BRAZIL Law and Practice Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys
2.5 Reimbursement and Pricing/Linkage Markets Brazil does not have a patent linkage system. MA decisions and decisions on pricing and reimburse ‑ ment are made irrespective of patent status. Pricing regulation for drugs is conducted by the Drug Market Regulation Chamber (CMED), which is responsible for setting maximum drug prices for retail markets, government purchases and consumers. Regulation for prices relies on a six-tier classification established by CMED’s Resolution No 2/2004, based on which the CMED establishes rules for pricing (eg, prices for generic medicines may not surpass 65% of the reference medicine’s price). The same considerations as discussed in 2.1 Infring- ing Acts apply also to biologics or biosimilar patents. 3.2 Data and Regulatory Exclusivity The same considerations discussed in 2.2 Data and Regulatory Exclusivity also apply here. 3.3 Acceptable Pre-Launch Preparations The same considerations discussed in 2.3 Acceptable Pre-Launch Preparations also apply here. 3.4 Publicly Available Drug and Patent Information The same considerations discussed in 2.4 Publicly Available Drug and Patent Information also apply here. 3.5 Reimbursement and Pricing/Linkage Markets The same considerations discussed in 2.5 Reimburse- ment and Pricing/Linkage Markets also apply here. 3. Biosimilar Market Entry 3.1 Infringing Acts
chemicals and its components, fertilisers and bioin ‑ puts, for different periods depending on the product to which they refer (all of which are counted from the award of market authorisation): • ten years for products using new chemical/biologi ‑ cal entities; or • five years for products not using new chemical/ biological entities. These terms may be shortened if the test data is released anywhere, in which case the applicant is entitled to enjoin a minimum one-year term of RDP. New data required by regulatory agencies after regis ‑ tration of products using or not using new chemical/ biological entities will also be protected for the same term awarded to the product. If the term has already expired, the new test data will be protected for the one-year minimum term. Although Statute #10,603/02 institutes RDP for a wide range of life sciences products (eg, agrochemicals, fertilisers), the statutory text carves out an exception for pharmaceutical products destined for human use. 2.3 Acceptable Pre-Launch Preparations Article 43 of the BPS establishes exemptions for infringing acts that are exclusively aimed at produc ‑ ing information, data and test results to attain market authorisation (ie, Bolar exemption) and non-commer ‑ cial acts directed at experiments, studies and scien ‑ tific research. For more information on the exemptions allowed under Brazilian law, see 1.15 Defences and Exceptions to Patent Infringement . 2.4 Publicly Available Drug and Patent Information Brazil does not have an Orange Book equivalent. ANVISA publishes information concerning new market authorisations (MA) and market authorisation applica ‑ tions (MAA) on its official website and on the National Official Gazette. However, MA holders are not notified of other MA or MAA for similar/generic products, so interested parties should be ever vigilant and set up monitoring practices in Brazil to obtain a comprehen ‑ sive outlook on the market scenario.
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