24 July 2019
When do clinical trial consent disclosures render a patent invalid?
www.twobirds.com/en/news/articles/2019/australia/when-do-clinical-trial-consent-disclosures-render-a-patent-invalid

In the recent case of InterPharma Pty Ltd v Hospira Inc (No 5) [2019] FCA 960 the Australian Federal Court has given patentees guidance as to novelty preserving practice in the conduct of clinical trials.

02 April 2020
A cure for COVID-19? – Don’t make the claim unless it is true.
www.twobirds.com/en/news/articles/2020/china/a-cure-for-covid-19-dont-make-the-claim-unless-it-is-true

Preferred summary The worldwide COVID-19 pandemic has led to a scramble for pharmaceutical and medical devices which can prevent or treat COVID-19 infections. Currently there is no vaccine or treatment for COVID-19 ...

03 September 2019
China Expands Medical Devices Market Authorization Holder Pilot Project to 21 Provinces/Municipalities
www.twobirds.com/en/news/articles/2019/global/china-expands-medical-devices-market-authorization-holder-pilot-project-to-21-provinces

On 1 August 2019, the National Medical Products Administration ("NMPA") issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No.33) ("Notice") to 21 ...

20 June 2019
China to accelerate the development of "Smart Supervision System" for drug and medical devices
www.twobirds.com/en/news/articles/2019/global/china-to-accelerate-the-development-of-smart-supervision-system-for-drug-and-medical-devices

The NMPA issued the Drug Smart Supervision Plan aiming to deepen the development of a drug supervision system embracing modern information technologies such as cloud computing, big data, and "Internet+" technologies.

06 September 2019
China passed new amendments to the Drug Administration Law
www.twobirds.com/en/news/articles/2019/global/china-passed-new-amendments-to-the-drug-administration-law

On 26 August 2019, China's National People's Congress passed the final amendments to the Drug Administration Law ("DAL"), which will take effect on 1 December 2019. The DAL was first enacted in 1984, then substantively ...

25 January 2019
Implications on the Draft Amendment to the Drug Administration Law and the Draft Healthcare Law in the Pharmaceutical industry in China
www.twobirds.com/en/news/articles/2019/china/draft-amendment-to-drug-administration-law-and-draft-healthcare-law

On 1 November 2018, the Standing Committee of the People's Congress in China ("NPC") announced two important draft documents for public consultation until 1 December 2018: (1) Drug Administration Law (Amendment Draft) ...

07 November 2019
Opening the gates for generics - E-prescribing requirements implemented in Australia
www.twobirds.com/en/news/articles/2019/australia/opening-the-gates-for-generics-e-prescribing-requirements-implemented-in-australia

The Australian Pharmaceutical Benefits Scheme (PBS) provides for and regulates government subsidies for the supply of certain medicines. A requirement to receive subsidised medicine under the PBS is that the medicine ...

25 February 2020
Surgical face masks – filtering out counterfeit copies
www.twobirds.com/en/news/articles/2020/global/surgical-face-masks-filtering-out-counterfeit-copies

This article discusses the key IP and regulatory issues relating to surgical masks and penalties for the production of counterfeit products.

11 February 2021
Patent Linkage Update in China - A Pre-Chinese New Year Gift
www.twobirds.com/en/news/articles/2021/china/patent-linkage-update-in-china-a-prechinese-new-year-gift

On 9 February 2021, the China National Intellectual Property Administration (“CNIPA”) issued the “Administrative Adjudication Measures for Drug Patent Dispute Early Resolution Mechanism (Draft for Public Opinions)” ...

11 February 2021
Australia: An update on the TGA’s post market review of face masks and important changes to the process for listing Class I medical devices in the ARTG
www.twobirds.com/en/news/articles/2021/australia/australia-an-update-on-the-tgas-post-market-review-of-face-masks-and-important-changes

The Therapeutic Goods Administration (TGA) announced in mid-2020 that it is conducting a post market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). The announcement came after an ...