Brussels, Belgium
August 21, 2020
Read our feedback to the European Commission's initiaitve of the Intellectual property action plan.
Life sciences and biotechnology drive strategic innovations in key industrial ecosystems – e.g. health, low-carbon and agri-food. These innovations would not be without a robust intellecutal property (IP) framework to encourage investments in high-risk research and diversified product development. Maintaining the criticality of IP for innovation requires policy coherence. In health, the ongoing “Incentives Review” must recognise IP as the main driver for innovation and not misidentify IP as a barrier to patient access.
Enable unitary patents
The EU biotechnology ecosystem is confronted with high costs of patenting, while competing with other high-tech regions (US, Japan, China). Enabling the unitary patent system to mitigate the patent cost hurdle will bring to market more innovative products. The Unitary Patent necessitates a timely, stable and uniform application, and all Member States using it.
SPCs
A Unitary SPC would reduce internal time and resources for SPC filings in each Member State. It would facilitate a consistent interpretation of the SPC Regulation and provide harmonisation in granting procedures by one authority and in appeal decisions in one court. It would ensure consistent and predictable decision-making if relying on examination guidelines, which should build on the recent case law. Despite the implementation challenges, a virtual granting authority of experts from NPOs and a virtual work-sharing platform with its decisions challengeable at the UPC is a way forward.
We support a Single Grant Mechanism if certain essential elements are ensured - identifying a suitable, appeal structure; and propose a Single Application Portal to work seamlessly alongside national SPC grants.
Better IP uptake for SMEs
A survey of 190 venture capital-seeking biotech companies showed that having at least one patent application filed reduced the time period to the first VC investment by 76% (Discussion Paper No. 09-003, To Be Financed or Not: The Role of Patents for Venture Capital Financing).
Biotechnology SMEs are particularly likely to struggle with high patent costs in the fragmented EU and post-COVID19. The risks include bankruptcy or filings elsewhere, missing out on the benefits for society.
SMEs need special incentives for the creation, registration, and use of IP assets, e.g. fast-track registration procedures, reduced filing fees, centralised advice, and technical assistance.
IP & data sharing
There are various examples of successful data sharing obligations and voluntary initiatives, e.g. IMI 'Big Data for Better Outcomes' program or the ClinicalStudyDataRequest.com. Biopharmaceutical companies have been operating satisfactorily with contractual and technical measures. Looking forward, the adequacy of the existing legal framework for a data-agile economy, incl. a Health Data Space, should be evaluated. In particular, the development of robust voluntary data sharing competition exemptions and appropriate incentives should be explored with stakeholders, incl. EuropaBio.
IP availability in crisis
In response to COVID-19, our industry has been collaborating broadly to develop quicker than ever more than 1000 potential treatments and vaccines. Products, knowledge and research capacity developed over many years relying on robust IP were the foundation for this unprecedented response. IP will continue to play a crucial role long after this pandemic to ensure preparedness with innovative solutions for pressing healthcare needs.
Global fair play
Our industry often finds itself the target of discriminatory localisation measures, which have serious consequences for its ability to operate in key markets, esp. for SMEs. Robust IP protection and enforcement is critical to incentivising investments in innovative industries and should be at the core of an ambitious EU trade policy.
Digitalisation is a key opportunity for the EU to become a trusted global leader. The EU needs to coordinate with relevant organisations (WIPO) to develop specific rules on AI.
Read the full feedback to the European Commission here.
Find out more about the Intellectual Property Action Plan here.
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