“Evergreening”, medical innovation and patents: separating fact from fiction

The extent to which follow-on pharmaceutical innovations should be protectable by patents is hotly debated amongst the public health and IP community in Geneva. But are fears that follow-on patents simply extend indefinitely, or “evergreening”, medicine patents justified?

Drawing on global experiences and real-world evidence, this working lunch examined what exactly is follow-on pharmaceutical innovation, how it impacts public health, and whether national patent laws should treat it differently to other forms of medical innovation.

The common theme amongst participants that “evergreening” is a problematic concept, and that follow-on innovations have produced real benefits for patients, and the ability to secure patents has been a critical incentive to underpin R&D in these areas.

Participants included representatives from the diplomatic community, multilateral organisations, academia and the private sector.

Prof Timo Minssen of the University of Copenhagen presented the findings of his recent joint paper Patentability Standards for Follow-On Pharmaceutical Innovation. He cited numerous examples from jurisdictions around the world in which patent offices and courts have applied the well-recognized requirements of patentability, including patent eligibility, novelty, inventive step and industrial application, to follow-on pharmaceutical inventions, and in so doing have advanced innovation in public health and ultimately the lives of patients.

He also put into perspective the concept of “evergreening”, pointing out that – unless there is a clear misuse of the regulatory system – a patent on an improved formulation, for example, is limited to that improvement and does not extend patent protection for the original formulation – and nor does it impede generic entry for the original version.

Of course, this assumes a reasonably well-functioning pharmaceutical market and competition. If that market breaks down in a manner that forces patients to pay higher prices for a patented new version of a drug that provides little real improvement over the original formulation, then it is the deficiency in the market or the regulatory system which should be addressed, rather than the patent system itself.

Finally, he emphasised the role of competition law in countering abuses of the patent system, and the mitigating effects of correctly and coherently applied patentability criteria. If the traditional patentability criteria are applied, there are no need for new ones.

Prof Prabuddha Ganguli of the Rajiv Gandhi School of Intellectual Property Law gave his perspective as an IP practitioner who has drafted and defended dozens of patents within the Indian patent regime. He explained the importance of follow-on innovation within medicine and discussed the details of section 3d of the Indian Patent Act and how that has forced innovators in India to change and adapt their approach to R&D and patent drafting. The ability to patent follow-on innovations has been particularly critical to help generic companies boost their innovative capacity and take their first steps into de novo drug R&D – critical for the long-term future of the Indian pharmaceutical industry.

Peter Thomsen of Novartis outlined the importance of patents to support investment in R&D into follow-on innovations, giving several examples of important follow-on medicines and formulations that have depended on patent protection. In his view, it would be a mistake to discriminate against these kinds of technologies within the patent system given their importance to innovation and advances in medical technology.

IP as a Driver of Competitiveness and Growth: Policy Challenges and Opportunities

World IP Forum, Taiwan

MODERATOR:

  • Philip Stevens, Executive Director, Geneva Network (UK)

PANELISTS:

Click here for more information: https://www.worldipforum.com/index.php

The Bangkok Insight covers the latest intellectual property rights report

The Bangkok Insight covers the latest Geneva Network Report, “Thailand must raise intellectual property protection standards”.

“…The research, “The importance of intellectual property for development: substance for reform in ASEAN countries” states that Thailand needs to improve in many areas, such as patent checking and patent protection to drive economic growth. And to avoid being caught in a middle-income trap Including being able to step into an economy with higher incomes…”

CodeBlue discusses latest Geneva Network report

CodeBlue chatted with Geneva Network Director, Philip Stevens, to discuss the latest report, “The importance of Intellectual Property Rights for progress”.

“…The report, which was recently launched by Malaysian Deputy Minister of International Trade and Industry Ong Kian Ming, looked at the strengths and weaknesses of the framework of intellectual property protection within key ASEAN member states such as Malaysia, Philippines, Vietnam, Indonesia and Thailand.

It considers that most ASEAN countries were still not up to mark, would be disadvantaged, and even left behind in the race for increased foreign investment and economies better adapted to the challenges of the 21st century.

We sat down with Philip Stevens from Geneva Network, one of the co-sponsors of the report to ask him to expand on some of the findings, defend a few positions and find out how best the economies in the ASEAN region can make the leap and be prepared for Industry 4.0 or the fourth industrial revolution…”

Click the link to read the full article, “Countries Need to Protect Fruits of Investment and Industry 4.0”

Intellectual property ASEAN

Bangkok Post coverage of Geneva Network IP report

Intellectual property ASEAN The Bangkok Post, “Improved IP rights crucial to progress”  has covered the latest report on intellectual property rights.

“Thailand is among the Asean countries that must raise their intellectual property rights (IPR) frameworks and enforcement mechanisms in line with global standards in order to join the ranks of high-income countries, new research by the Geneva Network shows.”

Click on the link above to read the full article.

WTO Public Forum panel on digital trade and health

Digital services hold enormous potential for improving healthcare delivery around the world, according to a panel convened by Geneva Network and the Information Technology and Innovation Foundation at this year’s WTO Public Forum. However, governance and trade issues need to be resolved to ensure the best management and cross-border flow of data.

Read a full account of the discussion here.

Panellists included:

Laurence Todd, Director IDEAS, Malaysia appeared on Bernama News Channel

Laurence Todd, Director of IDEAS Malaysia appeared on Bernama News Channel to discuss the findings of our joint report on the importance of IPRs for ASEAN Development.

Click here to see the full news item.

Geneva Network on Philippines ABS CBN

Geneva Network’s, Philip Stevens appeared on Philippines ABS CBN channel to discuss the importance of Intellectual property rights for Philippines economic development.

Intellectual property ASEAN

Trade secrets not so secret in PH, says UK report

The Business Inquirer of the Philippines article on the Geneva Network’s intellectual report, “Trade secrets not so secret in PH”.

Trade secrets get the least protection in the Philippines compared to the rest of Southeast Asia, at a time when the digital age has made information “easier to steal,” a report showed.

A report from England-based public policy research organization Geneva Network said the Philippines’ intellectual property law was not clear on the protection of trade secrets.

Click on the link to read the full article.

Business World, Philippines, covers intellectual property report

The Business World reports on the latest Geneva Network Report, “Philippine IP protections lag as regional economies shift to higher-value businesses”.

THE Philippines is “way behind” on intellectual property (IP) rights protections, a crucial consideration for investors deciding to put money in the country, the Geneva Network said in a report released to journalists Tuesday.

Click on the link to read the full article.