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First Judgment of the UPC Central Division Munich Section – Validity Assessment in Line with German Federal Court of Justice and Contradictory to EPO

Our partner Michael Wegerer summarized some key takeaways of the first judgement of the UPC Central Division Munich Section delivered on July 16, 2024 concerning the patent EP 3 666 797 B1.

Introduction

The judgment starts with the technical introduction and a summary of the background section of the patent, i.e. the prior art. Based thereon, the underlying problem of the patent is formulated. I.e. the underlying problem is not defined artificially based on a technical effect reached by a feature difference to a “closest prior art document”. The approach is rather a realistic approach and less an artificial approach: The skilled person endeavors to further develop the state of the art based on the existing state of the art. The technical problem is formulated rather broadly and generally. This is basically in line with the approach of the German Federal Court of Justice, cf. e.g. BGH X ZR 128/09 “Repaglinid” (2014) and contradictory to the problem-solution-approach performed by the European Patent Office (EPO).

Function-Oriented Interpretation of Claims

The judgement continues with a function-oriented claim interpretation, referring to the legal framework laid down by the Court of Appeal of the UPC e.g. in UPC_CoA_335/2023, NanoString/10x Genomics. Principles of claim interpretation are even summarized as a headnote in the judgement, cf.:

“When interpreting a patent claim, the person skilled in the art does not apply a philological understanding, but determines the technical meaning of the terms used with the aid of the description and the drawings. From the function of the individual features in the context of the patent claim as a whole, it must be deduced which technical function these features actually have individually and as a whole. The patent description may represent a patent´s own lexicon.”

The principles of claim interpretation would, as held by the Court of Appeal of the UPC apply to the assessment of validity. Starting the validity assessment with a claim interpretation is in line with the approach of the German Federal Court of Justice, cf. e.g. BGH X ZR 117/11 “Polymerschaum” (2012): “The examination of patentability regularly requires an interpretation of the patent claim, in which its meaning in its entirety and the contribution which the individual features make to the result of the invention must be determined.” The EPO in the past often saw no need to use the description to interpret the claims if the claims are worded so clearly and unambiguously as to be understood without difficulty by the person skilled in the art (cf. e.g. T 197/10) and thus followed another approach. It remains to be seen whether the EPO adapts its approach with current Referral G1/24 to the Enlarged Board of Appeal.

Definition of the Skilled Person – Concept of the “Team Skilled Person”

The claim interpretation is according to the judgement performed from the point of view of the skilled person in the light of their common general knowledge, which is the reason why the skilled person is explicitly defined in the judgement. Here, the UPC Central Division Munich Section applies the well known principle of the case law of the German Federal Court of Justice to define a “Team Skilled Person”. According to this principle it is assumed that the competent person skilled in the art may be expected to consult an expert or otherwise better qualified person skilled in the art or to make appropriate inquiries if they can recognize on the basis of their own expertise that they can find the solution in another field.

Assessment of Inventive Step

The UPC Central Division Munich Section follows an objective approach to the assessment of inventive step. Inventive step is to be assessed from the point of view of the skilled person on the basis of the state of the art as a whole including the skilled person’s common general knowledge. It would be relevant what the claimed invention actually contributes to the prior art. The decisive factor would be whether the claimed subject matter follows from the prior art in such a way that the skilled person would have found it on the basis of their knowledge and skills, e.g. by obvious modifications of what was already known.

Start with “Realistic Starting Point”, not with “Most Promising Starting Point”

The UPC Central Division Munich Section explicitly states that it would not be necessary to identify the most promising starting point, which is contrary to the approach of the EPO, however in line with the approach of the German Federal Court of Justice, cf. e.g. BGH X ZR 109/15 “Spinfrequenz” (2017): “For the assessment of the question whether a certain prior art suggested itself to the person skilled in the art as a possible starting point for his efforts, the classification of a certain starting point as – from the ex post point of view – the closest prior art is neither sufficient nor necessary.” In a headnote it is explicitly stated that there can be several realistic starting points. However, there would have to be a justification as to why the skilled person would consider a particular part of the state of the art as a realistic starting point. Requiring a justification is also a basic principle of the approach of the German Federal Court of Justice, cf. e.g. BGH X ZR 78/14 “Opto-Bauelement” (2016): “The choice of a certain citation or prior use as a starting point for the solution of a technical problem requires justification in principle.” The UPC Central Division Munich Section mentions a similarity of the underlying problem as justification example.

Motivation and Reasonable Expectation of Success

With respect to the assessment of inventive step, i.e. whether a claimed solution is obvious starting from the starting point, the UPC Central Division Munich Section requires a motivation or incentive to consider the claimed solution and to implement it as a next step. A technical effect or advantage achieved by the claimed subject-matter compared to the prior art might be an indication for inventive step. A feature that is selected in an arbitrary way out of several possibilities could generally not contribute to inventive step. Hindsight would need to be avoided.

The line of argument used by the UPC Central Division Munich Section seems unusual when considering the case law of the EPO, however applies some basic principles of the approach of the German Federal Court of Justice. In particular, according to the approach of the German Federal Court of Justice, the motivation for the skilled person may be only or mainly in the starting point, cf. e.g. BGH X ZR 59/16 “Kinderbett” (2018) or BGH X ZR 139/10 “Farbversorgungssystem” (2014). Moreover, according to the approach of the German Federal Court of Justice, if the skilled person had a motivation on the priority date to apply a specific method or to perform a specific experiment, the skilled person applies the method or performs the experiment, and a specific feature or a solution which is the result of said method or experiment is considered to be obvious for the skilled person (cf. e.g. BGH X ZR 65/18 “Tadalafil” (2020) or BGH X ZR 110/16 “Rifaximin α” (2018). In the present judgement the UPC Central Division Munich Section concludes that the realistic starting point provided a concrete incentive to develop antibodies that block the interaction of PCSK9 with LDLR in order to treat hypercholesterolemia and thus the skilled person as a next step would develop such antibodies. Generating and selecting such antibodies would have been a matter of routine for the skilled person at the relevant date. The skilled person would thus develop antibodies against PCSK9 that block the LDLR-PCSK9 interaction, thereby ending up with antibodies that fall within the claims of the patent. In order to further substantiate this conclusion, the UPC Central Division Munich Section applies another well-known principle of the approach of the German Federal Court of Justice, namely the examination of a reasonable expectation of success (cf. e.g. BGH X ZR 59/17 “Fulvestrant” (2019): “Whether it is obvious for the person skilled in the art to follow a solution path may also depend on the associated expectation of success.”; or BGH X ZR 150/18 “Pemetrexed II” (2020): “Whether there is a reasonable expectation of success for pursuing a solution path must be determined on a case-by-case basis […]”), which is also a rather unusual principle in the case law of the EPO.

The UPC Central Division Munich Section summarize their line of arguments with two further headnotes:

“In general, a claimed solution is obvious if the skilled person would be motivated to consider the claimed solution and would implement it as a next step in developing the prior art. It may be relevant whether the skilled person would have expected any particular difficulties in taking any next step(s). The absence of a reasonable expectation of success (or more in general: non-obviousness) does not follow from the mere fact that other ways of solving the underlying problem are also suggested in the prior art and/or (would) have been pursued by others. The decisive question that has to be answered is whether the claimed solution is non-obvious.”

“For assessing inventive step it is not the question whether the skilled person would inevitably arrive at the same result (falling within the scope of the claim or not). Rather, it is sufficient (but also necessary) for denying inventive step that the skilled person would without inventive contribution arrive at a result which is covered by a claim.”

Summary

The UPC Central Division Munich Section essentially perform their validity and in particular inventive step assessment in line with the approach of the German Federal Court of Justice, which is at least in the present case in many points contradictory to the EPO approach. It remains to be seen whether the Court of Appeal of the UPC follows the argumentation line of the UPC Central Division Munich Section in a potential second instance. Anyway, it has to be concluded that the approach and basic principles used by the UPC Central Division Munich Section in their judgement were mainly elaborated by the German Federal Court of Justice and thus also by Mr. Klaus Grabinski who is now the President of the UPC Court of Appeal.

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Can data about the size of a web browser window lead to an inventive step for a software invention at the EPO?

WEB-CONTENT MEASUREMENTS – T 1422/19-3.5.07 – May 19, 2021 – non-technical features which contribute to technical character

The software discussed in this decision carries out an indirect measurement. The software measures/ determines a web page viewing area based on the measurement/ input data/ raw data of the size of a browser window. Such indirect measurements are of a technical nature, regardless of what use is made of the results (cf. G 1/19, point 99).

Object of the Invention

  • Estimating the size of a browser’s viewport/ web page viewing area from within a cross-domain iframe (iframe is e.g. from a separate ad server). Due to security constraints, the size of the viewport cannot be accessed directly from within a cross-domain iframe.
  • Claim 1 differs from the closest prior art in that Document D1 in that the size of the viewport/web page viewing area is determined by reading the size of the browser window and subtracting from the size of the browser window the average size of one or more browser elements as determined by a statistical analysis based on historical measurements.

Examining Division

  • The determination of the estimated size of the viewport correspondeds to a technical implementation of a non-technical rule (compute the estimated size) based on a business requirement.
  • Since the determined output size was an estimated value, it circumvented the technical problem of actually measuring the viewing area rather than addressing it.

Board

  • It is true that the method of claim 1 does not include a technical use of the calculated/estimated content visibility. In fact, the claim specifies that the information about the visibility of the content item is reported to a content sponsor.
  • However, the method does not merely calculate this information from numerical input data but measures “raw” information about a running web browser and processes this information to produce an estimate of a technically meaningful parameter, namely the extent to which a content item displayed within a web page is visible to the user, and on the basis of technical considerations relating to what is possible with an unmodified browser that enforces standard security constraints.
  • Such an indirect measurement is normally of a technical nature (see G 1/19, point 99).
  • Subject matter of claim 1 is inventive.

Conclusion:

The below figure shows according to G 1/19, point 85 and 86 how and when “technical effects” or “technical interactions” based on inter alia non-technical features may occur in the context of a computer-implemented process. In this decision the software/ non-technical features contribute to the technical character of the invention via the input data.

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Protective letters for German courts and the Unified Patent Court

To enable proprietors of a patent in force in Germany to effectively protect their rights under the patent, they can apply for injunctions against alleged patent infringers as a means of interim legal protection. Injunctions can, for example, be aimed at prohibiting an alleged patent infringer from distributing or manufacturing a certain patent-infringing product within the area where a patent (injunction patent) is valid on pain of a fine or imprisonment.

The effectiveness of interim legal protection is expressed, among other things, by the fact that the competent court can issue the injunction without first hearing the alleged patent infringer. In order to nevertheless also protect the rights of the alleged patent infringer, whose product is only allegedly a patent infringement and therefore may also be considered not interferring with the scope of protection of the injunction patent, German and European law foresees the means of a protective letter as a possible defense measure.

The purpose of a protective letter is therefore to present arguments to a court, which has to decide whether to issue an injunction, that speak against issuing the injunction.

An injunction is issued if an applicant for an injunction credibly substantiates a claim for an injunction and urgency (grounds for an injunction).

The content of a protective letter in the patent system is accordingly aimed at

  • denying a claim for an injunction by
    • challenging the legal validity of the injunction patent and/or
    • challenging the facts of infringement and/or
    • objecting to the enforcement of the injunction patent (e.g. exhaustion or right of prior use),

and/or

  • denying the urgency.

As with the application for an injunction, the reduced standard of proof of prima facie evidence in interim legal protection also applies to the corresponding protective letter.

The place of filing of a protective letter depends on the type of injunction patent.

With regard to German patents and German parts of European patents for which the lack of jurisdiction of the Unified Patent Court (UPC) has been requested (opt-out request), protective letters must be filed in the German central electronic register of protective letters (ZSSR).

With regard to European patents for which no opt-out request has been filed and European patents with unitary effect (unitary patents), protective letters must be filed directly in the UPC’s case management system.

Since opt-out requests can be withdrawn at any time, it may also make sense to file a protective letter with the UPC for European patents for which an opt-out has been requested to date.

With regard to protective letters for the UPC, it should be noted that the area where the injunction patent is valid usually extends beyond Germany, so that non-German companies that are at risk of being affected by an injunction should also be mentioned in the protective letter. Protective letters for the UPC must also be drafted in the language of the proceedings of the injunction patent and can therefore be in English, French or German.

If you suspect that competitors could wrongly accuse you of patent infringements, so that the issuance of injunctions is imminent, we will be happy to support you in defending yourself by means of protective letters.

You can contact us here for further information: LVogel@wbetal.de or info@wbetal.de

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Patentability criteria for biotechnological inventions

Biotechnology is red, white and green

Biotechnology can be subdivided into three main areas: The largest area is called “red biotechnology” and is applied in the healthcare and pharmaceutical sectors. The second area of “white biotechnology” relates to the use of microorganisms in chemical production systems. The third area of “green biotechnology” is about agriculture.

Biotechnological innovations have become indispensible for reaching the Sustainable Development Goals (SGDs) of the United Nations and the European Green Deal objectives. Thereby, new medical treatments, clean energy sources and sustainable agriculture are just three examples how biotechnology contributes to these goals.

Patentability criteria specific to the biotechnology field

As in other technology fields, biotechnological inventions can be patented, if they are new, inventive and industrially applicable. They must further fulfill the formal requirements of unity, clarity and sufficiency of disclosure. In addition to these general criteria, the European Patent Organisation´s member states have agreed on a number of special rules for inventions in the biotechnological field. These rules are in accordance with the EU Biopatent Directive and address rules about patentability of plants as well as patentability of genetically modified animals, and provide ethical and moral criteria for patenting in the biotechnological field, for instance.

In this article, we have reviewed the current Guidelines for Examination in the European Patent Office and the Case Law of the Boards of Appeal with a focus on patenting of biotechnological inventions. Using the most important keywords (1) of the biotechnological area, we have summarized and linked the most important text passages relating to patenting in the biotechnological field in Tables 1 and 2.

Guidelines for Examination in view of biotechnological inventions

The current edition of the Guidelines for Examination in the European Patent Office (March 2023) includes several chapters and subchapters which address special features in the biotechnological area or are specifically dedicated to biotechnological inventions, and are summarized in Table 1.

Specific instructions for EPO patent examiners concerning applications including biological material can be found in A-IV, 4., E-IX, 2.4.4. and F-III, 6.. As biotechnological inventions often contain nucleotide and amino acid sequence information, the Guidelines for Examination dedicate several chapters to this topic (A-IV, 5., E-IX, 2.4.2., F-II, 6., F-IV, 4.24., G-III, 4.). Formal requirements on chemical formulae can be found in A-IX, 11..

Issues concerning patentable subject-matter of biotechnological inventions can be found in B-VIII, 2.1., G-II, 4./5., G-VI, 7./9., G-VII, 13.. Sufficiency of disclosure and unity of invention of biotechnological inventions are specifically considered in F-III, 6./9. and F-V, 3., respectively. F-IV 4.5.2 and F-IV 4.12. address rules on claim drafting with a focus on biotechnological inventions.

Table 1: Guidelines for Examination for biotechnological inventions. Chapters and subchapters related to the biotechnology field were identified searching for biotechnological keywords(1)

Part A – Guidelines for Formalities Examination
ChapterFocus on biotechnological inventions
IV – Special Provisions4. Applications relating to biological material
5. Applications relating to nucleotide and amino acid sequences
IX – Drawings11. Graphic forms of presentation not considered as Drawings
►11.1. Chemical and mathematical formulae
Part B – Guidelines for Search
ChapterFocus on biotechnological inventions
VIII – Subject-matter to be excluded from the search2. Considerations relating to specific exclusions from and exceptions to patentability
► 2.1. Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body
Part E – Guidelines on General Procedural Matters
ChapterFocus on biotechnological inventions
IX – Applications under the PCT2. EPO as designated or elected Office
► 2.4.2 Sequence listings
► 2.4.4 Biological material
Part F – The European Patent Application
ChapterFocus on biotechnological inventions
II – Content of a European patent application (other than claims)6. Sequence listings
III – Sufficiency of disclosure6. Inventions relating to biological material
9. “Reach through“ claims
IV – Claims4. Clarity and interpretation of claims
► 4.5.2 Definition of essential features
► 4.12. Product-by-process claim
► 4.24. Interpretation of terms such as identity and similarity in relation to amino or nucleic acid sequences
V – Unity of invention3. Assessment of unity
► 3.2.5 Markush grouping (alternatives in a single claim)
► 3.2.6 Claims for a known substance for a number of distinct medical uses
► 3.2.7 Intermediate and final products
Part G –Patentability
ChapterFocus on biotechnological inventions
II – Inventions4. Exceptions to patentability
5. Exclusions and exceptions for biotechnological inventions
III – Industrial application4. Sequences and partial sequences of genes
VI – Novelty7. Examination of novelty
9. Novelty of “reach-through” claims
VII – Inventive step13. Inventive step assessment in the field of biotechnology

Case Law of the Boards of Appeal in view of biotechnological inventions

The current tenth edition of the Case Law of the Boards of Appeal dedicates specific chapters, subchapters and sections to inventions in the biotechnological field, that are listed in Table 2.

In I-B of the Case Law, exceptions to patentability are specified. In chapter 2, the focus is set to breaches of “order public“ or morality, issues which may arise mainly in connection with biotechnological inventions (I-B 2.). One example is Case Law concerning elements isolated from the human body like sequences of a gene. Chapter 3 describes Case Law on patentability of plants/plant varieties (I-B 3.1.), animals/animal varieties (I-B 3.2.), essential biological processes for the production of animals and plants (I-B 3.3.) and microbiological processes and the products thereof (I-B 3.4.). In I-B 4., medical methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body, which shall not be granted, are addressed.

I-C 3. of the Case Law clarifies the availability of biological material to the public, and I-C 3.6.-8. specifically address issues about novelty of chemical inventions and first/second and further medical use, respectively.

In I-D 7-9., Case Law relating to the inventive step of biotechnological inventions is described.

Case Law II is about patent applications and amendments, and II-A 3.2. specifies clarity of claims, f.e. on diagnostic and surgical methods, whereas II-B 5.3. addresses the unity of claims, especially in the light of groups of chemical compounds.

In II-C on Case Law about sufficiency of disclosure, II-C 6.6.10 particularly addresses reproducibility of chemical compunds, and II-C 7. relates to sufficiency of disclosure in the biological field in particular.

Case Law laid down by the boards on the priority of inventions comprising nucleotide and amino acid sequences can be found in II-D 3.1.9.

II-E 1. focuses on Case Law on amendments with added subject-matter, with numerous specific biotechnological cases being listed in II-E 1.6.2 and II-E 1.6.3. II-E 2. describes Case Law on amendments with extension of the protection conferred. Specifically, in II-E 2.4.13 Case Law is laid down on narrowing down a generic list of chemical compounds.

Table 2: Biotechnological Case Law. Chapters, subchapters or sections related to the biotechnology field were identified searching for biotechnological keywords(1)

CASE LAW – I Patentability
ChapterFocus on biotechnological inventions
B – Exceptions to Patentability  2. Breaches of “ordre public” or morality
3. Patentability of biological inventions
4. Medical methods
C –Novelty3. Availability to the public
► 3.2.5 Biological material
6. Chemical inventions and selection inventions
7. First and second medical use
8. Second (and further) non-medical use
D – Inventive step7. Expectation of success, especially in the field of genetic engineering and biotechnology
8. Skilled person
► 8.1.3 Definition of the person skilled in the art in the field of biotechnology
9. Assessment of inventive step
► 9.21.12 Animal testing and human clinical trials
► 9.9. Chemical inventions
CASE LAW – II Patent application and amendments
ChapterFocus on biotechnological inventions
A – Claims3. Clarity of claims
► 3.2. Indication of all essential features
B – Unity of Invention5. The single general inventive concept
► 5.3. Unity of single claims defining alternatives (“Markush claims”)
C – Sufficiency of Disclosure6. Reproducibility
► 6.6.10 Chemical compounds
7. The requirement of sufficiency of disclosure in the biological field
D – Priority3. Identity of invention
► 3.1.9 Inventions relating to nucleotide and amino acid sequences
E – Amendments1. Article 123(2) EPC – added subject-matter
► 1.6.2 Selections from two lists – singling out a combination of features
► 1.6.3 Deletion of elements from lists – shrinking the lists without singling out a combination of features
2 Article 123(3) EPC – extension of the protection conferred
► 2.4.13 Narrowing down a generic class or list of chemical compounds

Taken together, in order to apply for a biotechnological patent numerous criteria specific to this area must be considered. Valuable sources for these criteria are the Guidelines for Examination and the Case Law of the Boards of Appeal. In this article, we have summarised the most important criteria for patents in biotechnology based on these two sources.

Our firm is characterised by a high level of commitment to advising founders on patent and trade mark law with regard to their innovative ideas and inventions.

Our concern is to protect innovations and to be your partner in the field of intellectual property.

Turning ideas into patents is an entrepreneurial decision based on weighing the expected strength of the invention, market potential and budget constraints.

We are pleased to offer you a free and non-binding initial consultation to get to know the law firm WINTER, BRANDL – Partnerschaft mbB and to clarify general questions!

We are looking forward to hearing from you. Please feel free to reach out to: CRegler@wbetal.de  and JRomic-Pickl@wbetal.de.

(1) keywords of the biotechnological field: biological, biotechnology, sequences, medical, surgical, diagnostic, animal, plant, pharmaceutical, chemical

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SYSTEM FOR MANAGING A VEHICULAR MISSION OF A GOODS DELIVERY VEHICLE: T1806/20-3.5.01 (17 November 2023)

At the EPO, data relating to software-related inventions may, under certain conditions, be regarded as data of a technical character. This means that such data will be taken into account as a distinguishing feature in the examination of inventive step. Data may have a technical character if they are so-called “functional data”. A typical example of “functional data” is data intended to control a technical device. In the following decision T 1806/20, the appellant tried to present “cognitive data” as “functional data”. The appellant relied on the earlier decision T 1194/97, which identifies a type of test method that can be used to determine whether the data are “functional data”.

Object of the Invention

  • A parcel delivery system that seeks to prevent damage to water-sensitive parcels by avoiding delivery to rainy destinations.
  • Claim 1 differs from the closest prior art (CPA) inter alia by rescheduling of the delivery based on the parcels’ sensitivity to water and a rain forecast.

Appellant

  • The prevention of damage to physical objects was a fundamental technical problem that was addressed throughout various areas of technology.
  • The appellant did not dispute that delivering multiple parcels at different destinations and planing such delivery constituted a non-technical logistics scheme.
  • The rescheduling of the delivery based on the parcels’ sensitivity to water and the rain forecast do not form part of the non-technical logistic scheme.

Board

  • Contrary to the appellant’s view, the Board judges that the requirement to ensure that parcels do not get damaged by water forms part of the non-technical logistics scheme.
  • The Board is not convinced by the argument that information about a parcel’s water-sensitivity is functional technical data, because its loss would impair the technical operation of the system (cf. T 1194/97, reasons, point 3.3).
  • It is self-evident that if a piece, either technical or non-technical, of any invention is taken out, it would not work as designed.
  • In the Board’s view, what T 1194/97 is saying is rather that the loss of functional data would make the system inoperable at the technical level.
  • In contrast, if cognitive data is lost, the system would still work but possibly produce results that would be unintended for non-technical reasons.
  • Thus in T 1194/97, the loss of functional data prevented the system from generating any television picture, whereas the loss of cognitive data only resulted in a meaningless television picture resembling snow.
  • In the present case, the loss of water-sensitivity information would not cause the system to stop working; the vehicle would still be guided, and parcels would be delivered. However, it would result in leaving water‑sensitive parcels standing in the rain – an unintended operation comparable to producing a television picture that resembles snow. The reasons why these outcomes are unintended are non-technical. In T 1194/97, it was the cognitive meaninglessness of the television picture to a human viewer; in the present case, it is the prevention of rain damage to a parcel. Hence, judged by the consequence of its loss, the water-sensitivity data is equivalent to cognitive rather than functional data.

Conclusion

This decision deals with “functional data”. Such data is intended for controlling a technical device may be considered to have technical character because it has the potential to cause technical effects. In G1/19, reasons, point 94 the Enlarged Board of Appeal has generalized this as follow:

In the context of the problem-solution approach and the COMVIK approach, such potential technical effects may be considered if the data resulting from a claimed process is specifically adapted for the purposes of its intended technical use. In such cases:

  • either the technical effect that would result from the intended use of the data could be considered “implied” by the claim, or
  • the intended use of the data (i.e. the use in connection with a technical device) could be considered to extend across substantially the whole scope of the claimed data processing method.

Data is considered to be functional data when its loss would impair the technical operation of the system (cf. T 1194/97, reasons, point 3.3). This means, data is considered to be functional data, when the loss of the data would make the system inoperable at the technical level. In contrast, if cognitive data is lost, the system would still work but possibly produce results that would be unintended for non-technical reasons.

E.g. in T 1194/97, the loss of functional data prevented the system from generating any television picture, whereas the loss of cognitive data only resulted in a meaningless television picture resembling snow.

E.g. in T 1806/20, the loss of water-sensitivity information would not cause the system to stop working; the vehicle would still be guided, and parcels would be delivered. However, it would result in leaving water‑sensitive parcels standing in the rain – an unintended operation comparable to producing a television picture that resembles snow. The reasons why these outcomes are unintended are non-technical. In

T 1194/97, it was the cognitive meaninglessness of the television picture to a human viewer; in T 1806/20, it is the prevention of rain damage to a parcel. Hence, judged by the consequence of its loss, the water-sensitivity data is equivalent to cognitive rather than functional data.

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The European Patent Office releases its latest biotechnological Insight Report on mRNA technologies

The European Patent Office (EPO) has released several Insight Reports since 2019 to inform about the latest important patent trends. Two of the ten Insight Reports released up to now relate to the biotechnology sector, which describe future and emerging technologies that are considered as groundbreaking in the medical sector. The present article focuses on the latest biotechnological Insight Report on mRNA-based vaccines, which is a particularly growing field of mRNA technologies.

Virus, RNA, Spritze
/MattLphotography, Depositphoto.com

mRNA technologies as important trend in biotechnology patents

mRNA technologies and mRNA-based vaccines in particular have the potential to fundamentally change the medical field in a wide range of applications aiming at preventing and treating several of the most widespread and lethal diseases worldwide including viral and bacterial infections, cancer and malaria. mRNA technologies are suited for the development of broad medical applications for the general public, as seen in the mRNA-based vaccines against SARS-CoV-2, which made a key contribution to containing the pandemic, as well as of tailormade medical applications like personalized cancer vaccines. Accordingly, mRNA technologies provide a flexible toolbox for preventing and treating a wide variety of human sufferings. In line with this, this year´s Nobel Prize in Physiology or Medicine and the EPO´s European Inventor Award 2022 has been awarded in the field of mRNA technology.

For the Insight Report, patent information drawn from the EPO´s databases of worldwide patent data was analysed. Comparing the number of inventions in the field of mRNA-based vaccines (termed by International Patent Families related to mRNA-based vaccines) with the total number of inventions across all fields of technology combined, a significantly higher increase rate was observed for mRNA-based vaccines over the last decade.

High proportion of International patent applications as indicator for high economic expectations

The highest amount of patent applications of mRNA-based vaccines take the international route that may result in patent protection in more than 150 countries worldwide, followed by US applications, EP applications, AU applications, CA applications, CN applications, and JP applications. The high proportion of International patent applications can be seen as indication of high economic expections and a corresponding multinational commercialisation strategy, as written in the Insight Report.

The importance of patents in biotechnology

Patents are legal rights which confer on patent holders the right to exclude others from comercially using the patented invention. Patents are likely to make a significant contribution to attract investment, secure licensing deals and provide market exclusivity, especially in the most IP-intensive sector of biotechnology, as shown in the recent EPO-EUIPO study „Patents, trademarks and startup finance“. In a nutshell, patents foster innovation, technology diffusion and economic growth.

Our firm is characterised by a high level of commitment to advising founders on patent and trade mark law with regard to their innovative ideas and inventions.

Our concern is to protect innovations and to be your partner in the field of intellectual property.

Turning ideas into patents is an entrepreneurial decision based on weighing the expected strength of the invention, market potential and budget constraints.

We are pleased to offer you a free and non-binding initial consultation to get to know the law firm WINTER, BRANDL – Partnerschaft mbB and to clarify general questions!

More detailed explanations and examples on this topic will follow shortly.

We are looking forward to hearing from you. Please feel free to reach out to: CRegler@wbetal.de  and JRomic-Pickl@wbetal.de

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New calculation of time limits by the EPO

What has been amended?

The amendments concern, inter alia, Rules 126(2), 127(2) and 131(2) EPC, which deal with service by postal services and by electronic means as well as the calculation of time limits triggered by the service of a document. (https://www.epo.org/en/legal/official-journal/2023/03/a29.html)

What is the essence of the amendments?

The new Rules 126(2), 127(2) and 131(2) EPC will enter into force on 1 November 2023 and introduce a new notification fiction, according to which postal and electronic notification are deemed to occur on the date of the document.

Elimination of the previous 10-day rule

These amendments eliminate the previous notification fiction of 10 days provided in Rule 126(2) EPC and Rule 127(2) EPC, according to which a document is deemed to be delivered on the tenth day after the date of the document, which is taken into account in the calculation of official time limits triggered by the delivery of communications from the EPO.

What are the reasons behind the amendments?

The EPO communicates that the changed notification fiction will result in a simplification for applicants, since it brings the EPC and PCT regimes more closely into line with each other. Thus, the revised provisions reflect the principle of instantaneous notification in the digital world.

Is there a safeguard in case of irregularities?

If a document could not be delivered, the EPO has the burden of proof. As is the case today, if the EPO is unable to prove that a document has been delivered, the notification fiction will not apply, and a period linked to that document will not be considered to have started. The document in question will then be reissued with a new date, which will then serve as the basis for applying the notification fiction.

On the other hand, where a document has been delivered exceptionally late, the new safeguard introduced in the last sentence of amended Rules 126(2) and 127(2) EPC will apply. More specifically, if notification is contested and the EPO cannot show that a document reached the addressee within seven days of the date it bears, a period triggered by the deemed receipt of that document will be extended by the number of days by which these seven days are exceeded (see also example 3, below).

What are the practical effects of the amendments?

In simplified terms, it can be said that these changes have generally shortened the time limits by 10 days. The elimination of the 10-day rule is not significant in practice for (extendable) 4-month periods. However, 10 days less in the case of the shorter and, above all, non-extendable time limits is much more significant. Examples of tight time limits would be in particular the 1-month time limit under Rule 137(4) EPC (“basis for amendments” – Article 123(2) EPC) and the 2-month time limit under Rule 63(1) EPC (“incomplete search”).

Practical examples

Some examples from the EPO are shown below to better illustrate the new Rules 126(2), 127(2) and 131(2) EPC.

Example 1:

The new Rules 126(2), 127(2) and 131(2) EPC will apply on 1 November 2023 as the effective date. The following example illustrates a case in which the document (examination report) is dated before this date, more precisely 28 October 2023. In this case, the procedure according to the previous 10-day rule applies.

Example 2:

The second example illustrates the new procedure under Rules 126(2), 127(2) and 131(2) EPC, since the document (examination report) is dated after 1 November 2023, more precisely 13 November 2023. The time limit therefore expires on 13 March 2024.

Example 3:

The third example illustrates the safeguard introduced under the last sentence of amended Rules 126(2) and 127(2) EPC. If a recipient receives the examination report (dated 13 November 2023) twelve days later, i.e. on 25 November 2023, the time limit is extended by five days (time limit extended by the number of days by which the seven days are exceeded; 12 – 7 = 5 days). The deadline therefore expires on 18 March 2024.

Conclusion and outlook

The new Rules 126(2), 127(2) and 131(2) EPC are intended to bring the EPO’s calculation of time limits more into line with modern practice of instantaneous notification and thus also more closely into line with the PCT. In the case of the (extendable) 4-month time limits, such as the examination report, the removal of the 10 days will not have any significant impact or consequences, whereas the already shorter time limits, such as the 1-month time limit to submit “basis for amendments”, will become even tighter (with an approximate 33% reduction in the time limit). It remains to be seen how the amendments to new Rules 126(2), 127(2) and 131(2) EPC affect practice and whether the EPO will need to make further adjustments, particularly with regard to the short time limits. This will require evaluation based on practical case studies.

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Referral to the Enlarged Board of Appeal – G 1/23 (“solar cell”)

A Technical Board of Appeal of the EPO has referred questions to the EPO’s Enlarged Board of Appeal regarding the definition of the state of the art in relation to a commercially available product (link).

The referring Board asks whether the commercial availability of a product and partial information about its composition (e.g. datasheets) can be state of the art, even when the composition or internal structure cannot be analysed or reproduced. This is critical for the referring case, as the possibility to use such a product in the inventive step assessment is decisive. The last question considers what threshold is required for the “undue burden” criterion in r.1.4 of G 1/92.

The referring board formulated the following questions:

1. Is a product put on the market before the date of filing of a European patent application to be excluded from the state of the art within the meaning of Article 54(2) EPC for the sole reason that its composition or internal structure could not be analysed and reproduced without undue burden by the skilled person before that date?

2. If the answer to question 1 is no, is technical information about said product which was made available to the public before the filing date (e.g. by publication of technical brochure, non-patent or patent literature) state of the art within the meaning of Article 54(2) EPC, irrespective of whether the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person before that date?

3. If the answer to question 1 is yes or the answer to question 2 is no, which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed and reproduced without undue burden within the meaning of opinion G 1/92? In particular, is it required that the composition and internal structure of the product be fully analysable and identically reproducible?

These questions will have relevance for the chemical field as well as many other technological fields. We now have some months to wait to see how the Enlarged Board of Appeal responds.

For more information please contact us.

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Overview of the new European Unitary Patent System, in particular with regard to the opt-out request

Currently, the new European Unified Patent System is being implemented, which is planned to start on April 1, 2023. The introduction of the Unified Patent System will have an impact on all European patents, including “old” European patents that have already been granted and are in force. Please find below more information on the new Unified Patent System.

After the start of the European Unified Patent System, an applicant of a European patent application can choose between the following options after grant:

  • European Unitary Patent which will be uniformly in force in (currently) 17 EU states, including Germany, France, and Italy. In Fig. 1 below, these are the EU states marked in blue.
  • Classic European Patent, which will be validated in one or more of the 39 member states (including Montenegro as of October 1, 2022) of the European Patent Organization, as before. In Fig. 1, these are all states marked in blue and green.
  • Mixture of the European Unitary Patent, which will be in force in 17 EU states (see Fig. 1 in blue), and the Classic European Patent, which will be validated in one or more of the remaining 22 member states of the European Patent Organization (see Fig. 1 in green).


Figure 1: blue and green: 38 EPC member states; blue : 17 EU states of the unitary patent

The new Unified Patent System provides for a Unified Patent Court. Patent infringement proceedings or nullity proceedings relating to a Unitary Patent can be conducted centrally via this court. The Unified Patent Court is responsible for European Unitary Patents and for classic European Patents and thus also for “old” European Patents which are still in force. However, in the case of a classical European Patent, during a transitional period of between 7 and 14 years after the start of the Unified Patent System, the national courts in the countries where the classic European Patent is validated will have jurisdiction in addition to the Unified Patent Court as before. In other words, for example, patent infringement proceedings in the case of a Unitary Patent will take place centrally before the Unified Patent Court, whereas in the case of a classic European Patent, a choice can be made between the Unified Patent Court and the national courts.

A patentee of a classic European Patent has the possibility – during the transitional period mentioned above – to exclude the jurisdiction of the Unified Patent Court. For this purpose, it is necessary to file a so-called “opt-out-request” for the classic European Patent. After the exclusion of the Unified Patent Court due to an opt-out-request, the national courts will continue to have exclusive jurisdiction for the classic European Patent.

Fig. 2 below shows the different possibilities.

Figure 2: different possibilities regarding a European patent protection

An opt-out-request can already be filed 3 months before the start of the Unified Patent system in the so-called “sunrise period”. It is currently planned that the sunrise period starts on January 1, 2023. The question as whether an opt-out-request should be filed for a classic European Patent depends on the individual case. An opt-out-request is only possible as long as no action is pending before the Unified Patent Court.

Patentees and applicants of classic European Patents should take the following steps with regard to the new Unified Patent System:

  • A patent proprietor of a classic European Patent should be aware in advance – i.e. preferably before the start of the sunrise period – whether an opt-out-request is necessary. If so, this should be filed during the sunrise period.
  • If a classic European Patent has several patentees, they must jointly decide on a possible opt-out-request. They should therefore reach an agreement – preferably in writing – regarding a possible opt-out-request.

 

If you have any questions about the new Unified Patent System – for example, about the steps mentioned above – we will be pleased to answer them personally.

 

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European Patent Office (EPO) and China National Intellectual Property Administration (CNIPA) strengthen Cooperation within the PCT Framework

The EPO and the China National Intellectual Property Administration (CNIPA) have agreed on a two-year pilot program last year that would allow Patent Cooperation Treaty (PCT) applicants filing a PCT application at the CNIPA to choose the EPO as their International Searching Authority (ISA). This agreement was signed on November 12, 2020, at their joint conference in Suzhou, China. Due to the outbreak of the new coronavirus, it had not been determined when the program will start until the middle of October 2020. 

The Start of the program is in December 2020

Recently, the EPO finally announced that this pilot program will start on December 1, 2020. The pilot program will be open to nationals and residents of the People’s Republic of China filing with CNIPA or the International Bureau (IB) of the World IP Office (WIPO). Further, there is a limit participation in the program to 2,500 patent applications for the first 12 months and 3,000 for the next 12 months.

Benefits for Chinese applicants

For Chinese applicants, this program will offer an additional option to optimize their international patent strategy, especially when considering protection in Europe. As a result, Chinese applicants interested in accelerating the prosecution of their applications will, by selecting the EPO as their ISA, gain up to one year by entering into the European phase earlier and getting direct examination of their files, without the need for a supplementary European search. For more detailed questions about the pilot program, please use the following link:

English: https://www.epo.org/service-support/faq/own-file/cnipa-epo-pilot.html

Chinese: https://www.cnipa.gov.cn/art/2020/10/20/art_364_153578.html

WINTER BRANDL Partnerschaft mbB, Tianhao Miao (Chinese Manager, German, European and Chinese Patent Attorney) and Michael Schueller (Partner, German and European Patent Attorney)