Posts Tagged ‘Patent Law’

Major Changes to IP Law in Australia Enacted

Thursday, April 19th, 2012

This guest post by Tom Gumley, PhD, a partner in the well-known Freehills Patent and Trademark firm provides a lengthy guide to the changes wrought by Australia’s new patent law, that was enacted on April 15, 2012. The law brings Australia closer to the US in many of its legal standards and, like the AIA, goes into effect at various times in the future.

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We are pleased to provide Freehills’ guide to Australia’s new patent law [available at the end of this post] that was signed into law on April 15, 2012.

This new law will have far-reaching consequences for those seeking and enforcing patent rights in Australia, and ultimately will establish a class of new Act patents to which higher validity standards required by the new law will apply, and old Act patents to which relatively lower validity standards established by the old law will apply.

There will also be important consequences regarding exemption from infringement for patentees and alleged infringers with the codification of experimental use provisions, and a broadening of old law exemptions to cover acts done for seeking regulatory approval of any product for which approval is required for marketing.

If you or your clients have business interests in Australia, it is very important that you come to an understanding of the new law sooner rather than later, as in many instances, the opportunities to be had and the risks to be mitigated under the new law will require you to take relevant action now.

Given the complexity of the new law, our commentary is necessarily of a general nature and we strongly advise you to contact us should you require professional advice on any particular issue.

Regards,

Tom Gumley PhD
Partner
Freehills Patent and Trade Mark Attorneys

Guide to Australia’s new patent law

Supreme Court Reverses In Caraco Appeal

Tuesday, April 17th, 2012

Today, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk, in an opinion authored by Justice Kagan (a copy can be found at the end of this post), the Court reversed the Fed. Cir.’s divided 2010 decision that an ANDA filer (a “generic drug company”) sued in para. IV litigation cannot assert a counterclaim that the NDA holder (“the innovator”) listed a use code in the FDA Orange Book that is overly broad. This question is important because during litigation, Novo had broadened its use code to cover uses Caraco alleged were not within the claims of the listed patents, but which Caraco wanted to be able to include in its labeling. So the question presented was:

“Whether an ANDA applicant may assert a counterclaim under Section 355(j)(5)(C)(ii)(I) by alleging that the brand name manufacturer’s patent information [the use code] does not accurately and precisely describe the method of use claimed by its patent.”

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Prometheus Q/A – Which Side Are You On?

Thursday, April 12th, 2012

A guest post from Robin Chadwick of SLW.

During the three weeks since the Supreme Court ruled that certain diagnostic claims are not eligible for patenting, four other patent cases have been impacted by this ruling.

The Court is shaping public policy by its ruling.  Do you approve of such a public policy?

Tell us what you think of the recent Supreme Court Prometheus decision!  Take a short survey by clicking on the link below.  We will publish the results of the survey so your voice can be heard!

Prometheus Survey

Aventis v. Hospira – How to Meet the Therasense Standards

Tuesday, April 10th, 2012

On April 9, 2012, The Fed. Cir. affirmed a holding by the district court that rendered two (then) Sanofi add-on patents on infusion vehicles for docetaxel unenforceable due to inequitable conduct. The inventors, particularly inventor/project manager Fabre, were found to have intentionally decided not to submit two material pieces of prior art to the PTO.

“Materiality” was not an issue on appeal, since the district court had invalidated the patents using the disclosures of the uncited references. Since the references were material under the “clear and convincing standard”, they had to be material under the PTO’s lower ”preponderance of the evidence” standard.

The section on intent is more interesting. The references were not “knock-out” s. 102(b) disclosures of the invention, but rather were used to support invalidation based on s. 103. This left the contemporary relevance of the reference open to some debate, and both the district court and the Fed. Cir. relied heavily on the testimony of inventor Fabre who, unfortunately, testified in detail about his reasons for not submitting the references.

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