Posts Tagged ‘apotex’

Australia – High Court Decision on Methods of Medical Treatment

Friday, December 6th, 2013

This is a guest post from Bill Bennett of Pizzeys in Australia. It covers Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013). (A copy of the full decision is available at the end of this post.)


The Australian High Court has handed down a 4:1 majority decision confirming that a method of medical treatment can be a “manner of manufacture” (i.e. patentable subject matter).  This is the first time that this issue has been directly considered by the Australian High Court.


Sanofi is the owner of a patent which claims a method of preventing or treating psoriasis by using a compound called leflunomide.

Apotex registered leflunomide on the Australian Register of Therapeutic Goods with the intention of selling it for the purpose of treating rheumatoid arthritis and psoriatic arthritis.  Most persons with psoriatic arthritis either have, or will develop, psoriasis.  Thus, the treatment of psoriatic arthritis will often simultaneously involve the treatment of psoriasis.


Astrazeneca v Apotex – Patent That Label!

Thursday, January 13th, 2011

I recently had a chance to re-read AstraZeneca LP v. Apotex, Inc., Appeal No. 2009-1381, 1424 (Fed. Cir. Nov. 1, 2010) and realized that it is a virtual case note on how to extend patent term by “patenting the label.” The primary patents on budesonide, an anti-asthma drug, had expired and AZ was trying to use two add-on patents (U.S. Pat. Nos. 6598603 and 6899099)claiming the drug administered in a  continuing once-a-day regimen for treating a respiratory disease and a kit containing the drug in a solvent and a label indicating the once-a-day regimen.

Apotex had filed a para. IV notification alleging invalidity and non-infringement but had been required by the FDA to copy AZ’s label which included a statement that the initial dosing, e.g., twice a day, should be titrated downward in some cases. AZ argued successfully that the Apotex labeling would induce infringement because titrating down from the recommended starting dose would necessarily lead to the claimed once-daily dosing regimen.

After interpreting the claims to exclude the drug encapsulated in liposomes (even though the specification of the patents taught this as an option, and no language in the claims excluded liposomal encapsulation—good lawyering Ms. Loring!), the Fed. Cir. agreed that the Apotex labeling would induce infringement. (There is a good discussion of the standards for inducing infringement in the opinion). However, the Fed. Cir. found that the kit claims were invalid, since the labeling packaged with the drug was not “functionally related” to the drug or to the kit: “Our decision In re Ngai foreclosed the argument that simply adding new instructions to a known product creates the functional relationship necessary to distinguish the product from the prior art.” Preliminary injunction affirmed.

Well, one valid “label claim” was all it took to keep a generic off the market, so read those labels when you are designing your client’s or company’s product life cycle management strategy. Conversely, if you are preparing a PIV opinion, watch out for attempts to patent (often obscure) portions of the label.

AstraZeneca v Apotex