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Impossible Foods secures reinstatement of EU patent for heme protein

The decision overturns the 2022 revocation of the patent and solidifies legal protection of the innovative ingredient that can be used in plant-based food production.

The patent, filed in 2014 and originally granted in 2017, protects a method for using heme proteins, produced via precision fermentation, in combination with flavour precursor molecules to give plant-based products the taste, smell, and appearance of conventional meat.

This decision issued by the European Patent Office (EPO) Board of Appeals on 20 December 2024 resolves a years-long dispute over the novelty, inventive step, and sufficiency of disclosure of Impossible Foods’ invention.

Soy leghemoglobin: at the bleeding edge

At the heart of the reinstated patent is soy leghemoglobin, a protein derived from genetically modified yeast (Komagataella phaffii). The yeast is engineered to produce leghemoglobin, a molecule naturally found in soy roots that contains iron and mimics the properties of haemoglobin found in animal blood.

Through a precision fermentation process, the company inserts DNA from soy plants into the yeast strain, enabling it to produce soy leghemoglobin, a heme protein that closely mimics the sensory properties of its animal counterpart. During cooking, the heme protein interacts with flavour precursors such as cysteine, glucose, and thiamine, creating the aroma and taste associated with meat.

Impossible Foods’ heme protein also enables its flagship burgers to “bleed” like traditional meat, a feature that appeals to consumers seeking authentic sensory experiences in plant-based products. It further provides bioavailable iron, addressing nutrient equivalence in plant-based foods.

The patent dispute

Impossible Foods’ patent was initially challenged in 2018 on the basis of the lack of novelty and sufficient disclosure. While the EPO’s Opposition Division determined in 2022 that the patent’s invention was novel, it revoked the patent on the grounds of insufficient disclosure.

The revocation cited the broad claims of the patent, which covered billions of potential combinations of heme-containing proteins and flavour precursors and stated that the patent failed to provide enough detail for skilled practitioners to reproduce the invention across its full scope.

The recent appeal overturned this decision. The EPO Board of Appeals ruled that the patent adequately described the process of isolating heme proteins and identified specific flavour precursor combinations that create the desired sensory effect. It also confirmed that the invention involved an inventive step, as the use of heme proteins in this specific context was not obvious based on prior art.

The decision secures Impossible Foods’ exclusive rights to its heme-based method in Europe, marking the resolution of a lengthy legal process.

Impossible to enter Europe?

The EPO’s decision comes at a time of heightened regulatory and market challenges for the plant-based meat sector in Europe. While consumer interest in alternative proteins remains high, the industry has faced opposition to the use of meat-related terms on labels, as well as regulatory hurdles related to novel ingredients and precision fermentation.

For Impossible Foods, the reinstatement of its heme patent is a key milestone as it seeks to enter the European market. Although its flagship burgers are already available in regions such as the US, Canada, Australia, and Singapore, the company has faced delays in the EU due to the regulatory approval processes.

Recent progress with the European Food Safety Authority (EFSA) has brought the company closer to market entry. In June 2024, EFSA’s food additives panel issued a positive safety assessment of LegH Prep, Impossible Foods’ heme-containing ingredient, concluding that it poses no safety concerns for its proposed uses. A further assessment from EFSA’s GMO panel in November 2024 confirmed the safety of the genetically modified yeast used to produce soy leghemoglobin.

Pending final approval by the European Commission and the Standing Committee on Plants, Animals, Food and Feed, Impossible Foods could bring its heme-containing products to European consumers in the near future.

Heme innovation

Beyond its implications for Impossible Foods, the patent reinstatement could be a broader victory for innovation in alternative proteins. As companies increasingly turn to precision fermentation to develop functional ingredients, the case reinforces the importance of heme proteins as a key area of research and commercialisation.

While Impossible Foods is currently the only company using heme in commercially available plant-based meat products, other companies are exploring alternative sources of heme to compete in this space. In 2021, US-based startup Back of the Yards Algae Sciences (BYAS), for example, developed a heme protein derived from spirulina, a type of blue-green algae.

The scientific community has also started to pay attention to alternative heme applications. An article published last year in the academic journal Algal Research investigated the potential for heme-enriched microalgae as a source of iron. The researchers concluded that “many hurdles remain until the idea of heme rich microalgal biomass is realised, but the possibilities for utilising such a product to address chronic iron deficiencies in humans and production animals are tantalizing.”