Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved biologic drug constitutes an “artificial act of infringement” for which the biologic’s patent owner may file suit.[1]  In the recent AbbVie Inc. v. Alvotech hf.[2] decision, the district court…

The Hatch-Waxman Act allows the FDA to permit a generic version of a branded product, which is partially patent protected, to come to market if the generic manufacturer “carves out” the patent-protected indication from its label. The scope of protection from a finding of induced infringement afforded to generic manufacturers by this “skinny label” provision…

In Omni MedSci, Inc. v. Apple Inc., ___ F.4th ___, Nos. 2020-1715, -1716 (Fed. Cir. Aug. 2, 2021), the U.S. Court of Appeals for the Federal Circuit held that the University of Michigan’s technology transfer bylaws did not constitute an automatic assignment of a professor’s patent rights. This decision has important implications for the drafting…

In this decision of the Patents Court, Meade J dismissed an infringement claim brought by Promptu against Sky, on grounds that Promptu’s patent lacked inventive step.  The decision is interesting as it grapples with issues of infringement where some steps of a claimed method are performed outside the UK.  The decision also provides helpful guidance…

As many readers will already know, two new full-time Patents Judges have been appointed to the English Court in the last 9 months – Meade and Mellor JJ.  Despite the challenges that the global pandemic has brought, the English Patents Court has coped remarkably well and there has been no let-up in the progress of…

In the past few years, India has produced significant case law on Standard Essential Patents (‘SEPs’), with the High Court of Delhi being the venue of several high-profile disputes. An important SEP decision in India – InterDigital v Xiaomi – was released by this court in early May 2021. The case relates to litigation occurring…

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 the 55 dissenting opinions that he wrote during his 29 years serving at the U.S. Supreme Court. Interestingly, over the years…

When transporting flowers, several measures need to be taken to maintain their freshness. Floriation’s patent required regulation of the ethylene concentration in the package. Whether Royal Flora Holland had used this feature was the central theme in this decision. The provisions judge found no direct infringement and also concluded that there was no equivalency, since…

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 despite the risk that the patent proprietor in such case could initiate infringement proceedings which often includes requests for a…