of ginger and celery as aphrodisiacs is known in traditional knowledge and is not patentable subject matter, but active ingredients in ginger and celery that enhance libido will not be excluded from patentability if those ingredients are not traditionally known.
The Council of Scientific and Industrial Research (CSIR) maintains a database of traditional knowledge called as the Traditional Knowledge Digital Library, which has 2.5 lakh formulations pertaining to Ayurveda, Unani and other ancient medicinal systems in India. It documents information relating to traditional knowledge with the objective of preventing patent grants over subject matter covered in TKDL. As of date, nine (9) patent offices including those of India, US and Europe have access to the library, and efforts are in progress to provide access to other patent offices. The information in TKDL is available to Indian patent examiners to search for traditional knowledge and assess patentability of traditional knowledge-based inventions.
The standards for assessing patentability of inventions relating to traditional knowledge are high compared to other inventions, and it is relatively difficult to convince the IPO and Courts to grant patents on modifications or improvements over traditional knowledge. In a case involving a traditional basket for hauling farm produce called ‘Kilta,’ the Himachal Pradesh High Court held that an invention claiming a plastic long basket instead of the traditional one made of bamboo with adjustable straps is not patentable under Section 3(p). The Court came to the said conclusion because mere replacement of bamboo with plastic and addition of straps, which are known in the prior art, does not make the invention an enhancement over traditional knowledge. Though the inventor in the case increased the size of the traditional basket, made it lighter and easy to carry, the Court placed the invention within the scope of mere aggregation and duplication of traditional knowledge components and revoked the patent.
B. INDUSTRIAL APPLICABILITY
Industrial applicability requirement checks if an invention is capable of being made or used in an industry (Section 2(1) (ac)). If a product can be manufactured repeatedly and has at least one use in an industry, it will be considered as industrially applicable. A process must be capable of being used in an industry to satisfy this requirement. Uncertain, vague, futuristic or non-specific use is not considered as valid use. The same is the case with insubstantial or non-credible use of a product or process.
In a case between Cipla and Roche, the Delhi High Court reviewed some Indian and foreign cases relating to the utility or industrial applicability requirement and observed that an invention must be commercially viable. It must have a commercial use, and commercial success need not be proved. At a basic level, the invention must have a practical use and has to be useful for the purpose claimed in the patent specification. Nothing more will be required to prove utility of an invention for patentability.
In another case between MSD and Glenmark, the Delhi High Court applied principles for industrial applicability laid down by the UK Court of Appeals to arrive at the conclusion that Sitagliptin, a pharmaceutical compound, is industrially applicable. The principles cited by the Court are as follows:
” i) The patent must disclose “a practical application” and “some profitable use” for the claimed substance, so that the ensuing monopoly “can be expected [to lead to] some … commercial benefit”;
ii) A “concrete benefit”, namely the invention’s “use … in industrial practice” must be “derivable directly from the description”, coupled with common general knowledge;
iii) A merely “speculative” use will not suffice, so “a vague and speculative indication of possible objectives that might or might not be achievable” will not do;
iv) The patent and common general knowledge must enable the skilled person “to reproduce” or “exploit” the claimed invention without “undue burden”, or having to carry out “a research programme”; …”
By applying the aforestated principles, the Court concluded that Sitagliptin is industrially applicable even if it cannot be put to practical use due to an ineffective carrier.
A product or process will be considered as an invention under the Patents Act only if it is novel and inventive. Novelty simply means newness based on what is existing as of the priority date of the patent application. An invention will be considered to be novel if it is different from what is already existing, which is referred to as ‘prior art.’ Novelty is always assessed in the light of a single prior art reference at a time, and prior art references are not combined for novelty analysis. Having said that, general knowledge of the art not expressly provided in a prior art reference may be read into the reference.
Novelty has not been defined under the Patents Act, and is provided under different sections pertaining to examination, anticipation, opposition and revocation. For purposes of novelty as well as inventive step analysis, prior art includes the following:
i. Prior patents relating to the invention, which include patent applications and granted patents in India, whose priority date precedes that of the patent application;
ii. Prior Publications relating to the invention, which include any document published before the priority date of the patent application;
iii. Prior commercial working of the product or process in India before the priority date of the patent application;
iv. Prior communication of the product or process to the Government before the priority date of the patent application;
v. Prior display of the product in an exhibition before the priority date of the patent application;
vi. Prior public working of the invention in India, before the priority date of the patent application; and
vii. Prior use of the invention in India before the priority date of the patent application.
Prior publication and prior patent filing will not negate novelty of an invention if the publication or filing was based on wrongful obtainment, or in contravention of the rights of the inventor or applicant. Public display in a Government recognised exhibition will also not negate novelty of the invention. Also, prior publication of the invention before a learned society will not amount to prior art for a period of twelve (12) months from the date of the said publication. A grace period of twelve (12) months is also available for prior public working, which amounts to a reasonable trial.
For a prior art reference to negate novelty of an invention, it must anticipate all elements of the invention. A single prior art reference must possess all elements expressly or inherently. Even if one element is missing the prior art will not anticipate the invention and negate its novelty. Relatively, the novelty requirement is more objective than the next requirement, which is inventive step.
D. INVENTIVE STEP
The inventive step requirement is the most subjective and complex of all patentability requirements. Under the Indian Patents Act, the assessment of inventive step includes two aspects, technical advance or economic significance; and non-obviousness. Section 2(ja) of the Patents Act defines inventive step as follows:
“(ja) “inventive step” means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;”
To satisfy this requirement, an invention has to:
- have technical advance over existing knowledge; or
- have economic significance; and
- must not be obvious to a person skilled in the art.
All prior art references constitute the knowledge for assessing technical advance as well as non-obviousness. Prior art references may be selected, combined and integrated for making inventive step determination. Obviousness is seen through the eyes of a person with ordinary skill in the art to which the invention belongs. Once the person with ordinary skill with respect to an invention is determined, the prior art references available to the said person on the priority date of the invention are identified and combined. Based on the prior art references on hand, if the person with ordinary skill would have found the invention obvious on the priority date, the invention is considered as obvious and will not meet the inventive step requirement.
Suggestion, teaching, motivation and other factors are considered for deciding what prior art references are applicable, whether they can be combined, and if the combination of prior art makes the invention obvious. The determination cannot be made based on hind sight, and secondary indications such as commercial success, long felt yet unresolved need, praise from experts, and so on, can sometimes be used to feed into the analysis if ambiguity subsists after the initial assessment of prior art. Cherry picking information from different prior art references and drawing prior art from diverse fields is not permitted for inventive step analysis unless guidance for such picking and drawing exists in the prior art.
In the Biswanath Prasad Radhey Shyam case, the Supreme Court spelled out the meaning of inventive step in 1978, which is applied for inventive step analysis even today. Relevant paras of the case read as follows:
“It is important to bear in mind that in order to be patentable an improvement on something known before or a combination of different matters already known, should be something more than a mere workshop improvement; and must independently satisfy the test of invention or an ‘inventive step’. To be patentable the improvement or the combination must produce a new result, or a new article or a better or cheaper article than before. The combination of old known integers may be so combined that by their working inter relation they produce a new process or improved result. Mere collocation of more than one integer or things, not involving the exercise of any inventive faculty, does not qualify for the grant of a patent. ‘It is not enough’, said Lord Davey in Rickmann v. Thierry (1896) 14 Pat. Ca. 105 ‘that the purpose is new or that there is novelty in the application, so that the article produced is in that sense new, but there must be novelty in the mode of application. By that, I understand that in adopting the old contrivance to the new purpose, there must be difficulties to be overcome, requiring what is called invention, or there must be some ingenuity in the mode of making the adoption’. As Cotton L. J. put in Blackey v. Latham (1888) 6 Pat. Ca. 184, to be new in the patent sense, the novelty must show invention”. In other words, in order to be patentable, the new subject matter must involve ‘invention’ over what is old. Determination of this question, which in reality is a crucial test, has been one of the most difficult aspects of Patent Law, and has led to considerable conflict of judicial opinion.
This aspect of the law relating to patentable inventions, as prevailing in Britain, has been neatly summed up in Encyclopedia Britannica, Vol. 17, page 453. Since in India, also, the law on the subject is substantially the same, it will be profitable to extract the same hereunder:
“A patent can be granted only for ‘manner of new manufacture’ and although an invention may be ‘new’ and relate to a ‘manner of manufacture’ it is not necessarily a ‘manner of new manufacture’-it may be only a normal development of an existing manufacture. It is a necessary qualification of a craftsman that he should have the knowledge and ability to vary his methods to meet the task before him-a tailor must cut his cloth to suit the fashion of the day-and any monopoly that would interfere with the craftsman’s use of his skill and knowledge would be intolerable.
The expression “does not involve any inventive step” used in Section 26(1) (a) of the Act and its equivalent word “obvious”, have acquired special significance in the terminology of Patent Law. The ‘obviousness’ has to be strictly and objectively judged. For this determination several forms of the question have been suggested. The one suggested by Salmond L. J. in Rado v. John Tye & Son Ltd. is apposite. It is: “Whether the alleged discovery lies so much out of the Track of what was known before as not naturally to suggest itself to a person thinking on the subject, it must not be the obvious or natural suggestion of what was previously known.”
Another test of whether a document is a publication which would negative existence of novelty or an “inventive step” is suggested, as under:
“Had the document been placed in the hands of a competent craftsman (or engineer as distinguished from a mere artisan), endowed with the common general knowledge at the ‘priority date’, who was faced with the problem solved by the patentee but without knowledge of the patented invention, would he have said, “this gives me what I want?” (Encyclopedia Britannica; ibid). To put it in another form: “Was it for practical purposes obvious to a skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he would or should make the invention the subject of the claim concerned ?” Halsbury, 3rd Edn, Vol. 29, p. 42 referred to by Vimadalal J. of Bombay High Court in Farbwrke Hoechst & B. Corporation v. Untchan Laboratories.”
The Supreme Court in the case revoked a patent relating to a means for mounting metallic utensils for turning them before polishing because the invention claimed was obvious, and no more than a mere workshop improvement. The Court came to the said conclusion after reviewing prior art pertaining to turning utensils that the invention lacked inventive step.
In a case involving Roche and Cipla, the Delhi High Court reviewed if selecting one compound from several compounds disclosed in the prior art and modifying the selected compound by substituting ethynyl with methyl at a specific position is obvious. The case involved Erlotinib Hydrochloride, which demonstrated capabilities as an Epidermal Growth Factor Receptor (EGFR) inhibitor which spiked survival benefit in cancer including non-small cell lung cancer (NSLC) patients. After reviewing relevant prior art references, the Court came to the conclusion that a person with ordinary skill would not have found the selection of the compound from a number of compounds and its modification obvious, and that structural similarities between compounds would not prima facie make the claimed compound obvious. While arriving at its conclusion, the Court expounded some important principles with respect to inventive step analysis, which read as follows:
“151. From the decisions noted above to determine obviousness/lack of inventive steps the following enquiries are required to be conducted:
Step No.1 – To identify an ordinary person skilled in the art,
Step No.2 – To identify the inventive concept embodied in the patent,
Step No.3 – To impute to a normal skilled but unimaginative ordinary person skilled in the art what was common general knowledge in the art at the priority date,
Step No.4 – To identify the differences, if any, between the matter cited and the alleged invention and ascertain whether the differences are ordinary application of law or involve various different steps requiring multiple, theoretical and practical applications,
Step No.5 – To decide whether those differences, viewed in the knowledge of alleged invention, constituted steps which would have been obvious to the ordinary person skilled in the art and rule out a hind side approach.
Thus obviousness is a question of law based on facts and the burden to prove is on the party which alleges obviousness. however, after the party which alleges makes out a prima facie case of invalidity on the ground of obviousness, the burden shifts on the inventor to disprove.”
This illustration elucidates novelty and inventive step analysis at a general level. For purposes of the illustration, assume that the invention does not exist today, and that it has only two prior art references.
Invention: Pencil with eraser fastened to it at one end.
Prior art references: Pencils and Erasers.
The claimed invention, pencil with eraser attached to it at one end, is novel because it is different from each of the prior art references considered independently. It has at least one difference when compared to pencils or erasers separately.
The invention satisfies the inventive step requirement because a person with ordinary skill in the art will not find the invention obvious based on existing prior art, and because the invention is a technical advance based on existing knowledge. The person with ordinary skill with respect to the invention is a mechanical engineer, who deals with writing and erasing instruments. He will not think about fastening an eraser to the pencil based on the prior art references. The prior art references are merely products existing in the market, and no guidance, requirement, or motivation to combine can be presumed.
Based on the same prior art references, it may also be argued that the invention lacks inventive step. The person with ordinary skill, a mechanical engineer, who is well versed with attachment and fastening of mechanical devices, components or parts will find attaching an eraser to a pencil very easy. If you give him a pencil and an eraser and ask him to attach them, he will do it without any difficulty. For him, this is merely a workshop improvement and not a technical advance.
Analysis of inventive step can be more complex than aforestated, and generally requires organised effort and application of mind to find relevant prior art references, combining them, and viewing the invention based on the prior art references through the eyes of a person with ordinary skill in the art. Novelty analysis on the other hand is relatively more straight forward and objective than inventive step analysis.
To obtain a patent, the inventor has to file a patent application containing a specification (Section 10). The object of the specification is to provide complete information to the public about the invention and the mode of carrying it out and to define the boundaries of the invention. The specification has to contain a written description of the invention and of the manner and process of making and using it. The written description may contain drawings where and when required to clearly describe the invention. A model or sample may have to be submitted if the patent office requires such a model or sample as an illustration of the invention. However, such a model or sample will not form part of the specification. If the invention involves biological materials, the biological materials may be deposited at a recognized depository in order to describe the invention and such materials would form part of the specification.
The specification has to enable the invention, which means it must fully and particularly describe the invention and its operation or use and the method by which it is to be performed. It must describe the embodiment of the invention claimed in each of the claims. The description of the invention must be so clear that any person in the field can carry it out and no further experimentation must be required to practice the invention. The specification must also disclose the best method of performing the invention which is known to the applicant at the time of filing the patent application.
Furthermore, the specification has to end with a claim or claims defining the scope of the invention for which protection is claimed. The function of the claims is to define the metes and bounds of the invention claimed in the patent application. Claims in a specification have to relate to a single inventive concept, and be clear and succinct. The claims must mark out with adequate distinctiveness, the boundary of the territory of the invention sought to be protected. The principle idea in the invention has to be presented in the claims and must not be left for general review of the specification. All claims in the patent have to be supported by the matter provided in the written description of the specification.
Though the specification requirement is normally not listed as one of the patentability requirements, it is as important as other requirements. If the invention is not fully described, claimed, supported or enabled in the specification, the patent application will be rejected. Through the specification, the inventor has to show that he is not only in possession of the invention, but also that the invention is workable without undue experimentation.
While deciding a Writ Petition praying for revocation of a patent relating to compositions for augmenting kidney function, the Madras High Court made important observations about the value and sufficiency of disclosure under the Patents Act. The relevant paras from the judgment read as follows:
92. The patent system is based on a “bargain”, or quid pro quo. An inventor is granted an exclusive right in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge.
The patent bargain encourages innovation and advances science and technology. This is the fundamental policy and rationale for grant of monopoly in the form of patent. The claim in a Patent limits the monopoly while the specification explains the invention. Thereto, specification has to describe the invention and the changes over the existing art.
In Tubes, Ld. v. Perfecta Seamless Steel Tube Company, Ld. (1902), 20R.P.C 77, Lord Halsbury observed as under:
“. . . if one has to look at first principles and see what the meaning of a Specification is . . . why is a Specification necessary? It is a bargain between the State and the inventor: the State says, “If you will tell what your invention is and if you will publish that invention in such a form and in such a way as to enable the public to get the benefit of it, you shall have a monopoly of that invention for a period of fourteen years.” That is the bargain. The meaning which I think, in my view of the Patent Law, has always been placed on the object and purpose of a Specification is that it is to enable, not anybody, but a reasonably well informed artisan dealing with a subject- matter with which he is familiar, to make the thing, so as to make it available for the public at the end of the protected period. [Emphasis added.] Lord Halsbury's view was cited with approval by Dickson J. (as he then was) in Consol board, atpara. 523.
 Therefore, adequate disclosure in the specification is a precondition for the granting of a patent. As Hughes J.stated in Eli Lilly Canada Inc. v. Apotex Inc., 2008 FC 142, 63C.P.R (4th) 406, at para. 74:
Thus, one must both advance the state of the art and disclose that advance in order to gain the patent monopoly. Failing to do so, thus invalidating the monopoly, can be in the form of one or more of several matters such as, the “invention” was not new, or the so-called invention was “obvious” or the disclosure was “insufficient” or “what you disclosed doesn’t support the monopoly that you claim”.
In return for such disclosure, patent is granted to the inventor for a specified period provided so that the patented invention is also worked in the country without undue delay and if there is any infringement by anybody, the patent holder invokes the rights under the Act to protect the claims in the patent.
country, a monopoly is given by the Government so that the patented invention is available to consumers at a cheaper cost and is available for being used at the end of the term of the patent.”
To conclude, patentability of an invention is subject to satisfaction of all patentability requirements provided under the Patents Act. Five patentability requirements may be crystallised from the provisions of the Act. They are provided in different provisions ranging from definition of invention to constituents of specification. Each requirement checks the worthiness of an invention for patent grant from a different perspective. The requirements are not water tight compartments, and analysis of one requirement sometimes merges with that of another.
Section 2(j), The Patents Act, 1970, last amended in 2005.
Sections 3 and 4, The Patents Act, 1970, last amended in 2005.
Section 3(d), The Patents Act, 1970, last amended in 2005.
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Section 3(j), The Patents Act, 1970, last amended in 2005.
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Section 3(p), The Patents Act, 1970, last amended in 2005.
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Novelty provisions – Sections 13, 18, 25 29, 30, 31, 32, 33, 34, and 64 of the Patents Act, 1970 as last amended in 2005.
Section 2(1)(ja), The Patents Act, 1970, last amended in 2005.
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