Medicine packaging and copyrights
ANVISA claims that harmonising the formats and contents of package inserts will make access to drugs easier and safer for Brazilian consumers and medical professionals.
Among several other important matters, Section 18 of the resolution addresses how the package inserts of generic drugs and similar pharmaceutical products (branded copies without bioequivalence data and no interchangeability requirement) should harmonise with those of new drugs (reference drugs) developed by the research industry, and approved after lengthy and expensive trials.
The package inserts of generic and similar drugs should convey to their readers the same relevant technical information as the reference drugs, and in a similar manner.
The regulation seeks the same quantity and amount of information in the package inserts of generic, similar and original new drugs. It states that their format and content should be “harmonised”.
Nevertheless, a non-literal interpretation of Section 18 is that it supports large-scale copyright infringement of package inserts developed by the research industry for new pharmaceutical products, with the sole goal of gaining undue competitive advantage. With ANVISA’s consent, companies selling generic and similar products are simply copying the package inserts of new original drugs.
Most of the time, the trademark, the name of the company and the address are the only differences between the text in generic products’ package inserts and those of reference drugs. References to clinical trials made by the research industry of the new drug remain in the text, misleading physicians and consumers alike, who believe that the copy product has also been subject to such trials.
“Companies selling generic and similar products are simply copying the package inserts of new original drugs."
Even if the resolution expressly permitted the complete reproduction of reference drug package inserts by generic and similar drug producers, a regulation enacted by ANVISA (well known to support local business interests ahead of patients’ interests and health) would not be able to overcome the Brazilian copyright statute. Brazil’s Copyright Law guarantees the protection of scientific texts through copyright and this encompasses the technical data’s form of expression, though not the data itself.
In the event of copyright infringement by generic and similar drug companies, first and foremost, the company that owns the copyright over the work should be able to demonstrate ownership before the courts.
It is worth stressing that, according to Section 18 of the Copyright Law, one need not register a work to obtain and enforce a copyright over it. However, only a natural person can be an author or creator of an intellectual work and, therefore, a pharmaceutical company must be able to present a document proving that the author(s) have transferred all economic rights tied to the work.
Then an analysis of the originality of the work is necessary before the courts, given that only original works are subject to protection through copyright. Of course, the analysis of the originality of scientific texts is limited to its form of expression.
Finally, the third step in the court action is to verify whether the generic or similar package insert indeed copied the scientific text used in the reference drug—a conclusion achieved after comparing the two.
It has yet to be seen whether the new scenario will be maintained, allowing generic and similar companies to profit from counterfeit materials by copying the package inserts of new genuine drugs.
The only certainty is that copyright owners should maintain a neat record and documentation of all transfers of economic rights tied to package inserts, and should monitor the market, scouring for any possible copyright infringement in order to act in a timely manner.
