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Policies & Legislation

NHS lawsuit against Servier Laboratories reaches Supreme Court

The UK National Health Service (NHS) has filed a GBP 220 million (US$280 million) lawsuit against the French pharmaceutical company Servier Laboratories. The Supreme Court has now agreed to hear the lawsuit, which relates to a patent used to block generic versions of a hypertension drug.

FDA to hold public meeting on its user fee programmes

The US Food and Drug Administration (FDA) is to hold a virtual public meeting to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA).

Impact of upcoming regulatory changes on patent disputes in Australia

Following a series of proposed transparency reforms from the Australian Therapeutic Goods Administration (TGA), a recent commentary explains what the changes will mean for pharmaceutical patent disputes.

Australia’s regulatory body proposes transparency reforms

Australia’s Therapeutic Goods Administration (TGA) has issued a number of proposed transparency reforms for feedback from industry stakeholders, including earlier notification of generics applications.

COVID-19 brings new collaborations to Australia and the EU

In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.

Five key questions about the ‘patent dance’ answered

Law firm Fish and Richardson have provided answers to five key questions for biosimilar makers when it comes to the patent dance.

CMS launches insulin co-pay at US$35

The Centers for Medicare & Medicaid Services (CMS) in the US has launched a new model to reduce co-pays for insulin products to US$35.

Alberta delays deadline for forced medication switch by six months

The Canadian province of Alberta has delayed its introduction of a switching policy to biosimilars for patients using biologicals for six months.

Opposition party in Alberta, Canada fights biosimilar switching policy

The opposition New Democratic Party (NDP) in Alberta, Canada has urged the province not to force patients to switch to biosimilars, citing concerns about patient safety.

Hospira asks Federal Circuit to reconsider Safe Harbor ruling

In December 2019, Federal Circuit judges upheld a Delaware district court’s judgment of patent infringement and its order that Hospira pay US$70 million in damages to Amgen [1]. Then in January 2020 Hospira filed a petition for rehearing ‘en banc’ asking the full Federal Circuit to reconsider the Safe Harbor ruling and reverse the judgment of infringement.