Patent linkages in SE Asia

Patent linkages allow the connection of marketing approvals (MA) for generic pharma products to the patents covering an innovator company’s original/reference drug. Their purpose is to ensure that MAs are not given to patented products; and to allow generic makers to plan their launches without infringement risk, and also to invalidate weak patents.  It also allows the innovator company to take action for infringement of relevant patent(s) to prevent MAs issuing to generic products too. In some countries, innovator company must list relevant patents so a generic company knows which patents cover the original/reference drug. Encouragement for generic pharma companies to seek MAs is sometimes provided by giving a period of market exclusivity to a generic company who invalidates a blocking patent.  

In SE Asia only Singapore has a patent linkage system in place now. For the MA, the generic applicant must file a declaration stating whether its product infringes any relevant patents.  This is a self declaration system, whereby it is up to the applicant to ensure there is no infringement. The generic applicant may also be required to notify the patentee of its MA application. The innovator company is entitled to take action for infringement, which stops the MA process until the patent issues have been decided.

Under the CPTPP treaty Malaysia and Vietnam will have to implement a patent linkage system, and possibly Singapore may amend theirs. The CPTPP requires for the MA, prior notice to the patent holder and a period for the patent holder to take legal action if needed. Unsurprisingly given the CPTPP's roots, this is a system based on the US one, which in essence allows the patent owner to intervene to prevent the MA issuing, and avoids the risk of infringing products getting to market (and leading to expensive litigation). The CPTPP however also allows alternative systems that make the MA dependent on non- infringement (Singapore's current approach). 

Vietnam’s Ministry of Science and Technology is circulating a draft outline of the amendments to their IP Law. The draft outline mentions a new Article on patent linkage. However the specific provisions have not yet been drafted.

The discrepancy in the approaches reflects a worldwide debate on the scope of patent linkages. Should they be preventative like the US or informational like Singapore. The EU has no patent linkage rules and only some national laws require an informational type approach to MAs. 

The other major regional IP treaty in Asia is the RCEP which is driven by China. That has no patent linkage provisions in the IP chapter.  All ASEAN countries are planning to join this. It will be interesting to see how 3 of the 10 ASEAN countries fare with patent linkages while the other 7 do not have them.

IP and technology developments from IPWeek@SG

At the IPWeek event in Singapore this week there were several patent and technology announcements. Nine of the ten SE Asian IP offices launched a new pilot initiative to speed up patent applications for “key emerging technologies” including fintech, cybersecurity and robotics. The program called ASPEC Acceleration for Industry 4.0 Infrastructure and Manufacturing (ASPEC-AIM) will run for 2 years and allow for faster track patenting in these new tech sectors.

The existing ASPEC patent prosecution highway will also be expanded under a new program called the PCT-ASPEC. This will enable use of PCT reports from another ASEAN International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) to accelerate their patent applications elsewhere in another ASEAN country. The ASPEC system has been moderately successful but update has not been as significant as hoped, despite business demand for faster patenting in the region. This widens the document scope to add other reports which can be submitted to ASEAN patent offices in support of expedited examination.

IPOS also announced that Alibaba Group was granted an artificial patent on only 3 months  three months. IPOS’s runs an Accelerated Initiative for Artificial Intelligence patents.

Singapore accredited for PCT searching and examination

The development of SEA and in particular Singapore as a patent centre continues with the appointment of IPOS as an International Search Authority (ISA) and International Preliminary Examining Authority (IPEA) under the Patent Cooperation Treaty (PCT).

MoUs have been signed with the Directorate General of Intellectual Property (DGIP) of Indonesia, and with the United States Patent and Trademark Office (USPTO). Already IPOS is an ISA and IPEA for a number of countries, including in SE Asia, Vietnam, Brunei, and Laos. IPOS launched operations as an ISA and IPEA on 1 Sep 2015, so is now the first IP office in SE Asia through which businesses and inventors can fast track patent applications for  protection in the  148 PCT member countries. IPOS has already received 41 PCT applications appointing IPOS as an ISA and IPEA.

 

Singapore is the first ASEAN PCT authority

The arrival of 2015 will see Singapore start to take on its work as an International Authority under the PCT patent system.
 
Singapore is moving to become the region's key IP centre, and this is part of plan. WIPO at present uses 17 countries to search and examine PCT patent applications and Singapore will become the 18th. It is first in the ASEAN region and the fifth in Asia (along with China, India, Japan and Korea). Applicants under the PCT may therefore select Singapore for searches and examination reports, which will be conduced by IPOS.

Singapore is presenting this as an advantage for the region (and their ability to handle Chinese is for sure). How ASEAN applicants can benefit is not yet clear. Singapore examiners will certainly be more in tune with some technologies in the region.  And it presents opportunities for ASEAN applicants to have an authority based in their region which they can contact easily.

Singapore's plan to be the regional IP centre in Asia

What is Singapore up to with the consultation paper issued in mid March to open up it's patent attorney profession? Singapore moved from a re-registration system to a full patent system in 1995. Since then it's been an upward trend for patent attorneys and patent holders alike as numbers of local and international patent filings had been steadily increasing and a technically proficient patent agency profession has grown up.

Now Singapore proposes to regulate offshore patent filing by foreign registered patent agents. In truth foreign registered patent agents who may or may not practice offshore probably should probably not be 'regulated' since activities performed in Singapore relating to another legal jurisdiction should surely be irrelevant to Sinagpore? In Hong Kong for example many US patent attorneys file directly in the US, provided they comply with the basic requirements for having a qualification and an address for US service.

Singapore now seeks  to regulate that to attract more international patent firms.  It is part of a wider plan for Singapore to become a professional hub for IP in Asia, grabbing a slice of the pie that was for many years eaten by default in Hong Kong. This pie is now more like crumbling pastry, as mainland China IP work and IP jobs leave Hong Kong for the PRC. Hong Kong has an urgent need to revinvent itself, IP wise. Arguably this is happening with the government issuing a consultation paper on a full patent system, and two groups quibbling over the establishment of a patent professional qualification. But they are over a decade behind Singapore which now far outpaces HK in patent production. 

IP Komodo observes a trend for MNCs to split legal functions in the emerging Asian markets (excluding Japan that is), between the PRC and Singapore. In the past they might have one regional IP lawyer or even team in Hong Kong. Singapore's IP Academy quite separate from its IP office, IPOS, seeks to promote IP leadership in the city. Now the government has embraced IP through policies to attract more IP functions to create a  regional centre of IP excellence for Asia in Singapore.