European Pharmaceutical Patents: Complexities, Challenges, and Human Rights Implications
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Introduction: Balancing Pharma Innovation and Access to Medicines
The most important characteristic of the innovation is that when the innovation takes place than it takessufficient investiture while the information gained after the discovery might involve the minor limit effort. Innovation is a complex process and it requires intensive research and development and then something new or unique can be innovated. In contrast to this copying, the components or the inventions of others and using them is an easy task. For example, if the entity is copying any of the novel design then the entity is not enduring the cost of R&D which is being required in the development of the invention and they are able to retail any of them would be subsequent from the merchandise at thecost which is lower than the mastermind. It is important to consider that IP security is not capable of protecting the data from the competition.
There can be different ways for curing the disease and obtaining the IP aegis and in this way one method or drug is not capable of restricting the others from making use of it until the merchandise is not making use of the same molecule as it is previously anintervention patent eg, Patents. One of the most effective and basic methods which is being used for the protection of the new invention for copying. The present report focuses on explaining the laws related to patents in Europe and especially in the pharmaceutical sector. In EC, the grammatical case is the most important and due to this reason, the validation of the patent is twenty years. The patent helps the owner in restricting the third party from using, creating,and retailing the inventiondeprived oftaking permission or the consent taken by the owner of the patent or by the owner of the patent.
When the innovator or the inventor returns out of the letter patent of the invention on a new creation or for the innovation then it is being known as the intellectual property of the candidate or to the legal entity as well. If the individual wants to get his invention or their new design to be patented then there are different requirements or they need to fulfill the eligibility criteria for the patent then only it can get the patent right. This implies that the patent diligence are required to cover the bailiwick issue that is deemed patentable. The different subject matters that are being excluded from the patentability include the subject matters such as breakthrough, mathematical method acting, aesthetic world, and the scientific theory as well. In the patent development scheme the social contract where the twist for the IP protection provided, it is important that the patent should offer full disclosure of the invention, which makes it possible for others to make and use it at the end of the patent protection period. This is being destinedfor offering the gain motivator to the innovating companies when they are encouraging more disclosure than the case if only the trade secrets can protect introduction. The patents are being granted by the international entity or by the sovereign state such as the European Patent Function. The IP for the innovation needs to be enclosed by the legal protection and also the inventor needs to discuss the patent reportage in all the related markets.
Previous Studies
Several research studies have been conducted for exploring the significance of patents for Research and Development investment and innovation action in the businesses operating in the USA and for this the researchers had focused on different industries that can help them in developing better views regarding the advantages of investing in the Research and Development department which is working for the development of drugs.
Edwin Mansfield (1986)[1] had conducted a research study for exploring theinfluence of patents on development and introduction of the invention without patent protection and this research is being conducted on the basis of the data which is being collected from around 100 US manufacturing businesses operating in 12 diverse industries. The results of this research study had shown that 65% of the respondentswho were introduced inventions in ancommercial manner in the pharmaceutical industry were not introduced without patents and around 60% of the inventions were not developed in 1981-1983 without patents.On comparing the data of the pharmaceutical industry with others it is found that theirfigures were remarkably low.
In 1987, Richard Levin, et. al., [2]had conducted a study in which they have conducted a survey with the 600 managersworking in R&D department of the US firms, and the study of this study had revealed similar results as that of the previous study. In this study, it is being found that the drugs are having the maximum rating for efficiency of the patents in the context of averting unlicensed duplication. This study also found that the pharmaceutical industry is having product patents was the as frequently used method for gaining benefits of innovation. Similar to this Cohen, et. al., (2000) [3]had also conducted a research study in which they have surveyed around 1500 managers belonging to R&D department in 34 different industries. In this study, the researcher had found that among all the 34 industries, two industries are having the highest rating regarding the effectiveness of patents used for the benefit of innovation and these two industries are the medical equipment industry and pharmaceutical industry.
Arora, et. al., (2007)[4]had also conducted a research study on this research topic only and in this study, the researcher had collected the data from the Carnegie-Mellon Survey which was conducted in 1994. In this survey, the data related to the return of patent protection and their effect on the organization and its R&D investment across the different industries had been conducted. In this study, the researcher had found that theinnovation due to patents was found to be significantly higher in the medical industries and it is also found that the higher number of patent returns is enhancing the investment in the R&D department.
European Laws And Patents
Different articles related to the patents mentioned in the European law were mentioned below such as:
Article 33 of Concord on Trade-Related Aspects of Intellectual Belonging Rights (TRIPS)
4 Article 52(2), (a), (b), (c), and (d) of The European Patent Convention.
Article Quintuplet 2(1) of the European Patent Convention.
Article 63 of the European Patents Normal Alism.
Other important laws that are being developed in the context of the patents are the Humankind Intellectual Property Organisation, theParis Convention for Protection of Industrial Holding, and Patent Cooperation Treaty.
Nature of the pharmaceutical industry of Europe is quite unique.The inquiry which is being conducted by the military commission sector which was presented in the final report had faced significant criticism by the industry and also by the faculty members and other people who have reviewed it. For understanding the arguments being made in the criticism it is important to start with the brief over Captain Hicksewand this approach can help them in listening to all the different arguments and then making a view regarding the topic. In this criticism, the major features which were being identified are mentioned below such as:
The pharmaceutical industry of Europe needs to be stronger.
The businesses operating in this industry need to have better funding which can help them in better researching and support them in growing independently.
The price ascendence and the purchase arrangements need to be maintained by the member states.
The pharmaceutical industry is not well appreciated by other industries and is not considered a business.
The pharmaceutical market needs to be considered as a single market.
This industry needs to have better residential district contention rules[5].
The complete process of discovery, production, and distribution of the drugs is different from all other industries. According to the Single Market Law Review,the pharmaceutical industry of Europe is being said that it is a highly fragmented industry in which different specific conditions require specific treatment, and due to this reason the individual drugs are having a limited market and contribute a significant small market share in the national market[6]. Majority of the drugs and especially the one which is being used in severe diseases are usually used by most of the member states[7]. Continues development of better medicines and treatment is essential for this industry and due to this reason the organizations of pharmaceutical industry are engaged in innovation, better production, attractive marketing, and a highly advanced distribution network[8]. The large firm operating in this industry are engaged in R&D and are also investing better capital in expanding the business operations outside Europe as well[9].
Categories Of Pharmaceutical Patents
In case an individual has synthesized a specific chemical substancewhich is used for the treatment of any disease then the individual can apply for the patent of invention for the chemical if there it meeting all the requirement of the patentability then the individual would be given the power takeoff for the patent[10]. The primary patent can be of exact value for the manufacturer for the reason that these types of patents are generally problematic to invent around. The primary letter patents in the pharmaceutical industry are the one which is not necessarily most important for the manufacturers as a matter[11]. In the context of biology if the substance is naturally occurring then legally it is not possible for the individual to get the patent because the matter is patent ineligible. In pharmaceuticals, the patents may cover different features of the ingredients used themselves[12]. These types of patents are known as the secondary coil patents and the individuals can claim for them[13]. The different claims which can be made for such patents are mentioned below such as:
The claim is related to the formulation of the drugs.
Claim for the methods used in the pharmaceuticals.
Claims related to the methods used for the manufacturing of the pharmaceutical product or the applied science which is used in the manufacturing process of the drugs.
Claim in the context of the approaches of administrating the drugs or the different technologies used in the administering of the pharmaceuticals.
Claims related to the use of active ingredients such as salts, intermediaries, metabolites, polymorphs, and crystalline forms.
Similar to all other conceptions it is important for the inventor to get the patent and they need to have better knowledge related to all the requirements of getting a patent which is being mentioned in the patent application program[14]. If the inventor had invented amelioration on any of the technology which is being used by them then they can file for the patents, the different thing which they can file for the patent include the formulation of the drug, finding a new use for the medicine,and also for the use of different fabrication process and many more[15]. In the present world, the pharmaceutical industry usually understands the phase "Betterment Patent" in an incorrect manner as in the latest version the patent needs not to be better for receiving the patentability.Betterment needs to be new or nonobvious rather than expectable use of the prior art as per the map which is already established[16]. If any of the candidatesneed to making improvement in the invention then they will need to get permission from the owner of the patent on the pilot engineering science and owner of the improved patents. If the master copy patent has expired and the improvement patent has not expired then the patent law does not hinder any of the candidates from making use of the invention[17].
Legal Tools For Protecting Ip For Pharmaceuticals
As per the European Union, the pharmaceutical industry is having several legal documents for the disposal of intellectual property and its rightful trade protection. The legal laws were letters patent of invention, supplementary protection certification, regulatory data protection, and a 10-year market exclusively designed for orphan drugs. According to the Latter, the European legislator had recognized the necessityfor encouraging the studyfor the drugs which are not much in demand and are used in rare conditions,and these drugs are not allowed for the R&D cost to be recouped by the anticipated sales and for this special grade of protection should be justified. The letter patent is nottotally harmonized in the EU and it is being assumed that the patent system in the member body politic is almost similar. Due to this the harmonizing effect of the stumble arrangement, member provinces are the party to the European Patent Convention 200053 and some of the member states had also accepted some of the tonality provisions of the community patent convention[18].
As per the Graphics, XXVIII of the stumble agreement 60, the letter patent of the invention had created a negative obligation due to which the third parties are being restricted or forbidden to the manufacturer to use the products and also restrict them to import such products as well.If the patent is being concerned with the physical cognitive operation then in this case the third parties are being excluded from making use of the product or the process. When the patents are being given then they offer rights for their holders and can also offer the licensing arrangement but these rights can only be enforced by the patent holder in the legal infringement proceeding and this can be done till the patent is lawful. For the pharmaceutical industry, patent applications are being filed every early in the Research &Development process since it offers the likelihood of entitling around 140 nations. Among all the patents some of the patents are filed with the EPO and some are being filed by the extremity state of matter[19].
Innovator Product Vs Generic- Extended Patents
In the reference of the genetic manufacturer, the conceiver use of the letter patent of invention recitation aims at swapping the original preparation by similar follow-on products by simple proprietary modification or by a name change. In the pharmaceutical industry, the drug manufacturers are not much involved in getting the broadest possible patent base for the first generation drug, and for further course of the product life cycle, the inventor should focus on developing innovation patentable variations which would help them to extend the product life cycle[20]. When the patent is being deceased then the generic make can also file an application for the drug. However, the is also referred to as a prodigious amount of investment is a danger for the innovators or the inventor companies. For protecting the involvement of the inventors the Ordinator companies get involved in the evergreening strategies and along with this the defensive strategies are often used in the pharmaceutical industryand the similar practices of the patent applications are not unprecedented in other industries[21]. Patents of inventions are being formed when the originator files numerous broad. Weak patents about the original molecule patent the divisional patent applications are being fragmented into one or more narrow patent applications[22]. Usually, the clusters and the coppice had to havebeen leading an increase in the issue for a generic manufacturer for the originator's IP rights when it is entering into the market because at this time they cant properly evaluate the scope of the IP portfolio of the innovator[23]. The generics are being left with two different decisionswhich areas to wait until all the patents forming the patent family had deceased or to apply for the marketing for the authorization and to run the risk of litigation.
Secondary Patent Applications
Other than the defensive strategy the innovator caller is to file the single application for the secondary coil or for the follow-on-patent of the invention[24]. The secondary coil is also known as reformulation and it remains the most general and arguable and the most effective way to delay awareness of the commercial message liveliness[25]. This can delay the competition between the products on the basis of the similar original invention[26]. Though, the patenting the aliveness of the product is not a novel and not restricted to the pharmaceutic sphere and it can be confirmed that the follow on the inventor has completed with the valuable development is not usually seen as an infringer and it courts tent to narrow the technical scope of the patent or they can refrain it from growing it by the doctrine of the comparison[27]. The further incentives had made him prevent him from the held up by an earlier patent[28].
Reverse Payments
The agreements which are being signed with the wine producer are central for the delay in the market entry and the generic corporations can receive the compensation payment or for another benefit for the innovator companies[29] or by entering into the liquidation agreements[30]. The agreements of the settlement of the patent infringement disputes are not only for considering it under the ambit of the combined law[31].
The Complexity And The Unpredictability Of The Litigation Across The European Union
The body structure of the EPC only providers the single European patent of inventions and also helps them in the grading system of the rules by EPO. The European patent is not unitary and lustiness is being governed by the different subject constabulary and deal with the subject courts under the different procedural rules. There are no four senses for the provision in the EPC for the court with the powers to settle the disputes related to the European floor. In several courts, the patent cases are not being heard due absence of knowledge, training, and experience. Also, the covering of the police force depends on the specific judge dealing with the particular case. The way in which the decisions are being made can advance the quality and the predictability of the patent litigation in these markets[32]. The IP enforcement directive is being designed for addressing the disparities in the means of enforcing intellectual prop rights. The directive also includes the arrangements for the application of the provisional measuring, conditions for applying the interim enjoinment which was launching into the force for the IP enforcement directive and varied widely from one member state to another one.
The IP Enforcement Directive is not creating the central judicature contains theexperienced book of judges who are properly equipped to deal with the different questions related to the validity and infringement on the patent European ground. The patent enforcement is an important matter of subject for the police force and also for the national courts and because of this it is difficult or challenging for the generic to develop the European launch strategy. The only option which remains for the generics is to litigate the same letters patent of invention and the same issue in the numerous nations with no self-assurance that the same decision would be reached in the jurisdiction. The generic medicinal drug troupe concerned with the given patent needs to be enforced against it and fundamentally it is having three different strategies that need to be chosen for the different nations in which the launch is contemplated and these strategies are mentioned below such as:
Launching at risk, awaiting and defending it against any litigation that the patent can bring.
Before the launch, the patent needs to be invalidated and this is important especially if the generic company thinks that the patent is invalid.
The company can also make an announcement of non-infringement and in this case, the court decided that a cartesian product does not infringe a right and this is being involved as a mandatory first whole tone which offers better information to the patent and the nature of the product as well.
If the letter patents are being multiplied by the act of commonwealth then in this case they can be provided the astonishing turns and can give a clear meter reading of tremendously complex minefield in which the generic wine medicines businesses are operating. Due to the lack of telephone exchange, the judicature having experienced patent judges are being considered as one of the main negative outcomes of the current patent scheme. It is being said that the ilot and the most price core ive results would be developed by the central European union patent court which can answer the questions related to the validity and violation at the pan-European level.According to the European committal, this approach is ab proposal for the community of interest patent. The community patent would be considered as a unitary patent core ive in all the different European economic community member DoS and it can be litigated on the unitary source in the courts which are being created for patent and these courts are known as community patent courtroom which is within the framework of the European Court of Justice. All the decision which would be made by this court is effective throughout the EEC. The topic is in a debate that whether the political consensus can be reached in the context of the community patent or not. EPLA might have developed set up a European patent count as a mugwump body from the EPO and this would manage the jurisdiction related to the validity and infringement of the European patents. But the proposal given by EPLA is against the insurmountable institutional hurdles and this had beenunrestricted. According to this, it can be said that the European Commission is still compromising a consensus on an ace patent litigation system in Europe and recognizing the inherent profitsof this proposal.
Monopoly Pricing
The transformation of the peoples calling the police force or the rhetorical oddity for the medical incoming is a complex textual artifact which is having different consequences for the way in which the patient getsadmission to the medicines and solves the issue of monopoly pricing[33]. The swiss calls are being made in the form of fabrication calls so that they can circumvent a preparation which states that the method used for the medical discussion is not patentable because they are not industrially applicable. This right is not disclosing any of the new or different methods for the manufacturers of the medicament and instead of it, this is only an absurd device that is shuffling the hitherto unpatentable content matter patentable. The swiss use calls are focusing on the derive bauble by the analogy by the use of new therapeutic use instead of the process of manufacturing the medicament and this claim is being inscribed as the manufacturing claim for escaping the exclusionary effect of another provision[34]. These calls can be considered as the heart of what is euphemistically called pharmaceutic lifecycle management and in this case, some of the claim types can lay the base for the formation of the new patents for the incremental innovation which surrounds the original patent, and they are used as the same substance for the new disease, new patient group, new selective information regarding the way in which pharmaceutical works and also the new dosage as well[35].
The Parabalinlitigation in the UK for the consequences of accepting the use rights for the prominent prescription medication develops the decrease the capability to make better use of the root and branch evaluation in the courts and it also exposes that how the time gizmo similar the swiss use the right for the axiomatic positions which are hard to deviate from a great hundred for bringing the idea of human rights at the time of practical coating of the letter patent. This norm requires abetter understanding and willingness to collect better information related to the issue which is being faced at the time of application[36]. In Europe, the patent officers are the ones who are providing all the important information related to the system of rules and regulation. This dominant position is imposing a barrier for the expertizing and also for technocratic reasoning, militating against the consequential and the functions as an epistemic firewall as well[37].
Combining The Elements Together: Trade, Patents, Access To Medicine As A Human Rights Issue
Trade agreements and the intellectual property are the important issues which are interconnected with the issues related to the human right[38]. Both the two concept of the monopoly and the protective covering is the important issue for the patents and their assess in the medicine as an human right issue.These human rights comprise the right to eliminate third parties from carrying out the following actions in relation to a patented invention: fashioning, using, offering for sale, selling or importing the inventions made by the innovators[39]. TRIPS Concord confers monopoly rights to a patent holder for a least of twenty years. These monopolistic rights bestowed upon patent holders enable them to guardianship price well over the marginal toll of product.
Along with the patents better IPR protection is also very important. When a pharmaceutic company takes a new drug against the market, a substantial amount of money is used on its research and development, marketing and promotion[40]. And the patent provide the right to the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect[41]. However, since exclusive right are conferred to patentee , generic manufacturers of pharmaceuticals are disqualified from the market for advantage of pharmaceutical companies who are frequently the mastermind and holders of patents on vital medicines[42]. The nations such as US, Japan and majority of the European nations[43] are having the patent system in the pharmaceutical sector[44].
Conclusion There is a great confusion that the where the letters patent rights hand and man right field are in fightregarding the human right field in an implied hierarchization of two dinner dress organization of the police force. The demand for the patent rightfield for giving the way to the human right is not just unproductive and it orchestrates the intervention and dampens the likelihood of any of the deep change being affected.Undecided of the human right to health and the contingent political moralism that can give it a shape and form is no match for an unyielding and technocratic patent law backed up with the resistance of the integrationist government shifting from the developed body politic. Letters patent law's epistemic firewall means that it is challenging for the outsiders and instead of it the uncouple human right field from the patent law is to take patent law on its own terms and then it seeks the normative cohesiveness and the doctrinal fidelity informed by the consequential reasoning.
Strategic patenting will be remaining in the proceeding and it would be subjected with the legal contravention and for a particular point of time this will become abusive practice. This can be regarded as an area which is not obvious legislative root for it other than expansions to process and view of confirmingreliable interpretation of the law and the creation of the European Patent Court as proposed by judge Jacob. This would remain as a number of the social dialogue among all the different participants such as conceiver, consumer, and generics as well. In this deference a general demonization of the pharmaceutic industry of which the mission can be observed as the guilty for at least the part of its conclusion and it is not constructive as well. In this study, the researcher concludes that it is important for the inventor to focus on the innovator to focus on both the invention and the challenger law which are crucial for the well-being of the customers and for the society as well. Patents inspirethe initiation and so does contention law by removing the danger of a lazy patentee who wants to boundlesslyeffort the similar patent and by disallowing letters patent that canhelp them in making effective development which can bring better improvements in their domains. One interrogationis still remaining for the future debates.
Recommendation
According to the above-mentioned research report, there are different recommendation which can be suggested to the pharmaceutic letter patent and these recommendations are mentioned below such as:
Better resources are required to be offered and it is important to inspire the EPO for making improvements in overall quality of the patents.
The patent needs to file high-quality applications and introduce the obligations of the candor which would help then in ensuring that entire entropy related to the patent which are examined by the EPO.
Can introduce the mechanism in which the patents are held to be accountable.
Should focus on removing the requirement for EPO examiners to be fluent in three languages.
Need to accelerate the opposition procedure.
Improvement is required in the timber of patent of invention.
Need to limit the scope of second and further medical use of the letter patents.
Can accelerate the opposition procedure.
It is important to focus on having the green banner of grounds and a duty on all parties to the litigation which can be presented as a evidence in the court both for and against awarding a preliminary injunction.
Preventing that the filing of divisional patent of invention that are essentially matching to the parent application.
Need to create a subject litigation framework with better technical support.
Reach to the consensus on a central patent judiciary in Europe.
Should include health care authority in the patent proceeding process.
References
101 ("Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . ." (emphasis added)).
-Arora A, Ceccagnoli Cohen WM, et al. R&D and the Patent Premium. Int J Indust Organ 2003;26:1153-79
Bengt Domeij, Patent Claim Scope: Initial and Follow-on Pharmaceutical Inventions in Europe, p. 8. Available at: https://www.kth.se/polopoly_fs/1.10601!initialfollow.pdf, accessed on 18 March 2011.
C Long, 'PTO and the Market for Influence in Patent Law' (2009) University of Pennsylvania Law Review 1965.
Carrier &Shadowen, supra note 9, at 181 ("The granting of a patent by the [PTO] certainly does not guarantee, or even suggest, that the reformulated product is superior in any way to existing products. The PTO requires only that the product be 'novel[]' and 'nonobvious,' not that it be an improvement [over existing technology]."); Custom Accessories, Inc. v. Jeffrey-Allan Indus., 807 F.2d 955, 960 (Fed. Cir. 1986) ("Finding that an invention is an 'improvement' is not a prerequisite to patentability. It is possible for an invention to be less effective than existing devices but nevertheless meet the statutory criteria for patentability.")
Carsten Fink, "Intellectual Property and Public Health: The WTO's August 2003 Decision in Perspective" (2003) World Bank Note 191 at 191.
Cases C-207/03 Novartis v. Comptroller General and C-252/03 Ministre de l'Economie v Millenium Pharmaceuticals, [2005] RPC 33. 75 Ibid,, para. 26
Cohen W, Nelson RR, Walsh JP, et al. Protecting their intellectual assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (Or Not). NBER Working Paper 2000;7552
Doctors without Borders, South Africa: Big Pharma Backs Down, online: Doctor's Without Borders
European Generic Association, Evergreening of Pharmaceutical Market Protection. Available at: http://www.egagenerics.com/gen-evergrn.htm, accessed on 18 March 2011
generally Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 589-96 (2013) (discussing the "natural phenomena" category of patent-ineligible subject matter and holding that a "naturally occurring DNA segment is a product of nature and not patent eligible"); Priti Deka Phukan, Patenting Proteins After Myriad, 23 FED. CIR. B.J. 619, 621 (2014) (analyzing "whether synthetically produced biological compounds," such as therapeutic proteins and hormones, are patentable "when the synthetic compound is indistinguishable from the naturally occurring compound")
at 6 ("[T]he primary patent on the molecule is rarely the only one associated with a drug. Typically, the innovator (or others) files additional patent applications [that] may cover methods of manufacturing the chemical or biological substance, purified forms, new salts or esters, new uses of the substance, new combinations, new delivery routes, etc.").
Julia Pike 2008 Patent-related Barriers to Market Entry for Generic Medicines in the European Union, A review of weaknesses in the current European patent system and their impact on market access of generic medicines
Levin R, Klevorick AK, Nelson RR, et al. Appropriating the returns from industrial research and development. Brook Papers Econ Activity 1987;3:783-832
M Shapiro, '"Deliberative, Independent" Technocracy v Democratic Politics: Will the Globe Echo the EU?' 2004 Law and Contemporary Problems 68, 341-56
Mansfield E. Patents and Innovation: An Empirical Study. Management Sci 1986;32:2
Margaret K. Kyle, Competition Law, Intellectual Property, and the Pharmaceutical Sector, 81 ANTITRUST L.J. 1, 2 (2016) ("[A]t least one type of pharmaceutical patent, the product patent on the molecule itself, is particularly hard to invent around.").
Marumo Nkomo, The WTO Medicines Decision in Light of its Utilization: Resolution or Resignation? (Berlin: Lambert Publishing, 2010) at 12
Nicoleta Tuominen2011 Patenting Strategies of the EU Pharmaceutical Industry Crossroad between Patent Law and Competition Policy
Russell Graeme Hunter, The Pharmaceutical Sector in the European Union: Intellectual Property Rights, Parallel Trade and Community Competition Law, Juristförlaget, Stockholm, 2001, p. 5.
S Parthasarathy, 'Breaking the Expertise Barrier: Understanding Activist Challenges to Science and Technology Policy Domains' (2010) 37 Science & Public Policy 355. Also see Arthur Daemmrich, 'Epistemic Contests and Legitimacy of the World Trade Organization: The Brazil - USA Cotton Dispute and Incremental Balancing of Global Interests' (2012) 4(1) Trade Law & Development 200 discussing questions of expertise, and methods for bounding disputes over scientific facts at the WTO.
S Thambisetty, IPQ (2017) ibid. 236-37; and could also become a problem in the case of personalised medicine.
Scott C. Hemphill, Drug Patent Settlements between Rivals: A Survey, 2007, pp. 1-49. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=969492, accessed on 18 March 2011.
See Article 3(2) of Regulation 1610/96, of 23 July 1996, concerning the creation of a supplementary protection certificate for plant protection products, [8.8.1996], OJ L 198, According to the Recitals of Regulation 1610/96, the provisions of Article 3(2) are for the interpretation of Article 3 of Regulation 1768/92
See JOHN R. THOMAS, PHARMACEUTICAL PATENT LAW 46-64 (3d ed. 2015) (describing these and other categories of pharmaceutical patent claims).
Subseries I: Impact on Manufacturing, Vol. 2: Pharmaceutical Products, „The Pharmaceutical Sector in the EU?, (1997), The Single Market Review, p. 99.
Sudip Chaudhuri, The WTO and India's Pharmaceuticals Industry: Patent Protection, TRIPS, and Developing Countries (New Delhi: Oxford University Press, 2005) at 15.
U.S.C. §§ 101 (allowing patents on "any new and useful . . . composition of matter"), 102-03, 112.
[1]Mansfield E. Patents and Innovation: An Empirical Study. Management Sci 1986;32:2
[2]Levin R, Klevorick AK, Nelson RR, et al. Appropriating the returns from industrial research and development. Brook Papers Econ Activity 1987;3:783-832
[3]-Cohen W, Nelson RR, Walsh JP, et al. Protecting their intellectual assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (Or Not). NBER Working Paper 2000;7552
[4]Arora A, Ceccagnoli Cohen WM, et al. R&D and the Patent Premium. Int J Indust Organ 2003;26:1153-79
[5] Russell Graeme Hunter, The Pharmaceutical Sector in the European Union: Intellectual Property Rights, Parallel Trade and Community Competition Law, Juristförlaget, Stockholm, 2001, p. 5.
[6] Ibid, p. 103
[7] Ibid.
[8] 1 Subseries I: Impact on Manufacturing, Vol. 2: Pharmaceutical Products, „The Pharmaceutical Sector in the EU?, (1997), The Single Market Review, p. 99.
[9] Nicoleta Tuominen2011 Patenting Strategies of the EU Pharmaceutical Industry Crossroad between Patent Law and Competition Policy
[10]See 35 U.S.C. §§ 101 (allowing patents on "any new and useful . . . composition of matter"), 102-03, 112.
[11] See Margaret K. Kyle, Competition Law, Intellectual Property, and the Pharmaceutical Sector, 81 ANTITRUST L.J. 1, 2 (2016) ("[A]t least one type of pharmaceutical patent, the product patent on the molecule itself, is particularly hard to invent around.").
[12]See id. at 6 ("[T]he primary patent on the molecule is rarely the only one associated with a drug. Typically, the innovator (or others) files additional patent applications [that] may cover methods of manufacturing the chemical or biological substance, purified forms, new salts or esters, new uses of the substance, new combinations, new delivery routes, etc.").
[13]See generally Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 589-96 (2013) (discussing the "natural phenomena" category of patent-ineligible subject matter and holding that a "naturally occurring DNA segment is a product of nature and not patent eligible"); Priti Deka Phukan, Patenting Proteins After Myriad, 23 FED. CIR. B.J. 619, 621 (2014) (analyzing "whether synthetically produced biological compounds," such as therapeutic proteins and hormones, are patentable "when the synthetic compound is indistinguishable from the naturally occurring compound").
[14] 1 See JOHN R. THOMAS, PHARMACEUTICAL PATENT LAW 46-64 (3d ed. 2015) (describing these and other categories of pharmaceutical patent claims).
[15] See 35 U.S.C. §§ 101-03, 112. 72 Id.
[16] 101 ("Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . ." (emphasis added)).
[17] Carrier &Shadowen, supra note 9, at 181 ("The granting of a patent by the [PTO] certainly does not guarantee, or even suggest, that the reformulated product is superior in any way to existing products. The PTO requires only that the product be 'novel[]' and 'nonobvious,' not that it be an improvement [over existing technology]."); Custom Accessories, Inc. v. Jeffrey-Allan Indus., 807 F.2d 955, 960 (Fed. Cir. 1986) ("Finding that an invention is an 'improvement' is not a prerequisite to patentability. It is possible for an invention to be less effective than existing devices but nevertheless meet the statutory criteria for patentability.")
[18]See Article 3(2) of Regulation 1610/96, of 23 July 1996, concerning the creation of a supplementary protection certificate for plant protection products, [8.8.1996], OJ L 198, According to the Recitals of Regulation 1610/96, the provisions of Article 3(2) are for the interpretation of Article 3 of Regulation 1768/92
[19] Cases C-207/03 Novartis v. Comptroller General and C-252/03 Ministre de l'Economie v Millenium Pharmaceuticals, [2005] RPC 33. 75 Ibid,, para. 26
[20] 1 ibid
[21] Bansal, supra note 90, p. 4.
[22] 3 Idem, p. 6.
[23]Mavroghenis, supra note 91, p. 7.
[26] 2 European Commission, Final Report, supra note 89.
[27] European Generic Association, Evergreening of Pharmaceutical Market Protection. Available at: http://www.egagenerics.com/gen-evergrn.htm, accessed on 18 March 2011
[28] 4 Bengt Domeij, Patent Claim Scope: Initial and Follow-on Pharmaceutical Inventions in Europe, p. 8. Available at: https://www.kth.se/polopoly_fs/1.10601!initialfollow.pdf, accessed on 18 March 2011.
[29] Scott C. Hemphill, Drug Patent Settlements between Rivals: A Survey, 2007, pp. 1-49. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=969492, accessed on 18 March 2011.
[30] Commission, Final Report, supra note 89, p. 12.
[32] Julia Pike 2008 Patent-related Barriers to Market Entry for Generic Medicines in the European Union, A review of weaknesses in the current European patent system and their impact on market access of generic medicines
[33]1 S Thambisetty, IPQ (2017) ibid. 236-37; and could also become a problem in the case of personalised medicine.
[34]Ibid. 236-37
[35][35]C Long, 'PTO and the Market for Influence in Patent Law' (2009) University of Pennsylvania Law Review 1965.
[36]S Parthasarathy, 'Breaking the Expertise Barrier: Understanding Activist Challenges to Science and Technology Policy Domains' (2010) 37 Science & Public Policy 355. Also see Arthur Daemmrich, 'Epistemic Contests and Legitimacy of the World Trade Organization: The Brazil - USA Cotton Dispute and Incremental Balancing of Global Interests' (2012) 4(1) Trade Law & Development 200 discussing questions of expertise, and methods for bounding disputes over scientific facts at the WTO.
[37]See M Shapiro, '"Deliberative, Independent" Technocracy v Democratic Politics: Will the Globe Echo the EU?' 2004 Law and Contemporary Problems 68, 341-56
[38] 1 TRIPS Agreement, supra note 19, art. 28.
[39]Marumo Nkomo, The WTO Medicines Decision in Light of its Utilization: Resolution or Resignation? (Berlin: Lambert Publishing, 2010) at 12
[40] Sudip Chaudhuri, The WTO and India's Pharmaceuticals Industry: Patent Protection, TRIPS, and Developing Countries (New Delhi: Oxford University Press, 2005) at 15.
[41]Xiong, supra note 12 at 81.\
[42] 5 Ibid at 129
[43] Doctors without Borders, South Africa: Big Pharma Backs Down, online: Doctor's Without Borders
[44] Carsten Fink, "Intellectual Property and Public Health: The WTO's August 2003 Decision in Perspective" (2003) World Bank Note 191 at 191.
