Posts Tagged ‘biotechnology’

Enzo Biochem V. Applera Corp. – When “Words Can Hurt You”

Thursday, March 19th, 2015

iStock_000010676885_SmallOn March 16, 2015 (Appeal no. 2014-1321), the Fed. Cir. reversed the district court’s construction of a claim term relating to the scope of “A,” a moiety capable of direct or indirect signaling that is attached by a linker to a nucleotide base. (A copy of the decision can be found at the end of this post.) The claim read: “wherein A comprises at least one component of a signaling moiety capable of producing a detectable signal [wherein the linker does not interfere] with formation of the signaling moiety or detection of the detectable signal….”

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Novartis Wins Landmark Biosimilar Approval

Monday, March 9th, 2015

iStock_000013653107_SmallNovartis Navigates The FDA-ACA Maze – Gets Approval For Generic Neuprogen.

Amgen will soon find itself in a price war with Sandoz – a Novartis company – as it tries to maintain its share of the market for Neuprogen (filgraslim). The drug is used to treat neutropenia –often a side effect of anti-rejection drugs or chemotherapy. No matter what you think of “Obamacare,” whoever slipped in a relatively small section authorizing biosimilar products and outlining a pathway to approval, may end up saving many consumers much more than they might realize from affordable health care. Sandoz will market the drug as Zarxio. Read more here.

Patents4Life is Six Years Old this Month. Happy Birthday to Us!

Tuesday, March 3rd, 2015

OLYMPUS DIGITAL CAMERASix years ago, In re Kubin caused a flurry of concern among biotech practitioners, and a short article on this decision was the first post on Patents4Life. That was a pretty big “story” at the time but we all had no idea what was coming our way. It is difficult to think of an area of patent law that hasn’t been through a sea change since 2009, or at least has not encountered some very high seas.

There are not enough hours in today to do even a cursory review of the “State of Patent Law” since Patents4Life was started. Of course, one of the hottest topics right now is the scope of s. 101, and its breadth will surely be adjusted as the precedent piles up. And just consider, all of this debate is completely outside of the changes wrought in 35 USC by the AIA, the rise of generic biologicals that was set off by the ACA (“Obamacase”) and the Therasense, Teva v. Sandoz and Nautilus decisions.

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Universities Response to Patent “Reform” Legislation

Friday, February 27th, 2015

iStock_000015456314_Small copyOn February 24th, a letter sent by the Association of American Universities, signed by 145 universities, to Senators Grassley and Leahy and Representatives Goodlatte and Conyers, objected to parts of legislation such as “The Innovation Act, H.R. 9” that purports to deter litigation by non-practicing entities, such as patent “trolls.” The Universities emphasized the damage that fee-shifting provisions requiring the loser of an infringement suit to pay the winner’s costs and fees would do to educational and research institutions that already find it financially difficult to enforce their IP rights. The letter pointed out the chilling effect such provisions would have on attempts to license technology, especially to start-ups. Also noted was the fact that mandatory joinder provisions could draw a university and its inventors into litigation initiated by third parties over which the university has little control.