IP experts remain positive in the face of changes to the global life sciences landscape
Contributors to the latest edition of the IAM Guide to Life Sciences stress that, while AI has the potential to revolutionise the global life sciences landscape, its integration in the pharma industry and the growing threat of cybersecurity breaches pose significant challenges to those operating in this space.
However, there are many opportunities of which rights holders can take advantage.
Mitigation efforts can help curb increasing concerns around AI and cybersecurity, while the trade secret enforcement environment is maturing in China, bolstering options for companies rich in this form of intellectual property.
In Europe, while upcoming legislation looks poised to destabilise the agritech sector, the UPC is attracting rights holders from many sectors. And in South Africa, taking several strategic steps to tackle the surge in counterfeits will go a long way to establishing the country as a pharmaceutical hub.
AI – more risk than reward?
The explosive growth of Big Data, significant advancements in machine learning and substantial investments from major tech companies have propelled AI into virtually every aspect of our lives, says Belle Van of Blaney McMurtry. “In the pharmaceutical industry, AI is revolutionising disease-target identification, discovery of drug candidates, prediction of molecule properties, optimisation of biopharmaceutical manufacturing, data interpretation and pattern recognition, streamlining of clinical trials and enhancement of patient care,” she reports. “These innovations have led to significantly shorter drug development times, reduced development costs and expedited market entry.”
Indeed, AI has the potential to “revolutionise many applications in the life sciences industry” from initial research and identification of drug candidates to marketing of pharmaceutical products, says Robert Paradiso of Lowenstein Sandler. AI can be used to accelerate drug discovery and can utilise post-marketing data in the development of personalised medicine and additional therapeutic indications, he posits.
“The application of AI technology to accelerate these efforts will also provide enhanced opportunities in the development of intellectual property,” Paradiso claims. “Patent-eligible subject matter will likely be available for new molecular entities, clinical trial results and post-marketing analysis, as well as other stages in the developmental and regulatory processes.” Taking these opportunities will be invaluable in product-lifecycle management, he adds.
However, Van stresses that the increasing integration of AI in the pharma field presents several legal and ethical challenges. Data bias, privacy, regulatory uncertainties in the absence of clear guidelines of AI use and other challenges to IP rights are posing significant hurdles, she warns. “It is imperative that we monitor future developments and engage in discussions to establish a framework for the responsible and ethical use of AI.”
Cybersecurity is also a major concern across many facets of the life sciences space “due to the industry’s generation, analysis and sharing of data”, Paradiso reports. The data itself and the systems used in its application are all vulnerable to breaches and ransomware attacks.
“One particular threat with potentially serious adverse implications is the theft of intellectual property,” he warns. “Information related to drug development, clinical trials and marketing analysis is highly valuable to cybercriminals.” If this information “falls into the hands of an unscrupulous competitor”, there can be myriad negative consequences – competitive products can have an accelerated timeline and, in extreme situations, can even beat the victimised company to the marketplace.
But Paradiso has guidance on how to combat these threats. “Life sciences companies need to invest in cutting-edge IT and infrastructure,” he urges. “They must also assure that employees at every level of the organisation are educated about cybercriminal tactics in order to help prevent and minimise breaches.” He adds that attention to the development of a robust patent estate is also critical to minimise damage due to cybertheft.
Legislative changes and courts rattle the landscape in China and Europe
Trade secrets – a maturing environment in China
In China, historically, life sciences companies have relied upon patents to protect their innovations. However, according to Benjamin Bai of King & Wood Mallesons, the greatest untapped opportunity to beef up IP protection in China lies in trade secrets. They are “often the overlooked sibling” because trade secret litigation is less common than patent litigation and more challenging for plaintiffs.
However, recent legislation and case law developments have brought positive changes for trade secret protection in China, he reports. “Chinese courts are now increasingly inclined to provide meaningful redress for trade secret wrongs and render record-setting damages awards.”
“Life sciences companies are replete with valuable trade secrets,” Bai insists. “They take years to develop but seconds to destroy.” It is therefore imperative that companies have robust policies and procedures in place for protecting this information. “A trade secret strategy upgrade for China is both warranted and necessary,” he adds.
Companies must adjust priorities following Supreme Court patent-linkage decision
“China has the second-largest pharma market in the world and offers unparalleled opportunities for innovative biopharma companies,” Bai says. It has a patent-linkage system that prevents marketing approval of generic drugs until after the expiration of patents covering the drugs or uses.
“According to a decision by the Chinese Supreme Court, an innovator’s drug must have been marketed in China for the relevant patents to be eligible for patent-linkage protection,” Bai reports. “This highlights the need for multinational biopharma companies to adjust their clinical and marketing priorities for China in the global context.”
However, not all is lost if an innovator is unsuccessful in using patent linkage to block generic approval, Bai says. “Patent litigation outside of patent linkage can still be effective to curb the commercial activities of generic competitors. Unfair competition should also be one of the arsenals against such competition.”
Europe in state of flux following first year of UPC and upcoming legislation
Having now celebrated its first anniversary, the UPC has made significant waves in the European court system. “From what we have seen in the augural year, the court has fully met the IP community’s high expectations,” Markus Grammel and Sebastian Ochs of Grunecker claim. They hold that the broad geographic scope of its decisions, the expected possibility to collect higher damages and the speed of proceedings have attracted patent owners from various tech sectors. These rights holders are willing to accept the risk of a central revocation of their patents in all participating member states in exchange for the advantages the UPC offers.
However, EU legislation that could substantially threaten intellectual property in the agritech sector is in the pipeline, Grammel and Ochs warn. “It seeks to facilitate market entry for new genomic technique (NGT) plants (eg, CRISPR) that can be considered equivalent to conventional plants (so-called ‘NGT1 plants’).” The legislation also initially proposes a far-reaching patent ban on these plants, but “this seems to be currently off the table”, they report.
“This legislation has not been passed yet and further modifications may still be possible – yet, as it stands, this would further tighten an already restrictive IP landscape in Europe for the agritech industry.”
South Africa’s blossoming life sciences sector under threat
South Africa’s life sciences sector is ripe with opportunities that are poised to drive significant advancement, Chyreene Truluck of Spoor & Fisher claims. Biotech stands at the forefront, offering solutions to pressing health and environmental challenges.
“The covid-19 pandemic ushered in renewed interest in moving South Africa from being a pharmaceutical importer to a manufacturer,” she reports. “The country’s medical devices sector is also a high priority with much room for growth in local development and production.”
Further, South Africa’s rich biodiversity provides a unique platform for bioprospecting, and the growing demand for personalised medicine presents a promising avenue for investment and innovation.
As South Africa positions itself as a hub for life sciences on the African continent, these opportunities not only promise economic growth but also hold the potential to address societal needs and improve quality of life. However, both current and future threats pose significant challenges in the IP realm.
Currently, the proliferation of counterfeit pharmaceuticals is a pressing issue, Truluck admits – as is the gap in regulations surrounding bioprospecting and use of traditional knowledge. “Future threats include the potential impact of international trade agreements on access to affordable medicines and the protection of South Africa’s genetic resources,” she says.
But hope is not lost. Truluck insists that “there are several strategic steps that rights holders can take to combat the various threats”. “Strengthening partnerships with local authorities and law enforcement agencies can enhance IP enforcement efforts, and investing in capacity-building initiatives to educate stakeholders about IP rights is vital.” Further, advocating for policy reform to align with global IP standards while safeguarding national interests is crucial, she adds.
“By proactively addressing these challenges, South Africa can foster a conducive environment for innovation and protect the integrity of its life sciences IP landscape.”
The IAM Guide to Life Sciences is now live and available to read here.