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BRAZILIAN HIGH-TECH LITIGATION:

Law, Business & Policy

Thursday, May 12 – Washington, DC

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BRAZILIAN HIGH-TECH LITIGATION: Law, Business & Policy The George Washington University Law School

Pharmaceutical Litigation: BRPTO, BRFDA, and Infringers

Ricardo Nunes Partner at Licks Attorneys

Pharmaceutical Litigation: BRPTO, BRFDA, and Infringers

Ricardo Nunes, Partner at Licks Attorneys

Thursday, May 12 – Washington, DC

• 1. Overcoming the backlog problem

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It is complicated...

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• Lawsuit at federal courts to

expedite examination

• Courts have been ruling against the

BRPTO – decisions ordering the BRPTO to examine specific applications within 60 days

• Some preliminary injunctions were

also granted

• Out of 32 cases, 26 favorable

decisions, 4 unfavorable ones and 2 pending cases

• Decisions from both lower and

appellate courts

BRPTO Backlog Judicially-induced fast track examination

• 2. Pharmaceutical litigation in

Brazil

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• Civil law system, usually no binding precedents
• (In)validity lawsuits must be filed against the BRPTO before federal district courts,

infringementlawsuits are filed before state trial courts (bifurcated system)

• Some judges have no expertise in patent law
• Court-appointed expert examination is key

Litigating in Brazil

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• Preliminary ex parte injunctive relief widely available
• Plaintiff must present enough evidence to establish
• likelihood of succeeding on the merits (presenting legal and technical opinions is key)
• irreparable harm (or harm that is hard to repair) if injunction is not granted
• injunction is not irreversible
• Lower standard in comparison to the U.S. (FRCP, Rule #65): no need to give notice

to adverse party, no need to give security or post a bond, balance of hardships and the public interest normally not an issue

• Judge may request plaintiff to post a bond

Litigating in Brazil

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• Decisions from federal agencies reviewed by special courts. Government decisions

must rely on statutory provisions, and are subject to judicial review. Government has no discretion with regard to the examination of patent applications

• Government is by far the most frequent defendant in Brazil. So far, over 7,000

lawsuits filed against the BRPTO. There is no political harm in suing the government

• Federal judges do not hesitate to rule against the government. Judges are not

elected, are appointed for life and have financial independence. Courts pay no deferenceto decisions fromthe BRPTO, review is obtainedmore often than not

• Overcoming unlawful rejections or limitations on the amendment of claims after

request for examination is made. Invalidity lawsuitsare also possible

• Invaliditylawsuits filed by the BRPTO against mailboxpatents

Litigating against the BRPTO

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• 2010: Cephalon v. BRPTO – Lawsuit filed before the Federal Court of Rio de

Janeiro seeking a declaratory judgement of validity of the patent covering Vigil (modafinil). Favorable decision on the merits and leading case establishing the criteria on nonobviousness

• 2012: Schering Corp. v. BRPTO – First lawsuit against BRPTO’s rejection of

pipeline patent application for matters claimed in a previous PCT designating Brazil (covering Noxafil - posaconazole). The only firm in Brazil with success on this matter

Leading cases

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• 2014: Bbraun v. BRPTO – Lawsuit filed before the Federal Court of Rio de Janeiro

seeking a declaratory judgement of validity of a patent covering a medical device (catheter)

• 2016: Merck v. BRPTO – Lawsuit filed before the Federal Court of Rio de Janero

against the rejection for obviousness of a patent application covering Invanz (ertapenem). Favorable decision on the merits issued on April 6 (last Friday), declaring the invention meets the patentabilityrequirements

Leading cases

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• Lawsuits seeking to restrain BRFDA from granting or invalidating Gx marketing

approvals, based on Food and Drug law (non-compliance with safety and efficacy requirements) and unfair competition

• Lawsuits to circumvent backlog
• Lawsuits to overcome rejection of prior approval to patent application based on

the alleged non-compliance with patentability requirements

Litigating against BRFDA

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• Section 229-C of the Patent Statute: “The grant of patents to pharmaceutical

products and processes will depend on the prior approval of the BRFDA” – no guidance on what kind of analysis the BRFDA should perform

• Two legal opinions issued by the General Attorney’s Office saying the BRFDA has

no statutory authority to examine patentability requirements, but only issues related to public health...

Overcoming denial of prior approval

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• BRFDA’s internal rule from 2013: “The patent application shall be considered

against public health when: I - The pharmaceutical product or process… presents risk to health; or II - The patent application of pharmaceutical product or process is

• f interest to the public policies of access to medicines and pharmaceutical

assistance of the Public Healthcare System (SUS) and does not meet patentability requirements and further criteria established by the Patent Statute”

• We are beating the BRFDA (100% success so far). Class action also filed

Overcoming denial of prior approval

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• 2002: Sanofi-Aventis v. Libra and BRFDA – Complaint filed before the Federal

Court of Rio Grande do Sul seeking to invalidate Libra`s MA for Gx of Sanofi`s Taxotere (docexatel). Leading case regarding the possibility

• f judicially

invalidating a MA granted by BRFDA due to non-compliance with the Food and Drug legislation. After more than 10 years of litigation, Sanofi prevailed before Superior Court of Justice (highest court of matters related to Federal Law)

• 2009: Genzyme v. EMS and BRFDA – Complaint filed before the Federal Court of

Brasília seeking to invalidate EMS’s MA for a Gx of Genzyme’s Renagel (sevelamer hydrochloride). Leading case in which a company had full access to the Gx dossier. No final decision was issued yet. However, since 2012 the Ministry of Health have ceased to acquire EMS’ product

Leading cases

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• 2009: Schering Plough v. Zodiac and BRFDA – Complaint filed before the Federal

Court of Brasília seeking to invalidate Zodiac’s MA for a Gx of Schering’s Caelyx (pegylated liposomal doxorubicin). Leading case discussing BRFDA’s technical

• rientation #46, which establishes a list of products that cannot prove its

equivalence to the innovator drug through pharmaceutical equivalence and bioavailability studies.No final decision was issued yet.

• 2014 – AstraZeneca v. EMS and BRFDA – Complaint filed before the Federal Court
• f Brasília seeking to prevent BRFDA from granting a MA to EMS’s for a Gx of

Astrazeneca’s Selozok (metoprolol succinate). Complaint was filed after we identified EMS`s MA applications. No final decision was issued yet. However, until this moment BRFDA has not approvedEMS’s products

Leading cases

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• Infringement cases decided by state trial courts
• Declaratory non-infringement lawsuits also available
• Paris Convention grants to foreigners the same level of protection afforded to local
• companies. No bias against foreign companies
• Injunction widely available (pre-litigation is key), and may include search and

seizure of products and accounting books

• NPEs are not an issue so far. May be hard to show potential to suffer irreparable

harm and therefore obtain an injunction

Enforcing patent protection

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• Compensation for loss profits (your losses or infringer`s profits or reasonable

royalties) + actual/consequential damages + moral damages (sometimes awarded as de facto punitive damages)

• Procedural measures make it hard to collect damages
• No incentives to settle, most cases go to trial
• Sham litigation (antitrust) and IP misuse defenses

Enforcing patent protection

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• 2004: Eli Lilly v. Pfizer – First declaratory non-infringement lawsuit ever filed in
• Brazil. We represented Eli Lilly against Pfizer and obtained and ex parte injunction

authorizing the sales of Cialis in the country, followed by favorable decisions on the merits

• 2010: Germed v. Merck – We represented Merck on a declaratory non-

infringement lawsuit filed by Germed (local Gx company) regarding patent covering Cosopt(dorzolamide/timolol). We prevailed and also obtained a decision stating that Germed was indeed infringing Merck’s patent. Germed was not able to launch its copy in the market

Leading cases

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• Monitoringof bioequivalenceand bioavailabilitystudies
• Monitoringof Gx MA applications
• Monitoringtrademark applicationsfor similar products
• Monitoring of API importation (amount imported, port of product entry, value of

the importation,country from where the product was exported)

Competitive intelligence through market monitoring to identify possible new Gx

Thank you!

Ricardo Nunes, Partner at Licks Attorneys ricardo.nunes@lickslegal.com T +55-21-3550-3704