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ANALYZING THE CHALLENGES PRESENT IN NOVELTY CRITERIA OF PATENTABILITY: USA, UK AND INDIA

NOVELTY PATENT CRITERIA IN USA, UK, AND INDIA

In the USA, novelty criteria assert that to be patentable, an invention is required to be a novel or new concept. The patentability of an idea can be prevented or held unpatentable through specific public disclosures, such as through common knowledge, priorly printed publications, or patent applications. As a sort of relief to the inventor in case of prior publication of their idea, a grace period of 1 year is given to the inventor, within which they have to file a patent application on the grounds of novelty. In an instance of missing this time period, the right to protection of a patent is lost. Even the innocent disclosure to friends can “trigger the clock”. It is advisable to file a patent application prior to any sort of public disclosure as, the way a grace period is offered by the USA, most of the other nations do not offer so. The Act on criteria of novelty was revised by the “America Invents Act”[1]. The filing of a patent application that was done on or before 16th March 2013 will follow the prior version of the Act, where a patent application may not be barred on the disclosures made within the time of 1 year by another person if it is made after the date of the invention of the Applicant. In the case of, “Helsinn Healthcare S A v Teva Pharmaceuticals USA Inc, (2019)”[2] the sale made by an inventor to a 3rd party, who has an obligation to maintain the confidentiality of the invention, constitutes invalidation of the prior art. Immediately before the enactment of the “America Invents Act (AIA)”, an “on-sale bar” was contained in the patent law, which held on-sale patent subjects to be invalid. The court found that when the same legal language is re-enacted by Congress and it adopts the prior existent judicial framework of the phrase, consequentially as AIA prohibits those patents that had been on sale previously. Thus, a sale for commercial purposes made to a 3rd party who is required to maintain the confidentiality of the invention comes under the ambit of an “on-sale bar” of the AIA holding the patent invalidated.

In the U.K., to obtain a patent, the legal requirement of novelty must be fulfilled. Conducting a search about the novelty of the idea can benefit a person in saving the legal and research and development costs. The novelty check requirement restricts patent grants for prior-art concepts already in the “public domain”. For say, the research articles, blogs, papers, and worldwide “public demonstrations”[3]. Novelty is either a prior art or not, it is a binary concept. Grant of monopolies for everlasting ideas such as paper are avoided in novelty patents. Innovation of new concepts is incentivized in novelty by means of rewarding such inventors who come up with innovative ideas which hugely benefit society at large. “Actavis Group PTC EHF & Ors v ICOS Corporation, UK (2019)”[4], according to the decision of the apex court, the appeals court was rightful in treating the failure of the judge to consider as a principle-error the rational outcome of a specific finding which authorized the appeals court to execute an evaluation at its own level. Accordingly, the appeals court was rightful in interfering with the assessment of obviousness criteria by the trial judge and deciding the “181 patent” to be invalid for lacking an “inventive step”[5] as, during the time of routine testing, the “skilled team” was likely to have seen the dosage which was subject of the patent.

In Indian law, a patent is a right, exclusively granted to an inventor by the “Patents Act of 1970” for a limited time period, to have him use his invention. It is mandated under the Act that the invention should be novel or new for which a patent is sought. It is emphasized under S 2(1)(l) of the Act, that a “new invention” is that which has not been anticipated and published in a document or used in the world anywhere. “Invention” is defined as a new process or product having industrial applicability. However, nowhere “new invention”[6] has been defined in the legislation, and novelty criteria can be understood from the intent behind the enactment of the Act. In the Act, the requirement for filing a patent application for an invention is that it mustn’t constitute a part of a “state of the art” matter, which comprises all the information and matter in access of the public at present, before the application filing date of the patent. This may be accessible to the public in oral, written, or other such forms. “Hoffman La Roche v Cipla (2008)[7], in this case, the court debated upon the newly added proviso of “anti-greening” in the “Patents Act”, further setting standards to measure infringement in suits of patent rights infringement. This was one of the initial cases tried in court on patent infringement after the amendment in the “Patents Act” in 2005. Finally, it was stated by the division bench that no infringement was there as to the patent in question. The subject of the patent was a mixture of Polymorphs A and B, whereas the drug “Tarceva” consisted of Polymorph B only. Here, the point to be emphasized is that the patent application was filed for Polymorph B by Roche but the same was rejected on the grounds that it didn’t fulfill the requirement of S 3(d) and the Novelty-test of Patentability by the “Indian Patent Office”. Further, the intent of the legislature was considered by the court in enacting the laws of “anti-evergreening” and S 3(d). And it held the interest of the public first and foremost. Here, it was acknowledged by the court that the question was about a life-saving drug, and thus, the drug produced by Cipla was available at 1/3rd the cost of the drug produced by Roche.

ANALYZING: SIGNIFICANT CHALLENGES IN THE NOVELTY CRITERIA OF PATENTABILITY OF- USA, UK AND INDIA

IN THE USA: The proviso of the grace period lets the inventor file an application for a patent within a year of disclosing it to the public. Even so, the level of uncertainty created by this can lead to, loss to the inventor of their “patent rights” in case they miss the deadline. Moreover, the criteria to determine “prior art” and “public disclosures” can be subjective and complex.

IN THE UK: Novelty Criteria restrict grants of the patent for those concepts which are already present in the “public domain”. Even so, what constitutes “public disclosure” according to the “prior art” definition can be vaguely uncertain. Little room is left by the two-fold nature of novelty for continuous improvements, as even incremental innovation may not fit in, the requirements for novelty.

IN INDIA: In the “Patents Act,” no explicit definition is provided for “new invention”, giving rise to vagueness in the applicability of novelty standards. All the information that is available to the public is included in the definition of “state of the art”, making the determination of a novel invention difficult. The strict criterion mentioned in S 3(d) for inventions also considers pharmaceutical inventions in which leaves it more complex.

MEASURES TO ADDRESS THE CHALLENGES PRESENT IN NOVELTY PATENT CRITERIA OF USA, UK AND INDIA

CLARIFYING AND HARMONIZING THE CRITERIA: In the “patent laws” of particular countries, explicit definitions of the keywords should be provided in order to reduce uncertainty and have it easy for inventors to evaluate the “novelty” of their invention.

ALIGNING TO INTERNATIONAL REQUIREMENTS: Harmonize the criteria of novelty with the standards acceptable internationally, like the ones framed by “World Intellectual Property Organization (WIPO)”. Such a step would encourage regularity and ease patent applications internationally.

STREAMLINE THE PROCESS OF EXAMINATION: The process of examination of a Patent is to be improved to make it efficient and effective, ensuring novelty assessment on time. This would let the inventors make reasoned decisions by providing them with expeditious responses on their inventions’ patentability and consequently reducing ambiguity to it.

PROMOTING CONTINUOUS IMPROVEMENTS IN INNOVATIONS: Development of such a system that acknowledges through rewarding the continuous innovative improvements cause they assist in the technological advancements. Including, the introduction of those criteria of the invention that acknowledges the “inventive step” and “non-obviousness”, instead of only concentrating on stringent criteria of novelty.

ON A CONCLUDING NOTE

For instance, Japan is one of the nations with a strong system of novelty criteria. The patent system of Japan is established well, it places significance on the criteria of “inventive step” and “novelty”. Their examination of patents is recognized for its accuracy and comprehensive meticulousness in evaluating the inventions’ novelty. There are specific standards for assessing “prior art” and “public disclosure”, facilitating inventors with more clarity by reducing uncertainty. By analyzing the essentials of Japanese system and adopting them the USA, the UK, and India can certainly improve their own system of “novelty criteria”.

Author(s) Name: Priya Mishra (Symbiosis Law School, Noida)

Reference(s):

[1] ‘Patent Requirements’ (BitLaw)<https://www.bitlaw.com/patent/requirements.html> accessed 12 July 2023

[2] ‘Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc. et al.’ (2019) 1

[3] Lain Croft, ‘How to carry out a patent novelty search’ (harperjames, 18 February 2021)<https://harperjames.co.uk/article/patent-novelty-search/> accessed 11 July 2023

[4] [2016] EWHC 1955 (Pat)

[5] Sara Moran, ‘Patent case: Actavis Group PTC EHF & ors v ICOS Corporation, United Kingdom’ (Kluweriplaw, 27 November 2019)<https://patentblog.kluweriplaw.com/2019/11/27/patent-case-actavis-group-ptc-ehf-ors-v-icos-corporation-united-kingdom/> accessed 11 July 2023

[6] ‘Patent Novelty: Decoding the requirements’ (Intepat, 6 January 2021)<https://www.intepat.com/blog/decoding-the-requirement-of-novelty-in-patents/> accessed 12 July 2023

[7] F-Hoffmann-La Roche Ltd. v Cipla Ltd. 2008 SCC OnLine Del 382