A patent is a conditional monopoly awarded to an individual or a legal entity for a limited period of time to encourage research and development (R&D), innovation and invention, essential for the neo-knowledge and innovation driven economy. The monopoly for a limited period is granted to allow the patentee to secure the return on investment made for the research. All the patent applications are automatically published, generally at the expiry of 18 months from the date of filing, however, unlike most of the “original peer-reviewed papers”, the publication is available free of cost. In addition, generally, there is no restriction to use the information in the published patent application for academic and research purposes with due reference, thus, making it easier for the research fraternity to progress with their own inventions.

 

 

The idea therefore, is to allow a free disclosure for encouraging R&D activities on one hand, and to deter potential competitors of the applicant in an attempt to restrain them from using any of the information disclosed in the patent specification wherein an inventor not only invests in terms of effort, time and money, but also in terms of a free disclosure of invention, and the authority allows a limited period of monopoly to secure the return on investment to the patent holder.

 

 

Now, coming to the disclosure, it is a general principle that an invention must be enabled, a universal principle even for peer reviewed publications in journals. For patenting, however, there may be another requirement very similar to address in the form of “best mode”, subject to the jurisdiction where the patent application is filed. In India, Section 10 of the Indian Patent Act, 1970 (hereinafter referred to as the “Act”) in tandem with Rule 13 of the Indian Patent Rules, 2003 (hereinafter referred to as “Rule”) prescribes these requirements, along with the requirement of a single invention in a patent application.

 

 

Section 10 of the Act says: “

(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 40 [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 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.]

[(4A) In case of an international application designating India, the title, description, drawings, abstract and claims filed with the application shall be taken as the complete specification for the purposes of this Act.]

 

 

[(5) The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification.]

 

 

(6) A declaration as to the inventorship of the invention shall, in such cases as may be prescribed, be furnished in the prescribed form with the complete specification or within such period as may be prescribed after the filing of that specification.

 

 

(7) Subject to the foregoing provisions of this section, a complete specification filed after a provisional specification may include claims in respect of developments of, or additions to, the invention which was described in the provisional specification, being developments or additions in respect of which the applicant would be entitled under the provisions of section 6 to make a separate application for a patent.”

Therefore, Under Section (U/S) 10(4)(a), the requirement of “enablement” is mentioned, whereas the addressable “best mode” requirement is demanded U/S 10(4)(b) of the Act. In addition, India has made “Enablement” as a valid ground for Opposition U/S 25 of the Act, whereas, “best mode” is not mentioned as a ground of opposition.

“(1) Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground-

 

(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed.” Post-Grant Opposition Under Section 25(2)(g): “

(2) At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller in the prescribed manner on any of the following grounds, namely:

 

(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed.” On the contrary, U/S 64, the Act made not only the lack of “enablement”, but also the lack of “best mode” disclosure as a valid ground for revocation of patents.

Revocation of Patents U/S 64 (1): “

(1) Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, [be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court] on any of the following grounds that is to say-

 

(h) that the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the instructions for the working of the invention as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection”.

 

Given the above, it may be noted that, the Indian Patent law requires the Applicant to mention the best possible way of carrying out the invention in the patent application. However, the said requirement may vary depending on a case to case basis. As “best” is a superlative phrase, i.e. it can be used only when more than two (2) options are referred to, in an invention, therefore, Best Mode provision should not be directed to a scenario where no mode has been disclosed, amounting to Non-Enablement or to a situation where only 1 mode has been disclosed clearly and categorically with an Example, and duly claimed; as best mode requirement may be considered addressed in the absence of any possible comparison between other modes.

 

 

Further, in cases of inventions using biological material, Section 10(4)(d)(ii)(D)) of the Act mandates the Applicant to deposit biological material to an International Depository Authority (IDA). However, this requirement should only be there when the material is not already deposited in any other depository(ies).

Thus, in India, a patent application is to be considered “sufficiently disclosed” U/S 10 of the Act, when both the “enablement” and “best mode” requirement is satisfied.

 

ORA/21/2011/PT/KOL: Ajantha Pharma v. Allergan; IPAB held that data and particularly comparative data was essential at the time of filing the application to support any advantage and claims of an Invention.

 

 

ORA/28/PT/2011/MUM: La Renon Healthcare v. Kibow Biotech; it was stated that there must be express support for a claimed process and that there must be examples, which support the alleged invention, and which can justify such claims to any advantage.

 

A revocation petition against Patent No.: 184038, IPAB concluded that the sufficiency requirement is addressed even if at least one way of working the invention is clearly described enabling a skilled person to carry out the invention; exemplifying all conceivable ways of operating the invention may not be required if the best method known to the applicant is disclosed in the specification, it satisfies the requirement of sufficiency of disclosure. Therefore, if a complete specification discloses ONLY one Example, wherein the parameters fall within a range whereas claiming said range, the “Enablement” requirement is addressed, so is the “Best Mode” requirement.

 

In Ram Narain Kher vs Ambassador Industries (AIR 1976 Delhi 87), Delhi HC identified that it is incumbent U/S 10(4) of the Act to fully and particularly describe the invention and its operation or use and the method by which it is to be performed and disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection ending with a claim or claims defining the scope of the invention for which protection is claimed, an important aspect for which the claim of the plaintiff is singularly silent, and that the claim revocation is possible U/S 64(1)(i).

 

 

Further, vide Order No. 189/2012, IPAB revoked the grant of a patent on the grounds of lack of novelty and insufficiency; patentee's request for amending the claims was not allowed due to there being no support in the description. Whereas the enablement requirement is constant, the best mode requirement is variable. Regarding this seemingly overlapping demand of “enablement” and “best-mode”, some examples may be cited from other jurisdictions as well as in the international arrangements.

 

Article 29 of the TRIPS Agreement demands that:

 

 

Therefore, the requirement of “enablement” is compulsory in all the member states, whereas, the best-mode disclosure requirement is optional for member states’ discretion to mandate. TRIPS refers to Inventor’s knowledge, only reference to Inventor in the TRIPS Agreement, which has been borrowed from the US, following “first to invent” principles as against “first to file” in India and most of the jurisdictions.

 

In the USA, the first Para., Section 112, Title 35 of the US Patent Act, 1952/ United States Code (USC) requires the inventor to adequately describe the three elements in the patent application: (1) a written description of the invention itself; (2) the manner and process of making and using the invention (enablement); and (3) the best mode contemplated for carrying out the invention (best mode). This used to be a valid reason for refusal of the grant of patent; as well as a valid ground to oppose/ challenge/ invalidation suit. However, the Patent Reform Act, 2007, stated that the best mode requirement continued to apply to all patents, but it no longer formed the basis for a defense to a charge of patent infringement during enforcement litigation or post-grant review proceedings. Thus, compliance with the best mode requirement would remain subject to review by USPTO examiners during the initial prosecution of a patent; still be a valid reason for refusal/ cancellation/ invalidation by examiners.

 

 

Article 83, EPC states: “The European patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.”, focussing upon the “enablement” requirement.

 

 

Like the US, in Japan, a patent applicant needs to disclose the invention with how to make and use the invention, along with the best mode contemplated for carrying out the invention.

 

 

Sec. 3.2.1., Part I, Examination Guidelines for Patent and Utility Models requires a patent applicant to describe in the detail at least one mode that the applicant considers to be the best among various modes of carrying out the invention, complying with Article 36(4)(i) of Japanese Patent Law. Both US and Japan require the patent to disclose specific technical information beyond enablement, however, due to the difference in “first to file” v/s “first to invent”, Japan refers to “applicant”, whereas USA refers to “inventor”, so does TRIPS. Besides, the demand is not in the Act, but in the Guidelines, therefore, there is no reason for refusal of grant of patent applications in Japan, making this a softer requirement as compared to the USA.

 

In the Peoples’ Republic of China (PRC), before the SIPO, no Best Mode, but Preferred Mode is needed. Rule 18, Implementing Regulations provides that in the description of embodiments of the invention, the patent application shall describe in detail the preferred mode contemplated by the applicant for carrying out the invention. Therefore, like Japan, this refers to applicant, not inventor. Further, this is not a provision under the Patent law, not a reason for refusal, and therefore, an Ineffective Rule as SIPO/ Chinese Courts never enforce the “Preferred Mode” requirement in invalidation/ appeal cases.

 

 

Likewise, the demand for Best-Mode exists in Canada, Ghana, Mexico, New Zealand, Zambia, South Africa etc., whereas Australia, Ireland, Mexico refers to the same as “Best Method Disclosure”. For example, Section 40(2)(a) Australian Patent Act says “A complete specification must describe the invention fully including the best method known to the applicant”, mentioning “applicant”, not the “inventor”. The most notable exception is Germany, which explicitly renounces the best mode disclosure requirement, by saying in the examination guidelines that it is not relevant to the issue of disclosure of the invention whether an item in the description has been mentioned as advantageous, useful or preferable as compared to other simultaneously disclosed solutions.

 

 

Now, regarding the demand of the nature of disclosure in the complete specification of a patent application, the Indian Act uses the phrases “clear”, “succinct” and “fairly” U/S 10(5). The same act U/S 25(1)(g) and 25(2)(g) uses the phrases “sufficiently” and “clearly” while describing the grounds of pre and post grant opposition; and U/S 64(1)(h) uses “sufficiently” and “fairly” while detailing the grounds for revocation. Further, regarding the same matter, Article 29 of the TRIPS Agreement demands sufficiently clear disclosure of an invention; similar demand is placed under Article 83, EPC.

 

Regarding these phrases, a reference to the Oxford Learner’s Dictionary, as available online, suggests that “clear” may mean “easy to understand”, “without doubt”, “easy to see” apart from “phonetics” or “not near” or “sum of money” or “period of time” etc. The same describes “sufficient” as “enough for a particular purpose; as much as you need”. The same further describes “succinct” as “expressed clearly and in a few words”; and still further describes the phrase “fair” as “acceptable/ appropriate”. However, it is understandable that the phrases are not absolute but relative, mandating a reference frame with respect to which, said clarity, fairness, sufficiency or succinctness are mentioned, h

 

 

owever, the Act is however, silent on the nature or quality of the reference frame i.e. it doesn’t disclose whether the matters should comprise all these features with respect to a layman or a person having ordinary skill in the art (PHOSITA) or a person having extraordinary skill in the art or a person with learned mind and general skill without having skill in that particular art as described in the invention i.e., the examiners and/ or the controller of the Patent Office technically examining the merits of the invention.

 

 

Despite this vagueness, while analyzing the impact of these related yet different phrases, it seems that the complete specification should be drafted in a manner easily understandable, expressed categorically with definitive phrases and data in a manner that is acceptable to the person reading and/ or judging the invention. Whereas, incomplete information or insufficiency of information in an invention may render said invention unclear and thereby creates a ground for opposition; for creating a ground of revocation, the invention must be proved to be unacceptable or inappropriate as a result of said incomplete information or insufficiency of information in said invention. Thus, it seems that the choice of vocabulary in the Indian Act is indeed ingenious, and the phrase “clearly” is consciously replaced by “fairly” when it comes to describing the grounds of revocation as against that of opposition.

 

 

Coming to the distinction between “Sufficiency” and “Best Mode”, for sufficiency, the Invention must be Enabled, but Best Mode requirement is territorial, often optional (TRIPS). These demands offer an ideal trade off against a Monopoly for a limited time, adding to the quality of invention. Before the IPO, India, thus, a broad claim claiming a range without specific example may not stop the grant of a narrow claim claiming specifically, while disclosing with example(s). Thereby, the rivals/ competitors/ importers may produce the Product, or build around the existing product, creating a niche. As more information becomes available to the Inventor, who assign(s) the patent to Applicant, the reference of inventors as in USA and TRIPS, seems more appropriate than referring to applicants in most of the jurisdictions including India; reason being that an update in technology may change the inventors’ perception/ information on “best-mode”, and there would be a need to verify the level of knowledge/ information at the time of filing. This also should be made a substantive condition for Patent Eligibility i.e. objectable if not found in the specification, however, may not constitute a reason for invalidation or opposition, although IPO, India, has made the non-existence of best-mode a valid ground for revocation.