In Canada, linkage regulations similar to the Hatch-Waxman Act in the U.S. ensure that generics manufacturers have to address relevant patents listed on the Patent Register (the analog to the Orange Book) if they want to market their product prior to the expiry of listed patents.   Generics manufacturers can do so either by accepting the terms […]

Take it for Pain. Take it for Life. ~ Bayer aspirin slogan Drospirenone is a progestin that inhibits ovulation. While known in the art, Bayer patented formulations of drospirenone, one of the active ingredients in Yasmin® a daily oral contraceptive. Now, the U.S. Court of Appeals for the Federal Circuit has ruled that the patent […]

The Australian Patent Office has handed down a significant decision in the land down under, which impacts the type of pharmaceutical subject matter that is eligible for term extension. N.V. Organon [2009] APO 8. According to Section 70 of the Australian Patent Statute, in order to be eligible for an extension of term, either or […]

In In re Kubin (08-1184), the US Court of Appeals for the Federal Circuit held that the US Patent and Trademark Office’s Board of Patent Appeals and Interferences was correct to hold claims as unpatentably obvious when applicants use “conventional techniques” to make an invention.  This is bad news not just for biotech but for […]

In Ariad v. Eli Lilly & Co. (08-1248) (a top 10 case for 2009), the Court of Appeals for the Federal Circuit set out a split decision on a case addressing patent validity and enforceability issues where Lilly contends that the asserted claims of US 6,410,516 are invalid for including non-statutory subject matter, for being […]

The European Patent Office (EPO) has announced more important rule changes, as part of its drive to speed up prosecution without apparently requiring any more from its examiners.  The new rules will come into force on 1 April 2010. Of particular note is that two of the new rule changes are actually beneficial to applicants! […]

The Senate Judiciary Committee voted to approve a patent reform bill, despite opposition from Sen. Orrin Hatch. This will send the bill to the Senate for a vote after including amendments. The Senate Judiciary Committee held an Executive Business Meeting to consider S.515, the Patent Reform Act of 2009 (Leahy, Hatch, Schumer, Whitehouse).  The legislation   […]

There have been mutterings and papers for some time about the EPO restricting the filing of divisional applications. They were viewed by some at the EPO as a thorn in the side of 3rd party rights. It is now official – the EPO Administrative Council met 26 March 2009 and considered the filing of divisional […]