Policies & Legislation

Impact of upcoming regulatory changes on patent disputes in Australia

Home/Policies & Legislation | Posted 22/05/2020

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

Home/Policies & Legislation | Posted 15/05/2020

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

Home/Policies & Legislation | Posted 08/05/2020

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

Home/Policies & Legislation | Posted 04/05/2020

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

Home/Policies & Legislation | Posted 17/04/2020

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

Home/Policies & Legislation | Posted 24/04/2020

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

Home/Policies & Legislation | Posted 03/04/2020

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

Home/Policies & Legislation | Posted 20/03/2020

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.

Allergan, Ironwood settle Linzess patent dispute

Home/Policies & Legislation | Posted 13/03/2020

In early 2020, Allergan and Ironwood Pharmaceuticals (Ironwood) reached agreements with Mylan Pharmaceuticals (Mylan), Sandoz and Teva Pharmaceutical Industries (Teva) to protect their irritable bowel syndrome (IBS) treatment Linzess (linaclotide).

China’s procurement programme cuts drug prices by half

Home/Policies & Legislation | Posted 06/03/2020

China’s national generics procurement programme, the second phase of which ended in January 2020, included 33 different drugs and cut prices by 53% on average.