Allergan V. Sandoz – When Everything “Old” Is “New” Again

On Tuesday, a divided panel of the Fed. Cir. found that Allergan’s claimed method of reducing the number of daily topical doses of brimonidine to treat glaucoma from 3 to 2 doses by administering a composition containing 0.2% brimonidine and 0.5% timolol, as unobvious, even though both drugs were known to be effective to treat glaucoma and the two drugs had been administered serially twice a day rather than three times a day. Allergan, Inc. v. Sandoz Inc., App. No. 2011-1619, -1620, -1635, -1639 (Fed. Cir. May 1, 2013). The majority of the panel reached this conclusion even after finding that the composition claims were obvious in view of the art, and after recognizing that an inherency doctrine may apply to an otherwise obvious claim, as well as to support an anticipation rejection.

In other words, the dissent (Dyk) “would find [the method claim] obvious on the grounds that it merely claims the result of treatment with an obvious composition.” The majority (Proust and O’Malley) distinguished decisions in which “patentee claimed either a previously unknown result or an undisclosed inherent property of an otherwise anticipated claim, citing Bristol-Myers Squibb v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir. 2001). In this decision, the court  considered a claim to reduce the side-effects of a known anti-cancer drug by using a specific dosing regimen. The process, in its entirety, was found in the prior art, and the B-M court stated that “[i]n the context of anticipation, ‘[n]ewly discovered results of known process directed to the same purpose are not patentable because such results are inherent.’” Id. At 1376.

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Marks & Clerk Releases Life Sciences 2013 Report

On Monday, the international law firm Marks & Clerk released it’s 2013 Life Sciences Report at the BIO International Convention in Chicago. This 50-plus page report is wide-ranging, containing both the views of life science leaders on marketplace issues like funding for new ventures (not favorable) and other trends in the pharma/biotech industry (more mergers and joint ventures). Although these opinion survey results are of some interest, particularly the focus on the AIA, SPCs and biosimilars, the “meat” of the report is Marks & Clerk’s attempt to summarize major IP trends in both the US (not good for diagnostics), the EP (not good for stem cells), Australia (scope of prior art broadened), India (compulsory licenses and attempts to clarify biotech patent standards) and even Thailand and Hong Kong. I think that  all of us working in the life sciences space should give this report at least a quick look – It is an ambitious and largely successful attempt to summarize “the year in IP law and business worldwide.”

2013 Life Sciences Report

 

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Myriad Argued Before The Supreme Court – Some Snippets

I confess that I’ve become addicted to this case and just finished all 63 pages of the transcript of the oral argument that took place on Monday. I won’t try to summarize it, but rather will try to review some trends.

1)  Four of the Justices (Scalia, Kennedy, Kagan and Roberts) all expressed concern that ruling that isolated DNA is not patent-eligible would discourage investment in the research needed to lead to further useful inventions based on isolated genes. The question is, of course, how concerned are they? However Hansen, arguing for Myriad was questioned about this early in his time slot.

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Saffran v. J&J – When Defining Equals Disclaiming

A guest post from Theresa Stadheim of Schwegman Lundberg & Woessner, P.A.

In Bruce N. Saffran, M.D., Ph.D., v. Johnson & Johnson and Cordis Corporation, Appeal No. 2012-1043 (Fed. Cir. April 4, 2013, decision by Lourie), the Federal Circuit reversed an Eastern District of Texas decision and held that the Eastern District of Texas erroneously construed claims of U.S. Patent No. 5,653,760 (“the ‘760 patent”).

The ‘760 patent discloses a method for treating complex bone fractures that used a “single, flexible, minimally porous sheet.” ‘760 patent at col. 7, lines 34-36.  The alleged infringing device was a stent comprised of a mesh with a microscopic layer of polymer coating each strut of the stent.

One of the issues on appeal was the district court’s construction of the term “device.”

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