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Tuesday, May 26, 2015

Gilead under attack from Thai health activists

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Health activists in Thailand are pressuring the government to issue further compulsory licenses for medicines.  This time their focus is on hepatitis C a common corollary illness with HIV. A consortium of NGOs have banded together to lobby for the hepatitis C medicine sofosbuvir to be compulsorily licensed.  Gilead Sciences Inc has applied for a patent for this drug in Thailand but it is not yet granted (there is a long backlog of pharma patents in Thailand).  The NGOs argue the cost of the US drug firm’s hepatitis C medicine is US$1,000 per pill and a full treatment needs nearly 100 of these. Meanwhile Indian companies manufacture them for a fraction of this cost.

In late 2014 a similar group lobbied the government to prevent the grant of a patent to Gilead. Their strategy then was to argue that sofosbuvir's chemical ingredients were not novel.

Explaining the importance of sofosbuvir, spokesmen have said the drug is a radical improvement on previous treatments and can cure the disease within three months.  The Commerce Ministry and the Food and Drug Administration are now considering the issue.

This is a classic access to health vs innovator situation.It is also part of a wider campaign against Gilead in multiple countries.  NGOs are seeking to use multiple strategies to break the innovator's patent monopoly.  Whilst one drug might not matter, one can imagine that if they target all medicines, the likes of Gilead will be reluctant to keep producing new products.


Saturday, May 23, 2015

Thailand's 2015 Special 301 report

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In its Special 301 report this year Thailand was maintained on the Priority Watch list. There are concerns over a lack of government priority for IP enforcement and weak coordination among government entities despite the National IPR Center of Enforcement operating since in 2013.

Outside practical enforcement, issues are raised about the backlog of pending patent applications, widespread unlicensed software in the public and private sectors, growing Internet-based copyright piracy, rampant trademark counterfeiting, lengthy civil IPR proceedings and low civil damages, the protecting of unfair commercial use, as well as unauthorized disclosure, of test data generated to obtain marketing approvals for pharma and agrochem products, and finally extensive cable and satellite signal theft.
On one hand the report praises the new Customs Act that provides Thai Customs officers with ex officio authority to suspend and seize illegal goods in transit, as well as copyright law amendments to address unauthorized camcording. On the other it complains of poor laws relating to the lack of a much-needed landlord liability provision, inadequate protections against the circumvention of technological protection measures and unauthorized modification of rights management information, and unclear operation of ISP notice-and-takedown procedures.

The Special 301 Priority Watch List doesn't compare countries at the same level. The interesting comparison with Indonesia reads in Thailand's favour since many of the above are complex IPR issues most of which are not even discussed in relation to Indonesia, given that Indonesia faces much more fundamental problems. Thailand is a more developed market so the US expects a higher level of IPR protection.

Thursday, May 21, 2015

Indonesia's 2015 Special 301 report

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In the USTR's Special 301 review this year announced last week, only Thailand and Indonesia now remain on the Priorty Watch list from South East Asia.
Concern is raised over Indonesia's high incidence of fake pharmacuticals as well as media box piracy.  Weak protection for undisclosed confidential information is mentioned as is the lack of clarity around compulsory patent licensing.

The woeful lack of IPR enforcement is the main practical concern. In 2014, the Indonesian National Police only investigated 97 criminal IPR cases and the Attorney General’s Office (AGO) only brought twelve IPR cases to trial, the report says. The USTR recommends better funding for IPR enforcement, specialized IPR inspectors and prosecutors, a special IPR task force within the police, improved interdepartmental coordination and more prosecutions.



Tuesday, May 19, 2015

Philippines Customs - ups and downs

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Philippines Board of Customs does not have a great reputation. The president once called them the Bureau of Corruption, a play on the BOC acronym. April's news that the previous reforming Commissioner of Customs John Sevilla was standing down was greeted with great disappointment in the IP community. He started a major push to reform (see here) This led to the commencement of regular border seizures (as opposed to suspicious inland seizures long after the goods passed through the borders). The change was encouraging. His resignation he said was due to politics, such as apolitical appointees like lawyer Teddy Raval, being made head of BOC’s Intellectual Property Rights Division (IPRD), which he did not approve. He also made it very clear that improving accountability and cleanliness was still a work in progress. He was replaced by Businessman Alberto Lina.
Now a case with suspicious circumstances has exposed certain shady practices. On May 1st Customs officials seized 12 packages of fake medicines for hypertension, heart ailment and vitamin supplements imported from Pakistan and destined for a trader called Jenelyn Higbok in Manila. A formal alert order had been issued by Customs' Intelligence Group seeking further investigation and examination of the packages. However the packages were released on May 7, 2015.  2 Customs officials have now been implicated in this unauthorized release. They have since been dismissed.  The suggestion was that the information was not properly circulated, but in many cases officials are known to be complicit in smuggling.  Fortunately the packages were located and seized again. They will be examined tested by the FDA. Then appropriate forfeiture proceedings should be instituted.

This is perhaps an important statement that the Philippines will not tolerate misbehavior at Customs. One hopes this continues the previous good work of the former director.

Friday, May 15, 2015

Cambodia joins Madrid

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Cambodia has announced that it is joining the Madrid Agreement. Cambodia said on 5th March that its Commerce Ministry had submitted an Instrument of Accession to WIPO. Applications can designate Cambodia after 5th June.

Cambodia joins Vietnam, Philippines and  and Singapore of the 10 ASEAN countries that are now Madrid members. All ASEAN countries are due to join as part of their formation of the ASEAN Economic Community.

Saturday, May 9, 2015

Indonesian National Standard certification

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Indonesian Law No. 20 of 2014 on Standardisation and Compliance Assessment is the first law to provide for standards. It covers manufactured goods, services, systems, processes, and individuals, and sets out the institutions that will carry out assessments, development, supervision, of the system.  The Indonesian National Standards (SNI) system was formulated by a technical committee and will be overseen by the BSN (National Standardization Agency).

The SNI is a standard that must be complied with for certain designated goods, services, systems and processes in Indonesia. The affixing of the SNI marking on the product or service is an indication that it meets the standard requirements to allow the product to be sold in Indonesia.  Currently there are 273 mandatory products that the SNI applies to and which must be labelled. These include electric, wood, rubber, automotive, agro and health products (e.g. medicine, cosmetics, health apparatus and traditional medicines).

Articles 62 up to 73 of the Law provide for criminal penalties in respect of SNIs. Importing any product, or trading and marketing without an SNI or unlawful use of the SNI attracts criminal penalties. This law is now the umbrella law for 37 other regulations relating standardisation, since none of them provide penalties.

The government may ban imports without SNI labels on the basis that they are unfit or unsafe. The BSN and Ministry of Trade are working together to monitor SNI label use in the market.

The standards system is hoped will improve quality in the run up to joining the ASEAN economic community and is part of Indonesia's attempt to build a bigger manufacturing industry. Producers and importers will need to understand which products fall into standards and produce appropriate product labelling.



Tuesday, May 5, 2015

Philippines patent litigation confusion

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The Makati Regional Trial Court has dismissed a patent case filed by Merck Canada against two local pharma companies Sahar and Suhitas. The basis of the case was patent infringement relating to two pain reliever drugs Xibra and Torico imported and distributed by the two companies.

A Search and Seizure Order was executed in October 2013 leading to seizure of various products, on the basis of patent infringement. The full case began leading to a decision last week. The court dismissed the case and ordered the return of all seized documents and items. The basis of the court decision was “forum shopping” since Merck had filed a similar case at the IPO.

Meanwhile a separate Search and Seizure Order was executed in June 2014 against 3 other pharma retailers, leading to seizure of the same products on the basis of patent infringement. A case for infringement was filed at the IPO's Bureau of Legal Affairs. The IPO's Bureau of Legal Affairs initially dismissed the case but later reversed its decision on appeal, in favour of Merck.

The Makati Regional Trial Court stated, “The plaintiff in this case [has already] filed a patent infringement and damages with an application for preliminary injunction and temporary restraining order before the Intellectual Property Office.” Because the same patent and facts existed in 2 cases, one of which had been decided, the court dismissed the case.

The decision is odd since the parties differed and so it cannot be said that the facts are the same. So IP holders will not be inspired by this decision. However the real message is about the IPO's administrative litigation system.  The fact that the court deferred to it illustrates its importance in IP litigation in the Philippines. And that it decided infringement here suggests the IPO is the best place for IP holders to bring cases.

Wednesday, April 29, 2015

Indonesia's new IP database

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The Directorate General of Intellectual Property Rights (DGIPR) has launched its new integrated Intellectual Property Data and Information Service System (LADI HKI) which includes Patent, Trade Mark and Industrial Design data at http://e-statushki.dgip.go.id. WIPO has been working for several years to help automate DGIPR, one of the last of the major SE Asian countries to be running manual systems.
This replaces the old DGIPR Online database. Users can filter and sort search results for - 
A. Patent and Utility models. The database includes rejected, granted, cancelled, pending and lapsed patents.  
B. Trade Marks, Collective Marks and Service Marks. It includes registered, renewed, pending, expired, cancelled, deleted, withdrawn, and rejected marks.
C. Industrial Design including registered, pending, expired, cancelled, withdrawn, and rejected Industrial Designs.
The language is Bahasa which will not assist overseas IP holders. There are still some question marks over the data quality given that until now manual systems have substantially been used by the DGIPR. So it may take a while before old manual derived omissions are remedied.