Brazil: Animal Health and Patent Litigation
Kluwer Patent Blog » Pharma
by Roberto Rodrigues Pinho (Licks Attorneys), Tatiana Machado (Licks Attorneys) and Maria Eduarda Falkenbach (Licks Attorneys)
1w ago
With 1.5 billion chickens and 234.3 million cows, Brazil is an important market for the animal health industry. According to the National Syndicate of the Industry of Animal Health Products (SINDAN, in Portuguese), in 2022, 700 million doses of vaccine were manufactured in Brazil for herbivorous animals, and 21 billion for aviary. The Brazilian animal health market generated a net revenue of 10.363 billion reais in 2022 (approximately USD 2.11 billion)—a growth of 13% in relation to 2021. With these strong numbers, it will come as no surprise to readers that Brazil is a key market for investme ..read more
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Highlights of Swiss patent litigation in 2023: Swiss Federal Patent Court on SPC for sitagliptin and metformin
Kluwer Patent Blog » Pharma
by Simon Holzer (MLL Legal Ltd.)
1M ago
From the potpourri of decisions that the Swiss Federal Supreme Court handed down last year, I have selected one in subjective hindsight that I consider to be particularly relevant regarding further cases. The outcome of most decisions of the Swiss Federal Patent Court in 2023 heavily depended on the specific circumstances and the effects of these rulings on other cases is therefore somewhat limited. A noteworthy exception is the dispute between Merck Sharp & Dohme LLC (MSD) versus Spirig HealthCare AG (Spirig, a Stada subsidiary). Said case concerned MSD’s Swiss SPC for the combination of ..read more
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UK – Merck seeks SPC relying on the law as set out in Neurim
Kluwer Patent Blog » Pharma
by Katie Cambrook (Bristows)
2M ago
Question: I applied for my SPC in reliance on the law as set out in Neurim[1], following Santen[2] can I still obtain my SPC? Answer: No, according to the English High Court[3]. In 2018, i.e. before the Santen decision from the CJEU, Merck applied to the UK IPO for an SPC for its medicinal product “MAVENCLAD”, which contains the active ingredient cladribine, for relapsing remitting multiple sclerosis.  In Spring 2023 this application was refused by the UK IPO on the basis that the MA for MAVENCLAD was not the first MA to place cladribine on the market. Cladribine had been previously appro ..read more
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China’s new Patent Term Extension: A Welcome Change for Innovators
Kluwer Patent Blog » Pharma
by Benjamin Bai (Allen & Overy) and Tina Tai (King & Wood Mallesons)
2M ago
On December 21, 2023, the China National Intellectual Property Administration (CNIPA) issued the final version of the revised Implementing Rules for the Patent Law and the Guidelines for Patent Examination, which will become effective on January 20, 2024. These Regulations complete legislative efforts on changes to the Chinese patent system introduced by the 4th amendment to the Patent Law that was promulgated in June 2021. They also provide details on the much-anticipated Chinese patent term extension introduced by Art. 42(3) of the Patent Law back in 2021. The patent term extension (PTE) is ..read more
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FINGOLIMOD or the Hesitation Blues: can preliminary injunctions be based on a patent application under French law?
Kluwer Patent Blog » Pharma
by Matthieu Dhenne (Dhenne Avocats)
3M ago
Yes and no, it seems. Well, yes and then no, if recent French decisions are anything to go by. In short, Hesitations Blues reign. This attitude is all the more interesting given that the question, which arose more especially in the FINGOLIMOD case, has been raised before several European courts, all of which are opposed to the position taken by the Paris High Court (“Tribunal Judiciaire de Paris”) (in Germany, Denmark and Spain). The discussion sparked off in France therefore remains singular. On the one hand, the Paris High Court has twice accepted this kind of actions (in the FINGOLIMOD case ..read more
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ANVISA approves skinny labeling in Brazil
Kluwer Patent Blog » Pharma
by Roberto Rodrigues Pinho (Licks Attorneys), Brenno Telles (Licks Attorneys) and João Vitor Esteves (Licks Attorneys)
4M ago
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow generics and branded generics (also called “similar” drugs) to remove patented uses from their labels – i.e., skinny labeling. The change will come into effect 60 days after the amended text of Rule No. 47/2009 is published in the Federal Register. The Brazilian Federal legislation does not allow skinny label or carve out (per article 3 of Law #6,360 of 1976) as it clearly establishes that a generic or similar (branded generic) must hav ..read more
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Biochemical substances and the realm of S. 3(d) (Novozymes vs The Assistant Controller of Patents and Designs): Scope of applicability of Section 3(d) redefined by Madras High Court?
Kluwer Patent Blog » Pharma
by Kameshwaris Sridhar (Intellectual Property Attorney, India)
4M ago
I) Introduction The science of biochemicals and the realm of Section 3(d) of Indian Patents Act! Can there be a reconciliation between the two? This question is a hot topic of discussion amongst the Indian biochemical patent community following the recent decision (Novozymes vs The Assistant Controller of Patents and Designs) pronounced by the Madras High Court on 20 September 2023. In a first-of-its-kind decision that may redefine the applicability of S.3(d) to the biochemical realm, the Court adopted a constrictive interpretation of the scope of substances that fall under the purview of S. 3 ..read more
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EU Pharma Package – Bolar exemption under scrutiny and first amendments being proposed
Kluwer Patent Blog » Pharma
by Jiří Slavík (European Patent Attorney | Director IP at Adalvo) and Toni Santamaria (European Patent Attorney | VP IP at Adalvo)
4M ago
In April 2023, the European Commission (EC) published the pharmaceutical legislation package, including the proposal for a Pharmaceutical Directive[1] , and further proposals for regulations on SPCs[2]. Article 85 of the proposed Directive aims at providing an amended provision for the so-called Bolar exemption, currently codified in Article 10(6) of Directive 2001/83/EC. The initial EC proposal intends to[3] inter alia increase competition from earlier market entry of generic and biosimilar medicinal products. The proposal aims to broaden the scope of the Bolar exemption and harmonise th ..read more
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First changes to ongoing SPC reform outlined by European Parliament
Kluwer Patent Blog » Pharma
by Oswin Ridderbusch (Vossius & Partner) and Alexa von Uexküll (Vossius & Partner)
5M ago
A sweeping reform of the European Union’s legislation on supplementary protection certificates for medicinal products and plant protection products is currently underway, which features the introduction of a new centralized SPC examination procedure at the EUIPO as well as the creation of a new unitary SPC on the basis of the unitary patent, as previously reported on this blog. While the initial legislative proposals tabled by the European Commission on April 27, 2023 have received largely positive feedback, a number of details have been harshly criticized by stakeholders and professional asso ..read more
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Divisional From Divisional Issue – New Insight From Russia
Kluwer Patent Blog » Pharma
by Kirill Osipov (ARS-Patent)
5M ago
A recently published ruling of the Presidium of the Court for Intellectual Rights may turn the issue of cascading divisional applications upside down and endanger many patents granted on such applications. Background A divisional patent application is a separate one that is derived from an initial (parent) application. The necessity of filing such a divisional application may be caused by, for example, the lack of unity among originally claimed inventions, or an applicant may simply want to have more patent applications to obtain a patent portfolio as a result. Russian patent law, like many ot ..read more
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