Surging litigation numbers and public distrust plague life sciences landscape
It has never been more exciting to be involved in the life sciences space – or more challenging. Innovative new technologies are transforming the design of clinical trials but they are also making it more difficult to predict trends in patent filings, while overregulation and increasingly strict legislation are creating new obstacles to patent protection.
We asked contributors to the IAM Guide to Life Sciences for their expert insight into the biggest challenges arising around the world. Detailed responses from Australia, India and Germany analyse the most critical threats facing those in the life sciences space in the Asia-Pacific and beyond, along with steps that innovators can – and should – take to mitigate risk.
AI, blockchain technology and 3D bioprinting are just some of the new tech transforming the sector. AI is aiding drug design, robotics are being used for automated pipetting and blockchain technology “has the potential to revolutionise the life sciences industry” from clinical trials to healthcare data storage, according to Manisha Singh and Shikha Singh of LexOrbis.
However, implementing new tools involves significant risk. Singh and Singh warn that “increased usage of cutting-edge technologies will certainly enhance concerns with regard to risks involved”, including:
- being unable to identify the actual owner of the rights; and
- data mining.
But there are measures that rights holders can proactively take. If an innovative product or process is developed by AI, then it is best practice that the “person/individual initiating such action should be the inventor of said product/process” under the laws of many countries. Industries heavily involved with R&D should also consider including relevant clauses in their employment agreements, so that “professionals are aware that an invention will be considered for IP rights protection”.
Further, as usage of data-driven technologies rises, so are levels of piracy. Singh and Singh advise rights holders to “employ data protection tools” to secure confidential information wherever possible.
Overregulation of the market and public distrust
Cohausz & Florack’s Arwed Burrichter, Natalie Kirchhofer and Romina Kuhnle express growing concern about the “underestimated but relevant threat” to life sciences: overregulation of the market and the general public and stakeholders’ “growing scepticism and distrust” around patents and new technologies, such as gene therapies or genetically modified crops. They argue that it is the responsibility of all rights holders to “relentlessly” educate all stakeholders involved, as well as politicians, courts and the public about the importance of science and intellectual property in “fostering innovation and making our world a better place”.
For R&D and development teams, a prominent issue is the increasing complexity of the IP situation surrounding new platform technologies, such as gene editing or digital solutions. “This makes freedom-to-operate assessments a big challenge and less definitive,” Burrichter, Kirchhofer and Kuhnle claim. “As the FTO situation is often complex and uncertain, successful life sciences companies have grown to accept a greater degree of risk for a prospect of return on investment.”
Because innovations rarely come solely from within one company, the keys to success here, they insist, are smart partnering, effective business development and deal strategies, as well as favourable licensing terms.
Challenges in the Asia-Pacific region
Divisional applications and Strawman oppositions
In India, the eligibility requirements for divisional applications are becoming increasingly strict, which is curtailing the protective scope for life sciences-based inventions, say De Penning & De Penning’s S Anitha Shirmila Elizabeth, Simran Kaur Khalsa and Divya Shekar. “As per these requirements, claims cannot be outside the scope of the original claims of the parent specification, and at the same time, there cannot be a duplication of claims.”
For rights holders hoping to file divisional applications in India, Elizabeth, Khalsa and Shekar emphasise the need to cover all bases. It is crucial that claims encompassing various aspects of the invention are incorporated in the parent application “so that the divisional applications can derive sufficient support from the parent application claims”.
Another threat looming on the Indian patent landscape is the surge in Strawman oppositions being filed against life science applications. Elizabeth, Khalsa and Shekar warn that these are significantly delaying enforceable terms. In order to curb such oppositions, “it is mandatory to have the proper credentials of the opponent established before contesting the patent application’s validity”.
More litigation in Australia
As the value of biological medicines grows, so does the likelihood of patent litigation. This is already the case in Australia, Katrina Crooks of Spruson & Ferguson reports – with the trend expected to increase in the coming months and years, especially in light of the Australian government’s initiatives to support biosimilar medicines in order to aid affordability.
Further, patents in the biologics field face particular challenges under Australian patent law. While subject to the same legal principles, “the courts’ evolving approach to the permissible scope of patent claims” puts life science patents on a different playing field. “Rights holders are best placed to counter these challenges by focusing on a strategic and careful approach to building their patent portfolio to support a particular product,” Crooks urges.
Similar to traditional small-molecule products, “the expiry of a foundational API patent also presents a threat to market exclusivity”, with follow-on patents often more likely to be the subject of validity challenges. In that context, Crooks asserts, rights holders should carefully consider patent term extensions in light of recent developments.
The pace does not look to be slowing down any time soon, making it critical to stay ahead of the latest twists and turns and new questions that lurk around every corner. From how to navigate Mexico’s patent linkage system to taking advantage of EPO prosecution, rights holders will want to be in the know.
The IAM Guide to Life Sciences was published in August 2023 and is available to read here.