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Launch-at-risk of generics not that risky anymore: when the intellectual property court will refuse to grant security to the holder of a patent for an original drug

The decision of June 4, 2024 of the Intellectual Property Division of the Regional Court in Warsaw handed in the case regarding rivoraxaban (reference no. XXII GWo 225/24), should be of interest to all producers of generics considering the so-called launch-at-risk. The launch-at-risk refers to a situation in which a generic product is introduced to the market while...

The ban on patenting of NGT plants?

On February 7, 2024 the European Parliament voted on the first reading in favor of the proposal for a regulation on plants obtained by certain new genomic techniques (NGT) and their food and feed. This method involves breeding plants by introducing specific changes to the DNA; in many cases it does not require the use of foreign genetic material from species that cannot interbreed naturally....

Data exclusivity

Despite the title of our series (“Patents without secrets”), this entry is dedicated to market monopoly, which concerns a specific group of products, and its source is pharmaceutical law rather than industrial property law. Data exclusivity is a special institution that provides additional protection to manufacturers of medicinal products. It is justified, as indicated by Prof. Du Vall...

Exhaustion of patent rights

Patent exhaustion determines the limits of the monopoly that the patent holder is entitled to. If a product that constitutes the material embodiment of the rights under the patent is placed on the market by the right-holder (or with their consent), they lose control over its further fate. Due to the exhaustion of the right, the right-holder cannot take actions aimed at opposing the use of their...

The possibilities of asserting rights by the co-inventor omitted in the patent application

What are the consequences of filing a patent application in which one of the inventors is omitted? We have already dealt with various aspects of this issue in our previous publications. We presented a case study regarding the invalidation of the CRISPR/Cas9 patent before the EPO due to the omission of one of the inventors (see here). We also pointed to the matter of criminal sanctions under...

The Polish translation of the patent description may be used when registering a unitary effect

In one of our previous texts (see here) we have described in detail the procedure specific to the registration of a unitary patent. It should be recalled that European patents granted after June 1 may benefit from unitary effect, with some minor exceptions provided for during the transitional period. An application for unitary patent must, in principle, be filed within one month of the...

New regulations regarding proceedings to secure claims in intellectual property cases

Three years after the establishment of intellectual property courts in Poland, we are witnessing the first significant change in the procedure before them, primarily in the area of the proceedings to secure claims. On March 9, 2023, the Polish parliament adopted an act amending the Act - Code of Civil Procedure and certain other acts. The provisions that are of interest to us entered into force...

The patent invalidation in Poland

The very nature of patents implies their temporal limitation, but the expiry of the protection period may not be the only reason for the termination of exclusive rights arising from the patent. In this article, we present the regulations in Polish law regarding the invalidation of a patent, which can basically take place in two procedures: • as a result of an objection; • in patent...

The launch of the Unified Patent Court

On June 1, 2023, the Unified Patent Court (UPC) launched. This is undoubtedly an important date for the protection of intellectual property in the countries of the European Union participating in the system - and not only. The UPC will have exclusive competence in the participating Member States in respect of actions for infringements and revocation of European...

Is the unitary patent cost-effective?

At the beginning of June 2023, a new patent protection system will launch in the European Union. Persons filing applications with the European Patent Office (EPO) will be able to apply for patents with unitary effect — i.e., providing uniform protection and having the same effect in all participating Member States (there are 17 of them as of this moment). We have already written quite a...

The claim to establish that the production does not infringe the patent

In the most recent entry in the series “Patents Without Secrets” we have written about claims that a patent holder can pursue in the scenarios of patent infringements. This time, we would like to analyze a situation where the roles are in a certain way reversed, and it is the patent holder against whom an action would be brought in aim to demonstrate that the infringement does not occur. ...

Clinical trials and the novelty of the invention

Can clinical trials of a new medicine that are conducted before a patent application is filed result in the loss of novelty by that invention? The caselaw of the EPO shows that it is quite a serious risk that we should take into consideration when preparing the placing of our medicinal product on the European market. In this Report, we would like to take a closer look at one of the most...

Claims available in the scenarios of patent infringement

In this article, we have gathered for you essential information regarding claims that are available in Polish legal system in cases of patent infringement: we are presenting their catalogue with brief descriptions, emphasizing particular possibilities and limitations in terms of their enforcement. At the beginning, it should be mentioned that the relevant provisions of the Act of 30 June 2000 -...

Unified Patent Court: an opt-out

In 2023, we will witness a major transformation in the landscape of industrial property protection in the European Union. The work relating to the launch of the unitary patent system is entering its final stage. As soon as on 1 April 2023 the Unified Patent Court (UPC) is supposed to become operative. The European Patent Office (EPO) indicates at its website 1 June as the date of the official...

Patent pools

Patent pools, in brief, constitute an agreement between two or more patent holders who share their patents between themselves or with third parties. In this article we would like to introduce you to this issue, paying attention in particular to purposes for which patent pools are set up and to challenges related to their assessment from the point of view of anti-competition law. ...

Criminal sanctions in Polish Industrial Property Law

The importance of including all the inventors in the patent application cannot be overemphasized. This is the lesson that scientists from Broad University have learnt the hard way when the institution’s European patent EP2771468 for a groundbreaking CRISPR/Cas9 technology was invalidated by the EPO in 2018. The decision was handed on the grounds of the omission of Professor Luciano Maraffini...

Sequences of Genes as Inventions

In this article, we would like to discuss one of the issues that involves the patent law regulations in the area of biotechnology. Is it possible to grant a patent for a sequence of a gene? In other words, would it be possible to treat genes as inventions and if yes, then what conditions should be fulfilled for such a classification? The debate on this subject is full of controversies. At...

Unified Patent Court: Representation of Parties to Proceedings Before the Unified Patent Court

The launch of the Unified Patent Court (UPC) is quickly approaching. With 24 EU Member States within its jurisdiction, it will be exclusively competent in matters relating to validity and infringements of the European patents with unitary effects, European patents and supplementary protection certificates granted for inventions protected by such patents. We have previously indicated in our...

Licensing agreements and other technology transfer agreements and the competition law

As we can read in “Patent Law” by Professor Du Vall, the economic and social rationales behind the IP law and the competition law are to a considerable degree convergent: “they are supposed to contribute to ensuring benefits for consumers and the effective allocation of the means of production”. The relation between these two fields of law remains, however, rather complicated: the...

SPC Manufacturing Waiver

The subject of the supplementary protection certificate (SPC) has already been featured in a number of our publications. The essential basic information about SPC can be found in one of the first entries in our series “Patents Without Secrets” (No. 7/2020 — available only in Polish language). We have also covered for you the case-law of the CJEU clarifying the conditions for granting of...