Patrick Marollé holds master degrees in biology and in law. He is an expert in patent law and is qualified both as a French and European patent attorney. In 2003, Patrick started his career as in-house patent agent of a French pharmaceutical and biotech company specialized in animal nutrition and health. Then from 2005 to 2013, he worked for a multinational corporation of the consumer goods industry in UK and in Germany, mostly supporting the cosmetics business. Since 2013, he is a private practitioner and Paris manager of the law firm VIDON. He handles Chemical, Pharma and Biotech cases for diverse clients, including public research institutions, start-up companies and SMEs, multinational corporations.
GoINPHARMA™: Patrick, even though IP rights especially patents are of great importance for innovative companies and institutions, many people are still unfamiliar with the “patent world”. Why don’t we first talk about what is a patent, the time of validity and your roles as a patent attorney?
Patrick Marollé: Innovations and patents are intrinsically linked to each other, and patents are the necessary corollary for legally protecting inventions. Indeed, the protection of an invention is not automatic and requires specific formalities to be accomplished. As would be explained hereinafter, such formalities are rather complex, long and expensive. There is the need therefore for being assisted by people specialised in the field of intellectual property (IP), including IP managers, patent attorneys and/or IP lawyers. That is to say, gaining patent protection should not be improvised. Any institution or company having solid research & development (R&D) activities and spending a significant amount of money on them should be proactive in making the R&D and management teams aware of this problematic. They should also be careful in having the right people – either in-house or via external counselling – for handling these matters.
A patent should be construed as a legal right on an invention. This right allows the inventors to prevent any unauthorized person to commercialise the patented invention. A patent protection is, however, neither worldwide nor perpetual. Indeed, patents are limited in time and space. Patents are usually national patents (e.g. in the USA, China, Japan, Canada and more) or regional patents (e.g. in Europe). They have a validity of twenty years from the date of filing. During this period of time, if the patent is validly maintained into force e.g. by paying maintenance fees, the inventors would benefit from an effective monopoly in the concerned territories. Once the patent has expired or lapsed, the invention will not be protected anymore and will fall within the public domain, so that any third party will be free to exploit it.
The path for obtaining granted patents is rather long and complex. First of all, after having identified a new invention, a patent application should be prepared and filed before the patent office. Usually, this first filing is done before the patent office of the country where the institution or the company has its headquarters. US companies would tend to file before the USPTO, Japanese companies before the JPO and European companies before either a national patent office such as INPI for France, DPMA for Germany and IPO for UK, or before the European Patent Office. After the filing (called date of priority), the Applicant benefits from a period of 12 months for deciding whether he would like to file in other countries. For example, there is the possibility to file an international application designating potentially 150+ countries. Within 30 months from the date of priority, the Applicant will have to decide which countries should eventually be selected. By then, the international application will split into a series of independent national and regional applications. Each national or regional patent office will examine the patent application, and decide eventually to grant a patent or refuse the application. The length of examination proceedings varies depending on the patent office and the complexity of the case.
It should also be stressed out that the monopoly conferred to a patent does not extend to the right to use the invention freely. Indeed, when an invention may fall within the scope of a previous patent, belonging to a third party, that would prevent the inventors for exploiting their invention. This second aspect is also of paramount importance, and inventors should ensure that they have the freedom to use their inventions, for analysing the patent landscape and identifying the relevant rights. To illustrate this aspect, a simple example can be given. Company Y has shown that the molecule A exhibits superior anti-coagulant properties, and they have obtained a patent on the therapeutic use of A as an anti-coagulant. Any unauthorized third party would be prevented then from commercialising an anti-coagulant drug comprising A. Likewise, the company Y may not be able to commercialise such drug if another company X has previously patented the molecule A itself. The company Y would therefore need to obtain first the right to exploit it e.g. by obtaining a license on company X’s patent.
GoINPHARMA™: As you mentioned, patenting an invention should not be improvised, as it is a rather long, complex and costly process it requires the assistance of patent experts. Could you explain what are the costs associated herewith? Should the innovators take any precautions to minimize the costs for obtaining, maintaining and defending patents?
Patrick Marollé: it is difficult to give general numbers or estimates, as the cost of protecting the invention would be dependent on many factors such as the length of the patent application, the filing strategy chosen, the numbers of countries covered, the complexity of the examination before the patent offices, and more. What should be kept in mind, however, in that managing a patent family requires a budget on the long run. Firstly, the Applicant would have to face costs in relation to preparing the patent applicantion, filing it and having it examined. Then, the Applicant would have to pay maintenance fees on a regular basis, e.g. yearly for a European patent, that would tend to increase over time. Hence, for ensuring that the money is used wisely, the Applicant should have a clear idea – as far as it is possible – about the interest and the value in having an invention patented. When a technology is effectively commercialised or licensed to a third party, there is little doubt that keeping the patents alive would be recommendable. In contrast, when the invention has not been launched to the market, or when the R&D project has been stopped, it is worth considering whether the patent family should be kept alive, or dropped, partly or in full.
Hence, as already point out previously, there is a need for inventors wishing to protect their inventions, for Applicants and/or for Patentees to familiarise themselves with the “patent world” and to make informed decisions. Once again, it is important for them to have the right people – either in-house or via external counselling – for handling these matters, for deciding (or helping to decide) which inventions to protect or not, and for defining the most appropriate strategy.
GoINPHARMA™: Patents seem indeed to be critical assets for research institutions and innovative companies, and that it is important to have a solid strategy. How institutions and companies tend to organize to protect their inventions? Do you see significant differences between public organizations, SMEs and large corporations? Which advises could be given to innovators for best protecting their innovations?
Patrick Marollé: Aspects or trends can indeed be identified. A first aspect is the need for discriminating fundamental science from applied R&D. The former usually leads to new discoveries, which are not patentable per se. Hence, laboratories specialized in fundamental science – most of them being public – have a limited or no patent activity. In contrast, the latter can lead to developing new inventions, which can be pioneering or which can be improvements of a known technology. One simple example can be given. Aspirin has been discovered a long time ago. However, over the years many new potential therapeutic indications were – and are still – identified. While aspirin cannot be patented again and again and belongs to the public domain for many years now, any new therapeutic indication can be protected.
A second aspect is about the size of the company. Innovative start-ups and SMEs would usually have a limited R&D portfolio, and would therefore focus their IP effort on these technologies. Getting patent protection for them would be critical on several aspects. Firstly, it would help them getting a monopoly on a new technology, preventing competition to enter their “playground”. Secondly, it would contribute to the company assets. Thirdly, it could be used for generating revenues, for example by licensing the technology to a big pharma. Actually, some start-ups even solely aim at developing and then patenting new technologies, for generating revenues by licensing-out or selling the patents, without any plans for commercializing themselves. The same would apply for large corporations in some ways. However, as large corporations would usually run several businesses, have a sustained R&D activity on many different projects, their patent portfolio would have tens if not hundreds of patent families. They would have therefore to have a more global approach of their portfolio, balancing the need for protecting each invention versus the overall budget available and the tier ratings of the different R&D projects.
A third aspect is about the attitude of the company. Some of them may decide to be very proactive, have ambitious R&D programs, and being very active in patenting and defending their inventions, as well as in challenging competition’s patents including via litigation. Others may wish to adopt a more prudent approach, and to engage into R&D efforts, when the path is cleared and when the risk of being litigated is limited. The latter may even decide to only rely upon technologies belonging to the public domain. Obviously, there are pros and cons for both policies, and there is no holy rule for determining what the best is. In real life, especially for large corporations, it is frequent that they have both business models. For example, in the pharmaceutical sector, many big corporations have divisions developing and commercialising princeps drugs, while others are devoted to generic drugs.
GoINPHARMA™: Now turning to the Chemical, Pharma and Biotech sectors, can you identify any specific characteristics of the sectors when it comes to patents.
Patrick Marollé: There is no different patent system for such sectors, in comparison to other technical fields such as electronics, physics, mechanics, etc. Indeed, the law is the same, the same patentability criteria apply (novelty, inventive step, industrial applicability), the patent examiners are using the same approaches, etc.
However, ethics plays an important role, when it comes especially to biotechnological inventions. Many controversies and debates have arisen from the eighties till today. To deal with this, the countries have implemented special rules. For example, in Europe, the directive 98/44/EC dated 6 July 1998 has ruled the legal protection of biotechnological inventions. For example, many technologies have been held unpatentable including plant and animal varieties, essentially biological processes, the human body including the sequence of a gene, processes for cloning human bodies, and more.
In addition, the specifics implemented by each country, notably the US, the differences between them, the still-debated issues, etc. may be discussed further. However, this would be too long presently, but may possibly be the object of a future article, should the readers be interested in it.
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