Biotechnology is an extremely fast-moving field in which new products and services are developed from an increasingly complex and cumulative set of underlying technologies. Latest treatments to diseases come from biotechnology where sequencing genes, identifying individual gene functions and mutations, creating systems to selectively express, regulate or silence genes, predict protein structures and expressions, mapping the influence of genetic make-up on metabolism and / or otherwise analyzing vast amounts of genetic data. These many technologies contribute to the rapid pace of advancement in the life sciences and offer tremendous promise for improving human health and furthering economic development. Organizations investing in research and development (R&D) in the field of biotechnology regularly file patents.
In general, biotechnology inventions require description by reference to the sequence of a gene or protein. A gene includes a polynucleotide chain, where each nucleotide is selected from an “A,” “G,” C,” or “T.” A protein includes a chain of amino acids. Each amino acid is given a unique one letter code, and there are twenty common and naturally occurring amino acids. A sequence listing will identify the gene or protein by a “SEQ ID NO.” (e.g., SEQ ID NO: 1), and provide the entire sequence.
One gene or protein may range from several hundred to over a thousand characters. A single gene or protein sequence usually would not be an issue since the entire sequence could be presented in a manageable and affordable number of pages. In rare but not unheard of applications, many sequences-perhaps thousands-are disclosed. In these applications the number of pages becomes very large.
The purpose of this post is to compare the cost of filing a possible gene sequence patent application from biotechnology field, in different countries and see the resulting application trend in India. There is one clear inference from the data: In India, the cost of filing a gene sequence patent application is extremely expensive as compared to other jurisdictions. Hat-tip: My ex-colleague and mentor, Douglas Bucklin.
This particular issue may result in the provision being challenged in litigation. It would not be an open and shut case, but it is extremely likely that there are adequate grounds to put a serious dent in the provision. In India applications including sequence listings are allowed. The specific provision is: In case the Application for Patent discloses sequence listing of nucleotides and/or amino acids, the same shall be filed in electronic form. However, the fee with respect to the equivalent number of pages shall be payable.
It is interesting to note here the fee structure adopted by our patent office. For an entity other than natural person, the fee for each sheet of specification in addition to 30 (sheets) is Rs.400 per sheet. Note that electronic filing is allowed but the fee with respect to equivalent number of pages is required. That is there is no benefit to file electronically.
It is here that significant differences arise. These differences are in terms of the fee paid for filing. Some countries make the fee affordable or some waive the additional fee altogether. For example, the U.S., the EPO (see also fee tables here), Japan, Canada, Australia, Brazil, Mexico allow for free or low cost filings of large sequence listings.
The forums where the fee is reduced, or where there is no additional fee for filing sequences, require electronic filing. In PCT applications, standard practice for writing specifications includes writing important sequences into the text of the application if possible. Such a step guarantees that the sequence is part of the application even if the electronically filed sequence listing is separated from the paper filing in a patent office. But in the case of very large sequence listings, this is not possible since the number of pages would be excessive. In some places, the sequence listing is still filed on paper but is not counted against the page limit. In these forums, printing fees for the sequence listing may apply
It is interesting to note that India has no provision to reduce the fees associated with large sequence listings. The number of pages of the entire application, including the sequence listing, is taken into consideration when calculating the filing fee. For example, an application with 45 pages of specification, five pages of claims, one abstract page, and 6024 pages of sequence listing would be counted as a 6075 page application. This is unlike the U.S., the EPO, Japan, Mexico, Canada, Brazil, or Australia where the application size would be counted as 51 pages.
One recent estimate on an application of roughly this size showed that the filing fees would be over $50,000 (US). In contrast, a U.S. non-provisional application of the same size where the sequence listing was electronically filed would cost $625.
China also has higher fees with a large sequence listing, but the fees are capped. The fees for an electronically filed sequence listing are calculated as if the application were filed on paper, but the fees are capped at the amount charged for a 400 page application.
Conclusion: This is the reason that the requirement for sequence listing applications to pay fees according to the total number of pages at our IPO may be challenged.
The argument is two fold – (1) there is no nexus between the large fees and filing electronically, (2) There is no nexus for examination and printing of the sequence because the comparison (between sequences) is done by computer, and not by
humans; and (3) India is not complying with the WTO requirements by creating a barrier for filing patent applications containing large sequence listings.