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.

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 ...

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 ...

16 September 2020
NMPA and CNIPA issue Draft Patent Linkage Measures in China
www.twobirds.com/en/news/articles/2020/china/nmpa-and-cnipa-issue-draft-patent-linkage-measures-in-china

On 11 September 2020, the National Medical Products Administration ("NMPA") and the China National Intellectual Property Administration ("CNIPA") issued the draft "Implementing Measures for Drug Patent Dispute Early ...

31 December 2020
Medical Device UDI System Goes Live in China on 1 January 2021
www.twobirds.com/en/news/articles/2020/china/medical-device-udi-system-goes-live-in-china-on-1-january-2021

Those in the medical device industry will be familiar with the Unique Device Identification (“UDI”) system for medical devices. While it has been a global discussion piece for many years, the timeline for implementation ...

09 April 2020
COVID-19 (Temporary Measures) Act 2020: Legal circuit breaker
www.twobirds.com/en/news/articles/2020/singapore/covid19-temporary-measures-act-2020-legal-circuit-breaker

In our previous article (Temporary Relief for Inability to Perform Contractual Obligations due to the COVID-19 Situation in Singapore), we had highlighted that the Ministry of Law had on 1 April 2020 announced its ...

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.

03 September 2018
New IP Act Passed in Australia: implementing Phase 1 recommendations of the Productivity Commission
www.twobirds.com/en/news/articles/2018/australia/new-ip-act-passed-in-australia

On 16 August 2018, the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 (Bill) passed through both Houses of Parliament and will shortly come into force upon ...