Sentences with phrase «patent term extension»
In parallel with the consultation on the Patent Rules, the CETA Implementation Act will also affect patents by introducing patent term extensions through certificates of supplementary protection (CSPs) for certain pharmaceutical inventions, and an overhauled the patent linkage system.
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Intellectual property was a contentious issue during negotiations, in particular aspects relating to pharmaceuticals, such as patent term extensions, data protection, and patent / drug approval «linkage» mechanisms.
Under CETA, Canada has already agreed to a two - year patent term extension due to delays caused by the marketing approval process.
The TPP requires countries to provide patent term extensions (sometimes referred to as «patent term restoration») to compensate for delays arising in two scenarios: unreasonable delays in the marketing approval process and unreasonable delays in patent prosecution amounting to more than five years from the application date or three years from the request for examination, whichever is later, subject to certain exclusions.
The TPP does not specify a maximum patent term extension.
Neither CETA nor the TPP has been ratified and the government hasn't issued any formal proposals for changes to the Patent Act or Rules to implement patent term extensions.
Our experience includes pharmaceutical compounds and formulations, therapeutic methods, and a range of Hatch - Waxman issues, including patent term extension, loss of exclusivity, and generic entry into the market.
In the wake of the Comprehensive Economic and Trade Agreement signing, the federal government has introduced an amendment bill into Parliament that will provide for a two - year drug patent term extension and drug litigation proceedings will be turned into full actions.
Patent owners can request a recalculation of the PTO's Patent Term Extension for two months after a patent issues.
The CSP Regulations established a mechanism for drug manufacturers to obtain patent term extensions to account for marketing delays arising from the regulatory review time of a drug, up to a maximum of 2 years.
Extensions are rare and are only granted (at the time the patent issues) for certain, specific reasons — a company can't simply request a patent term extension for the heck of it.
Counseling a large biologics company, providing an opinion on the eligibility of its new drug product for marketing exclusivity and patent term extension.
Patent term extensions are another TPP issue.
2) If any patent term extension is granted, How i come to know of that?
In Exelixis, Inc. v. Kappos in the Eastern District of Virginia, Judge Ellis stated that the USPTO's interpretation of the patent term extension for length of pendency is incorrect.
More specifically, CETA introduced a patent term extension of up to two years under the «certificates of supplementary protection» for regulatory delays and provided innovators with right of appeal under the Patented Medicines (Notice of Compliance) Regulations.
Kathleen's intellectual property practice is comprehensive, and encompasses contract and license negotiation, arbitration and mediation, due diligence, infringement and validity opinions, patent term extension, indemnity issues, research «safe harbor» issues, and biologics / biosimilars.