Tag: Apotex

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New Developments in Amgen v. Apotex
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Australia’s Very Exclusive Patent Licensee Club
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AstraZeneca Loses Latest Bout Over Rosuvastatin Patents
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Breaking News – High Court of Australia Confirms That Methods of Medical Treatment are Patentable

New Developments in Amgen v. Apotex

Apotex petitioned the Supreme Court for a writ of certiorari on September 9, 2016, seeking review of the following two issues: (1) “[w]hether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the BPCIA for the resolution of patent disputes . . . must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A)”; and (2) “[w]hether the Federal Circuit improperly extended the statutory 12-year exclusivity period to [12.5] years by holding that a biosimilar applicant cannot give effective notice of commercial marketing . . . until it receives [FDA approval].” The Supreme Court denied the petition on December 12, 2016, without comment.

However, the questions Apotex presented are narrower than the cross-petitions taken from Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), which remain pending before the Supreme Court. The Court sought the opinion of the Acting Solicitor General concerning the Sandoz petitions, and in an amicus brief filed on December 7, 2016, the Acting Solicitor concluded that the Court should hear the case. If the Court agrees, it may address Apotex’s questions in the course of deciding Sandoz. Meanwhile, biosimilar applicants and other interested parties should continue to watch the Sandoz petitions and take any decisions into account in developing strategies.

For further information, please see the update to a recently published alert on this case.

By: Margaux L. Nair, Kenneth C. Liao, Trevor M. Gates, Peter Giunta

Australia’s Very Exclusive Patent Licensee Club

Bristol-Myers Squibb Company v Apotex Pty Ltd [2015] FCAFC 2

The Full Federal Court of Australia (Court) has held that an ‘exclusive licensee’ within the definition of the Patents Act 1990 (Cth) (Patents Act), must be granted the exclusive right to undertake ALL of the activities falling within the meaning of “exploit”. Accordingly, a grant of a licence to advertise, market, promote, sell and distribute, but not manufacture, does not create an “exclusive licensee”, as defined in the Patents Act. There can only be one exclusive licensee and the patentee cannot reserve any of the exclusive rights to exploit to itself. Read More

AstraZeneca Loses Latest Bout Over Rosuvastatin Patents

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

Breaking News – High Court of Australia Confirms That Methods of Medical Treatment are Patentable

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors [2013] HCA 50

The High Court of Australia yesterday issued its long awaited decision in a dispute between Apotex Pty Ltd (Apotex) and Sanofi-Aventis Australia Pty Ltd and related entities (collectively, Sanofi) concerning Sanofi’s Australian patent entitled “Pharmaceutical for the treatment of skin disorders” (Patent). In summary:

  1. The majority (French CJ, Crennan, Keifel and Gageler JJ, Hayne J dissenting) held that assuming all other requirements for patentability are met, a method (or process) for medical treatment of the human body can be a “manner of manufacture” and therefore patentable for the purposes of section 18 of the Patents Act 1990 (Cth) (Act). Read More

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