Archive for December, 2012

Top Ten Biotech IP Stories of 2012

Friday, December 28th, 2012

I admit, I am a sucker for lists, esp. Top Ten Lists, and a few days ago, sat through a half hour of “local news” wherein the anchors breathlessly related the Top Ten Rhode Island News Stories of 2012. Well, readers, you deserve no less that my Top Ten List of IP “Stories” that broke, sometimes over us, in 2012. So that this post is not endless, I will write it from very abbreviated notes and leave it to you to dig the details out of the patents4life archives – or to just back up through the posts of 2012. Also, past Prometheus and Myriad, the list does not mean to prioritize the events reported.

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In re Rosuvastatin Calcium Patent Litigation – Making “Therasense” out of Confusion

Thursday, December 20th, 2012

Recently, a divided three judge panel sorting out a multi-party Hatch-Waxman suit, ruled that the patentee, Shinonogi, had not committed inequitable conduct in obtaining the patent that was subsequently reissued so as to obtain narrow claims focused on Rosuvastatin, or Crestor®, the popular cholesterol lowering drug. The majority of the panel also held that the patent was properly reissued due to error without deceptive intent. Although the deceptive intent element has been removed from the reissue statute by the AIA, it will remain relevant to earlier-filed reissues for some time to come. The opinion was subtitled AstraZenca UK Ltd v. Aurobindo Pharma Ltd, 2010-1460 to 1473 (Fed. Cir., December 14, 2012) and involved multiple “generic company” defendants. (A download is available at the end of this post.)

After finding the Crestor claim non-obvious over a Sandoz reference that disclosed a sulfonylated analog, the panel spent 7 pages discussing IC and 10 pages discussing whether or not the reissue application was properly filed. In terms of IC, Fed. Cir. panels continue to be reluctant to find IC in cases in which multiple parties create “a string of mishaps, mistakes, misapprehensions and misjudgment,” particularly if the “purported culprits” are “inexperienced and overworked,” to use the language of the district court, that also found no IC. It probably helped that the only two “purported culprits” were both Japanese patent attorneys apparently working in Japan, although it is hard to fathom how they carried out the prosecution of a U.S pharma application and then reissued the resulting patent with no input from U.S. counsel, but none are mentioned. The Japanese attorneys had failed to file an IDS during prosecution of the ‘440 patent, and then filed for reissue, listing the two references on an IDS, and obtained the ‘314 reissued patent with claims essentially limited to Crestor.

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Common Patent for European Union Adopted

Wednesday, December 12th, 2012

The European Union has finally decided to adopt a common patent that will be granted in three languages – English, French and German – but will cover all of the 27 EU countries. Note that there is not a perfect overlap with the 30 EPO contracting states, e.g., Turkey, Iceland and Albania are not yet members of the EU. A common EU patent has been debated and tabled since before I entered practice in 1981. Of course, this should permit a substantial savings in translations and “local” filing fees. When I worked at Kenyon & Kenyon in the early 80’s there was considerable skepticism about new-fangled PCT applications, and many attorneys would not advise their clients to do other than file in individual “foreign countries”, sometimes not even using the EPO (which only had ten member countries then, e.g., Spain, Norway and Finland had not joined, but you could file in Liechtenstein and Luxembourg). The new patent is planned to be available some time in 2014.

An update on this agreement can be found here.

Supreme Court Grants Myriad’s Petition for Cert.

Monday, December 3rd, 2012

I feel a bit like Al Pacino in “The Godfather – Part 3” when he shouts, “Just when I thought I was out, they pull me back in!” (Repeated memorably by Silvio Dante in “The Sopranos”.) Now the Supreme Court has granted cert. to resolve one question: “Are human genes patentable?” In isolation, presumably, since I have been explaining to patent “civilians” for years that no one can patent a gene – or any other chemical – as it occurs in situ in the human body and then demand a royalty from anyone using the gene to live.

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