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Patents have been considered to be essential to innovation, especially in the context of pharmaceutical, chemical and petroleum industries since the 1980s. Since innovation has become revolutionary in all sectors of modern life, patents have come to be recognised as important, but at the same time are controversial in terms of what is patent-eligible. This essay explores what is patent-eligible in the United States but not in Europe. Even though the general criteria that both systems are based on, may be the same, case law has resulted in different approaches in determining what is non-invention and non-patentable.
This essay outlines the difference between the European and United States’ patent systems in and the context of there being no statutory subject matter exclusions in the United States, and also discusses if the three criteria in the EU can be used as a base to obtain a patent. The essay also analyses the consequences of having the list of patentable excluded subject matter. The question of this difference between the American and the European system becomes relevant considering that there can be a situation where two people may have similar innovation. Therefore, hypothetically, two different people, living in two different jurisdictions in the world, may have the same idea at the same time, which is “a method that will make a faster and cost-sufficient way of filing insurance claims in damage recovering procedure” to make it faster and affordable, and one of them may field the application in the European Patent Organization (EPO), and the other one, in the United States Patents and Trademark Office (USPTO). Then the question arises as to who will grant the patent and what if there is a different result based on the jurisdiction where the application is made. This is the inventors’ concerns about patent at the field stage while in the EU or in US.
Patentable inventions: The differences between US and European approaches
Invention might be granted a patent if the invention is vulnerable to industrial application, is described as new, and contains an inventive-step that would not be obvious to the normal person. There is no definition of invention under the European Patent Convention, while the Enlarged Board of Appeal defines “invention” as “Human intervention, to bring about a result by using the forces of nature, pertains to the core of what an invention is understood to
be.” Moreover, the European system recognises the invention of different kinds and, “things (products), methods and processes, new purposes (new advantage of old things used in an old way), selection patents, new uses for old things”
Even though an invention that is useful and new might obtain a patent, some statutes do set a list of inventions that are not eligible for patent, and the requirements to determine eligibility is different in Europe and the US. Patentable excluded subject matter is one of the most controversial aspects of the European Patent Convention (EPC). The EPC does not include a definition of "inventions" which can be patented, but as pointed out in one critique, “takes a negative approach by defining an exception to patentability for medical treatments and sets out a number of areas which are not considered inventions.” Consequently, EPC also describes inventions which are related to “discoveries, scientific theories and mathematical methods, aesthetic creations, schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers and presentations of information” as non-inventions in Europe. On the other hand, according to the European Patent convention Article 53(b), there are other aspect to determining what is not-patentable; thus, patents are not to be granted where commercial exploitation of such invention would be contrary to "ordre public" or morality.
In contrast to the EU approach, the US approach sets out that, “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 therefore, subject to the conditions and requirements of this title.” This indicates that, the US method does not have an explicit legal provision when it comes to determine the eligibility of the invention. However, the US patent law does not provide a statutory definition of subject matter eligibility or non eligibility, the US Supreme Court has noted the exclusions to be “Laws of nature, natural phenomena, and
abstract ideas” in Mayo,and reiterated in Alice Corp v CLS Bank International. It is clear from this that claims to discover an invention that clearly relates to the nature is excluded patent because it should be “free to all men and reserved exclusively to none.” Moreover, the court uses these terms to meet the basic equipment of the technological and scientific work, such as mathematical algorithm, scientific principles and naturally occurring phenomena.
The Supreme Court’s decisions in Mayo v Prometheus, is particularly relevant here. Prometheus is a company that sells diagnostic kits and is the exclusive licensee for the use of thiopurine drugs, a drug used to treat autoimmune disease. When the drug is consumed, it is converted into a metabolite in the blood stream. Due to variation in metabolism between individuals, the intake of this drug varies. Therefore, the Respondent used to sell diagnostic kit to the Mayo Clinic that determines the required dose to be given to patients. In 2004, Mayo clinic offered and marketed its own diagnostic kit and was later sued by the respondent for infringement of their patents. The District Courts found the test infringed the patent, however, the process in question is natural law or phenomena. The correlation between the metabolite levels and the efficiency of the drugs are not patentable rights. However, on appeal, the Federal Circuit Court reversed the findings of the District Court and found the diagnostic test is a patent eligible as per the “machine and transformation test”. Mayo Clinic appealed, and the Supreme Court concluded that the Prometheus process is not eligible for patent. The reason is because the process used is to aid doctors determine the levels of drugs that should be used and is not patentable under the law. It was concluded that the levels of drug dosage and concentration of metabolites would show its either harmful or ineffective, therefore this is part of the laws of nature and not patentable.
The Supreme Court’s decision draws the boundaries of the patent eligible subject matter in the scope of life science. In this case, the Court has established that the test contains two steps: the first step “is determining whether the proposed process is an abstract idea”, and the
second step “is whether it limits it is potential abstractness by including an inventive concept”
As noted above, the difference between the EU and United States approaches is that while in the EU patent system, the technical character is a requirement to obtain a patent because it is relates to the “condition of invention”, which appears from the exclusions from patentability list in Art.52 (2)(C) of Munich Convention; accordingly things that are excluded from patent only “as such”, “the notion of technical character is used to distinguish an element excluded “as such.” Moreover, according to Art. 52(2)(a)- (c), discoveries are non-invention and as a discovery to grant a patent need to involve or add a practical use, discoveries related to natural substances might obtain a patent when it has been “isolated from [their] surroundings [and] properly characterized either by [their] structure, by the processes by which [they are] obtained or by other parameters [...] ”.
The EPC, Article 84 provides that the claims for patent are to clearly and concisely define and describe the matter for which protection is sought. To illustrate, the subject of the claim should be clear from the elaboration of the claim without checking the description, the claim should not contain a contradiction, and should be clear for the person skilled in the art and should not be obvious as it needs an attempt to understand the technical sense.
To obtain a patent there are three main criteria the patent application must be satisfy in the United States and in the European system. First criterion is “Novelty,” which means that the invention is new and has not been made public, before filling the application of patent. Second, an invention should involve an “inventive step,” which means a product should be an inventive solution, and should not be obvious to manufacturer. Third criterion is
industrial applicability, which means that the invention should be subject to manufacture, for example, you can obtain a patent on a new kind of playing card but you cannot if the invention is an idea for new playing card.
Business method is not patentable in the EPC. However, according to the European Patent Office, many business method applications have been granted a patent, that indicates, the exclusions of business method in the patent system has not been clarified for patent societies but experts. In addition, business method application is distinct due to the long examination time and because of lack of experts in the field. Importantly, the patents of business method always revoke, and this demonstrates that, the EPO unable to collect the prior art like other technology.
The current situation for the patent system became a source of anxiety for businesses, particularly for those who have just established their business and accessing the intellectual property right is necessary to develop their project. Moreover, unclear patent jurisdiction will impede patent holders due to the ambiguity in the jurisdiction.The scope of the patentable subject matter and patent jurisdiction should be certain for firms, otherwise they will avoid the jurisdiction overall because they believe that they cannot protect the patent rights, also cost will increase and competitors will not fund the R&D because they are not sure about the patenting.
Harmonization of the international patent systems is not completed yet. For example, in the field of biotechnology, the patentable subject matter combination criteria are worrying the patent society and they argue that such a diversity is harming patent holders who lack of information about the validity of their patents. Although these various approaches may confuse inventors, relying only on the three requirements which are novelty, inventive-step (non-obviousness) and industrial applicability (usefulness), to obtain a patent whether in Europe or in the US, will also cause bad results. To illustrate this point, the grant of a patent
for human gene therapy is one of the most controversial areas in the US. Scholars have compared the EU and US approaches for excluded subject matter. The EPO is prohibited from obtaining a patent for biotechnology and the reason why the EU excluded gene therapies from obtaining a patent is for protecting the medicine practice from anything that might affect the quality of medical services provided to people, specially affecting the funding on researches due to the high prices. Generally speaking, the EU approach concerns with “morality” in deciding the patent eligible but there is some criticisms on the way they follow to determine the “morality” involved in a given situation.
The Enlarged Board and CJEU have avoided engagement with the “morality” question, and they clarify the explicit morality exclusion which is the stereotypical approach. This may be because it is difficult to engage with a subjective criterion like morality; however, the lack of clarity on this issue while morality remains one of the criterion based on which patent can be denied is misleading and the courts’ lack of engagement with this question prevents the patent law to be developed in a way that might help to increase the number of inventions benefitting our societies.
In Mayo Collaborative services v. Promethues Laboratories, the US Supreme Courtredefined the patent-eligible subject matter in the US by adding an “inventive application” criterion onto section § 101 as a requirement of obtain a patent for practical applications of scientific discoveries. On the other hand, in Ariosa v. Sequenom the Federal Circuit decided that under Mayo, “a diagnostic process based on the discovery of cell-free fetal DNA in the maternal blood stream” was not eligible to obtain a patent under § 101, at the time were the invention was made the disclosing DNA and the amplifying steps were traditional. Furthermore, after Sequenom, the Supreme Court almost had the opportunity to revise the decision in Mayo that “discoveries are not patent-eligible unless inventively applied.” As a result of these overlapping decisions and legislations, there is an argument that the United States’ standing as leader in innovation will suffer, particularly in the field of medical diagnostics.
A suggestion is made that biotechnology industry and authorities that specialise in developing medical diagnostic technology would benefit from removal of the exclusions provided in §101 and in the Supreme Court decisions; at the very least there is a need to clarify some elements to bring certainty on the area of patentable subject matter exclusion and it is argued that the Supreme court decisions have damaged the field of medical diagnostics industries, biotechnology and personalised medicine.
The uncertainty in the legal system be it in the United states or the EPC can cause disputes and make it harder to expect the infringement outcome, which then impacts negatively on the investment decisions and sustainable development of electronic commerce. Moreover, the impact of this vague criteria of computer implemented inventions can lead to undesirable and perverse outcomes for public and inventors by increasing the number of the unnecessary lawsuits which then will increase the legal disputes costs to the public.
By comparing the United States and EPC approach on patentable excluded subject matter it can be said that both systems are confusing in different contexts, and the three general criteria are fair enough to decide whether the invention is eligible to obtain a patent or not. Using the three general criteria which is novelty, inventive step and industrial application are adequate to obtain a patent. Having a list of patentable excluded subject matter whether in the EU or US impacts the economic system, and affects business and confuses the patent community.
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