As per section 2(1)(j) of the Indian Patents Act 1970, meaning of the “invention” is a new product or process involving an inventive step and capable of industrial application. The “invention” is patentable only if it satisfies the following criteria of patentability of the Patent Act, 1970:
- Inventive step
- Industrial applicability
In relation to the determination of patentability, an inventive step plays major role to decide grant of the patent. Apart from determination of patentability, a lack of inventive step is a valid ground for opposition under section 25(1)(e) and 25(2)(e), and for revocation under section 64(1)(f) of the Patent Act, 1970.
As per section 2(1)(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.1 The invention is patentable only if it involves one or more inventive step(s). As per the statutory definition of the inventive step, the invention must have at least one of the ‘technical advance’ or ‘economic significance’ in comparison with the prior arts, thus making the invention non-obvious to a person skilled art. The statutory definition of inventive step is not clear and very subjective for the interpretation. Therefore, the meaning of inventive step is interpreted using case laws in India.
Assessment of inventive step in India:
the India, “Bishwanath
Prasad Radhey Shyam v. Hindustan Metal Industries” 2 case
law is considered as most important case law for interpretation of the
Though the case was decided in 1978, the principles laid down in the case are followed even today.
- Timeline of Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries:
- M/s Hindustan Metal Industries respondent herein, (hereinafter called the plaintiff) has filed patent application claiming priority of December 13, 1951.
- A notice, served on the M/s Bishwanath Prasad Radhey Shyam appellant herein, (hereinafter called the defendant), in the Court of the District September 9, 1952, asking for desistance from the infringement of its patent, but the appellant continued to use the patented method.
- The Patent (No. 46368-51) is granted to Plaintiff on May 6, 1953
- The plaintiff has instituted a suit for injunction and damages on August 8, 1953
- Defendant has filed a petition the defendant along with three other business concerns under Section 26 of the Patent Act, 1911 for revocation of the patent October 13, 1953, contending that neither was the plaintiff’s alleged invention a manner of new manufacture or improvement, nor did it involve any inventive step or novelty, having regard to what was known or used prior to the patent.
- The plaintiff’s suit along with the counter-claim of the defendant, was transferred to the High Court under Section 29 (Proviso) of the Patent Act, 1911.
- Thereupon, the learned Judge dismissed the plaintiff’s suit (No. 3 of 1955) but allowed the petition for revocation (in Suit No. 2 of 1954) with costs; and revoked the Patent (No. 46368-51) that had been issued to the plaintiff.
- The plaintiff preferred two Special Appeals to a Division Bench of the High Court.
- The Appellate Bench concluded: In our opinion the method of mounting patented by the appellant did involve an inventive step and was a manner of new manufacture and improvement.
- The appellant/defendant argued that the method and means claimed by the respondent/plaintiff in Patent No. 46368-51 did not involve any inventive step or novelty.
- The respondent/plaintiff, argued that whether the process got patented by the respondent involves a method of new manufacture or improvement, is one purely of fact, and should not, as a matter of practice, be disturbed by this Court. In the instant case, it is urged, that presumption is stronger because the trial Judge as well as the Appellate Bench of the High Court have concurrently held that the process patented had utility.
- The grant of the patent is invalid and was liable to be revoked on the grounds mentioned in Clauses (d) and (e) of Section 26(1) of the Patent Act.1911, decided on Dec 13, 1978.
- Based upon arguments presented by both parties, it is held that:
1. The fundamental principle of Patent law is that a patent is granted only for an invention which must have novelty and utility. It is essential for the validity of a patent that it must be the inventor’s own discovery as opposed to mere verification of what was, already known before the date of the patent.
2. 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. It must produce a new result, or a new article or a better or cheaper article than before. The new subject matter must involve “invention” over what is old. Mere collocation of more than one, integers or things, not involving the exercise of any inventive faculty does not qualify for the grant of a patent.
3. To decide whether an alleged invention involves novelty and an inventive step, certain broad criteria can be indicated. Firstly if the "manner of manufacture" patented, was publicly known, used or practiced in the country before or at the date of the patent, it will negative novelty or `subject matter'. Prior public knowledge of the alleged invention can be by word of mouth or by publication through books or other media. Secondly, the alleged discovery must not be the obvious or natural suggestion of what was previously known.
- Further, it is held that the expression “does not involve any inventive step” used section 26(1)(e) of the Patent and Design Act, 1911(section 64(1)(f) of the Patent Act, 1970) 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 following tests are suggested to determine the inventive step in any invention:
- “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.”
- 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 ?”
After a critical appraisal of the evidence produced by the parties the learned trial judge concluded that there has been no substantial exercise of the inventive power or innovative faculty. There is no evidence that the patented machine is the result of any research, independent thought, ingenuity and skill. Further, by the tests suggested by authorities, the patent in question lacked novelty and invention. In the result, the appeals are allowed, the judgment of the Appellate Bench is set aside and that of the trial Court restored.
F. Hoffmann-La Roche &Ors. vs. Cipla Ltd., 2016(65) case law 3:
- Timeline of F. Hoffmann-La Roche & Ors. vs. Cipla Ltd.:
- In February 2007, Roche along with Pfizer (as joint applicants), claimed that it had been granted a patent for Erlotinib drugwhich can be used in the treatment of cancer.The drug was in the tablet form and was sold under the trademark name ‘Tarceva’
- In January 2008, the Cipla Limited has announced a launch of a generic version of Tarceva (Erlotinib) in the newspaper.
- Roche moved this Court for infringement of rights in the drug Tarceva and also claimed an injunction restraining the Cipla from manufacturing and marketing Erlocip. Roche claimed that Cipla had infringed Patent in 774 also known as ‘Erlotinib Hydrochloride’ which is licensed to Roche.
- In defence, Cipla replied that the generic version of Erlotinib was sold by Cipla under the name Erlocip from October 2007. Secondly, Cipla said that patent granted to Erlotinib was invalid as Erlotinib was a derivative of a known patent ‘Quinazoline’. Also that the composition of Erlotinib was same as that of Quinazoline except for one substitution which was “obvious to any skilled person”. Roche’s invention, as disclosed in the complete specification and claims was obvious or did not involve any inventive step, having regard to what was publicly known or publicly used in India, or what had been published in India or elsewhere before the priority date. They pointed out that for any drug to be qualified as patentable under Section 3(d) it is essential that one shows that there is “any improved efficacy of the said drug. Further, what Cipla pleaded was public interest. It pointed out that the huge difference in price between Roche’s drug (Rs.4,800 tablet (approx. US$ 100) and Cipla’s drug (Rs.1,600 (approx US$ 33) should be taken into account when deciding whether or not to grant an interim injunction.
- Roche’s plea for interim injunction against Cipla was dismissed by a learned Single Judge of this Court on March 19, 2008, with a fascinating characterization of the public interest involved in, and the life-saving nature of, the drug in question playing a large part in the evaluation of the imponderables.
- Roche’s appeal to the Division Bench of this Court against the order passed by the learned Single Judge was dismissed on April 24, 2009, on the back of a heavily public interest-centric reading of the Patents Act, 1970 as amended from time to time, and a detailed discussion of the relative affordability of the two drugs to the common man.
- Roche’s subsequent agitation of the matter on special leave before the Supreme Court was also denied. And the case moved to trial.
- The learned Single Judge has dismissed counter claim filed by Cipla seeking revocation of patent in favour of Roche. Costs allowed in favour of Roche and against Cipla in sum of `5,00,000/- (Rupees Five Lakhs only).
F. Hoffmann-La Roche &Ors. vs. Cipla Ltd., 2016(65)PTC 1(Del), the Hon’ble Division Bench of Delhi High Court also provided the following steps to determine obviousness/lack of inventive step:
Step No. 1: To identify an ordinary person skilled in the art:
Who is an ordinary person skilled in the art?
Normal and grammatical meaning of the said person who is skilled in art would presuppose that the said person would have the knowledge and the skill in the said field of art and will not be unknown to a particular field of art and it is from that angle one has to see that if the said document which is prior patent if placed in the hands of the said person skilled in art whether he will be able to work upon the same in the workshop and achieve the desired result leading to patent which is under challenge. If the answer comes in affirmative, then certainly the said invention under challenge is anticipated by the prior art or in other words, obvious to the person skilled in art as a mere workshop result and otherwise it is not. The said view propounded by Hon’ble Supreme Court in Biswanath Prasad (supra) holds the field till date and has been followed from time to time by this Court till recently without any variance Therefore, it is proper and legally warranted to apply the same very test for testing the patent; be it any kind of patent. It would be improper to import any further doctrinal approach by making the test modified or qualified what has been laid down by the Hon’ble Supreme Court in of Biswanath Prasad (supra).” 4
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 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 hide side approach.”
Correlation between Bishwanath Prasad Radhey Shyam Vs. Hindustan Metal Industries case law and F. Hoffmann-La Roche & Ors. vs. Cipla Ltd. Case law:
Based upon above case studies it is understood that, the learned Single Judge of the F. Hoffmann-La Roche & Ors. vs. Cipla Ltd. has cast the “person skilled in the art’ as a competent craftsman and a skilled worker but nothing further; drawing on the decision of the Supreme Court reported as AIR 1982 SC 1444 Bishwanath Prasad Radhey Shyam Vs. Hindustan Metal Industries. Beyond this, any further characterization of the “person skilled in the art’ drawn from other jurisdictions is discarded entirely.
How IPO examines patent applications w.r.t 2(1) ja 5:
In relation to the determination of patentability, an Examiner first conducts an enquiry as to the novelty of the claimed invention and then proceeds to conduct an enquiry on whether the claimed invention involves one or more inventive step.
Determination of inventive step in India:
a) For determination of inventive step, all or any of the prior art(s) revealed during the search process to perform an enquiry as to whether such prior art(s) disclose(s) the claimed invention, are relied upon.
b) Publications existing on the date of filing of complete specification would be considered as a prior art.
c) However, Indian Applications filed before but published on or after the date of filing of complete specification of the instant application are considered as a prior claiming.
d) Invention as a whole shall be considered. In other words, it is not sufficient to draw the conclusion that a claimed invention is obvious merely because individual parts of the claim taken separately are known or might be found to be obvious.
e) If an invention lies merely in verifying the previous predictions, without substantially adding anything for technical advancement or economic significance in the art, the inventive step is lacking.
f) For the purpose of establishing obviousness of the invention, citing a mosaic of prior arts is permissible, provided such prior art is enabling.
g) If the invention is predictable based on the available prior art, merely requiring workshop improvement by a person skilled in the art, the inventive step is lacking.
Comparison for assessment of obviousness/inventive steps in US, EP and IN:
|Section||35 U.S. Code § 103||Article 56||2(1)(ja)|
|Statutory Definition||“A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.”||“An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.”||“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”.|
|Test for Interpretation||1. Determine the scope and content of prior art 2. Analyze the differences between the prior art and the invention in question 3. Determine the level of ordinary skill in the pertinent art 4. Ascertain the secondary considerations of non-obviousness. Secondary considerations like a long felt but unmet need for a device or the failure of others to solve the problem addressed by the invention in question suggests that a patent must be issued, even if the invention in question seems obvious.||In the problem-solution approach, there are three main stages: (i) determining the “closest prior art”, (ii) establishing the “objective technical problem” to be solved, and (iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person||“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.”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?” (Encyclopaedia 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 ?”|
|Case laws||Graham v. John Deere Co.||–||Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries|
- Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries on 13 December, 1978, Source: https://indiankanoon.org/doc/1905157/