INDEX

Pharma Patents in the Pandemic

In 2020, the number of international patent applications filed via WIPO continued to grow amid the COVID-19 pandemic, and within the field of technology, medical technology took 3rd  place with 6.6%. Many of us experienced a rush to claim antiviral usage of inventions that prior to 2020 might not have had that as their foremost aspect.

There is currently in particular a noticeable renewed interest in vaccine and antibody-related patents, as well as in second medical treatment patents for use in the COVID-19 spectrum.

Second medical use refers to the use of a known drug for a new therapeutic purpose. The advantage compared to developing a new drug from scratch is that the existing drug has already shown itself to be safe in the context of the original use. Developing and obtaining marketing authorization for the new medical indication can thus be quicker and more cost-effective.

In relation to COVID-19, several existing drugs with beneficial effects have been identified, e.g. Dexamethasone, a cheap steroid that has saved about a million lives, and Tocilizumab, originally a rheumatoid arthritis drug that reduces the risk of mortality in hospital patients.

Patents on medical inventions provide legal protection against being copied, and COVID-related inventions, both second medical uses and vaccines, are no exception.

Patents give inventors the rights to exclude third parties from commercializing their discoveries in exchange for laying public the new technology. This often means that the patent holder has a better chance ofmaking money from them – which is an incentive to encourage innovation, getting a return on the costly investments needed to develop new medicines.

But these are not normal times

Apparently, when it comes to the pandemic, in contrast to the rush to patents by originators in the field, in the public eye, patents and big pharma have become the hindrance for world protection, and the need for public availability of new research insights in this field far outweighs the individual inventor´s rights.

Large pharmaceutical companies usually have the financial muscles to keep secret know-how for a longer time. Scientists working outside this setting, e.g. at universities, need to regularly publish their scientific discoveries. In normal times, this can easily be combined with the need for absolute novelty for the patenting process. In pandemic times, though, there has been a rush to publish online long before an article has even been peer-reviewed and approved for publishing. E.g., in 2020 research outcomes related to the SARS CoV-2 pandemic were made openly available, including research papers (from preprints – MedRxiv and bioRxiv – to different mechanisms for waiving Article Processing Charges (APCs) or new specific Open Research platforms, as Elsevier or The Lancet). This is said to be in the interest of a quicker than normal sharing of information in the COVID-related fields, but brings with it not only unforeseen lack of novelty, making patenting impossible in large parts of the world, but also a clear questionability of scientific quality of the prematurely published research.

Last autumn, developing nations led by India and South Africa proposed to the World Trade Organization (WTO) that the patents on vaccinations and other Covid-related items should be waived, at least temporarily, a proposal that was recently supported by the US.

The argument is that, given the extreme nature of the pandemic, the recipe should be made widely available in order for vaccines to be produced locally in bulk by other manufacturers and thus reach the public in these countries quicker and at a lower cost. An overlooked factor is, however, that without access to all the know-how and necessary equipment and ingredients, a patent waiver might result in quality, safety, and efficacy issues and possibly even in counterfeits. This is particularly relevant for the novel-type vaccines which were developed by BioNTech/Pfizer and Moderna.

What is often forgotten in the present pandemic patent debate is that in certain circumstances, TRIPS allows any country to exploit a protected invention without the consent of the right holder in order to address public need., thus already offeringwell-considered solutions to situations that are not normal. Governments can impose compulsory licenses on vaccine makers, compelling them to share their know-howand tooverseeing the production process along the way. This solution also allows for compensations to the pharmaceutical companies, effectively leaving incitement to research and development in place.

It is easy to claim that exceptional times need exceptional solutions, but in all honesty, what makes the present pandemic essentially different from other catastrophic world-wide health situations? If we do not allow renumeration for research and development in medical areas of utter importance, such as not only viral pandemics such as COVID-19 or HIV, but e.g. malaria or cancer research, development of medicines for these indications will stagnate.

The patent system is an effective incentive to encourage innovation and to develop new medicines, a task that can simply not be achieved without the pharmaceutical sector, especially in times that are not normal.

 

INDEX

The CRISPR priority decision is out

ALL the applicants of a priority application must be named in a subsequent EP application

As discussed in a previous post, there were oral proceedings before EPO Board 3.3.08 on 13-17 January 2020 in appeal number T 844/18 in one of the so-called “CRISPR cases”. The written decision, which concluded that the patentee did not claim a valid priority, is now online. In the decision, the board confirmed the EPO’s use of the so-called “all-applicants approach” (in a simplified version):

  • A and B are applicants on the priority application.
  • A filed the subsequent application claiming priority from the priority application.
  • The priority is invalid because not all the applicants of the priority application were named on the subsequent application.

The board discusses in detail the meaning of the term “any person” in Article 87(1) of the European Patent Convention (EPC)/Article 4 of the Paris Convention (PC). The conclusion is that the term is not clear, but that it is established practice to require all applicants on the priority application to also be named on the subsequent application. Hence, abandoning the “all-applicants approach” would disrupt current practice, which in turn means (according to the board) that the patentee was faced with a heavy burden of proving the current practice wrong. The board found this burden not to have been lifted.

The board also considered the purpose and spirit of the Paris Convention as discussed in T 15/01:

  1. The right of priority is generally regarded as one of the cornerstones of the Paris Convention and was already incorporated in the original text of 1883 (cf Bodenhausen, Guide to the Application of the Paris Convention for the Protection of Industrial Property as Revised at Stockholm in 1967, 1969, Article 4, Section A(1), point (a); Ladas, Patents, Trademarks, and Related Rights, Vol. I, 1975, p. 456). Its basic purpose is to safeguard, for a limited period, the interests of a patent applicant in his endeavour to obtain international protection for his invention, thereby alleviating the negative consequences of the principle of territoriality in patent law.
  1. In the course of the revisions of the Paris Convention, several amendments were made to its priority provisions in order to enhance their flexibility and thereby ameliorate the legal position of patent applicants. It was considered that overly strict solutions would hardly be in accord with the spirit of the Union treaty which is aimed at fostering and encouraging inventive genius (cf Actes de la Conférence réunie à Washington du 15 mai au 2 juin 1911, Berne 1911, p. 45). In particular, the Paris Convention in its present version (Stockholm Act) explicitly recognises the possibility of claiming multiple and partial priorities (cf Article 4F) and guarantees the right to divide patent applications while preserving the benefit of the right of priority also for the divisional application (cf Article 4G Paris Convention). The same principles are reflected in the corresponding provisions of the EPC, ie Articles 76(1), second sentence, and 88(2) and (3).
  2. In the light of the above, the board disagrees with the view expressed in decision T 998/99 (point 3.1), according to which the international priority provisions contained in the Paris Convention have to be regarded as a body of exceptional rules which should be interpreted strictly. Rather, they have to be construed in a manner which ensures that the general purpose they serve, namely to assist the applicant in obtaining international protection for his invention, is fulfilled as far as possible.

The board agreed with these remarks but found that the Paris Convention does not aim to help others than the correctly determined “any person” and that it therefore did not help the patentee’s case.

The board also addressed whether it was competent to assess whether it was the correct (legal) person who had filed the subsequent application claiming priority. The board distinguished between the formal naming of applicants on the priority application and whether these applicants were in fact entitled to be named as priority applicants. The board found the EPO to be competent to assess the former and that the latter was not relevant for their decision.

Article 87 EPC also refers to a “successor in title” of the priority applicant. The board stated that the EPO requires evidence of succession in title, but that since no succession in title was alleged by the patentee, they did not have to review it. What remains unclear is what would constitute sufficient evidence (and what succession is in fact meant since the EPO is not required to assess entitlement to the priority application per se).

The board did not address the so-called “co-applicants approach” in their decision since it was not relevant for reaching the decision. Hence, the decision still leaves open a number of issues concerning the right to claim priority.

Further appeal cases that may clarify the EPO’s position on the right to claim priority are T 2749/18, T 1837/19, and T 477/19 (Aera is representing the patentee in the latter appeal). A decision in any of these cases is unlikely to be available for at least another couple of years.

INDEX

Can you patent the medical use of an inactive ingredient?

Patenting of a second (or further) medical use of an already known pharmaceutically active ingredient has been possible at the EPO since decision G 5/83. The Enlarged Board of Appeal introduced the so-called “Swiss type” claims, which have since been replaced by the format of Article 54(5) EPC of the updated convention (EPC 2000). Decision G 2/08 from the Enlarged Board of Appeal confirmed the body of case law developed for the Swiss type format for the new Article 54(5) EPC and further put an “expiration date” on the Swiss type claims.

Article 54(5) EPC refers to “substances or compositions” and it is well-established that medical devices do not benefit from the additional patentability afforded by this article (see decisions T 1069/11, T 2369/10, and T 1099/09). It is also well-established that “active ingredients” in the classic sense, i.e. a molecule interacting with some receptor in the body to cause a beneficial effect against a disease does benefit from Article 54(5) EPC.

Recent decision T 264/17 answers the question of whether a “chemical” that is not an active ingredient in the classic sense can nonetheless benefit from Article 54(5) EPC. The application concerned the use of a perfluorinated polyether as a replacement for synovial fluid in a damaged joint. According to the description, the perfluorinated polyether exerted its effect by not interacting chemically with the body. The application was refused by the Examining Division for lack of novelty over a document describing the same perfluorinated polyether for a different use since, in the opinion of the Examining Division, the perfluorinated polyether was not an “active ingredient” and therefore did not qualify for the exception in Article 54(5) EPC.

The Board disagreed. The Board referred to T 2003/08, which was based on the former version of the EPC and G 5/83, and the criteria established therein for determining whether something could be considered a “substance or composition”:

It is decisive for determining whether or not a “substance” or “composition” is used in a treatment to establish (a) the means by which the therapeutic effect is achieved and (b) whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities.

The Board answered that in the case at hand, (a) the perfluorinated polyether achieved its effect by not interacting with the surrounding tissue rather than by assuming a particular three-dimensional shape (as would be the case for a medical device), and that this (b) was caused by its chemical properties. The Board further concluded that it was less important whether the substance could be considered an “active ingredient”. The decisive criterion was whether it was the chemical nature of the substance that caused the beneficial medical effect.

This decision is encouraging for applicants who wish to rely on new medical uses of chemical substances, but who may have doubts whether these chemical substances could be considered “active ingredients” or “devices”.

INDEX

Is compulsory licensing the answer to the US’ buying of all Remdesivir?

Tuesday this week, it was revealed that Gilead, the producer of Remdesivir, which is currently known as the best drug against COVID-19, had sold nearly almost all of the next three months’ production of its medication to the US health department, leaving the rest of the world without access to buy more of the drug.

Tests of Remdesivir suggest that the recovery time is cut by using the drug, and the drug is therefore crucial in order to keep countries’ health systems from collapsing. The deal between Gilead and the US health department covers 500.000 doses to be used in US hospitals.

Even though Gilead in May signed a licensing deal with nine companies covering 127 primarily poorer countries, the situation could become critical. In many European countries, the supply might get short if the stocks are not filled or if the demand for the medication increases, for example in case of a second wave.

This situation, in combination with a price of more than 3,000 USD per treatment, has initiated a debate in which for example the Danish politician Pelle Dragsted yesterday has argued that hospital pharmacies should initiate their own production.

The question is whether this scenario is actually realistic?

Indeed, governments may use a backdoor to compulsory licensing as agreed in the Doha declaration on the WHO-based TRIPS agreement, stating that governments should not be prevented from protecting public health.

Compulsory licensing enables a government to license the use of a patented invention to a third party or government agency without the consent of the patent-holder, and it could arguably be the answer to the deal made by Gilead and the US.

There is to some extend existing examples in related areas, including HIV/AIDS drugs, but the process is not simple and there are also other factors to be taken into account, including:

  • There has to be an imminent catastrophic event
  • A negotiation with Gilead has to have taken place without success

There are several serious legal challenges in this approach:

  • The current infections numbers for Europe are much lower than for the US, which argues in favor of using the initial production for US hospitals
  • The legal process of compulsory licensing is complex and will most likely be longer than three months
  • There has, to our knowledge, not been a negotiation with Gilead about long-term production and delivery of Remdesivir in Europe, and license deals for 127 poorer countries had already been made. This argues against the idea that Gilead does not want to solve the problem.

There are also economic and practical factors that have to be taken into account:

  • Gilead would have to be compensated for the compulsory license, and there would as such not be an economic benefit to making Remdesivir
  • The process for making Remdesivir is highly complex and requires approximately 70 raw materials, reagents, and catalysts and approximately 25 individual chemical steps. Such process requires highly specialised production facilities and skilled scientists, which is a long process that certainly cannot be used by the local pharmacy.
  • Remdesivir is given to very sick COVID-19 patients, which means that the quality of the potentially alternatively-produced Remdesivir is important, and ensuring that the drug does not lead to unwanted harmful side effects will be essential. This requires testing and approval from the authorities, which again takes time.

Therefore, there are currently legal, practical, and regulatory arguments against a compulsory license for Remdesivir for the treatment of COVID-19.

On top of this, there is right now a significant initiative to produce as much Remdesivir as fast as possible, especially considering that there are ongoing merger discussions between Gilead and AstraZeneca.

The questions that remain are therefore: what type of dialogue is the European politicians having with Gilead? are they having a dialogue at all?

There are factories across Europe that could assist with the production of Remdesivir, under Gileads supervision and instructions. Why not discuss a license with Gilead to have them produce Remdesivir at a quality and quantity that could solve these issues? Or maybe Gilead already has an answer to these issues and no Europeans have bothered to ask them?

Based on the above, it would in our opinion make sense to test many alternative strategies before simply arguing that a compulsory license is the solution.