The system known as the “European Patent with Unitary Effect” (or “Unitary Patent,” as it is colloquially referred to) is expected to become a reality in the first half of 2023.

This system consists of two European Union Regulations (EU 1257/2012 and EU 1260/2012), which define:

• the creation of a European patent with unitary effect for all participating countries, and
• An international agreement establishing a Unified Patent Court (UPC), which will have exclusive jurisdiction over disputes involving these new unitary patents.

Currently, this system is in what is known as the provisional implementation phase, during which the necessary practical preparations (setting up the TUP’s headquarters, developing systems, hiring judges, etc.) are being made for the launch of this new court, which will have its main headquarters in Paris and Munich, as well as local offices in the countries participating in the TUP.

Under this new system, applicants for European patents who so desire may request that their European patent granted by the European Patent Office (EPO) have unitary effect in all countries that are participants in the system at that time. This means that the European patent will be considered in those countries as a single patent for all of them. One of the most immediate consequences of this system is that, if the unitary route is chosen, it will no longer be necessary to proceed with so-called national validations in the participating countries. However, if the applicant does not wish the granted European patent to have unitary effect, it will still be possible to validate the patent in those countries through the national route, as has been the case until now. In addition, it will still be necessary to validate the patent in countries that are not part of the system, such as Spain, the United Kingdom, Switzerland, Norway, Poland, Iceland, and Turkey, among others.

To benefit from this new system, applicants for European patents may request unitary effect within a non-extendable period of 1 month from the date the EPO grants the patent. This request must be accompanied by a translation of the granted European patent into English, if the European patent was granted in French or German, or into any of the official languages of the EU, including Spanish, if the European patent was granted in English, and does not entail the payment of any official fee.

As of today, the countries that have already ratified the system—and will therefore be part of the unitary patent system when it enters into force—are: Austria, Germany, Belgium, Bulgaria, Denmark, Slovenia, Estonia, Finland, France, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, and Sweden, while the ratification process is underway in Cyprus, Slovakia, Greece, Hungary, Ireland, the Czech Republic, and Romania. Spain has not joined this system, although Spanish applicants for European patents will be able to benefit from it, just as applicants from any other country in the world can.

When deciding whether or not the unitary effect is appropriate for a granted European patent, the following considerations must be taken into account:

Advantages of the unitary effect:

• The patent will remain in force in all countries participating in the system through a single payment of an annual maintenance fee to the EPO, which will cover all countries participating in the system; therefore, it will not be necessary to pay individual maintenance fees in each of those countries.
• It will be possible to bring legal action against potential patent infringers in the various countries participating in the system through a single infringement lawsuit filed with the TUP.
• A translation cost reimbursement of €500 is provided for those European patents for which unitary effect is requested and that were originally filed by small or medium-sized enterprises, NGOs, etc., in a language other than English, French, or German.

Disadvantages of the unitary effect:

• The unitary patent will be subject to centralized invalidation proceedings before the UPC, which, if successful, will automatically invalidate the unitary patent in each and every country participating in the system. Such invalidation proceedings may be filed at any time during the term of the unitary patent.
• It will not be possible to surrender protection in individual countries by failing to pay the corresponding annual fees in countries that are no longer of interest, as is currently possible in the case of patents subject to the national validation system. If the maintenance fee for the unitary patent is not paid, the patent will be surrendered in all countries participating in the system.
• The annual maintenance fee for the unitary patent is relatively high and is equivalent to approximately 4–5 annual maintenance fees in individual EU countries such as France or Germany. Therefore, if protection is sought in three or fewer countries within the system, the unitary patent will generally entail higher maintenance costs than the system of national validations.

The unitary patent system will enter into force on the first day of the fourth month following Germany’s deposit of its instrument of ratification with the Council of the EU, which will mark the beginning of the “sunrise period.” The “sunrise period” is currently scheduled to begin on March 1, 2023, and the Treaty is scheduled to enter into force on June 1, 2023. Starting January 1, 2023, holders of European patent applications nearing grant may either delay the grant to ensure they are in time to request unitary effect once the system becomes operational, or file a request for unitary effect in advance.

Finally, a very important issue on which the holders of currently granted European patents must make an immediate decision: the exclusive jurisdiction of the UPC will apply, from the first day of its entry into force, to all European patents for which unitary effect is requested, but also, by default, to existing European patents granted by the EPO prior to the system’s entry into force. This means that these already granted patents could face invalidation proceedings before the UPC as soon as the system enters into force. If this were to occur, the European patent could be invalidated in all countries participating in the system where it is in force.

To prevent this from happening, holders of already granted European patents whose patents are in force in any of the countries participating in the system will have the option, during the “sunrise period, ” to file a request to “opt out” their patent(s) from the jurisdiction of the UPC, which entails the following:

• If such an “opt-out” is requested, the affected patent(s) will no longer fall under the jurisdiction of the TUP but will continue to be subject to the jurisdiction of each country’s national courts and will therefore be litigated before those courts, as has been the case until now.
• Conversely, in the absence of an “opt-out” request, granted European patents will fall under the jurisdiction of the UPC and may be invalidated in all countries participating in the system through a single invalidation action filed with that Court.

Consequently, holders of European patents granted to date must decide now whether they wish to request an “opt-out” for those patents, so that they can prepare to file the “opt-out” request within the three-month “sunrise period.”

Naturally, it is not possible to offer general advice that applies to every single case; each case must be examined individually, weighing the pros and cons for that particular situation and taking into account economic, commercial, and strategic considerations. To this end, ELZABURU has professionals with the necessary qualifications to represent our clients before the Unified Patent Court, who can provide them with advice. For more information, please contact your usual point of contact at ELZABURU, or send your questions to patenteunitaria@elzaburu.es

ELZABURU S.L.P.

A German court hasbanned the sale and production in Germany of Ford carscapable of connecting to the Internet as part of a lawsuit alleging infringement of wireless technology patents. The ruling also orders the recall and destruction of the vehicles currently at Ford dealerships. The ruling can still be appealed.

Patent Dispute Between Manufacturers and Suppliers

Patent EP2294737B1, currently owned by IPBridge, protects a technology for a channel quality indicator and is essential to the LTE mobile standard. The judges have ruled that the FordPass-Connect connectivity module, which connects the car to smartphones, infringes the patent.

The ruling reflects the growing tension between automakers and technology companies that want automakers to pay royalties for the technologies used in navigation systems, vehicle communications, and self-driving cars.

Ford is also facing lawsuits related to connected cars in the United States and Italy.

The Automotive Industry and Mobile Communication Patents

IP Bridge had previously sued Volkswagen in Germany over the same patent. Before the court issued its ruling, the German automaker decided to pay for the rights to use an Avanci license, which also includes patents from other owners. Other automakers, such as General Motors and Tesla, have decided to acquire this license before being sued.

The lawsuits against Ford are part of a series of lawsuits involving connected cars against the automotive industry. In recent years, the Avanci group and other patent holders had focused on German automakers, such as BMW, Daimler, and the aforementioned Volkswagen, as well as their suppliers. For example, Nokiasued Daimlerover this very issue. BMW, Daimler, and Volkswagen ultimately decided to sign a licensing agreement with Avanci.

Author: Ruth Sánchez

Artificial Intelligence (AI) is changing the world we live in. The ability of AI algorithms to analyze vast amounts of data, make connections, draw conclusions, and even solve specific tasks by combining the knowledge gained from data analysis is leading to the emergence of computer applications and/or devices that perform tasks that were, until recently, impossible or had not even been considered.

AI is already present in every field

Artificial Intelligence is used in fields such as medicine, where it aids in the analysis, diagnosis, and prediction of diseases, as well as in the development of new drugs; in environmental science, where it enables the analysis of meteorological and/or environmental data on ecosystems, making it possible to prevent or respond to pests, fires, floods, etc.; or in the analysis of human behavior, such as road traffic, to help provide solutions to congestion in large urban areas.

This reality is also affecting industrial property. It is becoming increasingly common for companies to seek patent protection for inventions developed by an artificial intelligence application.This poses a challenge to most patent laws around the world, which generally define a patent as a right granted to a human inventor, rewarding their effort and granting them a period of exclusivity to exploit the fruits of their labor and knowledge. 

What should be done when the inventor is not human?

Many national patent offices and courts in many countries are finding themselves in the position of having to decide whether to grant patents for inventions that were not developed by a human mind.In the vast majority of cases, the decisions made by these bodies tend to reject such patents.

Aside from the question of whether current national and international laws allow for the protection of inventions developed using AI, this issue raises philosophical and practical implications regarding whether or not a patent should be granted for an invention produced by a machine.

For example: How can a human mind (that of a patent examiner) assess the criterion of inventive step required of an invention (the invention’s “non-obviousness”), when “the one” who invented it is an entity that has absolute knowledge of all data published worldwide and throughout history regarding that subject matter, and possesses a capacity to correlate that data that exceeds that of any human mind?

The Need to Update Laws

In any case, it seems necessary to address the issue of inventions created by artificial intelligence systems, and for countries to adapt their industrial property laws to provide at least some degree of protection for these developments. Otherwise,this could discourage the activities of technology companies that, with the help of such systems, seek to provide technical solutions that improve people’s lives.

Is it necessary to amend the regulations under current patent laws to include specific criteria for this type of invention? Would it be better to establish a new type of intellectual property protection to address the protection of these inventions? In any case, it seems necessary for all countries that are signatories to international treaties on the protection of industrial property to address this issue collectively, in order to harmonize the criteria to be followed for this type of invention.

Author: Juan Bosco de la Vega Churruca

One feature that distinguishes theEuropean Patent Officefrom the other IP5 offices is the requirement to align the description of a patent application with the claims as a prerequisite for granting the patent.

Although this requirement has been in place for several years, its specifics have varied over time and with each patent application.

The European Patent Office has been working for some time to harmonize these requirements.

Aligning the description with the claims

The legal basis for this requirement is found inArticle 84 ofthe EPC: “The claims shall define the subject matter for which protection is sought. They shall be clear and concise andbe supported by the description.”

Although theEPCdoes not clearly specify the scope of this support, as of today, as reflected in the European Patent Office’s Examination Guidelines, this support involves eliminating inconsistencies between the description and the claims.

This interpretation is supported by several recent decisions by the Board of Appeal, such asT1024/18andT121/20; however, there have recently been decisions—T1989/18andT1444/20—that could be considered contrary to current practice.

Challenges in Adapting the Description of a Patent Application

The need to adapt the description stems from the desire to define as precisely as possible the scope of protection conferred by a patent, in order to reduce uncertainty for third parties.

This greater certainty is not without potential problems for the patent holder, such as:

• Addition of matter, in violation ofArt. 123(2) EPC.
• Excessive limitation of the scope of protection, for example, resulting in a waiver of equivalents of the claimed subject matter.
• Abandon “fallback positions.”
• The processing cost increases; the longer the description, the higher the cost.
• Risk of making hasty adjustments to oral procedures.

How to Minimize Problems with Adapting the Description

While there are several ways to minimize these potential problems, perhaps the most cost-effective approach for processing them involves:

• Exclude or delete only what is strictly necessary, since the EPO’s practice in other cases is to give the applicant the benefit of the doubt.
• Decide on a case-by-case basis whether to exclude or delete, taking into account how it might affect the scope of protection and whether it might result in the addition of material. If it causes any of these issues, it is likely that strong arguments can be made against exclusion or deletion.
• Prepare any necessary adjustments in advance of the oral proceedings.

There are other, riskier alternatives, such as, for example, prolonging the proceedings in the hope that the EPO’s practice will change in the medium to long term, or filing the patent application with the BoA in the hope that the BoA will not require such an amendment to the description.

While this article has focused on the patent holder’s perspective, from an opponent’s standpoint, this amendment opens the door to new lines of attack, such as alleging an addition of subject matter under Article 123(2) of the EPC or filing third-party observations to force more risky amendments.

Author: Javier Polop

Spanish courts spend a great deal of time on “service of process.” Thus, when a defendant in a patent infringement case files a counterclaim challenging the validity of the patent, the court must serve the counterclaim on the plaintiff. This service of process is of vital importance because it triggers the two-month deadline for responding to the counterclaim. However, this is a symbolic service because the plaintiff already has the document in their possession thanks to the “service between legal representatives.” Wouldn’t it be more logical for the time limit to begin from that earlier service? Practical, yes, but an immediate affront to the principle that the proceedings must be driven and controlled by the court. The solution is simple. At a later stage, the court issues a ruling carrying out a symbolic “service” and initiating the time limit.

So far, so good. However, things became more complicated when the 2015 Patent Act allowed the patent holder to file a motion to limit the scope of the patent in response to the counterclaim. Although this had always been possible under Article 138.3 of the Spanish Civil Procedure Code (CPE), it lacked a specific procedural framework in the Civil Procedure Act, which had led to some improvisation on the part of the courts. Article 120 of the new Act changed all this by specifying that the request for limitation must be filed with the answer to the counterclaim and by setting a two-month deadline for a response. As usual, the court was required to “serve” the request on the counterclaimant, whose deadline for responding, however, began upon “receipt” of the request. This gave rise to a series of academic articles arguing that the start of this new deadline would not be the court’s “service,” but rather much earlier—from the moment of service between legal representatives.

In its order dated February 11, Commercial Court No. 5 of Barcelona ruled on this matter in favor of judicial service:“Any other interpretation of the proposals would mean leaving it up to one of the parties to determine when procedural deadlines begin to run and to drive the proceedings forward, in addition to rendering the provision set forth in the first paragraph of the statute meaningless. Taken to the extreme: if the time limit were to begin running from the moment the request is received—that is, upon transmission between legal representatives or between the parties themselves—what would be the purpose of transmission by the judge or court?” Article 120.5 “in no case authorizes circumventing or delegating the responsibility for driving the proceedings, controlling the timelines, and calculating them by the judicial body.”

Author: Colm Ahern

The real question is: Why are we so obsessed with transformation—especially digital transformation—right now, and why do all these innovation forums constantly encourage us to seek disruption? It’s repetitive and unrealistic.

Companies—well, the people who work for them—try to adapt to change, with varying degrees of enthusiasm; but sometimes it seems to us that if we don’t keep up with industry trends or new technologies, the same thing happens as in the fashion world: you become obsolete.

In writing this article, my intention has never been to provoke deep reflection or to ascribe any significance beyond what each reader might derive from it, but rather to offer a useful and practical perspective on this rich landscape of conflicting opinions.

From my humble perspective, what is happening now is a reevaluation of concepts in nearly every aspect of business, aided by more sophisticated methodologies and technological tools.

There are schools of thought that argue that extreme situations bring about major transformations in people, and they are surely right; but my hypothesis is based on the idea that this is true only if those people are internally predisposed to change. The same is true in companies—not just now, but it has always been that way.

It is common sense, grounded in honesty and reality, that should guide both private and public organizations in achieving their goals and ensuring their sustainability to guarantee their continued existence.

That said, I’d like to share some business tips that are “far from original” but nonetheless important and necessary—as a sort of refresher—so that professionals, amid the complexity we’re currently facing, can envision a new professional project with a certain degree of innovation or—why not?—disruption in their own environment:

• Back to thebasics. Review the standard management metrics.
  • Pursuit of efficiency in production areas.
  • Making decisions based on reliable, data-driven information and the right tools.
  • Review of Essential Processes.
  • Automation and robotization of areas to reduce risks and costs.
  • Enhancing the omnichannel experience.
  • Retaining and Managing Hybrid Talent.
• Combining Purpose and Profit Through Innovation.
• Create ecosystem networks that join forces toward a common goal, responding to new shifts in business paradigms.
• Create industrial technology platforms that foster collaboration between large and small companies to enable the scaling of new business models.
• Direct consumption, investment, and savings toward responsible products and services.
• Customers are regaining control; they are the primary drivers of change and expect greater involvement from their partners in their business.
• Clients will demand comprehensive professional service packages that address their business needs at all times. This will involve:

“THINK OUT OF THE BOX”

• The transformative role of professionals in service companies will be more significant than that of technology.
• Legitimacy and social awareness by providing solutions to societal problems that go beyond the company’s core business. These are the “Socially Responsible Projects” (PSR), which generate value and have a positive social impact in:
  • Science.
  • Culture.
  • Technology.
  • Life Sciences and Health.
  • Social Sciences.
  • Good Corporate Governance.
• Projects that reflect values such as ethics, responsibility, and exemplary conduct.
• Circular economy proposals that include products and services aligned with sustainable development goals and that have a real impact on the environment.

I would like to conclude by highlighting the importance of protecting and managing those innovations and intangible assets that help countries achieve greater well-being and progress for their societies and, consequently, for their citizens.

Good luck and keep up the good work on this exciting journey.

Author: Pilar Soriano

Judgment of the CJEU of July 9, 2020, Case C-673/18, Santen

One of the requirements for obtaining a Supplementary Protection Certificate (“SPC”) for a medicinal product is that the marketing authorization (“MA”) for the product for which the SPC is sought must be the first MA granted for that product as a medicinal product (Article 3(d) of Regulation (EC) No. 469/2009). The interpretation of this requirement has long been the subject of significant debate in legal scholarship and case law, particularly following the July 19, 2012, judgment of the CJEU in Case C-130/11 Neurim. In that judgment, the CJEU held that the existence of a prior MA for a veterinary medicinal product did not preclude the granting of a SPC for a different use of the same product.

However, following this ruling, the following questions arose:

• Did this interpretation apply only to cases in which the first marketing authorization concerned a veterinary drug and the second concerned a human drug? Or would it also apply to cases involving new indications or new uses of active ingredients whose first marketing authorizations concerned drugs for the same species (human or animal)?
• And would this also apply to cases involving new formulations of active ingredients whose first marketing authorizations pertained to drugs for the same species (human or animal)?

This second question was decided by the CJEU in the negative in its March 21, 2019, judgment in Case C-443/17 Abraxis: CCPs may not be granted for new formulations of existing active ingredients.

The CJEU has just resolved the first issue in its July 9, 2020, judgment in the Santen case referenced above. It also ruled against the claim: it is not possible to grant a CCP for a new therapeutic use of an existing active ingredient. Below, we summarize the national litigation that gave rise to this judgment and the reasoning followed by the CJEU in its decision:

The main dispute pitted the pharmaceutical company Santen against the French National Institute of Industrial Property (“INPI”). Santen, which specializes in ophthalmology, held, on the one hand, a patent protecting an ophthalmic emulsion whose active ingredient was cyclosporine and, on the other hand, a marketing authorization (MA) for a drug called “Ikervis,” whose active ingredient was cyclosporine, intended to treat severe keratitis in adult patients with dry eye. Relying on that patent and marketing authorization, Santen filed an application with the INPI for a SPC for the aforementioned drug. However, the INPI denied its application, finding that the marketing authorization in question did not constitute, for the purposes of Article 3(d) of EC Regulation No. 469/2009, the first marketing authorization for cyclosporine: in 1983, a marketing authorization had been issued for a drug called “Sandimmun,” whose active ingredient was also cyclosporine. “Sandimmun” was indicated to prevent the rejection of solid organ or bone marrow transplants and for other therapeutic uses, such as the treatment of endogenous uveitis, a complete or partial inflammation of the uvea, the central part of the eyeball.

Santen appealed the previous denial, and the case reached the Paris Court of Appeal, which referred the preliminary ruling question that the CJEU has just resolved.

The CJEU’s ruling is based on the following reasoning:

• The key to determining whether a CCP should be granted for a new therapeutic use of an active ingredient that was previously authorized for another therapeutic use is whether the products covered by the previous marketing authorization and the new marketing authorization can be considered different products simply because they are intended for different therapeutic uses.
• The text of EC Regulation No. 469/2009 defines the concept of “product” in relation to an active ingredient, not in relation to a specific therapeutic use of an active ingredient. It follows that the fact that an active ingredient is used for a new therapeutic use does not make it a “distinct” product when it has already been used for a known therapeutic use.
• Therefore, Article 3(d) of EC Regulation No. 469/2009 must be interpreted to mean that an authorization cannot be considered the first authorization for a product when it concerns a new therapeutic use of an active ingredient that was already the subject of another authorization for a different therapeutic use.

With this ruling, the CJEU overturns the Neurim doctrine, opting for a restrictive interpretation of the requirement set forth in Article 3(d) of EC Regulation No. 469/2009. This ruling will not have been well received by the pharmaceutical industry, which now finds its options limited when it comes to obtaining extended protection of its patent rights for new drugs consisting of a new therapeutic use of an existing active ingredient. However, as the CJEU points out, the EU legislature’s purpose “has been to promote not the protection of any pharmaceutical research leading to the grant of a patent and the marketing of a new drug, but rather that which leads to the first marketing of an active ingredient or a combination of active ingredients as a drug.”

Author: María Cadarso

PEACE OF MIND is the guiding principle for any holder of industrial and intellectual property rights starting at midnight tonight—that is, when Brexit, the United Kingdom’s exit from the European Union, takes effect at 12:00 a.m. CET.

Despite the storm clouds that at one point in 2019 foreshadowed an abrupt exit of the United Kingdom from the EU, an agreement has finally been reached that, in addition to setting the terms for that exit, provides for a transition period that, in principle, will last until December 31, 2020, EU law will continue to apply in the United Kingdom. This transition period therefore applies to the Regulations governing the European Union trademark and Community designs, the Regulation governing border measures to combat commercial piracy, and the procedural Regulations applicable to the pursuit of legal actions, among others. It should also be noted that European patents will not be affected by Brexit, since the European Patent Convention, which governs the granting of such patents, is not part of the EU legal system.

The effects of Brexit on industrial and intellectual property rights and other related matters are therefore postponed until January 1, 2021.

ELZABURU se propone enviar durante los próximos meses circulares informativas sobre las consecuencias del Brexit en relación con solicitudes y registros de marcas de la Unión Europea y registros internacionales de marca que designen la UE; también sobre los efectos del Brexit en materia de dibujos y modelos comunitarios; en relación con variedades vegetales y nombres de dominio <.eu>; sobre las solicitudes de intervención aduanera; sobre los procedimientos judiciales en curso o por iniciar; sobre la falta de incidencia hoy por hoy en cuestiones relativas a la patente europea; sobre procedimientos de oposición, nulidad y caducidad de derechos, así como cuestiones relacionadas con la representación para actuar ante la EUIPO.

For now, the message is clear. From February 1 through the end of the transition period, scheduled for December 31, 2020, everything will remain the same in practice: procedures regarding trademarks, designs, and other intangible assets will continue to operate as they have to date.

If you have any questions, please contact brexit@elzaburu.es.

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