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IP and Counterfeiting concerns in medical machines/pharmaceuticals

The web newsletter, Intellectual Property Watch, Recent Stories reports on the Obama administration’s release of its national intellectual property strategy (6/23-New US IP Enforcement Plan May Have International Impact) noting that Vice President Biden

specifically applauded search engines like Yahoo, Google and Bing, which in recent weeks took steps to stop selling advertising to illegal internet pharmacies.(1)
The 2010 Joint Strategic Plan on IP Enforcement ( 61+ pages) is presented on White House.gov.(2) Among a broad range of IP concerns, the Report indicates that counterfeits are being found in life saving medical machines and that there is an increased growth in the number of counterfeiting incidents. (Appendix info) The strategy to securing the supply chain includes increased enforcement efforts to guard against the proliferation of counterfeit pharmaceuticals and medical devices. Specific actions include mandating manufacturers to notify in the event of known counterfeits and also to implement a track and trace system authenticating products and the creation of electronic pedigrees for medical products with unique identifiers. The Report points out that
…counterfeit pharmaceuticals may contain a dangerous amount of harmful chemicals which can cause serious adverse reactions… others do not contain enough of, or any of, the necessary active ingredients, causing harm to patients who rely on these pharmaceuticals to overcome medical conditions and promoting drug resistant diseases.
For example, in May 2010, a man plead guilty to selling counterfeit cancer drugs on the Internet to 65 persons in the US, Canada, UK, Belgium and Netherlands. (P42) YTD DOJ actions also include: conducting drug inspection blitzes to id counterfeit and substandard drugs sent to US consumers (usually as a result of purchases over the internet); issuing warnings of counterfeit drugs being sold on the internet and warning of counterfeit surgical mesh used to reinforce soft tissue where weakness exist. In June 2010 the DOJ filed a brief in a significant patent case discussing the proper standard for evaluating reverse payments settlements in patent infringement litigation between branded and generic manufacturers (P42) See a chart summary of the overall enforcement strategy actions (PP21-22). According to the plan, a broad participation of Federal Agencies will share a database, work together to develop deconflict protocols and generally coordinate national law enforcement efforts to avoid duplication and waste. One action taken by the Dept of Commerce establishes the www.Stop Fakes.gov website as a part of the overall strategy to educate the US business community.(P24)

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