PODIS / Shutterstock.com
An increasing number of biologics and biosimilar products are appearing in the Thai market, but there are challenges concerning IP protection and regulation, say Alan Adcock and Atthachai Homhuan of Tilleke & Gibbins.
In 2002, the Thai government initiated a universal scheme to bring equitable healthcare access to the general public. Under the scheme, hospitals receive per capita funding based on 47 million people. At the outset, funding was approximately $38 per person; now, it is $83. Although per capita funding has more than doubled, the current figure is still low. This budget constraint has led the Thai government to favour generic companies as opposed to originator companies.
The Thai Food and Drug Administration (FDA Thailand) defines a biological product as any allergen, antigen, vaccine, hormone, cytokine, enzyme, product derived from stem cells or tissues, human whole blood and plasma derivative, therapeutic serum, immunoglobulin, or monoclonal antibody which is obtained from one of the following procedures:
- Microbial or eukaryotic cells culture;
- Extraction of substances from biological tissues, including human, animal, and plant tissue;
- Recombinant DNA techniques;
- Hybridoma technique; or
- Propagation of microorganisms in embryos or animals.
FDA Thailand’s definition of a biological product is quite broad, ranging from the well-established structure molecule to cells and tissues. Most biological products have a relatively large molecular weight and are more complex than conventional chemical drugs.
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
To continue reading this article and to access 4,500+ articles, our digital magazines and special reports published for LSIPR subscribers only then you will need a subscription.
If you are already subscribed please login.
Official LSIPR subscribers include:
Allen & Overy
Arnold & Siedsma
Birch, Stewart, Kolasch & Birch LLP (BSKB)
Carpmaels & Ransford
Cooley
European Patent Office
Finnegan LLP
GH Research
Gowling WLG
George Washington Law School
HGF Limited
IQVIA
Kirkland & Ellis International LLP
Marks & Clerk
Mintz Levin
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
Taylor Wessing
The United States Patent and Trademark Office (USPTO)
Valea AB
World Intellectual Property Office
For multi-user price options, or to check if your company has an existing subscription we can add you into for FREE, please contact Atif at achoudhury@newtonmedia.co.
If you have any technical issues please email tech support.
Alan Adcock, Atthachai Homhuan, Tilleke & Gibbins, Thai Food and Drug Administration, biologics, biosimilar, patent, Thai Patent Act, MA licences,