Patentability of plant products obtained by an essentially biological process

In a decision issued by the Technical Board of Appeal on 5 February 2019 (T 1063/18, 5 December 2018), plant products obtained by an essentially biological process were found to be patentable subject matter.

 

The decision deals with the conflict between the interpretation of Article 53(b) EPC by the Enlarged Board of Appeal, and Rule 28(2) EPC of the Implementing Regulations.

 

Essentially biological processes for the production of plants or animals are excluded from patentability according to Article 53(b) EPC.  However, the patentability of products of those essentially biological processes has remained a contentious area that has seen several landmark decisions from the EPO Board of Appeals over the last 5 years, of which this latest decision is another.

 

Conflict between Article 53(b) EPC and the Biotech Directive

 

Following decisions by the Enlarged Board of Appeal in G2/12 and G2/13, claims directed to plant products obtained by an essentially biological process were found to be allowable.  However, a subsequent review of these decisions by the European Commission found the board’s interpretation of Article 53(b) EPC to be at odds with Article 4 of the EU Biotechnology Directive (“the Biotech Directive”).  The intention of the Biotech Directive, the European Commission concluded, had been to also exclude products obtained by an essentially biological process.

 

Rule 28(2) EPC of the Implementing Regulations was subsequently amended by the Administrative Council of the EPO in an effort to preserve legal harmony.  This amendment excluded products obtained by an essentially biological process from patentability.

 

Decision in T 1063/18

 

The recent decision in T 1063/18 challenges the validity of this amendment to Rule 28(2) EPC, finding it to be in direct conflict with the interpretation of Article 53(b) EPC by the Enlarged Board of Appeal.  Since the views of the European Commission, and hence the amendment to Rule 28(2) EPC were not confirmed in a legally binding way, the board concluded that Article 53(b) EPC as interpreted by the EBA should take precedence.  Subsequently, the board found that the applicant’s claim directed to a chilli plant obtained by an essentially biological process was patentable subject matter.

 

Where do we go from here?

 

This latest decision is good news for rights holders with inventions relating to plants.  However, the decision highlights a conflict between the positions of the European Union and the interpretation of the provisions of the EPC by the EPO Boards of Appeal.  How will this conflict be resolved?  Further attempts to amend the Implementing Regulations to the EPC under the direction of the EU would likely arrive at a similar decision as in the present case.

 

An amendment to Article 53(b) EPC itself may be one way to restore harmony between the EPC and the position of the EU.  However, the European Patent Convention is an agreement that extends beyond simply the EU member states.  Amendments to the EPC at the request of the EU could be met with some resistance.

 

The decision could be seen as a victory for patent proprietors in this technical area, but given the interest of the EU Commission in achieving harmonisation in patent law for biotechnological inventions, one suspects that we have not heard the last of this matter.

[USA] Are You Sure You’ve Got Milk?

Alternatives to traditional food products have increased in availability, number, variety and popularity over the last decade.  So where does this leave consumers and the regulators who are tasked with ensuring food safety?  The Ninth Circuit has held that the reasonable consumer can digest the differences between almonds and cows.

In Painter v. Blue Diamond Growers, No. 1755901, 2018 WL 6720560, at *1 (9th Cir. Dec. 20, 2018), the Ninth Circuit affirmed the District Court’s dismissal of the plaintiff’s complaint with prejudice on the grounds of preemption and failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6).  On behalf of a putative class, the plaintiff claimed that Blue Diamond mislabeled its almond beverages as “almond milk” and that they should be labeled “imitation milk” because they are inferior substitutes for dairy milk.

The Ninth Circuit found almond milk is not an “imitation” of dairy milk within the meaning of the applicable federal regulations, emphasizing that “it is not plausible that a reasonable consumer would assume that two distinct products have the same nutritional content.”  The Ninth Circuit agreed with the District Court that “no reasonable consumer could be misled by [Blue Diamond’s] unambiguous labeling or factually accurate nutritional statements.”

The U.S. Food and Drug Administration is evaluating whether the labeling of plant-based alternatives may lead consumers to believe these products have the same key nutritional attributes as their dairy counterparts.  In particular, FDA is looking at children’s health issues related to plant-based milk alternatives.  FDA Commissioner Scott Gottlieb, M.D., stated that FDA “intend[s] to look at whether parents may erroneously assume that plant-based beverages’ nutritional contents are similar to those of cow’s milk[.]”  On this issue, FDA is soliciting public input to answer the following questions:

1. How do you use plant-based products?
2. What is your understanding of dairy terms like milk, yogurt and cheese when they are used to label plant-based products?
3. Do you understand the nutritional characteristics of plant-based products?  Do you know how they’re different from each other?  Do you know how their nutritional qualities compare with dairy products?

FDA has extended the public comment period on this issue until January 28, 2019.

Cellular agriculture alternative

Alternatives to dairy products are not the only “imitation” foods getting attention these days.  Cellular agriculture and plant-based dairy alternatives have raised similar questions.

Cellular agriculture produces meat, poultry and seafood from animal cell cultures to replicate the characteristics of muscle harvested from food-producing animals.  This process has led regulators to question how to label such cultured food products effectively.  Some suggest the “meat” grown in a lab, rather than on a farm, should be called “cultured meat,” “cell-based meat,” “artificial meat,” or “clean meat.”  Others feel these products should not be associated with “meat” in the traditional sense whatsoever.

At a public meeting this past summer, FDA engaged in a dialogue with food industry and consumer representatives about how to embrace cell-cultured foods, while keeping consumers safe and fully informed.  It has since been announced that FDA will create a joint regulatory framework with the USDA to oversee cultured livestock and poultry products.  The joint regulatory scheme’s details are yet to be determined, but the effort may implicate future jurisdictional issues with respect to cultured meat products.

It remains to be seen if FDA’s stance on labeling plant-based dairy alternatives will affect the agency’s stance on cell-based meat labeling.  Only time will tell how well consumers understand terms such as “milk” and “meat.”  What is clear is that “imitation” and cultured food products will be a hot topic to watch in 2019, especially from a regulatory standpoint.

Jessica Brennan and Abigail Luhn

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