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Biotech Starter Kit – Why does Intellectual Property matter for biotechnologies?

22/07/2024

FACTSHEET

Why does Intellectual Property matter for biotechnologies?

Intellectual property rights (IPRs) are the key drivers of biotech innovation. They enable scientific breakthrough to be translated into real-life applications, from commercial goods, medicines, or starting materials. Within the biotech ecosystem, IPRs are what gives company assets their value and supports their creation and continued activities.

In a highly competitive industry such as biotechnology, IPRs encourage industrial applications, safeguard investments into innovative research, and enable smaller companies without a substantial capital base to access financing in an already challenging European venture capital landscape.

Which IPRs are important for biotech:

  • Patents granted to protect inventions at national or EU level
  • Biopatents granted to biotechnology inventions under the Biopatents Directive
  • Regulatory data protection granted to medicine developers protect clinical trial data under the EU General Pharmaceutical Legislation
  • Orphan Marketing Exclusivity granted orphan medicine developers to support development of therapies in rare diseases under the OMP Regulation

Biotech innovation made possible by IPRs:

Industrial biotechnology uses enzymes, microorganisms and living cells to make biobased products from renewable raw materials. This is a key enabler of the EU’s transition from a fossil-based economy to a green and competitive bioeconomy in multiple sectors, including chemicals, pharmaceuticals, food and feed, fragrances, detergents, paper and pulp, textiles, and bioenergy.

Healthcare biotechnology, including gene therapies, gene editing tools, RNA-based therapies, enzyme replacement therapies, vaccines, and monoclonal antibodies, amongst others, has transformed the pharmaceutical industry. Healthcare biotech is increasingly the primary source of new therapies, transitioning from ‘manage’ to ‘cure’ with improvements to quality of life, freeing patients, families, and healthcare systems.

European biopatent applications by fields of use in 2021(European Patent Office data):

  • 70% for biopharmaceuticals
  • 26% for industrial processes
  • 4% for agriculture

EuropaBio position:

EuropaBio is concerned about recent developments at EU and global level, including the proposal to lower incentives for novel medicines, the proposed Regulation on compulsory licensing, the European Parliament’s vote to ban the patenting of NGT plants, that undermine IPRs and send the wrong message to biotechnology innovators worldwide.

EuropaBio believes the EU should reinforce IPR for biotechnology as critical technology innovation at EU level and champion IP at global level to address shared health climate and environment challenges.

Biotech Starter Kit - Why does Intellectual Property matter for biotechnologies?


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Francesca Degli Agostini
Francesca Degli Agostini

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Important links

  • Industrial Decarbonisation Accelerator Act – EuropaBio Position
  • EuropaBio Position on the Critical Medicines Act

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