David Stewart, Director and Group Head (Wrays Lawyers), Partner (Wrays Patent and Trade Mark Attorneys)
This year we attended both the Pharmaceutical Anti-Counterfeiting conference in Singapore in September, and the Pharmaceutical Trade Mark Group conference in Prague in October.
Some interesting facts have come out of these conferences:
- in developing countries, more than 30% of medicines are counterfeit. This figure is 10% in developed countries. But for medicines sold online, more than 50% are counterfeit. The World Health Organisation estimates the annual trade is worth USD 32 billion. In recent times the counterfeiting trade concentrated only upon lifestyle drugs - Viagra, oxycontin, Rogaine, and Cialis. But the most recent trends in counterfeiting are heading towards over the counter ("OTC") drugs. In sub Saharan Africa, 70% of all medicines are counterfeit, which causes a significant loss of life.
- the Anti-Counterfeiting Trade Agreement is intended to stop counterfeit medicines. But, the complaint of at least some generic manufacturers is that it has been used to stop generic medicines. The alleged motivation is the approach of the "patent cliff" in 2014/15: as many blockbuster drugs fall out of patent, use of ACTA by big pharma to stop generics becomes more animated.
- the Singapore Health Authority uses several techniques to uncover counterfeit medicines:
1.Analysing products using infrared spectroscopic analysis, and Raman profiles;
2.Analyzing coating eg. Cialis has a titanium oxide coating, whereas counterfeits tend to use silicon coating;
3.Analysis of ink coating. Genuine products, for example, use sparkling ink, which is more expensive. Defects in printing are very common in counterfeits, and commonality in defects are a way of tracking down the source of counterfeits gathered in separate seizures. Tool marks in embossed lot numbers and expiry dates also indicate the same source;
4.Isotope ratio mass spectrometer: ratios of C, N, O, and H are isotopic fingerprints which indicate the same or different sources. Even within authentic stock, these ratios are different. The HSA has a counterfeit isotopic library; and
5.Plastic blisters - for Cialis, counterfeits only have one PVC coating, but authentic products have three PVC coatings of different types of plastic