Oppositions launched by 16 organisations against patents for mutant barley owned by Carlsberg & Heineken highlight the tensions that exist over the grant of monopolies for plant products. We consider which party will most likely be raising a glass to victory in light of recent legal changes, and the lessons applicable to patentees across the spectrum of plant innovation.
A recipe for dispute
The patents in question, EP2384110 (EP'110) and EP2373154 (EP'154), relate to a beverage prepared from a barley plant carrying a particular mutation, and the mutated plants themselves. EP'110 covers barley plants comprising mutations that cause loss of functional lipoxygenase (LOX)-1 and LOX-2 enzymes, while the mutation described in EP'154 causes functional loss of methionine S-methyltransferase (MMT). These mutations are said to improve the taste of the resulting beer.
The patents were opposed by a group of organisations represented by Dr Cristoph Then of the campaign 'NO PATENTS ON SEEDS!'. The opponents object that the patents cover conventionally bred barley, which they argue is excluded from patent protection by Article 53(b) of the European Patent Convention.
Article 53(b) states that patents cannot be granted for essentially biological processes - processes based on crossing of whole genomes and subsequent selection – but is silent on whether the products of those processes are patentable. Although previous decisions of the EPO's Enlarged Board of Appeal (G2/12 and G2/13) found in favour of patentability, these decisions were later contradicted by a controversial amendment of Rule 28(2) EPC to explicitly state that plants or animals obtained exclusively by an essentially biological process are not patentable. This rule is the foundation of the opponents' case against the Carlsberg/Heineken patents.
Round 1: Glass half empty
In the case of EP'110, the EPO's Opposition Division noted that plants carrying a mutation introduced by technical means, such as incubation of seeds with a mutagen, are not excluded from patent protection. Nevertheless, the claims were considered to encompass both plants created by technical means and plants obtained by an essentially biological process, the latter falling foul of Rule 28(2). As such, the patent was found invalid.
The patentees overcame this problem by clarifying that the barley plant had not been exclusively obtained by an essentially biological method. However, the Opposition Division then deemed the claimed plant to be insufficiently disclosed. Although the patent described one method of making a mutant plant (the seeds of which were deposited in a publicly accessible culture collection), this method relied on random mutagenesis and subsequent screening of 35000 mutants, placing an undue burden on someone trying to reproduce the invention. Accordingly, it was held that the patent does not enable the skilled person to obtain any mutant barley plant lacking functional LOX enzymes, but only the specific mutant deposited. This appears consistent with established case law on sufficiency, as re-affirmed by the UK's Supreme Court in Regeneron v Kymab.
Eventually, the patentees were able to satisfy the Opposition Division by further limiting the claimed plant to the specific mutations carried by the deposited strain. The opponents' argument that the invention was obvious was unpersuasive, and the patent was upheld in amended form. The opposition against EP'154 proceeded analogously.
While this may appear to be a partial victory for Carlsberg/Heineken, the claims being limited to specific mutations makes it easier for third parties to circumvent the patents by creating different mutations in the barley genome that result in the same loss of function. Unsurprisingly, both parties have appealed the decisions.
The EPO's Enlarged Board of Appeal recently confirmed that plants and animals produced by essentially biological processes are not patentable (G3/19). While this decision will be welcomed by groups like NO PATENTS FOR SEEDS!, it does not apply to patents filed before 1 July 2017, thereby undermining the opponents' main arguments against the Carlsberg/Heineken patents which were granted in 2016 and thus are assessed according to the previous case law (G2/12 and G2/13). We therefore expect the Board of Appeal to find the plant claims of EP'110 and EP'154 valid insofar as they encompass the products of essentially biological processes.
This will leave sufficiency and inventive step as the only potential grounds of invalidity. Unusually, sufficiency was not raised as a ground of opposition by the opponents but by the EPO of its own volition. The opponents themselves only have their inventive step attacks to fall back on – attacks which are based on limited prior art. It will be very difficult for the opponents to introduce new documents at this stage of the proceedings.
The outcome of the appeals could therefore depend on whether the patentees can persuade the Board that the Opposition Division did not have a prima facie case to raise sufficiency as ground of objection. Dates for the appeal hearings are expected to be set later this year.
- Patents with claims to plants obtained by essentially biological processes are valid under Article 53(b) EPC if they were filed before 1 July 2017, although they may be challenged in revocation proceedings before national courts which are not bound by G3/19. Opponents will therefore need to rely on alternative grounds of attack before the EPO.
- For more recent filings, patentees should ensure that claims intended to protect the products of a technical process (e.g. mutagenesis) do not encompass products obtained by conventional crossing and selection.
- Importantly, the restrictions on essentially biological processes and products thereof do not apply to microorganisms. For example, a new strain of yeast which improves fermentation is still patentable.
- These cases show the value of depositing key mutants in a culture collection. Without these deposits, the Carlsberg/Heineken patents would be at severe risk of revocation.
- To avoid the sufficiency issues faced by the patentees, applicants should explain how mutations can be reliably achieved, e.g. using site-directed mutagenesis as described in Carlsberg's recent applications for mutated barley (WO2019129739 and WO2019129736). Notably, the plants claimed in these applications may additionally comprise mutations resulting in functional loss of LOX-1, LOX-2 and/or MMT, giving Carlsberg another chance to protect the mutants described in EP'110 and EP'154. This will at least partially alleviate Carlberg's hangover should the Board of Appeal limit or revoke the EP patents.
- By relying heavily on one ground of attack, the opponents have significantly reduced their chances of successfully challenging the patents. This may prove to be a sobering reminder about the importance of getting opposition strategy right at the outset.
Originally published by HGF, August 2020
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