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Healthcare & Life Sciences

10 October 2018
Brandon Heard Teva succeeds in Section 8 bortezomib action

Canada - Smart & Biggar/Fetherstonhaugh

The Federal Court recently granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations for losses suffered while market entry of Teva's bortezomib product was delayed by Janssen's applications under the PMNOC Regulations relating to Patents 2,203,936 and 2,435,146. Teva had succeeded on allegations of obviousness in both proceedings.

Author: Brandon Heard
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Katie Lee Apotex's appeal in judicial review of decision seeking further information from India facilities dismissed

Canada - Smart & Biggar/Fetherstonhaugh

In 2017 the Federal Court dismissed Apotex's application for judicial review of the Therapeutic Products Directorate decision which continued to require Apotex to submit additional information with respect to products manufactured or tested in its facilities in India. The Federal Court of Appeal recently dismissed Apotex's appeal of the Federal Court's decision.

Author: Katie Lee
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Riccardo Fruscalzo Parallel import of medicinal products – when a name change is a game changer

Italy - Hogan Lovells Studio Legale

The Lazio Administrative Court recently decided that, as a rule, parallel importers of medicinal products have no right to change the trademark affixed to products in their country of origin unless this change is strictly necessary due to safety grounds or national regulatory restrictions. The court found that the right to undertake the parallel import of medicinal products should not unduly take advantage of the national reputation and trust built by the marketing authorisation holder in the products' state of origin.

Authors: Riccardo Fruscalzo, Carlotta Busani
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Klaas Meersma For-profit hospital care: don't hold your breath

Netherlands - AKD NV

For-profit hospital care is a toxic political subject. Those in favour will achieve no political gain by fighting for it, while those opposed can easily cash in on the sentiment or conviction that healthcare is best provided if financial motives are neutralised. Nonetheless, the current administration is carefully reviving the discussion about for-profit healthcare. However, given the current political landscape, prolonging the regulatory twilight zone seems the most likely outcome.

Author: Klaas Meersma
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Recent updates

Urszula Wojtyra Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations

Canada - Smart & Biggar/Fetherstonhaugh

Author: Urszula Wojtyra
Jaime L M Jones Court vacates Medicare Advantage overpayment rule and curtails DOJ's pursuit of False Claims Act damages

USA - Sidley Austin LLP

Authors: Jaime L M Jones, Sean Griffin, Jennifer M Haney
Joanne van Harmelen Bioprospecting and biotrade requirements

South Africa - Edward Nathan Sonnenbergs Inc

Author: Joanne van Harmelen
E Sevi Fırat How will VERBIS affect pharmaceutical companies?

Turkey - Fırat Izgi Attorney Partnership

Authors: E Sevi Fırat, Ata Umur Kalender
José Alberto Campos Vargas The great hemp debate: marijuana or not?

Mexico - Sanchez-DeVanny Eseverri SC

Author: José Alberto Campos Vargas