When is a patentable idea considered inventive? What standards are used to evaluate inventiveness? What are the best practices to overcome an inventive step objection? These are fundamental inquiries for those pursuing a patent application.
In India, a patent must meet the requirements detailed under Section 2(1)(j) regarding novelty, U/S 2(1)(ja) for inventive step means technical advancement or economic significance or both, and U/S 2(1)(ac) for industrial application in addition to not falling U/S 3 and 4 of the Indian Patent Act, 1970, to be granted.
In case we create a hierarchy of these three requirements in terms of importance, “Industrial Application” may come first, followed by “Novelty”, and further followed by “Inventive Step”. However, it is easy to establish industrial application or “Utility” as it is known in many jurisdictions. In a valid novelty objection, the examining authority needs to identify a single document in which the claimed process, product or composition of matter is fully disclosed. Even if one essential feature in a claim is absent in the prior art document, a novelty objection cannot be sustained. Addressing the novelty argument, therefore, requires listing out all the salient or essential features of the invention under consideration and comparing these features with the features disclosed in the prior art documents. This is comparatively a simple exercise.
To sustain an inventive step objection, instead of using one prior art document, the examining authority can use two or more and theoretically several documents in which the inventive features are partially disclosed in this collection of documents. This exercise is not only difficult for examine authority to sustain but also difficult for applicant to overcome. During the examination exercise, some measures of arbitrariness and subjectivity arise. This is because theoretically it is possible to find a feature or element or a process step in some document or the other. The law has faded this arbitrariness and selectivity by suggesting that an inventive step objection is sustainable only if the elements or features are present in relation to the same subject matter, and it has also been suggested that the greater the number of documents used by the examining authority, the lower is the sustainability of the inventive step argument. It can well be said that sustainability of an inventive step argument is inversely proportion to the number of documents used to sustain the inventive step argument in the first place.
It is pertinent to note that the requirement of Inventive Step is comparatively newer, and there used to be two requirements for patent-eligibility i.e. Novelty and Industrial Application.
Inventive Step and Non-Obviousness
According to the guiding principle of Inventive Step of invention or innovation must not be a compilation and repackaging of pre-existing knowledge. When a patent is obvious, it indicates that a person with ordinary knowledge of the subject matter would be aware of prior art(s) references, which can be combined to reveal every minute detail of a patent claim. The abstract idea merely cannot be used; therefore, it must be reduced in practice. rather, it should include technological advancement in relation to the current state-of-the art. The landmark case of Supreme Court M/s. Bishwanath Prasad Radhey Shyam Appellant v. M/s. Hindustan Metal Industries form the basis of the Inventive step in India. Another landmark case in India is Enercon (India) Limited v. Alloys Wobben which dealt with the interpretation of the inventive step.
The term "state-of-the art" is not defined in the Indian Patent Act of 1970, but we can infer from numerous case laws that it refers to the prior art, prior knowledge, and prior use—all of which would violate the patentee's claim if used and would have been expected. In other jurisdictions, the term "state-of-the-art" refers to any innovation that was publicly accessible before the date of priority of the invention through written or oral descriptions or any other means and includes any product, process, or information about either, or anything else. In the European context, the Inventive step can be evaluated by a simple problem-solution approach. Moreover, the combined teaching of the prior art(s) must not be present in a single invention and therefore it must be inventive and must not be obvious to a person skilled in the art.
Another way to defend the inventive step is to define the same in terms of better selectivity, accuracy, efficacy and so on. Obviousness is always four steps analysis, as was established in the Windsurfing International v. Tabur Marine case, and the court restated all of these requirements in the Bishwanth Prasad case. The first step includes recognition of inventive steps in the form of previously (use, art, or knowledge) disclosed; Secondly, a distinction between known material and an asserted innovation by a knowledgeable person is required; Thirdly, it's crucial to develop or note distinctions between the aforementioned competent person's asserted innovation and Fourth, the extend of the invention. Regarding non-obviousness, the US Supreme Court examined three factors known as the Graham Test (Graham v. John Deere Co) which include the extent of the prior art, distinctions between the claims and the previous, and assessing the level of skill in the art.
The significance of the inventive step is to enable businesses to continue developing new concepts without being concerned about breaking a patent regulation. This clause permits businesses to keep updating their systems to save money and resources rather than halting natural progress.
While judging the merit of the present invention, the functional aspect of the said invention may be considered apart from the structural aspect. It needs a lot of brainstorming and experimentation to find a solution to a given problem. An inventor only can start looking for a valid solution once a problem is in the domain, which is never otherwise. It needs plenty of effort to find a said solution, a lot of calibration, and optimization of parameters both in product composition as well as in process parameters. Once there is an achieved solution or possibility of a solution on the horizon, the solution may appear obvious to an observer, giving rise to hindsight bias. Therefore, concerning the cited prior arts, the present invention may be judged considering the required function the claimed procedure should be performing on the required substrate.
Challenges
Person Having Ordinary Skill in the Art (PHOSITA)
The question of whether a subject matter is Novel or not may easily be decoded through a search without any confusion, however, decoding an inventive step may always be a grey area as it requires not merely an objective verification, but also a subjective judgment i.e. whether or not a person skilled in the art would achieve the invention considering the existing information at a point of time, in a definite space and under a set of causation. This consideration of dynamic factors namely time, space, and causation are immensely important as always, the examination of the proposed invention applied in a patent application happens on a future date, and demands judgment of the invention designed in the past.
The “Inventive Step” requirement is a little more complicated in the use of phrases for the person, based on who said the requirement is decoded such as, Indian Patent Act talks about “Person Skilled in the Art”, however, the degree of skill may never be pragmatically defined. US Patent Act defines the hypothetical reference person as “Person Having Ordinary Skill in the Art (PHOSITA)”, without any specific definitional limitation to the phrases “ordinary” and “skill”, leaving always a degree of discretion to the examining authority with regard to identification of Inventive Step.
Hindsight Bias
The propensity to predict a result after it has already happened is known as hindsight bias. Hindsight bias is frequently present in legal systems. The factor in determining patentability in patent law in terms of non-obviousness or innovative steps is influenced by hindsight bias. Hindsight bias results in evaluating past actions or occurrences where the evaluator is aware of how those actions or events turned out. This bias is most prevalent when evaluating the likelihood, foreseeability, or predictability of prior art from an ex-ante perspective. Hindsight bias also leads to harsher assessments of others since it makes people think that the target of the judgment should have anticipated the outcome and made preparations for it.
Because judging whether an invention contains an inventive step is a highly subjective decision that can be influenced by the evaluator's memories of the past, and because it is frequently at the centre of patent examination and litigation, hindsight bias is a crucial issue in patent law. Patent examiners, jurors, and judges analyze patent applications while knowing the invention in question and how it functions in relation to earlier known techniques or devices, hindsight bias occurs in inventive step analysis. These judges are more likely to believe that an invention is apparent and decline to grant a patent as a result of their knowledge. Although several strategies have been used by courts to overcome hindsight bias, very few of these strategies have been successful. Jury verdicts on obviousness appear to be little or unaffected by instructions directing jurors to disregard hindsight bias.
Simple education is less effective at reducing hindsight than procedures that make evaluators take the foresight position and generate alternative potential outcomes. Patent offices should implement several additional measures that are known to lessen the impact of hindsight bias than should courts. Hindsight bias is lessened by knowledge and experience in a given sector, which enables patent examiners with technical knowledge and familiarity with the criterion of obviousness to assess an invention objectively.
Strategies
When the controller claims that the claimed subject matter lacks an inventive step due to a combination of prior arts, it becomes challenging to convince the controller that it would be obvious for PHOSITA to exercise claimed combination of prior arts.
A strategy for bolstering the applicant's justifications based on "Prior art Teachings and Motivation" is the counter-Intuitive (CI) Approach. In this approach, the limitations of combination(s) of the various prior art are used to establish the status of inventive step or non-obviousness. Such arguments assist in persuading the controller that it "would not be clear to a person skilled in the art to go against the well-known facts and integrate the prior arts." Furthermore, arguing against the well-known drawback(s) of the asserted combination allows the applicant to go around the controller's common-sense justification for merging the prior arts.
The argument presented in application no.: 201817044581 to refute the inventive step is highly commendable. The first examination report (FER) issued for the case includes novelty, inventive step, non-patentability, sufficiency of disclosure, scope, clarity and definitiveness objections. The invention basically relates to a stable liquid pharmaceutical formulation containing (A) an infliximab; (B) 0.001 to 5% (w/v) of a surfactant comprising polyoxyethylene sorbitan fatty acid ester, polyoxyethylene alkyl ether, alkylphenyl polyoxyethylene ether, polyoxyethylene-polyoxypropylene copolymers, sodium dodecyl sulfate or a mixture of two or more thereof; (C) 0.1 to 30 % (w/v) of one or more a sugar and/or its derivative selected from the group consisting of sorbitol, mannitol, sucrose and trehalose (D) a buffer comprising acetate or histidine.
The argument defending the non-obviousness or inventive step is appreciable. The distinction between the invention's technical features and those of the cited prior arts is a strong point of contention. The response draft presented distinctive technical advancements with respect to the documents cited in the FER (WO 2016066688, WO 2015151115 and WO 2015177057). The cited prior art by the learned examiner are introduced at the outset of the argument during the examination procedure
The technical aspects of the invention are then demonstrated, along with how their presence helps to progress the invention and resolve the problem that already exists in relation to the particular technology. For instance, the liquid formulation of the invention is related to infliximab while the cited documents deal with adalimumab. In addition, the antibody origin for infliximab is murine while for adalimumab is human. Both the antibodies have different structures and amino acid sequences. Due to the difference in antibodies, the formulations have the same composition yet possess excellent different properties such as low viscosity, long-term storage capability and improved stability, thereby making the invention distinct and non-obvious.
The technical aspects of the invention are well supported by the well defined examples and additional document mentioned in the defense.. For instance, Lee et al., (IJMS -2017) support the difference in the amino acid sequence of the antibodies, infliximab, and adalimumab, and Wang et al., IJP-1999) supports the difficulty in predicting the effects of protein formulations containing antibodies. And a convincing conclusion demonstrating how merging the previous art documents could not have resulted in the present invention. Finally, patent has been granted to the application with grant no: 400516 by overcoming the raised various objections.
Conclusion
In summary, it is usually advantageous to support the primary line of arguments with technically sound methods while addressing the lack of inventive steps. An essential factor in determining whether to grant a patent for an invention is its inventive step. An enhanced invention must enhance technology relative to what is already known and not just be a workshop improvement. Therefore, determining an inventive step is necessary to prevent the patent application from being rejected during the examination of the patent application.
