Resources

Country and Regional Highlights

INDIA

India’s Unique Strengths for life sciences development efforts

Highest number of FDA approved sites for biopharmaceutical manufacturing outside the US (100+)
Cost advantage estimated at 1:3 compared to development efforts in the US
Aggressive government funding of life sciences R&D facilities which collaborate with industry – e.g. laboratories of CSIR (Council of Scientific and Industrial Research), which are one of the world’s largest in public funding and capabilities
Preclinical research well-developed and growing for small animals models, but lags somewhat for large animal models
Amongst the highest genetic diversity in the world, ideal for biopharmaceutical development and clinical research
Increasing activity in clinical trials, growing at above 10% a year with a largely treatment-naive population. Diagnostic trials expected to drive growth

India as a life sciences market

Expected to demonstrate double digit growth for the next couple of decades
70% of growth in the global biopharma industry through 2015 is expected to come from Emerging Markets with a substantial contribution from India
Highly segmented Indian market, with wide differences between segments and geographic regions
85%+ of healthcare expenses are paid out-of-pocket, although this scenario is set for substantial change in the next few years

Some Intellectual Property (IP) considerations in India

India became a signatory to TRIPS in 2005 (Trade Related aspects of Intellectual Property Rights) under the aegis of the WTO
IP generation, protection and enforcement in India is evolving rapidly
Precedence such as compulsory licensing of IP is highly dynamic (e.g. a compulsory license of Bayer’s kidney cancer drug Nexavar was granted)
Patents for incremental improvements without demonstrated therapeutic benefits can be challenging (e.g. for pharmaceuticals)

GERMANY

Germany’s Unique Strengths for life sciences development efforts

Optical technologies and medical imaging are unique German strengths in terms of development capability, with a 70% export ratio
Rapid prototyping, nanotechnology and process engineering are some of the other traditional strengths in Germany
Highly innovative life sciences track record. Germany is 2nd after the US in terms of issued patents. One-third of the turnover in the German medical technologies industry is derived from products less than 3 years old.
The German medical technologies space is made up more than 85% by small and medium sized enterprises (SME), which offer rich opportunities for global contracts and collaborations
Germany boasts of highly evolved R&D organizations such as the Max Planck Society, Leibniz Association, Hemholtz Association and the Fraunhofer Society – with impressive track records of collaborating with industry
Timelines for contract evolution and related language barriers could be a challenge in Germany, although these can be successfully navigated
Germany has consistently ranked very high for a favorable business environment and competitiveness
Germany is often the choice for first-in-man clinical trials for medical devices

Germany as a life sciences market

Germany is the world’s third-largest market for pharmaceuticals as well as medical devices after the US and Japan
The market is experiencing downward pressure on prices
German demographics are expected to evolve towards more people in the 65+ age group

Some Intellectual Property (IP) considerations in Germany

Because of employee inventions provisions in German IP Law, express IP assignment language is highly recommended while collaborating with entities in Germany. The German law differs somewhat from other European jurisdictions
German IP law offers the utility model for protection, a kind of “mini patent”. Amongst important considerations are the lower cost and the shorter duration of protection

TAIWAN

Taiwan’s Unique Strengths for life sciences development efforts

Taiwan offers unique strengths and expertise in medical device design, botanical and herbal medicine, electronic control systems for devices, and in miniaturization
Specialized expertise exists in Taiwan for biotech orchid technology, vaccine research and liver diseases, including hepatitis and liver cancer
Highly productive innovation track record in terms of number of international patents
The Taiwanese life sciences space is dominated by small and medium sized enterprises, which offer rich opportunities for global contracts and collaborations
Entities in Taiwan have a long history of collaborating with global partners, with contractual enforcement and IP protection as traditional strengths
Taiwan has highly evolved life sciences R&D organizations such as the ITRI (Industrial Technology Research Institute), with a very strong track record in global collaborations and working with industry
Taiwan boasts a strong life sciences talent pool, with many R&D personnel trained in the West
Taiwan enjoys an excellent location in terms of access to other Asia-Pacific markets
Taiwan is a popular location for clinical trials. It follows ICH-GCP guidelines, which were adopted by the Department of Health (DoH) in 1997

Taiwan as a life sciences market

Some Intellectual Property (IP) considerations in Taiwan

IP protection scenario in Taiwan has undergone a sea change in the last 10 years, with vastly improved protection
There are some unique considerations for international patent applications from Taiwan, given that Taiwan is not a signatory to the Patent Cooperation Treaty (PCT)