Novartis Wins Landmark Biosimilar Approval

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!

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.

Read the rest of this entry »

Universities Response to Patent “Reform” Legislation

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.

Pacing Technologies v. Garmin – D&D Explained

February 20th, 2015

disclaimer marked on rubber stampIn this decision—No. 2014-1396 (Fed. Cir., Feb. 18, 2015)—the court affirmed a grant of summary judgment (a copy can be found at the end of this post) that Garmin’s exercise products do not infringe the claims of Pacing’s US Pat. No. 8,101,843. The court reviewed the case de novo because the district court had relied entirely on the intrinsic evidence. The claims were directing to a systems comprising  “playback devices” that the judge ruled do not play target tempo or pace information as “audio, video or visible signals,” e.g., while the user is running.

The panel affirmed that the preamble should be given weight as a claim limitation because:

“[w]hen limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” Eaton Corp. v. Rockwell International Corp., 323 F.3d 1332 (Fed. Cir. 2003).

Read the rest of this entry »