T 1553/22 - Human-pig chimeras

Key points

• "Claims 3 [] of auxiliary request 2 read as follows: "3. A chimeric non-human blastocyst expressing human ETV2 and lacking expression of said non-human animal ETV2, wherein the blastocyst is porcine."
• "The application concerns the generation of pig-human chimeric animals with the aim of using them as a source of human vasculature and blood. The chimeric pigs are obtained by methods involving "blastocyst complementation". This involves creating a non-human (host) blastocyst lacking one or more genes involved in the development of the cells of interest. This creates a so-called "niche" which is complemented by introducing into the blastocyst human pluripotent (donor) cells having those lacking genes. Specifically, in the application, the host blastocyst lacks the Etv2 gene, whose function is to promote hematoendothelial development"
• " claims 3 and 4 do not include language that would exclude chimeras having human cell participation in the brain or germ cells."
• The applicant is a university.
• "In the appealed decision, the examining division refused the application for ethical reasons pursuant to Article 53(a) in conjunction with Rule 26(1) EPC and Recital 38 of the Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (point 4.16 of the Reasons). "
• The Board: " The ethical dimension of patent law has found its expression in Article 53(a) EPC, together with the implementing regulations in Rules 26 to 29 EPC. These Rules were introduced in the EPC to align the EPC with the Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (the "EU Biotech Directive"). In order to achieve harmonised protection in the field of biotechnological inventions in Europe, the EU Biotech Directive provides a supplementary means of interpretation for the EPC (Rule 26(1) EPC). Thus, when the compliance of a biotechnological invention with ethical principles has to be assessed, the legal framework is a composite one, in the sense that the EPC provisions should be understood in the light of the EU Biotech Directive, also including considerations which are outside the strict patentability requirements."
• "Human-animal chimeras are not mentioned in Rule 28(1)(a) to (d) EPC, nor in the provision from which this Rule is derived, namely Article 6(2) of the EU Biotech Directive. However, specific forms of human-animal chimeras are mentioned in Recital 38, which relates to the illustrative list of exclusions for reasons of ordre public and morality provided in Article 6(2) of the EU Biotech Directive. Recital 38 includes the following wording:

"...whereas processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability;".

• "Recital 38 does not exclude chimeras as such, but specifically identifies processes to produce chimeras from germ cells or totipotent cells of humans. Since the present invention involves the use of pluripotent cells, which are distinct from totipotent cells and germ cells, it can be said that Recital 38 does not apply directly.
• This sets up the legal puzzle: if the EU legislator intentionally did not wish to exlcude human-animal chimeras in general (and, at the time of drafting, did not think of pluripotent cells, perhaps), what is excluded? Only the recited type of chemiras? Or some intermediate class?
• "The board takes the view that the exclusion of Article 53(a) in conjunction with Rule 28(1) EPC may extend to other chimeras, where the rationale underlying the examples identified in Recital 38 is also applicable to the chimeras concerned. Thus, by means of Rule 26(1) EPC a further special case is added to the non-exhaustive list of Rule 28(1) EPC."
• Rule 26(1): "For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the Convention shall be applied and interpreted in accordance with the provisions of this Chapter. Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation."
• "the board finds that the reason why the chimeras identified in Recital 38 are regarded as offensive against human dignity is due to concerns that, in chimeras including human germ cells or totipotent cells, these human cells may integrate into the brain and/or develop into germ cells and result in a chimera with human or human-like capabilities. 
•  This reason is straightforward for chimeras including totipotent cells, which in view of their developmental capability to form an entire organism may form a brain with human-like cognitive abilities or human germ cells. 
• The Board finds it 'straightforward', but that may be a case of hindsight in solving a legal problem.
• "However the same reason applies to pluripotent cells, which despite lacking the ability to differentiate into totipotent cells or cells of the placenta, nevertheless have the ability to differentiate into neural cells or germ cells. Thus, if an invention relates to a situation where human cells might integrate into the chimera's brain, potentially giving the chimera human-like cognitive or behavioural capabilities, or into its germ line, potentially giving it the ability to pass on humanised traits, the board considers that the underlying rationale of Recital 38 of the Directive would be relevant and shall be taken into account in examining compliance with Article 53(a) in conjunction with Rule 28(1) EPC."
• "the board does not consider it necessary to refer to the preparatory work to the EU Biotech Directive. Whereas the recourse to the preparatory work is possible as supplementary means of interpretation under Article 32 Vienna Convention, the board finds that in the present circumstances there is no ambiguous or obscure meaning in the wording of the exclusions in Recital 38 which needs to be clarified, nor does the interpretation on account of its object and purpose lead to a result which is manifestly absurd or unreasonable."
• Article 32 Vienna Convention indeed limits the use of the preparatory documents to these two cases, though the EPC travaux are cited more freely by the Boards.
• "With regard to the present case it must therefore be established whether the invention defined in claims 3 to 5 includes embodiments that fall under the scope of Recital 38 [by analogy?], thus contravening the requirements of Article 53(a) EPC in conjunction with Rule 28(1) EPC. Specifically, it must be determined whether the claims define chimeras and methods of producing chimeras including embodiments where human cells participate in the brain or germ cells of the chimera."
• "Document D15 is a scientific article on research into ways of regulating the differentiation of the donor cells into the endodermal organs, in order to address concerns that human cells might be present in the germ line or participate in the brain of chimeras resulting from blastocyst complementation. These ethical concerns are set out prominently in the abstract of the document:"Blastocyst complementation, which exploits the capacity of PSCs to participate in forming chimeras, does not, however, exclude contribution of PSCs to the development of tissues - including neural cells or germ cells - other than those targeted ..."."
• "Even years after the date of filing of the application, these concerns remained undiminished, as evidenced by documents D9 and D10, which were made available to the public in 2019 and 2021 respectively."
• " On the basis of the documents on file and on the balance of probabilities, the board can only conclude that there is no technical reason to dismiss the ethical concerns, raised in the relevant literature, that human cells may be present in the brain or germ cells of a chimera according to the present invention. These concerns are relevant for chimeras resulting from the method defined in claim 5, as well as for the chimeras as defined in claims 3 and 4. This conclusion also takes into account that the method defined in claim 5 has no limitations as regards either the number of human cells injected in step (c) and that claims 3 and 4 do not include any limitations as to the number of human cells or exclude their presence in the brain or germ line."
• The relevant date is the filing date, I understand: "14. The assessment of objections under Article 53(a) EPC, as well as under Rule 28(1) EPC, should be based on the understanding in the technical field at the relevant date of the patent application, although evidence arising after that date may be taken into account, provided it reflects the state of the art at the effective date (see decision T 315/03, Reasons 8.2, 9.5, 9.7 and 10.9)."
• Cf. G 2/08: "Rule 28(c) EPC (formerly Rule 23d(c) EPC) forbids the patenting of claims directed to products which - as described in the application -  at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims." (not cited in the present decision; and Article 83 EPC might be relevant here).
• "the appellant stressed also the dramatic importance of the present invention in the field of xenotransplantation, potentially the very first step to repair and replacement technology which was previously regarded as pure science fiction. This fact should be balanced against the unsupported ethical concerns raised by the examining division."
• "The board recognises the importance of the present invention. However, for the reasons stated above, balancing tests are irrelevant in the context of the categories of inventions which are excluded from patentability ipso facto. Considerations involving balancing the potential benefits of the invention for humanity/the medical benefit against prejudice to human dignity/animal suffering, are limited to the so-called "real" Article 53(a) EPC objections or to inventions related to the genetic modification of animals within the meaning of Rule 28(1)(d) EPC. Instead, where the legislator wanted to exclude inventions offending life and human dignity as such, there can be no room for manoeuvre (see also G 2/06, Reasons 31)."
  
  
• "since the claims were not drafted to exclude embodiments where human cells are present in the brain and/or germ cells of the chimera (for instance by the inclusion of features based on technologies capable of preventing the presence of human cells in the brain and/or germ cells of the chimera) the board did not have to decide on the patentability of such subject-matter."

• As a comment, if these "technologies capable of preventing the presence of human cells in the brain and/or germ cells of the chimera" are now available and common general knowledge, the Art. 53(a) EPC objection can be addressed with an undisclosed disclaimer (G2/03), most likely, and Article 83 EPC is complied with by the availability of these preventive technologies (and appropriate reference to them in the application as filed).
• 
  
• 
  
• Suppose the preventive technologies also work for the chimeras from germ cells or totipotent cells of humans and animals" are these then patentable (under a dynamic interpretation, perhaps)?

EPO 

The link to the decision can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t221553eu1

T 2510/18 - Traditional knowledge, alleged biopiracy, and novelty of natural products

Key points

• Article 53 EPC
•  The Board, in translation: "in the early 2000s, the respondent [proprietor] conducted research on traditional anti-malarial remedies among the populations of French Guiana. As part of this project, a survey was conducted in 2001. 117 people from different communities in French Guiana responded to this questionnaire. The traditional remedies used for the treatment of malaria were collected. The project led to the identification of 45 curative recipes involving the use of 27 species of plants. The researchers studied these traditional remedies and subsequently focused their efforts on studying the plant Quassia amara. As a result, the researchers managed to identify an anti-malarial molecule, SkE."
• The molecule is now claimed: claim 1 is a compound claim directed to the molecule SkE.  
• "These observations [submitted by the appellants/opponents] were not contested by the respondent [proprietor] and can therefore be considered as facts."
•  "As indicated by the respondent [proprietors] , none of the appellants' allegations concern the commercial exploitation of the invention, a prerequisite for concluding that the invention would be excluded under Article 53 EPC."
• " the commercial exploitation of this molecule, of the drug containing it and of its isolation process is not contrary to morality, good customs or public order. On the contrary, there is a great need for drugs against malaria, and finding new antimalarial drugs is a mission whose aim is to treat populations at risk and save lives."
• "In the present case, the original development of the invention and the historical process by which the SkE molecule was discovered and isolated have no relevance to the commercial exploitation of the present claims, which require only the isolation of SkE from the plant Quassia amara and its administration to patients. The development of an invention is therefore distinct from its commercial exploitation once it has been achieved."
• "even if the respondent's conduct during the discovery and development of the invention as described by the appellants above were considered to be contrary to good morals and public policy, this does not concern the commercial exploitation of the invention, and therefore does not constitute a reason to exclude the claimed invention from patentability under Article 53(a) EPC."
• I refrain from adding comments on this point of the decision. 
• 
  
• Novelty of natural products
• Claim 1 recites the molecule. I understand that the molecule as such is present in the leaves or stems of a particular plant, Quassia amara. The claim does not recite 'isolated' or 'purified', only the structural formula of the molecule. Is it novel? 
• EPO Guidelines, G-II,3.1 "To find a previously unrecognised substance occurring in nature is also mere discovery and therefore unpatentable. However, if a substance found in nature can be shown to produce a technical effect, it may be patentable. An example of such a case is that of a substance occurring in nature which is found to have an antibiotic effect."
• Here, implicitly, "patentable" means not excluded by Article 52(2), novel and inventive, in combination. Hence, the Guidelines here kind of say that there are no novelty issues on the ground that the compound, as such (and as claimed), existed in nature before. In particular, "it", i.e. the substance, may be patentable, not only the method or use wherein the technical effect is achieved. 
• I'm looking for the EPO case law that supports the statement in the Guidelines.
• Of course, the German decision is BPatG 28.07.1977, 16 W (pat) 64/75, GRUR 1978, 238 Antamanid (no open access copy known to me): "Aber selbst wenn der beanspruchte Stoff Antamanid nachweisbar als solcher in der Natur vorkommen würde, stünde diese Tatsache einer Patentierung nicht entgegen." "Das beanspruchte Antamanid ist neu. Geht man von der Identität des beanspruchten Antamanids und dem im grünen Knollenblätterpilz enthaltenen Stoff als, so steht dieser Umstand der Neuheit der vorliegenden Erfindung nicht entgegen. Nach § 2 PatG gilt eine Erfindung nicht mehr als neu, wenn sie zur Zeit der Anmeldung in öffentlichen Druckschriften bereits derart beschrieben oder im Inland bereits so offenkundig benutzt ist, daß danach die Benutzung durch andere Sachverständige möglich erscheint. [this is the old German law] Am Anmeldetag war aber kein Sachverständiger in der Lage, das cyclische Dekapeptid Antaminid mit der in Anspruch 1 angegebenen Formel zu benutzen. Ihm war der Stoff als solcher und erst recht dessen wertvolle Eigenschaft, nämlich die Wirkung einer absolut tödlichen Dosis Phalloidin aufzuheben, unbekannt, Die Tatsache der Existenz dieses Stoffes in der Natur ist aber für sich genommen noch kein neuheitsschädlicher Umstand, sofern nicht die Kenntnis des Durchschnittsfachmanns von dieser Existenz hinzukommt. Nur ein öffentlich zugänglicher Naturstoff ist im Sinne des Gesetzes nicht mehr neu." . 
• I would be grateful to learn about the corresponding decision of the Technical Boards of Appeal.
• The court in the Antamanid case referred to the identical sentence in the first edition of the EPO Guidelines. 
• "Documents D2, D3 and D5 therefore do not explicitly disclose the SkE molecule or SkE in combination with other compounds. Rather, these documents disclose traditional antimalarial remedies, i.e. preparations derived from the leaves or stems of a particular plant, Quassia amara."
• 3.14: "even if one accepts the presence of SkE in the extracts of D2, D3 and D5, and even interpreting the scope of claim 1 in the broadest possible manner, as the applicants argue, for example to include the plant Quassia amara and its extracts disclosed in D2, D3 and D5, a direct and unambiguous disclosure of the technical features of claim 1, or even of the SkE molecule alone or in combination with other compounds, is still necessary to conclude a lack of novelty. 
•  See also point 4.4.2: " Although the scope of claim 1 may include preparations as set out above,"
• "There is no question of implicit disclosure of the SkE molecule or its combination with other compounds in these documents either. According to the consistent case law of the Boards of Appeal, a prior art document destroys the novelty of the claimed subject-matter if it follows directly and unambiguously from that document, including features implicit for the person skilled in the art. However, an alleged disclosure can only be considered "implicit" if the person skilled in the art immediately recognizes that nothing other than the alleged implicit feature is part of the disclosed subject-matter ... This situation does not apply to the SkE molecule and its combination with other compounds."
• "The fact that the SkE molecule may be contained in the extracts of D2, D3 and D5 does not amount to an implicit disclosure either. According to the decision of the Enlarged Board of Appeal in G 2/88 (points 10 and 10.1 of the Reasons), the question is what has been made available to the public, not what could be inherently contained in what has been made available to the public. Even if that decision concerned a use, the same applies in the present case: the presence of the SkE molecule in the leaves of Quassia amara or their decoction has not been made available to the public by the extracts of D2, D3 or D5."
• G 2/88 was about second non-medical uses. However, the remark is there in point 10.1 - imprecise in my view: "the Enlarged Board would emphasise that under Article 54(2) EPC the question to be decided is what has been "made available" to the public: the question is not what may have been "inherent" in what was made available (by a prior written description, or in what has previously been used (prior use), for example). Under the EPC, a hidden or secret use, because it has not been made available to the public, is not a ground of objection to validity of a European patent. In this respect, the provisions of the EPC may differ from the previous national laws of some Contracting States, and even from the current national laws of some non-Contracting States. Thus, the question of "inherency" does not arise as such under Article 54 EPC. Any vested right derived from prior use of an invention is a matter for national law (see, in this connection, e.g. Article 38 of the Community Patent Convention, not yet in force).". 
• Note, indeed 'secret prior use' is no prior art. That, however, is not very relevant to the issue of novelty of a second non-medical use claim over a public prior use of a method (with the same method steps) as at hand in G2/88, nor to the public prior use of the extracts for treating malaria in the case at hand. The EBA's term 'hidden prior use' is unclear to me, I'm unaware of a legal definition of it.
• In my view, at least for product claims and method claims, it is  relevant "what may have been "inherent" in what was made available (by a prior written description, or in what has previously been used (prior use), for example)."
• Thanks to the IP Kat comment: "Lord Hoffman's comments in Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1995] UKHL 14 (26 October 1995): 
  "There is an infinite variety of descriptions under which the same thing may be known. Things may be described according what they look like, how they are made, what they do and in many other ways. Under what description must it be known in order to justify the statement that one knows that it exists? This depends entirely upon the purpose for which the question is being asked. Let me elaborate upon an example which was mentioned in argument. The Amazonian Indians have known for centuries that cinchona bark can be used to treat malarial and other fevers. They used it in the form of powdered bark. In 1820, French scientists discovered that the active ingredient, an alkaloid called quinine, could be extracted and used more effectively in the form of sulphate of quinine. In 1944, the structure of the alkaloid molecule (C20H24N2O2) was discovered. This meant that the substance could be synthesised. 
  Imagine a scientist telling an Amazonian Indian about the discoveries of 1820 and 1944. He says: "We have found that the reason why the bark is good for fevers is that it contains an alkaloid with a rather complicated chemical structure which reacts with the red corpuscles in the bloodstream. It is called quinine." The Indian replies: "That is very interesting. In my tribe, we call it the magic spirit of the bark." Does the Indian know about quinine? My Lords, under the description of a quality of the bark which makes it useful for treating fevers, he obviously does. I do not think it matters that he chooses to label it in animistic rather than chemical terms. He knows that the bark has a quality which makes it good for fever and that is one description of quinine."
• Incidentally, I believe there were indeed some national laws in Europe that at one time considered even secret prior use to be part of the state, but I would have to find a source for more details.
• In my article in EPI Information 2020/4, I wrote that "it is established case law that the ‘falling within’ test for lack of novelty can be satisfied based on inherent features of the prior art subject-matter", footnote: "T 12/81 hn.1, see e.g. also T 680/00, r.3. The exceptions are, of course, the special rules for first and second medical uses of Art. 54(4) and (5) EPC 2000, and the special rule for second non-medical use claims of G 2/88; however, these exceptions could also be seen as special rules for claim interpretation (cf. T 308/17, r.7). The remark in G 2/88, r.10.1 that ‘the question of “inherency” does not arise as such under Article 54 EPC’ is probably restricted to use claims as considered therein."
• T12/81, point 6 of the reasons: "If inventions relating to chemical substances defined by claims of this kind are patented, it necessarily follows that the resulting patent documents, once they enter the state of the art, will be prejudicial to the novelty of applications claiming the same substance although in a different and perhaps more closely defined form. This is the case with the present application."
• The present Board does not seem to be of the view that  G 2/88, r.10.1  is limited to use claims.
• Note that the Board expressly states that the claim is novel even if understood as covering "the plant Quassia amara and its extracts" (such extracts undisputedly being known from D2, D3 and D5) (point 3.14; see also point 4.4.2. Hence, the claim covers extracts that were described in scientific articles, e.g. D2: M. Vigneron et al., Journal of Ethnopharmacology 98 (2005), 351-360. These extracts are now patented.
• "D2 is an article that describes a study of antimalarial remedies used in French Guiana. The study found that the most commonly used species was Quassia amara alone or in combination with other plant species [...]. D2 describes that this plant is used in the form of decoctions [i.e. extracts] in water". 
• Hence, D2 discloses technical teachings about the plant and the extract and how to use it in a practical manner. It does not seem that the inventor of the patent discovered the plant or found a practical, technical use for the plant or a use of the extract from it. 
• I believe that in the Antamanid case, there was no known technical use of the poisonous mushroom (death cap) from which it was isolated. 
• Also, the court in that case did not explicitly state that the claim (reciting the compound as such) covered the mushroom. The court held that it could leave open the question of whether "eine ausdrückliche Beschränkung des Stoffanspruchs [to synthetic compounds] unnötig ist, weil es sich von selbst verstehen könnte, daß unter den Schutz des Patents nie das Naturvorkommen als solches fällt, kann hier wegen der mangelnden Nachweisbarkeit der Identität beider Stoffe unentschieden bleiben. Die Regelung im britischen Patentgesetz in Art. 4 Abs. 7 deutet in die Richtung, daß chemische Stoffe, die in der Natur als solche vorkommen, nicht unter das Patent fallen."
• The Board: "SkE was not disclosed in Documents D2, D3 and D5, and the molecule was not made available to the public through the use of Quassia amara leaves to prepare remedies disclosed in those documents."
• 
  
• On inventive step: "Although the scope of claim 1 may include preparations as set out above, the technical features of the claim relate to a specific compound. Therefore, the objective technical problem must also include the provision of a compound. Furthermore, as stated by the respondent, and not disputed by the appellants, the SkE molecule has low toxicity"
• "The objective technical problem can therefore be formulated essentially as proposed by the respondent, namely to provide a specific compound, or a preparation comprising a specific compound having good antimalarial activity and low toxicity. "
• The Board's review of inventive step is then quite detailed and fact-specific.
• "Therefore, the subject-matter of claim 1 involves an inventive step."
• "The same conclusion applies to claims 2 to 6, which depend on claim 1 and relate to a medicament comprising the SkE molecule"
• Claim 3 is a second medical use claim, in translation: "Medicament according to claim 2, for its use in the prevention and/or treatment of malaria". Claim 2 specifies "Medicament comprising the molecule of formula I according to claim 1 and a pharmaceutically acceptable carrier."  Depending on the interpretation of the claim term  "a pharmaceutically acceptable carrier", claim 3 could possibly cover exactly the already known use of the aqueous extracts of the plant to treat malaria, as known e.g. from D2 - which describes the traditional knowledge.

EPO 

The link to the decision and an extract of it can be found after the jump.

T 2612/19 - Medical method - omitting step does not avoid Art. 53(c)

Key points

• Is Article 53(c) EPC to be examined on the basis of the claims, or on the basis of the overall description?
• The Board: "if essential features of the invention are missing from the claim, these must be read into the claimed method when assessing whether it falls under the exceptions of patentability in accordance with Article 53(c) EPC."
• "It must therefore be clarified whether the claimed invention is fully and completely defined by the features of claim 1. For this purpose, the description, among other elements, must be consulted."
• Turning to the case at hand: "Claim 1 concerns a method of managing delivery of an orthodontic treatment plan [M1]. As argued by the appellant, the claim only mentions steps effectively performed before (features [M2] to [M4]) and after (features [M5] to [M7]) the actual treatment, i.e. the application of the appliances to the patient's teeth. However, as conceded by the appellant, the treatment step is a prerequisite for the claimed method to be applicable. This is not only evident from the wording of the claim and in particular from the step of comparing a digital representation of an actual arrangement of the patient's teeth following administration of a set of appliances to a planned arrangement (feature [M6]). For this step to be carried out, it is inevitable that the appliances have been applied to the patient's teeth beforehand. It is also evident from the flowchart in Figure 3A and the corresponding description (A-Publication, paragraphs [0021] to [0023]). Omitting the step 210 of administering appliances would render the step 212 of progress tracking meaningless since there would be no progress that could be tracked."
• "It follows that administering a set of appliances (the application of the appliances to the patient's teeth) is an essential feature of the invention. This method step must therefore be seen to be encompassed by the claimed method because otherwise the claimed invention would not be fully and completely defined by the features of the claim (see G 1/07, point 4.3.1 of the Reasons)."
• "The subject-matter of claim 1, therefore, is excluded from patentability under Article 53(c) EPC."
• 
  

EPO T 2612/19 -

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0682/16 - Non-human genetically engineered organisms

Key points

• This is a kind of Oncomouse case (opposition appeal T315/03) with a claim directed to non-human organisms comprising a host cell comprising a genetic construct. The Board applies Art. 53(a) and Rule 28(d) in great detail in the preliminary opinion (here) but that opinion does not become case law, alas, since patentee restricts to AR-2 cancelling the claims to the organism. 
• The genetic construct is a gene expression system that can be used to express a gene of interest in the cell. This is similar to T 0606/03. 
• The Board finds a likelihood of animal suffering is established because the claim is so broad so as to encompass cases wherein the genetically engineered animal suffers.
• On the other hand, a medical benefit is not credible because of the breadth of the claim.
• The Board applies the 'correspondence principle'.
• The Board also refers to the 'real test' of T 19/90 (Oncomouse examination appeal).
• The Board comments on the case where, for the purpose of Art.53(a), a claim covers both allowable and non-allowable embodiments.
• Claim 45 directed to the isolated host cell was not opposed.

• Over to the procedural stuff. The decision states that " Several oppositions were filed" and that " An appeal was lodged by one of the opponents (appellant).". The OD found that only a single opposition fee was paid and that there was a joint opposition filed by nine legal persons. I'm not aware that it would be established case law that an individual member of the 'group of joint opponents' may appeal individually. However, the Board does not comment on this in any detail.

• A question for trainees. In the present case, the letters for the joint opponents in the first instance proceedings were signed (only) by a Mr. Then. Mr. Then is neither a professional representative nor a lawyer. Explain why this is not a problem and explain the facts you have to assume for reaching this conclusion. What kind of evidence could the opposition division request from Mr. Then to show his entitlement to act in the proceedings? (normally, the question works out the same in appeal, but see the particularity above, so I limit the question to the first instance proceedings).
• Mr. Then showed up alone at the oral proceedings before the opposition division (besides the professional representative for the patentee) and wishes to present opponents' case. Would this be a problem?

EPO T 0682/16 -  link

Reasons for the Decision

Admissibility of the joint opposition and of the appeal

1. In reply to the statement of grounds of appeal, the respondent contested the decision of the opposition division on the admissibility of the joint opposition and requested the board to dismiss both, the opposition and the appeal, as inadmissible.

2. In its communication pursuant to Article 15(1) RPBA 2007, the board drew the parties' attention to the opposition division's summary in both, its summons to attend oral proceedings and the decision under appeal, of the facts and submissions on the basis of which the respondent argued against the admissibility of the joint opposition (cf. pages 2 to 4 of the Summons to attend oral proceedings; pages 3 to 6 of the decision under appeal). The board further noted that these facts and submissions were not contested in appeal and, indeed, were identical to those put forward by the respondent in appeal proceedings.

3. After consideration of the facts and submissions as well as of the respondent's arguments and the evidence on file, the board informed the parties that it saw no reason to deviate from the findings of the opposition division as regards this issue, namely that "Testbiotech e. V., represented by Mr. Then [as executive director of Testbiotech e.V.], continues to be regarded as opponent and common representative of the joint opposition" (cf. bottom of page 6 in the Summons to attend oral proceedings, and pages 6 to 8 of the decision under appeal).

4. Since the parties have not contested the board's provisional opinion on this issue, the board thus considers the joint opposition and the appeal to be admissible.

Admission of the main request into the appeal proceedings

5. The main request was filed (as auxiliary request 2) in response to the communication pursuant to Article 15(1) RPBA 2007, wherein the parties were informed of the board's provisional opinion on the issues of the appeal. The main request is thus an amendment of the respondent's case and may be admitted into the proceedings only at the discretion of the board (Article 13(1) RPBA 2020).

6. The appellant has not provided any reasons against the admission of this request into the appeal proceedings.

7. By deleting claims 48 to 53, the respondent addressed all issues raised by the appellant and by the board in its communication. The main request does not give rise to new objections and contributes to the efficiency of the procedure.

8. Therefore, the board, in the exercise of its discretion (Article 13(1) RPBA 2020), admits the main request into the appeal proceedings.

Main request

9. In the present case, the opposition was only directed against claims 48 to 53 to the extent that they related to "a non-human organism" comprising a host cell of claim 45.

10. The main request no longer contains claims directed to "a non-human organism". Thus, it overcomes all grounds of opposition. This has also been acknowledged by the appellant.

11. Therefore, the patent can be maintained on the basis of the main request and a description to be adapted thereto (Article 111(2) EPC).

Order

For these reasons it is decided that:

1. The joint opposition and the appeal are admissible.

2. The decision under appeal is set aside.

3. The case is remitted to the opposition division with the order to maintain the patent on the basis of claims 1 to 51 according to the main request filed on 8 April 2020 and a description to be adapted thereto.

T 0385/14 - Activated oocytes

Key points

• This is an opposition case. The OD had issued the decision 19.12.2013 finding the method of claim 1 unallowable as it involved stem cells derived from human embryonic stem cells.
• The CJEU decided on 18.12.2014 that "unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a 'human embryo'" (ECLI:EU:C:2014:2451).
• The Board: "In view of this ruling and the fact that a protocol to derive human parthenogenetic embryonic stem cells from parthenotes (activated oocytes) was made available by [WO 2003/046141] on 5 June 2003, the European Patent Office now considers that an objection under Article 53(a) EPC and Rule 28(1)(c) EPC [] cannot be raised in respect of an application pertaining to human pluripotent stem cells, [] if (i) the application has an effective date[] on or after 5 June 2003, and (ii) its technical teaching can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes."
• "The board sees no reason, in the context of the present case, to question [this] revised interpretation [by the  EPO].
• "Consequently, the method of claim 1 cannot be regarded as excluded from patentability under Article 53(a) EPC."
• As a comment: the "revised interpretation" appears to never have been published by the EPO. See e.g. T2365/13. I add that in T2365/13 actually had remitted the examination appeal without any substantive findings. 
• As a comment, the present Board appears to adopt the substantive position that activated oocytes are not "human embryos" in the sense of Rule 28 EPC without any examination of the technical merits of that position (I note that the opponent made no submissions on Rule 28). A question is whether the Board has a duty to consider the technical merits of the CJEU's position that oocytes are not "human embryos" in view of the reference to the EU Biotech directive in Rule 26(1) EPC, laid down by the Administrative Council, and the Board's task and independent responsibility under the EPC. 

EPO T 0385/14  link

Reasons for the Decision

Main request (claims as granted) - Articles 100(a) and 53(a) EPC and Rule 28(1)(c) EPC

1. In the decision under appeal, the opposition division, referring to decision G 2/06 of the Enlarged Board of Appeal (OJ EPO 2009, 306) and the Guidelines for Examination in the EPO, Part G, Chapter II-32.5.3(iii), found that the method of claim 1, as far as it involved the use of in vitro differentiated cardiomyocytes that were derived from a human embryonic stem cells, was excluded from patentability under Article 53(a) and Rule 28(c) EPC, because at the effective date such cells could be prepared exclusively by a method which necessarily involved the destruction of human embryos.