09/12/2013
The Enlarged Board of Appeal (“EBA”) of the European Patent Office (EPO) is hearing a referral from a Technical Board of Appeal (“TBA”) in case G2/13 (also known as “Broccoli II”) concerning the patentability of plants obtained using essentially biological process steps. Third parties were invited to submit comments to the EBA by the end of November 2013 on how the referred questions should be answered. The present article outlines comments provided by the UK’s Chartered Institute of Patent Attorneys (“CIPA”).
CIPA considers that plants per se should not be excluded from patentability in view of the Article 53(b) EPC exclusion of essentially biological processes for the production of plants (explained below), even if the plants are defined as “product-by-process” claims where the process steps which are used to produce the plants might themselves be excluded.
By way of background, the EBA issued an earlier decision in the consolidated cases G2/07 (“Broccoli I”) and G1/08 (“Tomato I”) concerning the scope of the Article 53(b) EPC which excludes from patentability plant varieties and animal varieties, as well as “essentially biological processes for the production of plants and animals”. The EBA decided that a non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is excluded from patentability. Furthermore, they noted that such a process does not become patentable merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.
After issuance of the above-mentioned EBA decision, the Broccoli I and Tomato I cases went back to their respective referring TBAs, where a further issue arose: is a plant per se obtained or obtainable solely by an excluded essentially biological process also not patentable? The TBAs each deemed that an unprecedented further referral to the EBA was required, resulting in the Broccoli II case and also G2/12 (called “Tomato II”). Although the questions to the EBA in the Broccoli II and Tomato II cases are slightly different, there is significant overlap and the cases are (again) expected to be consolidated. CIPA submitted comments in respect of Tomato II on 30 November 2012, and the newly submitted comments in Broccoli II served to supplement those earlier comments.
In Broccoli II, the main focus of the present article, the key questions (different from those in Tomato II) are:
2(a) Is a product-by-process claim directed to plants or plant material other than a plant variety allowable if its process features define an essentially biological process for the production of plants?
and
4. If a claim directed to plants or plant material other than a plant variety is considered not allowable because the plant product claim encompasses the generation of the claimed product by means of a process excluded from patentability under Article 53(b) EPC, is it possible to waive the protection for such generation by “disclaiming” the excluded process?
CIPA submitted that the answer to question 2(a) should be “Yes”, for the following reasons.
The basic criteria according to EPO case law for product-by-process claims are that (1) the claims are admissible only if the products themselves fulfil the requirements for patentability and (2) there is no other information available in the application which would enable the applicant to define the product satisfactorily by reference to its composition, structure or some other testable parameter. Product-by-process claims should be interpreted in an absolute sense, independently of the process features. Furthermore, EPO case law suggests that a product-by-process claim must be considered to be nothing else but a product claim in which a particular way of defining the product is chosen, namely by describing steps of its manufacturing process. The manufacturing steps are not protected and do not fall under the scope or ambit of the product-by-process claim.
Within the context of the Broccoli II, plant products are not excluded from patentability according to Article 53(b) EPC unless the plant products are limited to plant varieties. How a plant variety is obtained – i.e. the process for producing the plant variety – does not affect the exclusion of such a product from patentability according to Article 53(b) EPC. The corollary of this point is that how a plant (not limited to a plant variety) is obtained does not affect the non-exclusion of such a product from patentability according to Article 53(b) EPC. Accordingly, Article 53(b) EPC does not exclude plant products which are defined in a product claim either by process features or structural features.
CIPA considered that if the legislator had intended to exclude from patentability plants or plant material other than a plant variety defined by a product-by-process claim in which the process features define an essentially biological process for the production of plants, he would have done so. Rather, amendment of the EPC would be required to achieve this exclusion.
In summary, CIPA was aware from various statements filed as amicus briefs in Broccoli II and Tomato II that certain parties have argued that the answer to question 2(a) should be “No” to protect the interests of traditional plant breeders. However, CIPA submitted that such parties should seek to have the EPC amended rather than suggest that the EBA adopt an incorrect interpretation of the current EPC.
CIPA also submitted that a narrow interpretation of patentability exclusions is an established EPO principle, and should be applied here.
With respect to referred Question 4, CIPA submitted that a disclaimer is not needed because plants or plant material other than a plant variety should be considered allowable where the plant product claim encompasses the generation of the claimed product by means of a process excluded from patentability under Article 53(b) EPC. However, if the EBA comes to a different conclusion on the above questions, and particularly if the EBA provides a “No” answer to Question 2(a), then CIPA submitted that a disclaimer should be allowable to waive protection for the essentially biological processes per se involved in the generation of a plant or plant material other than a plant variety recited in a product-by-process claim. The EBA was requested to provide clear guidance as to what the wording of any such allowable disclaimer should be.
Various other parties have also submitted comments to the EBA concerning Broccoli II (and Tomato II). A decision from the EBA is expected sometime in 2014 or 2015.
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This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.
