IAM Life Sciences: Key issues for senior life sciences executives 2020

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The key IP issues that entities operating in the pharmaceutical and biotechnology industries may confront as they develop and roll out their business strategies.


Patenting artificial intelligence in the life sciences: a practical guide

Discussion about artificial intelligence (AI) is booming and examples of AI applications are being reported in all technical fields, including the life sciences.

Deadly pitfalls and lessons learned – claiming priority at the EPO

This chapter explains the EPO’s requirements for a valid transfer of the priority right and summarises the relevant case law.

Patent issues in CAR-T technology

Haley Guiliano LLP
In view of the increasingly crowded CAR-T field and the commercial value of CAR-T products and patents, innovators, follow-on developers and late entrants in the CAR-T field should develop early on a sound patent strategy and thoroughly vet their products and processes for any freedom-to-operate issues.

A guide for second medical use claims in Brazil

Montaury Pimenta, Machado & Vieira de Mello
One of the most common questions regarding patent protection in Brazil refers to whether there is a possibility of protecting second medical use of known chemical compounds. The answer is simple: yes, it is possible to protect second medical use in Brazil.

Patenting personalised medicine in Canada: navigating choppy waters

Oyen Wiggs Green & Mutala LLP
This chapter will guide the reader through the types of diagnostic method that are likely to be considered patentable under the current regime and which may potentially encounter patentability issues in Canada.

Making sense of the doctrine of equivalents in pharmaceutical patent litigation

McAndrews Held & Malloy
Companies should be mindful during prosecution of patent applications to avoid inadvertently surrendering claim scope and barring themselves from later relying on the doctrine of equivalents. Conversely, companies looking to design around competitors’ patents must study the specification and prosecution history carefully to determine where they can safely practice without risking infringement.

Second medical use inventions – Russian and Eurasian patent legislation

Gorodissky & Partners
When patenting inventions in Russia, one potential route is granting a patent for an invention relating to a well-known product used for a new purpose, the so-called ‘second medical use invention’.

Doctrine of equivalents for life science patents in China

Liu Shen & Associates
The doctrine of equivalents is an important principle in patent infringement disputes. It could prevent the accused infringer evading liability for the infringement by making insubstantial changes to a patented alternative. However, determination of an equivalent feature can be tricky.

Navigating the therapeutics market in Australia: the role of intellectual property

Griffith Hack
Australia is a sophisticated market for therapeutics and a favourable country in which to patent. Despite many changes in law and practice in recent years, patenting is relatively low in cost and quick to grant.

Biologics and biosimilars in Brazil – the strategic questions

Kasznar Leonardos
This chapter highlights the strategic questions surrounding patent prosecution, patent litigation and the regulation of biologics and biosimilars on the Brazilian market.

Trends in biopharma and biosimilar patents in India

Legal protection for IP rights in the science and technology domain is a topic of long debate around the world, particularly regarding those technologies that generate economic growth, are beneficial to society and improve patient lifestyle.

Regulatory framework – healthcare products and intellectual property in Mexico

With Mexico’s change of government, new trends and practices have been introduced, affecting, among other things, the regulatory and IP framework. This chapter contains an overview of the main ammendments made throughout 2019 and a brief discussion on what it is expected for 2020.

Life sciences battlefields – hot litigation topics in Switzerland

Lenz & Staehelin
This chapter aims to give a brief overview of the patent litigation system in Switzerland and highlight some current trends in life sciences patent litigation.

Section 505(b)(2) new drug applications – untapped opportunities

Buchanan, Ingersoll & Rooney PC
Each year, the US Food and Drug Administration (FDA) approves approximately 120 new drug applications (NDAs). But contrary to what many might believe, the majority of these NDAs are not, in fact, new chemical entities (NCEs).

The future of pharmaceutical patent litigation

Formosa Transnational
On 20 August 2019 the newly amended patent linkage system was officially implemented in Taiwan, changing the practice of the biopharmaceutical industry – one of the biggest patent litigation growth areas in Taiwan.

Market exclusivity for pharmaceutical products in Japan

TMI Associates
This chapter provides a concise introduction to these unique systems that constitute de facto market exclusivity for new pharmaceutical products in Japan.