life sciences – Page 3

Pendulum Swings in Favour of Generic/Biosimilar Companies at Interlocutory Stage in AU

Dec 09 2015

By Naomi Pearce

FCA Confirms Commonwealth may Claim Relief Under “Usual Undertakings as to Damages”

The much anticipated Court of Appeal decision in Commonwealth of Australia v Sanofi ¹ was handed down on Monday. The decision is a win for the Commonwealth, and for generic/biosimilar companies in Australia, and (if upheld in any appeal) will result in Sponsors adopting a more circumspect approach to seeking interlocutory injunctions for patent infringement in Australia.

Except where a generic/biosimilar applicant has “cleared the way” (cleared any patent impediments to launch through the Courts in Australia) or all relevant patents have expired, interlocutory injunctions are routinely sought by the Sponsor, and are routinely granted.

Productivity Commission’s broad IP review in Australia – Submissions due 30 November

Nov 20 2015

By Naomi Pearce

There are two weeks left to make submissions to the Productivity Commission (the Commission) on the Commission’s Intellectual Property Issues Paper published in October.

The IP Issues Paper can be found here and the process for making a submission (by 30 November) is outlined here.

Australian Patent Office Seeks Comment on Proposed Examination Practice Arising from the Myriad Genetics High Court Decision

Nov 06 2015

By Rachel Young and Nigel Lokan

The Australian Patent Office has commenced a public consultation on their proposed changes to examination practice, as a result of the recent High Court decision in D’Arcy v Myriad Genetics Inc¹.

As reported in our earlier blog² the High Court unanimously decided that claims directed to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide were not patentable subject matter.

High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter

Oct 08 2015

On 7 October 2015, the High Court of Australia (High Court) issued its decision[1] in the long running dispute concerning Myriad Genetics, Inc.’s (Myriad) patent relating to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide. Mutations in the BRCA1 gene can serve as indicators of a woman’s risk of developing breast cancer.

In a unanimous decision, the High Court found that claims directed to the isolated nucleic acid are invalid on the basis that they are not a ‘manner of manufacture’ and therefore not patentable subject matter. The High Court took the view that the claimed invention would extend the scope of the concept of “manner of manufacture” and that this was not something which was appropriate for courts to do. In light of the High Court’s decision, it will be interesting to see whether there is a legislative response to this issue.

Recording Trade Mark Licence Agreements in the Middle East

Dec 09 2014

Many businesses operate in the Middle East through entities licensed to use their trade marks. These businesses should be aware that many Middle Eastern countries require that trade mark licence agreements are recorded with the respective Trade Mark Registers or other named authorities in these countries. Not recording a licence agreement could lead to monetary penalties being imposed on the licensee or an inability to enforce trade marks against third party infringers.

For example, Bahrain, Qatar, Saudi Arabia and the United Arab Emirates each have more or less equivalent provisions in which a trade mark licence agreement must be in writing, it cannot include unregistered trade marks and it has no legal effect against third parties unless it is recorded on the respective Trade Mark Registers (or other named authorities in these countries). Each of these countries has slightly different processes and requirements for seeking registration of a trade mark licence agreement. Read More

High Court of Australia Decides Landmark Trade Mark Case

Dec 05 2014

Decision in Cantarella Bros Pty Ltd v Modena Trading Pty Ltd Clarifies Test for Distinctiveness of Trade Marks in Australia

This week, the High Court of Australia (High Court) handed down only its third decision considering trade mark issues since the enactment of the Trade Marks Act 1995 (Cth). This decision could make it easier to register foreign language words as trade marks.

Business Method Patents in Australia: Mere Computer Implementation Not Enough

Nov 20 2014

Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150

On 10 November 2014, the Australian Full Federal Court (Court) held that a method of creating an index of securities using a standard computer was a ‘scheme’, and, hence, not a patentable invention.

The Court applied the Australian High Court test from National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 that a patentable invention must produce an “artificially created state of affairs”. The Court said that this test is not satisfied by mechanistic application of artificiality or physical effect, but by understanding the claimed invention as a matter of substance not form. Read More

Special Leave Sought to Appeal Gene Sequencing Decision to the High Court of Australia

Sep 25 2014

We recently reported on the decision by a five judge bench of the Full Court of the Federal Court of Australia (Full Court) which found that Myriad Genetics Inc’s patent covering the isolated BRCA1 gene is valid. The Full Court unanimously rejected an appeal by Ms. Yvonne D’Arcy from a decision by Justice Nicholas at first instance. Read our alert here.

It is now being reported that Ms. D’Arcy has sought special leave to appeal the decision to the High Court of Australia (High Court).

AstraZeneca Loses Latest Bout Over Rosuvastatin Patents

Aug 12 2014

The Full Federal Court of Australia has upheld the first instance judgment of the Federal Court of Australia that the three patents protecting AstraZenica’s rosuvastatin products (marketed as Crestor) are invalid.

In judgment handed down on 12 August 2014, the court unanimously dismissed the appeals by AstraZeneca against generic pharmaceutical companies Apotex Pty Ltd, Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd. Read More

Tag:life sciences