IAM Life Sciences: Key issues for senior life sciences executives 2021

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IAM puts together this yearly supplement to help senior life sciences executives to better understand the distinctive set of strategic and legal IP challenges that they face around the world. As such, it aims to help them protect, enforce and monetise the IP rights that are so crucial to businesses in the sector.


Patent Examination Guidelines – inventive step of a monoclonal antibody

CCPIT Patent and Trademark Law Office
In biopharmaceuticals, an antibody patent is one of the most valuable patents in the field.

Patent practice in China – diagnosis or treatment?

China Science Patent & Trademark Agent Ltd
A substance can have a medical use for the diagnosis or treatment of a disease.

Patenting plant inventions via the EPO after G 3/19

Over the past decade, the Enlarged Board of Appeal (EBA) of the EPO has changed its case law several times on the patentability of plants (and animals) produced by essentially biological processes according to Article 53(b) of the European Patent Convention (EPC).

IP strategies for biotech SMEs

Formosa Transnational
A year into the covid-19 pandemic, the value and importance of biotechs has been elevated considerably.

Strategies for pharma patent litigation

Gorodissky & Partners
According to official statistics, the pharmaceutical industry in Russia was among the industries that showed maximum growth in 2020.

Drug repurposing and skinny labels

Haley Guiliano LLP
The ongoing covid-19 pandemic has demonstrated the speed at which the biopharma sector can act when facing a medical emergency.

Regulatory data protection on marketing authorisation extensions – the second medical use problem reloaded

The approval of a drug does not mark the end of its development – research and development continues.

Personalised medicine in Brazil: IP and regulatory challenges

Kasznar Leonardos
With the development of techniques such as CRISPR and increasing knowledge in the ‘omics’, science can now provide what only a few years ago looked like science fiction: personalised medicine (sometimes referred to as ‘precision medicine’ or ‘personalised healthcare’).

Compulsory licensing in a (post) covid-19 world

Lenz & Staehelin
Medical science’s battle against SARS CoV-2, the virus that causes covid-19, has been impressive.

Protecting patent rights in the life sciences in India

The life sciences industry in India has improved significantly in the past three to four decades.

Preparing for China’s patent linkage system

Liu Shen & Associates
The patent linkage system refers to the ‘linkage’ between the regulatory approval of generic drugs and the patent protection of the relevant innovative drugs.

Wallflowers: biosimilars don’t dance – they go to the PTAB

McCarter & English, LLP
Biologics are drugs produced from microorganisms or that contain components of microorganisms (eg, antibodies, proteins, stem cells and nucleic acids) and are often made through biotechnology processes, such as gene editing and cloning.

Legal tech and biotech patents

NLO Shieldmark
Patents are a true form of capital: nice to have, hard to get and looking at others will rarely make you happy.

Mexican patent linkage according to the USMCA and the new IP Law

Since 19 September 2003, Mexico has been managing a patent linkage system.

Process patent pitfalls: developments in method-of-treatment and diagnostic-method claims

Williams & Connolly LLP
Patents on processes have been a mainstay of the US patent system since its earliest days; the very first patent issued in the United States in 1790, signed by George Washington, was for “making Pot ash and Pearl ash by a new Apparatus and Process”.