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.

US patent office rules in Biogen’s favour on Tecfidera

Home/Policies & Legislation | Posted 28/02/2020

Biogen has won a patent challenge from Mylan over multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate).

US-Mexico-Canada agreement to benefit generics makers

Home/Policies & Legislation | Posted 21/02/2020

The amended United States-Mexico-Canada Agreement (USMCA) will benefit biosimilar and generic drug companies through changes to patent protection for originator drugs.

European Court of Justice backs UK in pay-for-delay fine against GSK

Home/Policies & Legislation | Posted 14/02/2020

The European Court of Justice has backed an earlier decision by the UK financial regulator, the Competition and Markets Authority (CMA), to fine pharma giant GlaxoSmithKline (GSK) in connection with ‘pay for delay’ deals for one of its off-patent medications.

New pricing system for drugs in Russia

Home/Policies & Legislation | Posted 07/02/2020

The Russian Government has passed a decree mandating ceiling prices for drugs on the country’s essential drugs list.

Chemically synthesized polypeptides to use biosimilars pathway

Home/Policies & Legislation | Posted 31/01/2020

The US Food and Drug Administration (FDA) is supporting a change in the government spending bill that will allow for chemically synthesized polypeptides to also be classified as biologicals.

US government department proposes rule to lower drug prices for its citizens

Home/Policies & Legislation | Posted 24/01/2020

The US Department of Health and Human Services (HHS) announced a string of changes in November 2019, including a proposal to lower drug prices for US citizens based on Trump’s ‘most favored nation’ approach.

US and EU sign milestone mutual recognition agreement

Home/Policies & Legislation | Posted 17/01/2020

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have signed a historic mutual recognition agreement which means the US will now recognize the good manufacturing practice (GMP) inspections of all EU Member States, and vice versa.