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A French Collective Tribune of Experts for Covid-19 Compulsory License
Regular readers of the Blog may be aware of my particular interest in pharma patents and, more especially since the Covid-19 pandemic, for compulsory licensing (see for instance here). I was therefore...
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Brazilian Senate Approves Bill on the Compulsory Licensing of COVID-19...
While pressure is building up on TRIPS Council for the suspension of certain obligations under the TRIPS Agreement during the COVID-19 pandemic, the Brazilian Senate approved on 29 April 2021 a bill...
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Launch at risk concept still is not at risk in Sweden following C-688/17
Introduction A key mechanism in patent litigation and specifically for generics is the concept of “launch at risk”. In short the concept means that a product is launched prior to the expiry of a patent...
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Pharma Patent Litigation in Portugal: A skewed perspective
When it comes to the judicial enforcement of pharmaceutical patents in Portugal, over the past few decades the general public has been driven to the misconception that the system protects...
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How much is needed to find a threat of patent infringement? A respectful dissent
As any aficionado of American legal history will be well aware, Judge Holmes, the third most cited American legal scholar of the 20th century, was nicknamed “the Great Dissenter.” This was a tribute to...
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International Law Talk Podcast: EU Competition Law Developments in the...
We are happy to announce the new International Law Talk Podcast episode on EU competition law developments in the pharmaceutical sector. And this one is twice as good! Not only are we discussing both...
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Further Updates on Patent Linkage and Patent Term Extension in China
On 1 June 2021, the Amended Patent Law took effect and introduced patent term extension (“PTE“) and patent linkage (“PL“), which are closely related to the pharmaceutical industry. The legislative...
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“An Error of Principle and Approach” – Birss LJ clarifies the law on breadth...
In undoubtedly one of the most important decisions of the year so far, on 24 August 2021, the English Court of Appeal handed down its judgment in FibroGen v Akebia (FibroGen Inc v Akebia Therapeutics...
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Everolimus breast cancer use patent considered valid in preliminary...
On 9 July 2021, the Court of Milan issued a preliminary injunction (PI) prohibiting a generic company from selling everolimus for use in combination with an aromatase inhibitor in the treatment of...
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Recent Trends For § 112 Challenges In PGRs
In recent years, the Court of Appeals for the Federal Circuit has invalidated or affirmed the invalidity of various biopharma patents under 35 U.S.C. § 112, which requires that a patent specification...
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The Recurring Dream
On 15 to 17 December 2021 a three-day trial took place to determine preliminary issues in a second action brought by Neurim against Mylan in relation to patents protecting the product Circadin (“Neurim...
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Round and round and round we go: Another Article 3 SPC Reference
SPCs are often valuable and therefore important to their proprietors. Indeed, such is the potential value of an additional period of exclusivity, that in the last decade or so, we have seen SPCs...
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Pharmaceutical patent term extensions now back to the “earliest first”...
In two separate judgments, the Full Court has provided much needed clarity on how to identify the pharmaceutical products that can support a valid patent term extension in Australia, as Natalie...
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“AVELUMAB SPC Case”: A key U-turn in French case law
25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the “nivolumab” case law...
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Moderna vs. Pfizer & BioNTech: French perspective
The news was announced last week: Moderna is suing Pfizer for infringement of two of its patents related to Covid-19 vaccines. These highly targeted actions are likely to spread to many other...
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First Decision on the German Proportionality Defense in a Pharma Case
The so-called proportionality defense according to Sec. 139(1) clause 3 (hereinafter simply “proportionality defense”) is one of the newest provisions of the German Patent Act. It has only been...
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Fingolimod – The Danish Eastern High Court definitively affirms dismissal of...
In an appeal of a PI decision, the Danish Eastern High Court has ruled to uphold the dismissal of Novartis’ application for a preliminary injunction against Glenmark, Zentiva, and Viatris, based on...
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Gilead Sciences v NuCana – two trials for the price of one (or two)
On 21 March 2023, Meade J gave a bumper judgment in the revocation action brought by Gilead in respect of two of NuCana’s patents from the same family (EP (UK) 2 955 190 and EP (UK) 3 904 365, the...
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Plausibility post G2/21 – Apixaban in the UK
On 4 May 2023, a mere two weeks after the conclusion of the hearing, the Court of Appeal handed down its decision in Sandoz and Teva v BMS. The appeal decision is centred on the question of...
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Overactive bladder patent upheld on a-PEE-al
On 25 July 2023, the Court of Appeal handed down its decision in Teva & Sandoz v Astellas[1] concerning the validity of Astellas’ patent to mirabegron for use in the treatment of overactive bladder...
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