BRIC Countries

A Review On Intellectual Property Issues

Patent Prosecution
Patent applications for pharmaceuticals may take up to 10 years to be granted Patent term is the later of 20 years from application or 10 years from grant. Third parties and the Brazilian PTO (INPI) may request the initiation of post-grant opposition procedures. No patent term extensions available. ANVISA (Brazilian FDA) must give prior approval to pharmaceutical patent applications (Art. 229-C of the Patent Law).

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ANVISAS Prior Approval

Patent applications must be submitted to ANVISA before the allowance by the PTO. Different interpretations of the provision since 1999: ANVISA was denying approval based on the lack of patentability requirements. Leading case: Takeda v. ANVISA - Decision on the merits issued January 2011. - Limited ANVISAs authority to block patent allowance except for the assessment of matters contrary to public health (Art. 18, I, of the Patent Law). - This case is not binding, but has strong persuasive power.
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Data Submitted to ANVISA

ANDAs can rely on the innovative drugs` safety and efficacy data submitted with the NDA. The Brazilian Law requires ANVISA to treat this information as confidential. Generic manufacturers do not have direct access to the data. The unauthorized access to data in an NDA is a crime under the Brazilian Law and the parties involved may be prosecuted before a Criminal Court.
2011 Special 301 Report :The United States also encourages Brazil to provide an effective system for protecting against unfair commercial use, as well as unauthorized disclosure, of undisclosed test and other data generated to obtain marketing approval for pharmaceutical products.
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Data Package Protection

Defined: Temporary exclusivity right over the dossier submitted for the marketing approval of a new, innovative product or new biological product. Set forth in article 39, section 3, of TRIPS Agreement. Implemented by article 195, XIV, of Law No. 9.279/96, without an express time limitation to the protection. Prior case law interpreted the lack of a definite statutory term as a barrier to the protection granted by art. 195, XIV. Recent case enforces the Data Package Protection and limits it to a 10-year term.

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Data Package Protection

Leading case: Lundbeck v. ANVISA, Ach Laboratrios Farmacuticos S/A and Biosinttica Farmacutica Ltda: - Decision on the merits issued May 2011. - Applied by analogy the 10-year statutory limit established for the protection of data submitted during the marketing approval proceedings for veterinary pharmaceuticals, fertilizers and agrochemicals. - This decision is not binding, but has important persuasive power.

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Linkage and Patent Infringement

Linkage: - No public database listing patents for a specific product (e.g. Orange Book); no certification requirement that patents are not being infringed or paragraph IV certification; no notice requirement. - Result: ANVISA does not prevent or delay registration of ANDAs because of patent rights.

Patent Infringement: - Lawsuits tend to be lengthy. Preliminary injunctions, however, are available and fast. - Companies in the legitimate market tend to respect patent rights. - Counterfeit drugs are still an issue.

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Industrial Property

Despite the availability of Russian patent protection, enforceability of patent laws is still weak. Consequently, in numerous cases, generics versions of branded drugs are available in Russia, even when the brand appears to be patent protected. In recent years, several different sets of legislation and policy decisions have been made which have had, and will continue to have both positive and negative impacts on the generics industry as a whole in Russia; significant investment will be required to achieve this, and with limited financial resources, progress is likely to be slow.
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Data Protection

In 2010, Russia passed amendments to the Law on Circulation of Medicines to protect undisclosed test or other undisclosed data generated to obtain marketing approval. Russias Accession to the World Trade Organization: Membership for the largest nation will now be put to a vote at a December 15-17 meeting of trade ministers in Geneva. PhRMA : Unfortunately, to date, Russias intellectual property (IP) protection has been lacking. But we are strongly encouraged by the inclusion of the provision of six years of regulatory data protection

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Indias Intellectual Property Protection

Until 2005, Indian patent law only allowed for process patents for pharmaceutical products India favors its domestic generic drug companies Indias Patents Act of 2005, enacted after Indias entry to WTO, extended its patent protection to pharmaceutical products, however Derivatives of known substances, combinations, and new delivery systems are not patentable, unless they differ significantly in properties with regard to efficacy Indias IP protection shows signs of Improvement Recently adopted the Mashelkar committee's recommendation to allow patents for incremental innovation
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Data Exclusivity
Indias data exclusivity Although India is a signatory to the TRIPS Agreement, Indian law has no statutory provision for data exclusivity India does not regard it as India's national interest to grant "data exclusivity" to pharmaceutical drug data Indias data protection India does not have a legislation that ensures non-disclosure of the data that is submitted to regulatory authorities India does not have a non-reliance provision (this means that data obtained illegally can be used to obtain regulatory approval) 2011 Special 301 Report : The United States encourages India to provide
an effective system for protecting against unfair commercial use, as well as unauthorized disclosure, of undisclosed test and other data generated to obtain marketing approval for pharmaceutical products

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Chinas Intellectual Property Protection

China has recognized patents for pharmaceutical patents since 1992 Pharmaceutical patents in China are harder to obtain than for other inventions and the scope of allowed claims is narrower The third amendment to the patent law was enacted in 2009 to encourage innovation Increased possible damages for patent infringement Enforcement problems persist in administrative, civil and criminal judicial pathways for protection of patent rights
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Data Exclusivity And Data Protection

On accession to the WTO in 2001, China revised its laws to comply with TRIPS to: Protect data submitted during a regulatory application Data submitted to the SFDA for the approval is protected against improper commercial use Introduce a six-year data exclusivity period Only for drugs containing a new chemical entities

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Corruption
11/10/2011 : The recent death sentence imposed on the former president of Shanghai Pharmaceutical reminds the market that China is serious about its crackdown on corruption. Chinese law prohibits corrupt payments in the commercial as well as the government-related context, and international businesses are well advised to keep in mind Chinas prohibitions on commercial bribery. In November 2011, the former president of the state-owned Shanghai Pharmaceutical Group was sentenced to death for taking more than $1.8 million in bribes and embezzling another $5 million. Background As in many other countries, bribery is a criminal as well as a civil offense in China. In 2010, China ranked above average among the countries surveyed in Transparency Internationals Corruption Perception Index (78 out of 179). This placed it above India (87th) and Russia (154th), but below Brazil (69th). Compared to Chinas ranking, Singapore and the Scandinavian countries made up the top five, followed by Canada; the United States ranked 22nd and Italy 67th.
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Conclusion

Many IP data protection issues

Handle with care

However, law & case law are quickly evolving

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