Plurality of distinct inventions: Distinct practices of India, Europe and the United States in the field of biotechnology

13 July 2022

Plurality of distinct inventions: Distinct practices of India, Europe and the United States in the field of biotechnology

India 

In India, provisions dealing with plurality of distinct inventions have been discussed and interpretated in a catena of decisions issued by the Indian courts. It has been held that the presence of multiple inventions which are not linked so as to form a single inventive concept is a prerequisite for filing a valid divisional application.  

Section 10(5) and Section 16 of the Indian Patent Act, 1970 are the relevant provisions in this respect.  

As per Section 10(5), the claim or claims of a complete specification shall relate to a single invention or to a group of inventions so linked so as to form a single inventive concept.  

Section 16 provides the remedy for an application containing more than one invention. This provision permits division of a patent application which defines more than one invention which are distinct and not related to each other so as to form a single inventive concept. Therefore, the applicant can file one or more such divisional applications either suo moto (voluntarily) or in response to an objection (pertaining to lack of unity of invention) by the Indian Patent Office (IPO). It is pertinent to mention here that a divisional applicant can only be filed before the grant of the parent application. Meaning thereby, that a divisional application should be filed during the pendency of its parent application. Filing divisional applications merely to continue prosecution of similar subject matter as claimed in parent application are not entertained by the IPO and objection pertaining to Section 16 are being actively raised by IPO in such cases.  

A divisional application must contain a complete specification along with claims (related to distinct invention) and requisite official fees. Importantly, as per current rules, a request for examination must be filed subsequently after filing of such divisional application. Such request for examination is independent of claim numbers.  

Also, as per the current manual issued by the IPO in 2019, it is required that claims of the divisional application should find support in the originally filed claims of the parent application.  

The IPO has clarified its stance for dealing with such biotech patent applications wherein more than one invention is disclosed in the Guidelines for Examination of Biotechnology Applications for Patent issued 2013.  

The IPO has noted in aforesaid guidelines that in case of biotechnological inventions more often many polynucleotide and polypeptide sequences are claimed in a patent application.  

In order to determine whether claimed sequences relate to a single invention or to a group of inventions linked so as to form a single inventive concept, the following two ways have been outlined by the IPO: 

A priori, i.e., before consideration of prior art is established, if the claims falling in different groups and do not share a same or corresponding technical feature. 

Illustrative example: 

Claims  

Claimed Invention  

Analysis  

A DNA construct for improved expression of a heterologous or homologous polypeptide comprising: (a) isolated DNA sequence (SEQ ID NO: A) or a portion thereof which retains promoter activity adapted for recombinant protein expression, (b) DNA sequence encoding the desired polypeptide such that said DNA sequence is in operative association with said promoter and is expressed under the control of the said promoter, wherein said isolated DNA sequence is a constitutive promoter for citrate synthase (citA) gene from filamentous fungi Aspergillus niger. 

DNA construct produced using SEQ ID NO: A 

A DNA construct for improved expression of a heterologous or homologous polypeptide comprising: (a) a promoter sequence according to SEQ ID NO: B or a portion thereof which retains promoter activity, (b) DNA sequence encoding the desired polypeptide such that said DNA sequence is in operative association with said promoter and is expressed under the control of the said promoter.  

DNA construct produced using SEQ ID NO: B 

A DNA construct for improved expression of a heterologous or homologous polypeptide comprising: (a) a promoter sequence according to SEQ ID NO: C or a portion thereof which retains promoter activity, (b) DNA sequence encoding the desired polypeptide such that said DNA sequence is in operative association with said promoter and is expressed under the control of the said promoter.  

DNA construct produced using SEQ ID NO: C 

Table 1. 

From the analysis provided in the table above, it is noted that the DNA sequences as described as SEQ ID NO. A, B & C do not share any common structural feature. There is no technical feature that binds the aforesaid group. Therefore, each of the above groups is considered as separate inventions and hence lacks unity a priori. 

A posteriori, i.e. after the search of the prior art is established, if the shared technical feature fails to make a contribution over the prior art. 

Illustrative example:  

Claims  

Claimed Invention  

Analysis  

A composition comprising a combination of X and Protein Y to identify a gene for prostate cancer, wherein X is selected from a group of hetero-cycles as depicted in formula 1 [Formula 1 given]  

Combination of X and Protein Y. 

A composition comprising a combination of X and Protein Z to identify a gene for prostate cancer, wherein X is selected from a group of hetero-cycles as claimed in Claim 1. 

Combination of X and Protein Z. 

Table 2.  

As evident from the analysis mentioned in the above table, Claims 1 and 2 are two separate groups of inventions which are linked by a technical feature “X”. When the technical feature X is subjected to prior art analysis, it is found that X is already known in the prior art. Evidently, this feature is not a special technical feature since it does not contribute to the technical advancement over the prior art. Hence, Claims 1 and 2 do not comply with Section 10(5) and the application lacks unity a posteriori. 

Europe 

As per Article 82 of the European Patent Convention, a European patent application shall relate to one invention only or to a group of inventions so linked so as to form a single general inventive concept. 

Rule 44 of the convention further elaborates that the inventions must be linked to form a single general concept. This is possible only if there is a technical relationship between the claimed inventions involving one or more of the same or corresponding special technical features. 

Also per the convention, a lack of unity in two or more inventions may become evident before considering the claims in relation to any prior art document or after reviewing the claims concerning the searched prior art document(s). A lack of unity after considering the application in view of a prior art may happen if, on the comparison, an independent claim is shown to lack novelty. Then the dependent claims lack a common inventive concept, thus not contributing to establish single inventive concept.  

Once the Examining Division forms an opinion about the unity of invention in an application, the division informs the applicant that the application lacks unity of invention and the official search fee for claims categorised as separate invention(s) will have to be paid by the applicant to get all the inventions searched. If the applicant fails to pay such search fee, the only consequence the applicant faces is that the search will only be conducted for the first claimed invention. Further, the Examining Division may order a refund of the additional fee, upon applicant request, provided the division feels that the demand for additional fees was not justified. 

United States of America 

As per the Manual of Patent Examining Procedure (MPEP) issued by USPTO, a patent application can relate to only one invention or to a group of inventions so closely linked so as to form a single general inventive concept. Section 1.475 of MPEP further lists out combinations where the inventions are considered to have unity: 

  • A product and a process specially adapted for the manufacture of said product; or 

  • A product and process of use of the said product; or 

  • A product, a process specially adapted for the manufacture of the said product, and use of the said product; or 

  • A process and an apparatus or means specifically designed for carrying out the said process; or 

  • A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. 

The USPTO first issues a restriction requirement if the examiner believes that there is more than one invention in the application and that these inventions can be patented distinct from each other, then the examiner will issue a list of groups of inventions and provide a detailed reason as to why they are different from each other. Particularly in cases of biotechnology, the requirement states the different genera and species for election. The applicant is required to choose one invention (i.e. a specific genus and related species) from the group either with traversal or without traversal. If the restriction requirement is filed with traversal, then if patentability of the elected genus is proved then the species not elected may be re-joined in the allowed claims. The other invention will be considered withdrawn, and the applicant may file a divisional application for the withdrawn invention at extra cost. 

Conclusion 

It has been noticed in in some cases that the above way of assessment is not applied and erroneously objection of lack unity is raised on claims defining a polynucleotide, a construct comprising the same, a vector comprising the construct and a host cell comprising the said vector, even though such claims are prima facie linked with a single invention concept. Such is not the case with either EPO or USPTO. The objections are arguable; however, the concern here it why such argumentation is required. Further, a significant difference which one may experience is with respect fee payable and the stages it should be paid for distinct inventions in Indian, European and American patent offices. 

About the author

 Shikha Singh

Shikha Singh

Shikha Singh is a managing associate at LexOrbis in New Delhi, where she is a qualified biotechnologist with a bachelor’s degree in technology. She also holds a bachelor’s degree in law and is a registered Indian patent agent with the government of India. Singh has more than eight years of experience in the IP domain. Her primary roles are providing opinions to clients on various complex and contentious issues related to the patentability of an invention, and searching, drafting, filing and prosecuting national and international patent applications. She deals with patent applications related to biological sciences, pharmaceuticals, biomedical engineering, nanotechnology, immunology, neutraceuticals, bioinformatics, bioprocess engineering, polymer technology, organic and inorganic chemistry, biochemicals, peptide chemistry, medicinal chemistry, organometallic chemistry, food technology and oil and gas chemistry. She frequently appears before the Indian Patent Office and the Delhi High Court for various matters.  

 Manisha Singh

Manisha Singh

Manisha Singh is a founder and the managing partner of LexOrbis in New Delhi. She overviews and supervises all practice groups at the firm,and is known for her deep expertise on prosecution and enforcement of all forms of IP rights and for strategizing and managing global patents, trademarks and designs portfolios of large global and domestic companies. Her keen interest in using and deploying the latest technology tools and processes has immensely helped the firm to develop efficient IP service delivery models and to provide best-in-class services. She is also known for her sharp litigation and negotiation skills. She has been involved and successfully resolved various trademarks, copyright and design infringement and passing off cases in short timeframes and in the most cost-.nbvcefficient manner, applying out-of-box strategies and thinking.

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