According to a New York Times report three US patients suffering from the enzyme deficiency Fabry disease have filed a petition asking the Department of Health and Human Services (HHS) to force Genzyme to license patents to other manufacturers.
The move comes as a result of continued Fabrazyme shortages following well documented manufacturing problems at the plant in Allston, Massachusetts where US biotechnology firm Genzyme produces the drug.
The patients say that since the shortages began last year remaining supplies of Fabrazyme, the only Fabry disease treatment approved in the US, have been rationed to less than one third of the usual does each, resulting in some suffering increased pain and gastrointestinal problems.
Quite what impact forcing Genzyme to license its Fabrazyme intellectual property (IP) would have is unclear given that it is unlikely that any alternate manufacturer would be up and running within the 12-month period the firm said it will take for production levels to return to normal.
All of which is bad news for US Fabry disease patients whose only alternative to Genzyme's $250,000 a year treatment is Shire's European Medicines Agency (EMA) approved drug Replagal, which is being used by some as an emergency stop gap despite not being cleared in the US.
French drugmaker Sanofi Aventis will also be keeping a close eye on the development given that rumours persist that it is thinking about buying Genzyme to boost its flagging product pipeline.
The latest news, according to the Wall Street Journal, is that Sanofi and Genzyme are in takeover talks while others, including Citigroup analysts quoted by Bloomberg, suggest the French firm is considering a hostile move after failing to reach an agreement on price.
In either case, a successful bid to break Genzyme’s Fabrazyme patent is likely to impact negotiations as the drug is one of the firm’s biggest earners and a major part of its market value.
Another potential impact may be to make Genzyme a less attractive target in the eyes of Sanofi CEO Chris Viebacher
Last week he told the Associated Press that: "Above all, what I'm looking for is businesses that are not dependent on patents," explaining that "This is my fourth patent cliff in my career and I'm looking to avoid a fifth."
Any such vulnerability that any enforced US patent breach reveals in Genzyme may therefore cause the French drugmaker rethink any takeover- plans.