CET5 Studies Patent Eligibility of 3D Printed Tissues and Organs
CET Group 5 (Biotechnology and Pharmaceuticals) has conducted an extensive study of the issues surrounding the eligibility for patenting of inventions relating to artificial organs produced by three-dimensional (“3D”) printers. Improvements in computer science now allow 3D printers to use solid matter as ink, allowing the reproduction of solid objects, including creating artificial organs using living cells rather than ink. The production of artificial organs by 3D printers could avoid many problems related to transplantation, particularly in the situation where a suitable donor is not available, or when the patient’s own cells can be used to produce the artificial organ. CET5 has studied whether 3D printed organs could be patentable subject matter in various jurisdictions, and in April, 2019, FICPI passed a resolution supporting the subject matter eligibility of the same.
FICPI Turkey - Roundtable Meeting on EP Opposition Procedures
FICPI - TURKEY arranged its sixth roundtable meeting on opposition proceedings of European Patents before the European Patent Office (“EPO”), the protection of the amended version of already validated patents in Turkey following the opposition procedures and how the opposition procedures of the Turkish Patent and Trademark Office (“Turkish Office”) should be as per the new law.
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Over the last few years, CET Group 5 (Biotechnology and Pharmaceuticals) has conducted an extensive study of the issues surrounding the eligibility for patenting of inventions relating to artificial organs produced by three-dimensional (“3D”) printers. A 3D printer can produce an artificial organ using cells (preferably cells cultured from the same patient needing such an organ), after which the artificial organ will hopefully be appropriate for transplanting into a person needing such an organ.
Improvements in computer science have led to the development of 3D printers that use solid or molten matters as ink. This has allowed the reproduction of solid objects. Indeed, 3D printers have been used to successfully produce very diverse objects. Attempting to use 3D printers to produce artificial organs has been a natural step forward, i.e., by using living cells rather than ink. The production of artificial organs by 3D printers is of great interest, particularly since it could result in many human lives being saved. Even if the artificial organ were not as good as the natural organ, it could nevertheless improve the quality of the patient’s life.
Artificial organs produced by 3D printers could avoid many problems related to transplantation, particularly in the situation where a suitable donor is not available. Moreover, even if there were a suitable donor, the risks of rejection and other potential side effects would be substantially reduced where the patient’s own cells are used to produce the artificial organ. Thus, even in the absence of a donor, surgery could be scheduled while the patient is in better condition than they would be if they had to wait for a donor to be available. This would not only be better for the patient, but also for surgeons who would be able to schedule surgery at an optimum time rather than having to rush to implant when a donor organ becomes available. Furthermore, it would avoid the death of patients for lack of donors as sometimes currently happens. It would also allow production of as many organs as needed. Finally, it might well improve the organs for transplantation since donor organs currently vary in quality.
Unfortunately, the attitude in many jurisdictions toward eligibility for patents of artificial organs produced by 3D-printers is not favourable.
The above considerations prompted FICPI to address this issue. During the ExCo in Zurich, Switzerland in 2016, it was decided that the first step should be to collect data from a number of jurisdictions to get a precise idea of the magnitude of the problem. A briefing paper was then prepared and discussed during the ExCo in Hangzhou, China in 2017. After further discussions, a position paper was prepared and approved during the Congress in Toronto, Canada in 2018.
As explained in that position paper, FICPI believes that the production of such organs, and the organs themselves, should be eligible for patenting provided they meet the other requirements to obtain a patent.
However, particular attention should be given to claim drafting to avoid rejections on the basis that the claims would read on natural organs. Accordingly, it will be important to write the claims in a way such as to only cover artificially produced organs.
It is FICPI’s opinion that claims referring to processes for the production of artificial organs should in fact be eligible, since such processes are clearly human activity and not naturally occurring processes. Claims to prostheses incorporating biocompatible materials should also always be eligible, since such prostheses do not occur in nature.
In the case of artificial organs produced using living cells in 3D printers, one possibility would be for claims to refer to the frame or core employed for their production. Another possibility would be to refer to the way cells are to be arranged around the frame or core.
FICPI invited by EUIPO to share views on the new Strategic Plan for 2020-2025.
The meeting was introduced by João Negrão, followed by an address by the Executive Director, Christian Archambeau, which provided a very high level review. He considers that interaction with users will be strengthened under SP2025, which comes into force in July 2025. The Office sees the most important challenge is how to continue to deliver value to users. The plan is based on three strategic drivers – Stakeholders, Users, the Office.
This was followed by an introduction to the draft plan by Miguel Gusmão. The consultation process involves the European Commission and European Parliament. By 2025, the Office expects to receive 210,000 EUTM applications and 135,000 RCD applications. IP Value for Businesses & Citizens in Europe is a key aspect of the plan.
The assembled group was split into two groups; exchange of views on SP2025 initiatives and benefits for users, institution and society, as well as the possibilities for the involvement of users in the SP2025.
Summary of Workshops
Happy with EUIPO being present in non-EU settings, as long as supporting EU undertakings
Need to keep a focus on key services of granting TM and RCDs, but good to see interest in other services
Increased customer focus of all of the Office would be useful
The Office should avoid giving advice as opposed to information
SD1 – generally supportive, with some caution of over-reaching of the office. As the Office looks to develop new relationships, it was thought checking in with users to see if the proposals are suitable.
SD2 – experience of auditing have been very positive, and it would be good to extend to new areas. The Office should plan a thorough review of current services to look for inconsistent results. For some of the new services, more clarity on these in the plan would be helpful – for example, on IP Valuation, the Office would be better directed to providing data and tools to support such services.
SD3 – no real issues here
The initial reaction of the Office showed positive engagement with the comments from the workshops – many of the comments would be taken into account either in the plan or the subsequent work plans.
A few other areas of specific interest that came up in the workshops were the need for the Office to introduce a clear framework for users contacting them, including reliable means for contacting examiners. The Key User Programme currently has about 750 members – to join a user needs a EUIPO current account, and to have all communications with the office via e-comms.
After a pleasant lunch, we continued with a session of consultation on new European Cooperation Projects led by José Izquierdo. Generally, the feedback from the users was supportive of the plans, with a few detailed comments. In particular, it was noted that CP6 (SMEs) should offer practical support, and will likely have the most impact on users. There was also interest in what interest there is amongst national IP offices in the new projects in ECP8. We were told that comments on the ECPs may be submitted up to the Liaison meeting, which is due to take place from 22 to 24 October 2019. It is worth noting that working groups under the new ECPs will likely now start until October 2020.
FICPI Vice-president, Ivan Ahlert, represented FICPI at the XXXIX International Congress on Intellectual Property of the Brazilian Association of Intellectual Property (ABPI) in Rio de Janeiro, Brazil, 25-27 August 2019, with more than 700 registered participants. ABPI kindly offered a booth to FICPI during the congress, where we distributed brochures advertising our federation and its activities, and contacted people interested in FICPI.
Potential cooperation arrangements between FICPI and ABPI and ABAPI were discussed with the respective presidents, including the possible creation of a Committee of FICPI members in ABAPI.
After a presentation by the lady head of the Patent Division at the BPTO, Mrs. Liane Lage, Ivan Ahlert congratulated her and her team on behalf of FICPI for the adoption of new streamlined procedures to expedite patent examination, and substantially to reduce the examination backlog within 2 years, and also expressed FICPI’s support for this initiative, referring to FICPI’s resolution (EXCO/CN17/RES/004) on extreme backlogs and TRIPS.
FICPI Turkey - Roundtable Meeting on EP Opposition Procedures
FICPI - TURKEY arranged its sixth roundtable meeting on opposition proceedings of European Patents before the European Patent Office (“EPO”), the protection of the amended version of already validated patents in Turkey following the opposition procedure and how the opposition procedures of the Turkish Patent and Trademark Office (“Office”) should be as per the new law.
Mr. Barış Atalay, who is a European and Turkish Patent Attorney and member of FICPI – TURKEY, moderated the meeting. 24 participants were present at the meeting including some FICPI-TURKEY members.
Following the opening speech made by Ms. Ayşen Kunt, the Secretary General of FICPI - TURKEY, Mr. Atalay firstly gave information regarding the admissibility in the European opposition proceedings by referring to the Guidelines of the EPO for examination and mentioned the possibility that any of the opposition grounds can be rejected since every single opposition ground is taken into consideration separately.
Afterwards, Barış Atalay by addressing the content of the oppositions stated that when an opposition is filed, facts, evidence and arguments are submitted and all of these make up the reasoned statement; however in the Turkish procedure there is a need for a guide on how these statements should be.
Barış Atalay referred to the subject of intervening to an opposition and that the defendant of an infringement action or a party who received a warning letter and filed a negative declaratory action can be an intervening party like a real opponent to an opposition within 3 months even if the 9 month opposition duration expires. However the intervening parties cannot have the status of an opponent and cannot proceed with the file as a party if the real opponent withdraws his opposition.
He noted that regarding the public prior use, while there is little information in the Turkish law and the opposition proceeding in Turkish law, detailed information is available under the European procedure.
Thereafter, Barış Atalay gave information about how the oppositions are examined in case of multiple opponents. He stated that although all notices of opposition will be considered as new in terms of procedure and examined separately, all the grounds, evidence and arguments of the opponents are gathered in a pool and the opponents can use each other’s grounds in the pool system of the European legislation.
Regarding the late-filed requests, Barış Atalay mentioned that the Opposition Division would consider a late-filed prior art document only if it endangers the maintenance of the patent, and it is unlikely to introduce late-filed grounds before the Opposition Division. He also stated that the patent owner should not present late-filed amendments in the same way and surprise the opponent, that the rules for submitting late documents and requests during the opposition process will be applied to the patent owner, too.
Later on, regarding the clarity objection Barış Atalay stated that clarity is not a ground for opposition, both before the EPO and in Turkish law; however it is a subject open to be abused and that clarity is taken into consideration only with regards to amended claims. However, he stated that the patent owners may tend to amend their claims by correcting potential clarity problems in non-amended text as granted while filing amendments against the counter evidence filed during the opposition before the EPO and the Turkish Court. He emphasized that while the patent owners are entitled to do so, attention should be paid to the grey areas.
Lastly, the participants have made evaluations regarding the opposition procedures both before the EPO and the Turkish Office and discussed that the Turkish Office should organise a workshop with the relevant civil society organizations and practitioners regarding the opposition procedure. It was also discussed that drafting of the guideline would benefit both the consistency of implementation and the conduction of a healthy opposition procedure, which would reduce the burden of the courts.
Most participants actively took part with their questions and discussions both during the meeting and the closing cocktail. FICPI – TURKEY will continue providing these discussion platforms for the practitioners by the traditional Roundtable meetings and seminars.
Brazilian IP Office (INPI) adopts new procedures to reduce the patent examination backlog
INPI has published Resolution 241/19 providing for a streamlined examination of pending patent applications having a search report issued by another IP office, to be executed during the next 2 years. In such cases, Brazilian examiners will not perform additional prior art searches.
A preliminary office action (code 6.21) will be issued concerning applications filed on or before December 31, 2016, a response being due within 90 days. The applicant will be given an opportunity to amend the application to overcome any relevant prior art and/or submit arguments. Amendments will be required to comply with Brazilian law and regulations, in particular with respect to INPI’s strict interpretation of the law in the sense that during examination claims may only be amended to restrict their scope. Failure to respond will result in the unappealable shelving of the application.
Following submission of amendments/arguments considered suitable by the examiner, the application shall be allowed.
Such preliminary office actions will not be issued in connection with patent applications already being examined or which expedited examination was previously requested, or which are subject to third party observations.
Since the opinion issued by another IP office will be taken into consideration, adapting the claims in Brazil to those already granted by that office will presumably improve the chances of allowance.