The IPKat EPO Boards of Appeal (BA) Year in Review 2021

Following on from our IPKat EBA 2021 Year in Review, here is some more festive holiday reading on some of the important decisions to come out of the EPO Boards of Appeal this year. 2021 saw key decisions on claim supremacy, types of antibody claims, the data threshold for second medical use inventions and the AI inventor debate. 

🎅 DABUS: An AI inventor or the Emperor's New Clothes?

As the year draws to the close, the EPO has announced the Legal Boards of Appeal decision on whether an AI can be named as an inventor (J 8/20 and J 9/20). Upholding the previous decision of the Receiving Section (IPKat), the EPO has decided in line with the US and UK courts that an AI can not be named as an inventor on a patent (IPKat). 

The team driving this forward have already announced their intention to continue the argument in a divisional application. As applicants will know, this can be an expensive strategy, especially as the EPO can be expected to refuse the divisional case in short order, for the same reasons as the parent. In the meantime, this Kat can only give her two-pennies' worth again that the AI inventor debate has been blown out of all proportion, particularly given the lack of evidence that the AI is even capable of inventing (IPKat). 

• The first AI inventor - IPKat searches for the facts behind the hype (15 Aug 2019)
• EPO refuses "AI inventor" applications in short order - AI Inventor team intend to appeal (22 Dec 2019)
• The mirage of AI invention - nothing more than advanced trial and error? (3 Sep 2020)
• Is it time to move on from the AI inventor debate? (2 Dec 2020)
• DABUS: An AI inventor or the Emperor's New Clothes? (15 Sep 2021)

🎅 Description amendments: Claim supremacy & the doctrine of Equivalents (T 1127/16)

Beautiful Howie

The EPO is unusual among patent offices in that it requires applicants to amend the description in order to bring it into alignment with the allowed claims. To comply with this, it used to be standard practice to merely replace "invention" with "disclosure" or similar thorough-out the description. However, the new EPO Guidelines for Examination for 2021 controversially required applicants to make much more significant changes to the description.  Particularly, the 2021 Guidelines require the description to be amended so that embodiments which are no longer covered by the claims are deleted, or the description amended to explicitly state that the subject matter is not part of the invention (IPKat). 

The introduction of the newly onerous requirements for amending the description was controversial, and not only because of the extra burden (cost and time) associated with having to make the amendments. Making significant amendments to the description is risky business given the potential interaction between the claims and description post-grant. 

Deleting subject matter is undesirable, given that it is not possible to use subject matter that was deleted from the specification before grant as basis for a claim amendment. On the other hand, including statements that subject-matter does not fall under the scope of the invention may create problems for enforcement. The description, for example, may be used to interpret the claims under the doctrine of equivalents in the UK. In the High Court case of Illumina v MGI this year, the judge found that a definition in the description prevented a finding of infringement under the doctrine of equivalence (IPKat) (Although, in contrast, the EPO emphasised the usual supremacy of the claims over the description this year in Boeing "comma" decision T 1127/16, IPKat). A patentee might therefore expect a statement in the description that certain subject-matter does not fall under the scope of the invention, to come back and bite them during litigation. 

It now seems that the EPO may have listened to the criticism of the new guidelines. According to an EPO press release, "the next edition of the Guidelines for Examination [...] will enhance clarity and legal certainty with regard to adaptation of the description [...] the relevant sections in the Guidelines will reflect users' requirements with a view to legal certainty in the post-grant stage of their European patents". We await the draft version of the 2022 guidelines with interest. 

In the meantime, the Boards of Appeal published a decision just before Christmas that looked for and failed to find any legal basis for the requirement that the description should be amended in line with the claims (IPKat). 

• Highlights from the new EPO guidelines for examination 2021: ViCo oral proceedings, description amendments and antibodies (14 Feb 2021)
• Illumina v MGI Part 2: Has the UK lost its way on the doctrine of equivalents? (27 Feb 2021)
• Boeing's comma drama: Commas and taking the description into account when construing a claim (T 1127/16) (12 Apr 2021)
• Board of Appeal finds no legal basis for the requirement to amend the description in line with the claims (T 1989/18) (26 Dec 2021)

🎅 Defining antibodies: Hybridomas and epitope claims (T 0032/17)

A bauble binding molecule

The updated guidelines for 2021 included for the first time a section devoted to antibodies (IPKat). The new Guidelines confirmed that antibodies may be defined in a patent claim by functional features, e.g. binding to the sequence of antibody target (epitope), or by reference to a hybridoma (cells that have been genetically engineered to produce antibodies) (Rule 31 EPC). 

The decision in T 0032/17 considered whether a reference to hybridoma in the form of an antibody product-by-process claim limited the claim to the antibody structures produced by the hybridoma (IPKat). The Board of Appeal found that reference to deposited hybridoma did not in fact convey any technical information about the structure of the antibodies produced by the hybridomas, either explicitly or implicitly. As such, the claim could not be said to be limited by reference to these hybridomas. The Board therefore viewed a prior mention of the hybridomas as novelty destroying for the product-by-process claim. 

As the field of therapeutic monoclonal antibodies has grown, functional and epitope claims have become progressively more difficult to obtain. There is also a dearth of Board of Appeal case law on the sufficiency bar for epitope claims (Case Law of the Boards of Appeal, II-C-7.3). Nonetheless, in contrast to the US, epitope claims are still possible in Europe, at least at first instance (IPKat).

• Patenting Antibodies: The epitope claim is dead, long live the epitope claim (15 Nov 2021)
• Reference to a hybridoma does not limit a product-by-process antibody claim (T 0032/17) (1 Jun 2021)

🎅 Patenting a second medical use: The challenge of sufficiency and "obvious-to-try" (T 966/18, T 966/18)

Hungry Byron

The earlier a patent is filed for a second medical use, the lower the risk of disclosures before the priority date destroying novelty and inventive step. The later a patent application is filed, the more time there is to obtain data and satisfy the requirement that the invention is sufficiently supported and disclosed. The amount of data required at the filing date versus how much data can be used to supplement the application later on is currently the subject of a referral to the EBA, although the referral relates explicitly to inventive step as opposed to sufficiency (IPKat).  Leaving aside the question of post-published data, there have been a couple of interesting decisions from the Boards of Appeal on the sufficiency/plausibility bar for second medical use claims. 

The decision in T 966/18 was an example of a case in which pre-clinical data, together with common general knowledge, was deemed as plausibly demonstrating a claimed therapeutic method (IPKat). It could be said that the Board of Appeal in this case was surprisingly lenient given that the data provided in the application as filed lacked statistical significance. Inventive step was not considered by the Board of Appeal, but will be dealt with by the first instance department. 

The decision in T 799/16, was a rare example of dose claim found both sufficient and inventive (IPKat). The claim in question was found to be sufficiently disclosed over the entire scope of the claim, despite the claimed treatment being shown as non effective in almost two thirds of patients. The Board of Appeal further found the claim inventive in view of prior art disclosing clinical trial information, information that included the claimed dose itself. The key factor in persuading the Board of Appeal on both counts was the particularly challenging nature of the target indication (multiple sclerosis). 

Decisions from national courts this year none-the-less were a reminder that obvious-to-try remains a challenging objection to overcome during litigation of second medical use patents. In the UK, the High Court found Bayer's formulation patent for an approved salt form of sorafenib obvious-to-try in view of the preliminary phase I clinical trial results for the drug (IPKat). In Canada, the Federal Court found Teva's COXPONE second medical use patent obvious-to-try in view of a mention in the prior art of a phase III clinical, and a "strong consensus" in the field that the drug would work in the target patient population (IPKat). 

• Canadian Federal Court considers whether Teva's COPAXONE second medical use patents were obvious-to-try (Teva v Pharmascience) (25 Jan 2021)
• Second medical use dosage regimen claim successfully traverses both insufficiency and "obvious-to-try" attacks (T 0799/16) (8 Mar 2021)
• When does pre-clinical data plausibly support a therapeutic effect? (T 966/18) (14 July 2021)
• Bayer v Teva: Drug formulation patent found "the result of standard and routine considerations" ([2021] EWHC 2690 (Pat)) (28 Nov 2021)

🎅 Strawman oppositions and the patent bargain (T 1839/18)

Creepy Christmas Straw-person

In T 1839/18, a patentee questioned whether straw person oppositions are in line with the principle that acts performed before the EPO require a legitimate purpose (IPKat). The case related to the admissibility of an opposition filed in the name of a clearly uninterested party (a Spanish garage owner). The patent (EP 2531085). The patentee argued on appeal that the Spanish garage owner opponent had no interest what-so-ever in the outcome of the opposition, and that the opposition was therefore inadmissible. In its decision, the Board of Appeal confirmed the established case law that anyone should be able to file an opposition (apart from the patentee themselves). The Board cited the broader public interest that invalid patents should be challenged in view of the patent bargain between the state and the patentee, regardless of whether opposing the patent is in the interest of the opposing party or not.  

• Board of Appeal upholds the principle of "any person" opposition in view of the broader public good (T 1839/18) (10 May 2021)

🎅The cost of procedural efficiency (T 1370/15, T 1604/16)

The Boards of Appeal are under pressure to reduce the back-log of cases on appeal. To assist with this, new Rules of Procedure of the Boards of Appeal (RPBA) were introduced in 2020 (IPKat). Part of the stated aim of the rules were to reduce remittal of cases from the Boards of Appeal back to the department of first instance (so-called "ping-pong"). The RPBA state that a case should not be remitted back to the first instance department unless there are "special reasons" for doing so (Article 11, RPBA). 

There has been a diverging interpretation by the Boards of Appeal as what constitutes "special reasons" for remitting a case. Many Boards have appeared to be comfortable with a lack of consideration of an objection at first instance to be sufficient reason  for remittal. However, in stark contrast to this approach was the decision by the Board of Appeal in T 1370/15. In this case the Board of Appeal (3.5.04)  introduced an inventive step objection for the first time in their preliminary opinion (IPKat). The Board of Appeal did not consider it necessary to remit the case back to the Opposition Division for consideration of the new objection. 

The Board of Appeal in T 1370/15 did not even consider it necessary to provide evidential support for the common general knowledge (CGK) on which the inventive step objection was based. The Board of Appeal reasoned that its own technical expertise in the field as justifying the inclusion of the CGK. The patentee was thus faced not only with a new inventive step objection on appeal, but an inventive step objection that was based on the Board of Appeal's own unevidenced CGK. Regardless how obvious the CGK might be considered to be, the principles established by this case are worrying. 

In another case (T 1604/16), the Board of Appeal found themselves competent to overturn a finding of fact at first instance, raising questions as to what aspects of an Examining or Opposition Division decision may be challenged by an appellant. 

• Board of Appeal relies on its own CGK to support an inventive step objection without remittal to first instance (T 1370/15) (19 Apr 2021)
• Boards of Appeal are competent to overturn a finding of fact at first instance (T 1604/16)

🎅 Final thoughts

The above is, of course, not an exhaustive list of the most important Boards of Appeal decisions this year. Readers are encouraged to post decisions they think have been overlooked in the comments below. 

Happy holidays!