Biosimilars: balancing access to affordable medicines with safety

Biological medicines (biologics) are agents derived from a biological source.  As a consequence, they are complex and there is a high degree of variability between molecules of the same active substance.  Biosimilars are medicines that are closely related, pharmaceutically and therapeutically, to their reference biologic.  However, biosimilars are not identical to, and cannot be characterised as bioequivalent to, the reference …

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The future is now: Gene therapy lands in the United States

The United States Food and Drug Authority (FDA) has just given the green light to America’s first ever gene therapy treatment. It’s called Kymriah and it’s a genetically-modified autologous T-cell immunotherapy (CAR-T cell therapy).  For the layman: individually customised, cancer-killing white blood cells. This is why it’s a big deal, and what the future could hold for us here in …

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Here’s the drill: The Full Federal Court clarifies the requirement that patents disclose the ‘best method’ of performing the invention

The Full Federal Court recently drilled down on the ‘best method’ requirement in Australia in Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2017] FCAFC 138. Under Section 40(2)(aa) of the Patents Act 1990 (Cth) a ‘complete specification must … disclose the best method known to the applicant of performing the invention’. This requirement has been …

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In Good Shape – the Federal Court’s reminder to fit-out and shape your trade mark protection

In the recent case of Shape Shopfitters Pty Ltd v Shape Australia Pty Ltd (No 3) [2017] FCA 865, the Federal Court of Australia considered whether certain marks that included the word “SHAPE” were deceptively similar: Applicant’s registered mark   Respondent’s marks Although a large proportion of the decision focused on whether there had been breaches of the Australian Consumer …

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Drugs in the fast lane: provisional drug registration and other proposed changes to the Therapeutic Goods Act

Following the Australian Government’s Response to the Review of Medicines and Medical Devices Regulation in 2016, the government recently released exposure drafts for a set of significant reforms to the Therapeutic Goods Act 1989 (Cth). The proposed changes include modifications to the regulation of complementary medicines, and a new class of “provisionally registered goods”.  This new class provides an opportunity …

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All’s fair in love and war? The limits of the “fair dealing” copyright exception

The Fair Dealing-Fair Use war has been raging in Australia since antiquity. The Fair Users fondly yearn for the green pastures of American-esque copyright law. They imagine a vast nation where creative works are freely and peacefully disseminated as Fair Use, their benevolent sovereign, smiles on creators and consumers with equanimity and impartiality. The Fair Dealers on the other hand …

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Sorry – your name isn’t on the list! Canada’s Supreme Court orders Google to de-index certain unlawful websites globally

A decision in June by Canada’s Supreme Court in Google Inc. v. Equustek Solutions Inc., 2017 SCC 34 has ordered Google to de-list certain unlawful websites from its search results worldwide. The decision has sparked immediate debate about the implications of such global takedowns on freedom of speech and on the power of Internet intermediaries. Background Equustek Solutions (Inc.) (Equustek), …

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Rock, racism and the Constitution: the US Supreme Court takes a different slant on trade marks

America! It’s a land of flags, Twinkies, NASCAR. and Constitutional amendments.  Matal v Tam (PDF) is the most recent warning not to get between an American and any of those things. The case concerned the application by a “new-wave dance rock” band to register their band name as a trade mark. Ordinarily, the US Patent and Trademark Office (PTO) would let …

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Stuck between some wine and a hard case – some lessons from the Barokes “wine in a can” saga

Every now and then a case cracks open a delicious mix of intellectual property and commercial problems. Recent litigation by Barokes over “wine in a can” is one such example. After centuries of drinking wine out of glass bottles (or ‘goon sacks’ [1]) two inventors took the plunge and developed revolutionary technology for “wine in a can”. Barokes Pty Ltd (Barokes) …

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