Intellectual Property Rights
Pharmaceutical companies rely on government-granted patents to protect their huge investments in researching and developing new medicines. It takes 10 to 15 years and costs more than US$ 800 million in average to bring a new medicine to the market.
Panel: EU Accord Threatens India; World Customs Body Scales Back IP Enforcement
Patent

A patent is a property right granted by a sovereign state to the inventor of a novel, non-obvious and useful invention. Because the invention must be novel and because it cannot be obvious to one ordinarily skilled in the art, the grant of the property right cannot interfere with the public’s access to what already exists. A patent owner has the right to exclude others from making, using or selling his or her invention for a period of 20 years from the filing of the patent application.

Without patents to protect all the inventions necessary to develop a drug for a limited time, others could simply copy the drugs and offer their versions at a reduced price since they did not need to spend a fortune to develop the drugs in the first place.  This would seriously impact the research-based pharmaceutical companies’ ability to recoup their costs and reinvest in other valuable research projects.

  • IFPMA position
    Strong Patent and intellectual property rights are vital incentives for continuing innovation.  
    >> read more

  • WHO on IPR
    In the context of public health, patents are the most important IPR. Patents provide the inventor with the right to prevent others from making, selling, distributing, importing or using their invention, generally for a period of 20 years.
    >> read more  

 

  • WTO on trade-related aspects of intellectual property rights (TRIPs) and health. >> read more


Pfizer wins Canadian patent protection for Viagra
Data Exclusivity

Data exclusivity is separate and independent from other forms of IP – it is not the same as trade secret or a patent. It is the term used in the U.S. to refer to the intellectual property right reference stipulated in Article 39.3 of the Agreement on Trade-Related Intellectual Property Rights (TRIPs).

Article 39.3: “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

Data exclusivity is a practice whereby drug regulatory authorities, for a certain period of time, do not allow the clinical test data submitted by an originator as part of the requirements to prove safety and efficacy of a new drug to be used to register therapeutically equivalent generic version of the drug.

Data exclusivity is crucial because marketing approval for new medicines requires considerable time and costs for pharmaceutical companies to conduct chemical, pharmacological, toxicological, and clinical research and testing. In addition, protection of the costly test data is legally required (TRIPs) and economically necessary (for maintaining incentives).

Compulsory License

The TRIPs Agreement allows WTO member governments to produce a patented product or process without the consent of the patent owner for public non-commercial purposes (government use).

While the agreement does not specify the grounds for compulsory licensing, it does set a number of conditions that have to be met in order to safeguard the legitimate interests of the patent owner. These include:

  1. An effort must have been made first, as a general rule, to obtain a voluntary license on reasonable commercial terms and conditions;
  2. Adequate remuneration must be paid to the right holder in each case, taking into account the economic value of the license.

Thailand and Brazil are examples of countries that make use of compulsory license primarily for the production of HIV/AIDS drugs.

Click here for WTO on compulsory licensing of pharmaceuticals and TRIPs

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IPR
» Hainan Province, Hengda Health and Korean Yuanchen Signs Strategic Cooperation Agreement
Boao, China - In the evening on March 29, Hong Kong listed company New Media (HK.708) (to be changed into Hengda Health Industry Co., Ltd.) announced that it has signed a strategic investment cooperation framework agreement with the Management Committee of the pioneer district of the international medical tourism in Lecheng, Boao, Hainan Province; and Korean Yuanchen Medical Cosmetology Group on March 28 to establish an international medical cosmetology and anti-aging center at the above mentioned pioneer district. An original report from Sina Leju follows.

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Counterfeit
» BPOM seizes Rp 150 m worth of fake drugs distributed online
The National Drug and Food Monitoring Agency (BPOM), in conducting its fifth Pangea Operation, has seized thousands of illegal and fake drugs marketed online.

BPOM chairwoman Lucky S.Slamet said Monday that during the operation, her agency had identified 83 websites that allegedly distributed illegal and fake drugs, up from the 30 sites it uncovered during the previous Pangea Operation in 2011. Read full article here .
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