PATENT EXTENSIONS
With regard to patent linkage, Japan’s Ministry of Healthcare, Labour and Welfare announced that it would not approve an application for a generic drug that cannot be manufactured due to the existence of patent rights. But the regulatory authority will prevent approval only if infringement is clear, which generally applies only in the context of compound patents.
Japan’s regulatory regime for market exclusivity is stronger than those of most Asian countries due to its re-examination period and patent term extension rules. Japan’s patent
term extension
rules are to some degree more permissive than those in the US, allowing the extension of multiple patents for related compound, use, and process patents. As in other countries, strong patents (such as compound patents), plus any available patent
term extensions, are highly effective at maintaining market exclusivity.
Key mechanisms Beyond pure patent protection, patent
term
extensions and data exclusivity (or its equivalent) are the key mechanisms for extending market exclusivity of innovator drug companies in the US, EU, Taiwan and Japan. In the US, and to some extent Japan, patent linkage is also an effective
means for maintaining market exclusivity when a pending dispute involves patents covering an innovator drug.
Generally speaking, the regulatory regimes for extending market exclusivity are not as strong in Asia as they are in the EU and US, so careful patent portfolio strategy, planning and enforcement are crucial for innovator pharmaceutical and
“PATENT TERM EXTENSIONS AND DATA EXCLUSIVITY (OR ITS EQUIVALENT) ARE THE KEY MECHANISMS FOR EXTENDING MARKET EXCLUSIVITY OF INNOVATOR DRUG COMPANIES IN THE US, EU, TAIWAN AND JAPAN.”
biologics companies looking to market and sell products in Asia. Although China has a “monitoring period” for new drugs—which provides a certain level of market exclusivity— the drug has to be manufactured in China for the monitoring period to apply, and China remains a challenging regime for obtaining and extending market exclusivity for innovator drugs.
The authors of the article thank the following for providing their legal insights on the topic of product market exclusivity: Grace Shao (partner, Taipei), Daisuke Tatsuno (partner, Tokyo), Stephen Jones (partner, London), and Guy Birkenmeier (of counsel, Dallas).
Isabella Liu is a partner at Baker & McKenzie’s Hong Kong office. She can be contacted at:
isabella.liu@
bakermckenzie.com
Mackenzie DeWerff is an associate at Baker & McKenzie’s Dallas office. She can be contacted at:
mackenzie.dewerff@
bakermckenzie.com
Haitao Sun is an associate at Baker & McKenzie’s Hong Kong office. He can be contacted at:
haitao.sun@
bakermckenzie.com
www.worldipreview.com
World Intellectual Property Review July/August 2012
37
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84