Tuesday, 9 February 2010
Chile Industrial Association of Pharmaceutical Laboratories (Asilfa) responds to the American Chamber of Commerce (AmCham)
Ricardo Garcia, president of the Chilean Amcham, has noted that one of the reasons Chile stayed in the "red list" of intellectual property was for allegedly copying certain American laboratories medicines.
The debate has just started. Yesterday, Asilfa’s Vice President, María Angélica Sánchez, rejected the accusations, saying that no patents have been infringed because, in cases where they have been challenged, they are not subject to patenting. She added, “our laboratories comply faithfully with the issue of industrial property and pharmaceutical patents”. Miss Sanchez also explained that those trials and questioning refer to cases of medicines produced or created before 1991. It is good to bear in mind that medicines were only incorporated in the Chilean Industrial Property Law in 1991.
Trying to make her point, Miss Sanchez clarifies: "These are drugs that, although they were created before 1991, the laboratory of origin makes them a little modification and applies for a patent, which usually never sees the light. They use that application to say the product is patented.” She adds “while the application is made, which may take three to five years, the [applicant] laboratory sent a letter to the [infringer] lab explaining that they can not manufacture the product because it is under patent application, but that means nothing because it is not patented”.
Clearly, the protection afforded by a patent does not start until the actual grant of the patent BUT it is possible to claim damages for infringing actions which happen between publication and the grant. That said, it may be that the labs that are making the generics will not only become liable from the date of the patent being granted but even before.
To say that the ‘letter’ (to put the potential infringer on notice) does not mean anything because the patent has not being granted is reckless. Otherwise, according to her declarations, once an invention has been published (so anyone can acquire the knowledge because it is made public) everyone can use the invention until it is granted!
Another point that is made is the fact that the medicines were not new because they existed before 1991 (but they could not be registered because of the law). However, once Chile accepted medicines to be patented, the said labs filled in the applications with some modifications (as to appear as new inventions). Clearly, if Asilfa believes so, they can challenge the validity.