Modern biotechnology creates next generation therapies and cures, delivers value to patients and the economy, cuts greenhouse gas emissions, reduces reliance on fossil fuels, and generates higher crop yields with fewer resources. These critical activities and advances thrive only in an environment where biotechnology is supported by policies that maintain incentives for future innovation including the form of intellectual property rights while, at the same time, providing fair and equitable consumer access to innovative products. On both fronts, biotechnology enterprises face unprecedented challenges that, if not addressed, will slow the innovation engine. The consequent negative effects will be felt by all nations. Today, the biotechnology industry faces enormous challenges caused by deep public concern about pricing and access to medicines. The consequent political and public pressure is leading to rapid fire and poorly considered legislation. This, in turn, will likely result in an erosion of incentives to innovate, as it impacts return on investment and access to capital.

There was unparalleled surprise in New York when a powerful alliance of UN-backed asset owners announced it will drive it’s portfolio companies to carbon neutrality by 2050. This could mean a fundamental change in capital markets.

Every year, drug developers lose billions of euros because of late-stage clinical or postmarking safety problems with drugs. A recently kicked-off IMI consortium now wants to qualify a set of safety biomarkers that allow for the prediction of drug-induced injury of kidney, liver, vasculature, CNS, and pancreas. European Biotechnology spoke with Dr Michael Merz, the coordinator of the TransBioLine Project, and consortium member Prof Dr Stefan Wnendt about the plans and impact of the project.

By Ute Kilger, Patent Attorney, European Patent and Trade Mark Attorney, Boehmert & Boehmert Anwaltspartnerschaft mbB
The US Supreme Court has mutilated US Patent law with the law of nature doctrine created from the decisions Mayo v. Prometheus and AMP v. Myriad Genetics. Since then, the US-PTO has implemented guidelines, and the highest patent court in the US, the CAFC, has issued numerous decisions applying these Supreme Court decisions, making it hard or impossible to obtain useful patent protection and/or enforce it, in particular for inventions directed to diagnostic methods, or directed to naturally occurring substances.

As food producers are taking up current health and sustainability trends more and more, the next EFIB (30 September??2 October, 2019) will see a lot of technology providers and ingredient producers showcasing biotechnological solutions in Brussels. European Biotechnology spoke with Dr Gerhard Schmid, Head, Wacker Biosolutions, about the market, challenges, and growth strategies within the bioeconomy.

By Ute Kilger, Patent Attorney, European Patent and Trade Mark Attorney, Boehmert & Boehmert Anwaltspartnerschaft mbB
The Life Science Industry needs a strong, predictable, reliable patent system that incentivizes innovations in order to bring new drugs and diagnostics to the patient, drives innovations and prevents patent abuse. The US Supreme Court has rendered a series of decisions about patent eligibility (§101 of the Patent Act) that make entire parts of Life Science Technology ineligible for patent protection and/or renders granted patents unenforceable. This makes the patent system unreliable and unpredictable and averse to investment into innovations.   Change will need to come from Congress. Recently, a group of Senators and Representatives of the US Congress released the draft text of a bipartisan, bi­cameral proposal to reform Section 101 of the Patent Act. The initiative to reform Section 101 of the Patent Act needs political support from all life science stakeholders including from those in Biotech.

The recently released IACG report testifies that the antimicrobial resistance (AMR) problem is now receiving some echo at the political level. Literature exploring ways to fix the acknowledged market failure is growing. Stakeholder meetings deciphering the impact of the proposed models are being organised all over the world. Still, time is against us.

Rare functional sugars provide huge market opportunities. European Biotechnology spoke with Stefan Jennewein, Founder and CEO of Jennewein Biotechnologies, about the company’s strategy and its latest expansions to the Chinese market.

With partner Indivior exchanging a late-stage addiction programme for early-stage alternatives, 2019 did not start exceptionally well for Addex Therapeutics. But, the Swiss drug developer has shown the stamina to withstand far more serious setbacks in the past. For EuroBiotech, Addex’s CEO Tim Dyer recounts the company’s history and outlines its future.

Within the record time of nine months, the Austrian government, together with experts of the Austrian Bioeconomy plattform and the sustainability think tank Denkstatt, has worked out a national bioeconomy strategy. European Biotechnology spoke with Josef Plank, Secretary General at the leading Federal Ministry of Sustainability about the focus and ambition of the national initiative.