Marketed medicines should comply with local requirements and be effectively and safely used. Thus, a close eye on market trends and carefully monitoring the opportunities/threats that lie ahead facilitate and protect international expansion of the company’s operations and provides the necessary tools to prepare and design the most efficient business strategy.
Inevitably, regulatory affairs professionals (RAPs), by stepping outside regulatory world, must adopt a satellite view of the pharmaceutical business. Undoubtedly, only after applying your knowledge across various areas, whilst being principled by a big picture approach, are solutions achieved.
RAPs can only be the master key of a pharmaceutical enterprise if they have equipped themselves with the deepest possible knowledge in all areas, even those that would be, at first glance, considered outside of their professional scope. Only through this, can RAPs sensibly react to the unprecedented and constant challenges that development presents to Pharmaceuticals.
Globalization, national political, economic and technological development, social demands and the enormous expectations of consumers/governors/industries highlight the need for global protection and consequently global harmonization of the patent system currently in force.
Indeed, the obvious divergence in the protection granted by each of the three major offices (EPO, USPTO and JP) may sprout a fearful mindset in inventors when dealing with weakened patent protection in some territories.
In recent decades, WIPO has made efforts towards a harmonization system for substantive examination. However, these attempts have encountered several barriers to their success, namely the firm stance of the USA in its decision not to change some of its requirements, such as the prior art and patent object, as well as the resistance of several developing countries to adopting a robust patent system. These selfish positions resulted in the stagnation of the project, which has remained so since 2007 (3).
Even after the entry into force of TRIPS/TRIPS, many countries continue signing bilateral, trilateral or multilateral on the basis of so-called TRIPS-plus Agreements, through which partners can agree on stronger terms of protections than those required by TRIPS/TRIPS.
In a bold attempt to weaken the difficulties and limitations across various works already developed, JPO proposed the PPH-Project. This project assumes that claims already considered patentable by one office are subject to a simplified examination by a second office.
USPTO proposed a relatively informal cooperation between the three ICH regions (Europe, USA and Japan), so one system of harmonization of the substantive examination of patents is developed.
Later, the Common Citation Document and the trilateral PPH-Paris were proposed. Several other projects were developed and improved: i. PPH-MOTTAINAI; ii. Global PPH; iii. IP5-PPH; iv. important accommodations related to priority date and state of the art by USA; v. Single Patent. (2).
It is clear that the 3 regions recognize the need to work together on developing a harmonized global patent system, so that the granted patent resulting from examination of the filed application carried out by only one office would subsequently be validated by the others. This system aims to: i. increase the exam quality and reduce decision time; ii. develop common infrastructure and databases; iii. solve common problems; iv. harmonize examination practice; v. Facilitate patent information dissemination; and vi. enhance institutes work and avoid wok duplication.
Perhaps, if relevant procedural divergences were addressed and resolved in an innocuous way, by eliminating all interests inherent to the protection of industrial property (interests of the inventor, the state and society itself) and by leaving the controversial issue of impossible convergence aside, solutions may be easily achieved. If so, stepping outside of a conservative stance would not be imperative for overcoming obstacles. Nevertheless, these interests are a constant threat to patent system harmonization.
Therefore, as long as mobilizing and harmonizing all relevant concepts, like those more related to global aspects (such as the patent object and its limitations), and not just formal ones, are not a geostrategic goals in the analysis of patentability requirements (novelty, inventive step, industrial application), any attempt to obtain a harmonized global patent system will fail.
Still, different interests (political, social and industrial) result in an approach to industrial property from prisms that are most often antagonistic. On the one hand, societies considering harmonized systems a threat, due to their economic incapability to offer innovative medicines, end up fighting in silence for their failure. On the other hand, developed countries with great economic capability make great efforts to maintain a strict and strong patent system, protecting inventions as best as possible.
Innovative industries are the great activists for the development and activation of a global patent system, since it represents cost reduction, an increase in effective protection times and greater robustness in protection (1) (4).
Indeed, if a consensus in some of the most important patent aspects, namely the scope of the patent object and its limitations, is achieved, a harmonized global system would unquestionably bring only benefits to all stakeholders.
In summary, only when countries find a solution, at a governmental, industrial and also social level, with which they all feel comfortable, will the inevitable and fundamental step be taken: the success of a patent system that confers global protection.
It is therefore irrefutable that much still needs to be done to achieve the much-desired harmonization of the patent protection procedure not only by the three regions, and it is still utopian to imagine a near future where patent applicants will benefit from a harmonized patent system that is valid even if only the three ICH regions are considered.
Bibliography:
- APDI – Associação Portuguesa de Direito Intelectual. Direito Intelectual Vol. VII, 2010
- Changes To Implement the Prioritized Examination Track (Track I) of the Enhanced Examination Timing Control Procedures Under the Leahy-Smith America Invents Act. Vol. 76. September 2011
- Grubb, Philip W & Thomsen , Peter R. Patents for chemicals, Pharmaceuticals, and Biotechnology. 5th edition. s.l. : Oxford University Press, 2010
Moura Vicente, Dário. A Tutela Internacional da Propriedade Industrial, 2008
