» Legal Reports

Prior national rights

Pursuant to Art. 93 of the 1973 Convention on the Grant of European Patents (hereinafter: EPC), the European patent application is published after the expiry of a period of 18 months from the date of filing or, if priority has been claimed, from the date of priority (or at the request of the applicant, before the expiry of that period). However, it may occur that during this 18-month period...

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....

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...

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...

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...

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...

Patent linkage in the proposed amendment to the Polish Reimbursement Act

In Poland, the work on the amendment of The Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices is currently in progress. The project developed by the Ministry of Health was published in the Public Information Bulletin of the Government Legislation Center on 30 June 2021. On the same day, an invitation to public...

Infringements of second medical use patents: an overview of the selected case law

The matter of the protection of new medical uses is one of the most controversial and the most often discussed subjects in patent law. In one of our previous articles in the cycle “Patents Without Secrets” concerning fundamental aspects of the protection of second and further medical uses (“New medical uses: the basic information,” Patents Without Secrets No. 4/2021) we made a promise...

The New EPO Guidelines: An Overview of the Key Changes

Since March 1, 2021 new Guidelines of the European Patent Office (EPO) are in force. Until now, such an update tended to take place annually in November; this shift in calendar is consistent with a broader plan of reforms related to the Strategic Plan 2023 being currently implemented by EPO, which among its key initiatives lists fostering social dialogue and engaging stakeholders. The new...

What is permitted under the TRIPS Agreement when it comes to the scarcity of SARS-CoV-2 vaccines?

In last December we published an issue of our Legal Report concerning the legal aspects of development of vaccines against the SARS-CoV-2 virus. We wrote in it about the race of pharmaceutical companies — at that moment back then only several weeks had passed since Moderna and Pfizer submitted first motions for emergency authorisations of their products and the optimistic news about...

New guidelines published by the President of the Polish Patent Office

In October 2020 the Polish Patent Office (PPO) published the latest version of the President’s guidelines regarding inventions and utility models. The guidelines elaborate quite often on certain matters that are not expressly addressed in relevant statuary and executive provisions, they suggest possible directions for interpretation of binding law, and specify numerous formal and technical...

The Unified Patent Court: A new episode in the long-running series

The Unified Patent Court and innumerable obstacles on the way to its launch have already been featured in our Legal Reports (see: WTS Legal Report No. 6/2020 and WTS Legal Report No. 7/2020). We decided that, at the beginning of the new year, it is worth to return to this controversial subject and present our take on the recent developments in this series that has already been running for...

Patent rights: an obstacle for development of a vaccine against COVID-19?

Recently we have been anxiously following a race of major pharmaceutical concerns: who would be the first to develop an effective vaccine against COVID-19? On 8 November Pfizer announced that their vaccine has an effectivity rate of 90%; just a week later Moderna "outbid" it, boasting 94,5% effectivity rate of their product. The dominant narrative emphasizes the common effort of the whole...

First filing requirement in Poland

Many states adopt in their legislation certain limitations when it comes to permissibility of filing patent applications before foreign offices: usually they are imposed on citizens of those countries or their residents; they can apply as well to inventions developed within their territories. Such regulations of given states provide that the first filing for an invention must take place with...

The claim to increase a remuneration for an employee’s invention in the Polish legal system

Quite often our Clients approach us with questions concerning the regulations of renumeration for employees’ inventions in the Polish legal system, particularly in the context of the claim under Article 23 of the Act of June 30, 2020 on Industrial Property Law (from now on as IPL). In this issue of the WTS Legal Report we would like to provide you with a detailed overview of this matter,...

The judgment of the CJEU in the Santen case: A new medical use of an existing product and an SPC eligibility

When it comes to conditions of the grant of a supplementary protection certificate (SPC), we covered this matter in our previous Legal Report that was published over summer. We indicated that issues related to SPCs are a subject of extensive, continuously expanding caselaw of the Court of Justice of the European Union (CJEU). Whereas the last time we focused on the decision of April 30, 2020 in...

The conditions for granting an SPC: a product is covered by patent claims if it was identifiable at a filing date (the judgment of the CJEU in Royalty Pharma case)

The conditions for granting a supplementary protection certificate (SPC) laid down in the EU law quite often raise some serious doubts and notoriously cause problems in practice. The Court of Justice of the European Union (CJEU) has frequently presented its position on that matter: the judgment in the case C-650/17 Royalty Pharma Collection Trust against Deutsches Patent- und Markenamt of April...

Deposit of Biological Materials

In this issue of the WTS Legal Report we would like to discuss a matter of great practical significance: Polish and international regulations concerning the deposit of biological materials. One of the grounds on which the Polish Patent Office can make a decision refusing patent protection is insufficient disclosure of an invention (Article 49 Section 1(2) of Act of June 30, 2000 on...

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