For the past couple of weeks, the patent news has been saturated with reports and commentaries on the Board of Appeal decision in the CRISPR hearing (T 844/18). Many readers may not have the time and/or enthusiasm to read all of these articles. However, what this Kat lacks in time she makes up for in enthusiasm, and provides your post-hearing highlights:

First, a case refresh...

The Board of Appeal in the CRISPR hearing has found the Broad Institute's patent to lack priority and dismissed the appeal (T 0844/18). George Schlich (Opponent 1) in the CRISPR appeal has just told IPKat: "After nearly 4 days at the Board of Appeal, this was a hard fought case. We now know for absolute certain - appeal dismissed. Patent revoked."

After yesterday's hints from the Board of Appeal that they intended to refer the issue of priority to the Enlarged Board of Appeal, many were predicting that the Board of Appeal would go ahead with the referral (see IPKat's report on Day 1, and Days 2-3). However, it seems that the Board of Appeal were convinced by the arguments from the opponents that the referral was not necessary. After hearing 3 days of arguments on the issue of priority, the Board felt confident that they could decide on the point of law and dismissed the appeal. The Board of Appeal agreed with the opposition division that the priority claim was invalid.

End of the road for EP2771468

The Board of Appeal (3.3.08) finished hearing submissions on priority from the parties this morning. Proceedings were then adjourned until the afternoon whilst the Board conferred. The parties undoubtedly had a tense lunch. The Board was either going to decide on the issue of priority or refer the issue to the EBA for clarification. There was a strong feeling following the comments made by the Board of Appeal on Day 3 that a referral to the EBA was likely. However, news came soon after recommencement of the proceedings that the Board of Appeal was to dismiss the appeal. [In a classic fake news saga, Merpel watched with bemusement today the ongoing proliferation of reports that the Board of Appeal had referred the matter to the EBA].

The immediate impact of the referral would have been to prolong the dispute. Even if the EBA had accepted the referral (far from certain), any decision from the EBA would not have been the end of the matter. The EBA is there to provide clarity on points of law. After a EBA decision, the case would then have had to be sent back to the Board of Appeal. Those wishing for legal clarity will welcome the Board of Appeal's decision to settle the matter today.

On the other hand, a fact easily forgotten amidst the all the excitement over this week's appeal hearing, is that the patent in dispute, EP2771468, is far from being the Broad Institute only patent relating to CRISPR. Whilst today is the end of the road for EP2771468, there are 5 divisional applications in the same family as the patent in dispute: EP2784162, EP2896697, EP2940140, EP2921557, EP3144390.

EP2784162 and EP2896697 were revoked in opposition earlier last year. The appeals are pending. EP2940140  and EP2921557 have been opposed. EP3144390 has been accepted by the Examining Division, but not yet granted. In other words, despite the dismissal of the appeal today, we may see the dispute rumble on. However, presumably, should the other cases in the family reach the Board of Appeal, with the same issues at stake, the appeals would be dealt with in the same way as the one today.

The patent family of EP2771468 is also, of course, not the only family relating to CRISPR. There are many other patents relating to aspects of CRISPR technology, owned by the Broad Institute and other parties, most notably University California Berkeley.

We now await publication of the minutes of oral proceedings and the written decision. Thanks again to all our Katfriends for their faithful reporting.

Twitter was awash today with news that the Board of Appeal in the CRISPR appeal case had referred questions on priority to the Enlarged Board of Appeal (EBA). However, these reports proved premature. None-the-less, there seems no doubt that the Board of Appeal are leaning towards a referral. The European patent community is advised to adopt the brace position.

Today is the third day of the proceedings in the CRISPR appeal case (See IPKat's report on Day 1 for full background to the case: the Broad Institute's CRISPR patent appeal hearing: Day 1, Setting the Stage).

Image source: a Katfriend

In brief summary, the Broad Institute's CRISPR patent was revoked by the opposition division for lacking a valid priority claim under the well-established EPO approach to priority, based on mountains of Boards of Appeal case law. The Patentee's argument on appeal is that the EPO approach to priority is wrong because it is not in line with the Paris Convention or a proper interpretation of Article 87 EPC. There are three threads to the Patentee's argument: (I) Entitlement to priority should not be assessed by the EPO, (II) the EPO incorrectly interprets the phrase “any person” in Article 87 EPC and Article 4 Paris Convention, and (III) US law should govern the interpretation of “any person” in Article 87 EPC when the priority application is a US provisional.

Today was Day 1 of the Board of Appeal hearing on the validity of one of the Broad Institute’s patents relating to fundamental aspects of CRISPR technology. The simple question at the heart of the dispute between the Broad Institute and the opponents was summarised with admirable succinctness by the Board of Appeal in their preliminary opinion:

“A and B are applicants for the priority application. A alone is the applicant of the subsequent application. Is this priority claim valid even without any assignment of priority right from B to A? The appellants say that the answer is ‘yes’ and the respondents that the answer is ‘no’”.

In the second of IPKat's 2019 Patent Year in Reviews, we provide a break-down of some of the important Board of Appeal cases published this year . The end of 2019 comes too early for the most highly anticipated appeal case of the times (the Board Institute's CRISPR appeal), for which oral proceedings are being held in January. However, the discerning EPO case law enthusiast can still find plenty to interest them in the Boards of Appeal cases published this year. Highlights include a new approach from a Board of Appeal on the novelty of purity inventions (T 1085/13), a couple of cases on the burden of proof (T 2037/18, T 1299/15) and a foreshadowing of the type of arguments expected to become more common following introduction of the revised Rule of Procedure of the Boards of Appeal (RPBA) on 1 January 2020 (T0688/16). See also the IPKat 2019 Enlarged Board of Appeal Year in Review.

Celebrating the end of 2019

Priority

The European patent community is eagerly awaiting the outcome of oral proceedings in the high-profile CRISPR case. The exceedingly long written submissions (and occasional impassioned rhetoric) are a mark of the cases's importance: "Should everyone else change, or just the Patentee?": Progress of the Broad's CRISPR appeal. The Board of Appeal (3.3.08) has already issued its preliminary opinion: BREAKING: Board of Appeal provides some initial thoughts on the Broad Institute’s CRISPR appeal (T0844/18). It is widely expected that the Board of Appeal will dismiss the appeal. In a straw poll of the audience of the recent 2019 CIPA life science conference delegates, not one hand was raised to indicate an expectation of a positive outcome for the patentee. A decision in favour of the patentee would send a shock-wave through the European patent community.

However, the issue at stake in the CRISPR case is not the only game in town when it comes to priority at the EPO. There is growing appreciation that another issue of the EPO's approach to priority needs consideration by the Boards of Appeal. The EPO's approach to co-applicants when assessing a priority claim is one that is growing in prominence. It is hoped that the Board of Appeals will soon consider this issue and provide some much needed clarity for applicants: Clarity is needed from the Boards of Appeal on the EPO's "co-applicant approach" to priority.

Another Board of Appeal case to consider priority this year was T 0725/14. This case was an interesting reversal of the norm in cases of invalid priority. We are used to situations in which the patentee is called on to prove an assignment of the right to priority before the filing date of an application claiming priority. In T 0725/14, the Opponent faced a different but related challenge. The priority application and the PCT application were filed in the name of the same applicant. The Opponent successfully argued that the rights to claim priority had in fact been transferred to another company before the PCT application was filed. The priority claim was therefore found invalid: Assigned or not assigned? - the tricky issue of priority right transfer (T 0725/14)

Novelty: Purity, prior use and undisclosed disclaimers

For many years the EPO considered an increase in the purity of a compound a special case with respect to novelty. The burden of proof was placed on the applicant to show that the claimed level of purity was never achieved in the prior art. However, in perhaps one of the most important Boards of Appeal decisions published last year (T 1085/13), a Board of Appeal (3.3.02) found that previous decision of the Boards of Appeal were contrary to the principle that novelty can only destroyed by a clear and unambiguous disclosure in the prior art: Purity can be unconventional, a new position for the EPO boards of appeal (T 1085/13).

The novelty of a claim may be destroyed by an accidental anticipation, i.e. your claim may, by accident, cover something entirely unrelated to your inventive concept. In such cases, the Enlarged Board of Appeal established in G 1/16 and G 1/03 that an undisclosed disclaimer may be introduced into the claims to restore novelty, but not inventive step. The Board of Appeal (3.3.02) in T 1218/14 provided an important nuance to the criteria under which an undisclosed disclaimer will be allowed. In particular, the test is not whether the previous disclosure may be considered for the purposes of inventive step. The test is a higher one than this. The disclosure must be so removed from the invention that it would never be considered for inventive step or even thought about at all in relation to the claimed invention: Nuances in the definition of accidental anticipation (T 1218/14).

Novelty may also be destroyed by the prior use of a claimed invention. Prior use was a topic considered by both the EPO Boards of Appeal and the UK court's this year: Mr Justice Nugee and the Superhose: The potentiality of disclosure. The case before the Boards of Appeal related to the prior use of a train carriage: Proving the existence of confidentiality agreements and the celestial teapot - T 2037/18. The Board of Appeal (3.2.01) considered the question of where the burden of proof should rest with regards to the existence (or not) or conditions of confidentiality.

Sufficiency of disclosure

Another case to consider burden of proof was T 1299/15. This case considered where the burden of proof should rest in cases of alleged insufficiency. An opponent arguing that an invention is insufficiently disclosed generally must provide evidence that, despite making all reasonable efforts, they were unable to put the invention into practice. However, as the Board of Appeal (3.2.05) in T 1299/15 confirmed, it is possible for the burden of proof to shift back to the patentee if "serious doubts" exist regarding whether a skilled person could carry out the invention: Burden of Proof was Shifting the burden of proof back to the patentee (T 1299/15).

Exceptions to patentability

Perfect teeth

Methods of surgery are excluded from patentability under Article 53(c) EPC. T 2699/17 was an appeal from the Examining Division on the question of whether a method of restoring dental crowns was invasive and risky enough to fall under the exclusion (as interpreted by G 1/07). The Board of Appeal found that there were substantial health risks associated with crown restoration in general, including permanent damage to the gums and teeth. However, the applicant submitted evidence that the claimed method posed far less of a risk. The Board of Appeal agreed with the appellant that the claimed method was not invasive and posed a risk that could be equated to that of tattooing and piercing. The method was therefore of low substantial risk to health. The training required by a medical profession to perform the method was also found to be minimal. The claim was therefore found not to relate to an exception to patentability.

Following EPO procedure

There were also a number of Board of Appeal decisions this year dealing with some intricacies of EPO procedure. T0688/16 foreshadowed the type of argument  that may become more common following the introduction of the new Rules of Procedure of the Boards of Appeal (RPBA) in January: Event Report: CIPA seminar on the revised Rules of Procedure of the Board of Appeal. The Board of Appeal in T0688/16 particularly had to consider "arguments about arguments". The Board of Appeal found that the Opposition Division had inappropriately used their discretion under Rule 116 EPC in not allowing submissions from the patentee in opposition oral proceedings. This was because Rule 116 EPC only applies when there has been a negative preliminary opinion from the Opposition Division. In the case considered by T0688/16 there had been a positive preliminary opinion, and so Rule 116 EPC did not apply: An inappropriate use of discretion leads to ping-pong (T0688/16).

Appropriate EPO procedure was also at issue in T 0703/19. This case related to the topic of appeal fee payment (appeal fee payment was also the subject of the Enlarged Board of Appeal referral G 1/18: Enlarged Board of Appeal opinion on G 1/18). In T 0703/19, the Board of Appeal (3.2.08) considered the question of when a user of the EPO has a legitimate expectation to be informed of an underpayment of an appeal fee. The Board confirmed that to create such a legal expectation, the EPO must be able to recognise that the appeal fee should have been paid. The EPO should also have been able to recognise this in time for the failure to be rectified. A key fact of the case in T 0703/19 was that "legitimate expectations" had been created by the mention in the notice of appeal that the appeal fee was thereby paid: The three Rs of legitimate expectation: Recognizability, recoverability and responsibility (T 0703/19).

The prize for creative legal reasoning this year goes to the Board of Appeal in T 1003/19. This case was an appeal from the Examining Division (ED). The ED had granted an application based on a text-intended for grant in which all of the drawings showing the invention were missing. The Board of Appeal (3.3.05) found that the document provided by the ED as the text-intended for grant contained amendments that were neither requested by the applicant nor explicitly suggested by the ED. Thus, the Board of Appeal reasoned, the text provided as the text-intended for grant was not, in fact, intended for grant. The Board concluded that the applicant could therefore not be said to have approved the text for grant. The decision to grant the patent was therefore set aside: When is the “text-intended for grant” not intended for grant? (T 1003/19).

Moving on to the failure of an applicant (or their representative) to follow correct EPO procedure, the legal Board of Appeal (3.1.01) in J 05/18 considered the requirements for re-establishment (Article 122 EPC). The Board of Appeal concluded that even if a mistake results from an isolated error in a well-functioning system, the mistake may still demonstrate lack of all due care. The error in the case in question stemmed from a failure of the US attorneys to monitor a deadline for further processing (and arguably the failure of the EP representative to confirm with the US attorneys that the client did not wish to request further processing): Re-establishment: An isolated error in a well-functioning system may not be equivalent to all due care (J 05/18).

A welcome innovation of the new RPBA is that the upcoming cases of each of the Boards of Appeal are now available to view online: Annual list of cases.

Opposition and infringement

The Board of Appeal in T 0439/17 considered the circumstances under which a third party may intervene in opposition proceedings after the opposition period has expired. Article 105(1)(a) EPC provides that such an intervention may be made if infringement proceedings are brought against the third party. However, the meaning of "infringement proceedings" presents some difficulties, given the diversity of potential "patent infringement" related court proceedings in EPC member states. The Board of Appeal in T 0439/17 decided that pre-infringement evidence procurement procedures in Germany are not considered sufficient to allow a third party to intervene in opposition proceedings (even if an infringement action is subsequently brought): No benefit of hindsight: BA rejects ex tunc assessment of an intervention in opposition (T 0439/17).

Exams

To many trainee European patent attorneys, the European Qualifying Exams (EQEs) will be looking a lot closer this side of Christmas. As part of their preparation, they may wish to take note of the Disciplinary Board of Appeal's decision in D 11/18 [Warning: Paper B 2018 spoilers]. The Board of Appeal provides confirmation, if any were needed, that in the EQE candidates should take all of the information in the paper at face value. It is often necessary for candidates to ignore any specialist technical knowledge that they may have of the field of the invention. For this reason, it is often said that the EQE disadvantages candidates already familiar with the technical field to which an exam paper relates. These candidates will find it harder not to question the paper's assertions. Candidates are thus encouraged not to challenge what a EQE paper states as fact (an approach that may not come naturally to many patent attorneys...): EQEs - don't speculate beyond the content of the paper (D 11/18).
Proviso

The above review is, of course, not an exhaustive list of all the important Board of Appeal decisions published this year. On the contrary, the list merely represents this Kat's particular favourites. Readers will undoubtedly have their own preferred EPO decisions of 2019, and are invited to provide these in the comments below.

____________________________________________________________________

Other decisions of interest:

T 1731/12 - Exclusions from patentability
A device that is defined by a feature that can only be produced by a surgical or therapeutic step is exempt from patenting under Article 53 (c) EPC

T 1845/14 - Unclear parameters
If a parameter in a claim is essential to solving the technical problem to be solved by the claim (according to the description), the ability of the skilled person to solve that problem is not a suitable criterion for assessing sufficiency of disclosure if the problem to be solved is not part of the claim.

T 0592/15 - Postponement of appeal decision
A request to postpone the taking of the decision on the allowability of an appeal until a divisional application was filed was refused. The Board of appeal reasoned that such a request would oblige the Board of Appeal to examine questions outside of the framework of the appeal concerned.

A year ago, this Kat reported on the surprise ruling by the CJEU that organisms obtained by gene-editing should be considered genetically modified organisms (GMOs). The consequence of this ruling was that gene-edited food products became subject to the stringent regulatory requirements laid down by the GMO Directive (Directive 2001/18/EC) (IPKat post here). 

The CJEU decision was met with dismay by European research institutes and agri-tech industry. The EU has been criticized for not basing its policy on the scientific evidence. The EU is also notably at odds with other major agri-tech markets, including the U.S. and Japan. As highlighted in a recent report from the EU's own testing laboratories, scientists are also currently unable to reliably distinguish gene-edited plant products from natural products. The EU is therefore incapable of enforcing the GMO Directive as applied to gene-edited products imported from outside the EU, putting its own agri-tech industry at an even greater disadvantage.

Out of step with science and the rest of the world

Marking the anniversary of the CJEU decision, 120 research institutes from around Europe (including the University of Cambridge and the Max Plank) released a statement, under the heading "give CRISPR a chance", arguing that EU regulations no longer correctly reflect the current state of scientific knowledge:

There are no scientific reasons to consider genome-edited crops differently than conventionally-bred varieties that have similar alterations. Plants that have undergone simple and targeted genome edits by means of precision breeding and which do not contain foreign genes are at least as safe as varieties derived from conventional breeding techniques...

The consequence of the ECJ ruling is that the use of precision breeding techniques like CRISPR are becoming the privilege of a select group of large multinational companies to exploit it in large cash crops. Consequently, the inability to market genome edited crops in Europe will cause a chilling effect on the investments in R&D in the European breeding sector. The result will be that the further development of beneficial varieties in a faster and much more directed way will be halted in Europe, while the rest of the world embraces the technology.

Testing for gene editing

Notably, the EU's position is in contrast to that of the U.S., Japan, China, Brazil and Australia. Earlier this year, for example, Japan followed the U.S.'s example by concluding that gene edited food products need not be subject to safety screening (provided that the gene-editing techniques satisfy certain criteria).
The GMO Directive can not be enforced for gene-edited products

It has recently become apparent that enforcement of the new stringent requirements for gene-edited products in the EU may not be possible. EU member states are under an obligation to test for unauthorized GMO release in the EU and for the presence of GMOs in imported food, animal feed and seeds (Regulation (EC) 882/2004, and Regulation (EU) 2017/625). This testing is carried out by the European Network of GMO Laboratories (ENGL). The CJEU ruling that gene-edited organisms fall under the GMO umbrella, required EU testing laboratories to also test for gene-edited organisms.

However, ENGL have recently confirmed that developing methods to detect unauthorized gene editing may be a challenge (ENGL report). Testing for the presence of gene-editing is not as straightforward as testing for the presence of traditional genetic modification. GMO cloning techniques generally involve the insertion of large sections of foreign DNA into an organism's genome. The presence of this foreign DNA can be easily detected. Gene-editing, by contrast, may involve editing of only one or two single residues in an organisms DNA. It is difficult to identify these changes as being artificial as opposed to the result of natural variation.

In its recent report ENGL confirmed that:

validation of an event-specific detection method and its implementation for market control will only be feasible for genome-edited plant products carrying a known DNA alteration that has been shown to be unique. Under the current circumstances, market control will fail to detect unknown genome-edited plant products.

Attacked on all fronts

In the meantime, the European agri-tech industry is also in limbo with regards to the patent eligibility of plants produced by essentially biological processes (i.e. natural breeding techniques). The EPO President has recently referred the issue (again) to the Enlarged Board of Appeal (EBA) (IPKat post here). The majority of legal experts are of the opinion that the EBA should consider the referral inadmissible. If the EBA were to find the referral inadmissible, this would maintain the disparity between the opinions of the EBA and Boards of Appeal, and that of the Administrative Council and the EU Commission. The EU agri-tech industry therefore faces attacks on multiple fronts. The President of the EPO seems determined to ensure plant products produced by natural breeding methods should not be patentable, whilst the EU requires that gene edited food products should be subject to stringent regulation.

Gene-editing patents

The predominant gene-editing technique, CRISPR/Cas-9, has been the subject of high-profile patent disputes, both in the U.S. and Europe (IPKat post here). The main players in the field are the Broad Institute and The University of California, Berkeley. However, the CRISPR patent field is growing ever more complex. Thousands of CRISPR patent applications have been filed, by hundreds of organisations. In order to simplify licensing requirements for CRISPR, there were calls for a CRISPR patent pool. However, its seems that these calls have lessened significantly within the European agri-tech industry, following the CJEU ruling on gene-editing. Industry experts and insiders have reported a significant decrease in CRISPR innovation in Europe since the ruling, making the need for CRISPR IP agreement less pressing.

The impact of Brexit

The UK prime minister envisaging the post-Brexit future

If the UK leaves the EU with no-deal (as is looking depressing likely...), the UK will of course be no longer subject to the GMO Directive. On his first day in office Boris Johnson bombastically promised to "liberate the UK’s extraordinary bioscience sector from anti-genetic modification rules".

However, the value of the UK going it alone on gene-editing regulation without the rest of the EU 27 is doubtful. The EU is the UK's largest export market for plant and animal products. The UK agri-tech industry may be as significantly damaged by an inability to export to the EU as it is by stringent GMO regulations. If the UK wished to influence EU policy on GMO's, would it not have been more productive to keep its seat around the table? As it is, it seems the UK will have to sit on the sidelines and hope that the EU will listen to the scientists and industry experts and rethink the gene-editing regulations.