UPDATED 01.26.10 @ 5 PM EST -- Teva WINS -- full 40 page PDF of the Judge's opinion here!
As long as I am covering the Clarinex (descloratadine), Integrilin (eptifibatide) and Zetia (ezetimibe) patent disputes/potential generic competitors' "at risk" launches in the United States, I might as well cover the Temodar® matter, right? Right. 
A generic form of temozolomide, the active chemical-compound in Temodar, is already available in the EU. The branded version, here in the US, is an FDA approved cancer drug -- generating sales revenue of around $950 million a year, wordwide, for Schering-Plough (albeit creating smaller margins, here, as the sales-rights to the product are in-licensed from a third party). The recently filed Schering-Plough Form 10-Q (page 28, "Legal Proceedings") discloses that the patent infringement trial in the federal courts in Delaware was completed in April. Barr Labs (now a wholly-owned, private subisiary of one of the Teva Pharmaceuticals family of companies), and Schering-Plough are awaiting a decision from the trial judge, on that trial:
. . . .in July 2007, Schering-Plough and its licensor, Cancer Research Technologies, Limited, filed a patent infringement action against companies seeking approval of a generic version of certain strengths of TEMODAR capsules. The trial concluded April 2, 2009. A decision has not yet been rendered. . . .
[From the Court filings -- Barr/Teva's Disputed Questions of Law]
. . . .'291 Patent is Unenforceable Due to Prosecution Laches Resulting from [Schering's] Delay in Prosecuting the Applications Leading to the Issuance of the ‘291 Patent
Prosecution laches is an equitable doctrine that "may render a patent unenforceable when it has issued only after an unreasonable and unexplained delay in prosecution," and may be applied even though a patent applicant complies with pertinent statutes and rules. Symbol Tech., Inc. v. Lemelson Med. Educ. & Research Found., 422 F.3d 1378, 1385 (Fed. Cir. 2005); In re Bogese, 303 F.3d 1362, 1367 (Fed. Cir. 2002). When addressing the issue of the burden of proof applied to prosecution laches, this Court has agreed with other district courts that “the preponderance of the evidence standard should apply. . . ."
. . . .As an equitable doctrine, there are no firm guidelines for determining when prosecution laches should render a patent unenforceable, and the determination is "subject to the discretion of a district court before which the issue is raised." Symbol Tech., 422 F.3d at 1385. Prosecution laches requires “an examination of the totality of the circumstances.” Id. at 1386. Factors district courts have considered to determine whether a delay in prosecution was unreasonable are (1) whether the prosecution history of the patentee’s patents is atypical of patents in that field or patents generally; (2) whether there are unexplained gaps in the prosecution history; (3) whether the patentee took any unusual steps to delay the application process; (4) whether a change in the patentee’s prosecution of the application coincided with or directly followed commercial developments or evolutions in the field of the claimed invention; and (5) whether legitimate grounds can be identified for the abandonment of prior applications. . . .
Will there be a decision in this case, soon? We'll see.
In any event, perhaps the "meta-narrative" here, should be that while Wall Street has been touting Schering-Plough's relative dearth of patent expiries (with most patents lasting beyond 2014, strictly by the as-granted terms of each) -- the actual substance of Schering's various patent-infringement-lawsuits might suggest that Schering will lose exclusivity on many of its franchise products even sooner than some of its compatriots in the multi-national pharmaceutical arena -- here plainly including Merck & Co.
And that's rather ironic, no?
2 comments:
with the potential losses from a number of patented drugs...maybe selling to Merck was not only a good thing for S/P but...a brilliant sale by Fred?
Thanks for your thoughts -- true enough, these four patent suits alone involve over $4 billion of annual revenue, to Schering-Plough.
However, I actually think what Merck is learning, day by day -- while conducting its deep-dive due diligence, now -- might actually increase the chances of someone scuttling the deal.
Not directly -- not as the announced reason for backing up, and renegotiating -- but in a softer way.
Consider what J&J's sending a notice of arbitration on the Remicade/Simponi reversion of non-US rights (about $3 billion per year in sales at Schering) might do. . . . Ouch.
That would put the annual Schering-Plough "sales revenue in danger" figure at over $7 billion (on a company that only had $17 billion in total revenue last year)!
That's almost half -- at risk -- and that's before we consider the continuing swoon of Vytorin/Zetia in the US (another $1 billion in sales decreases, there).
Yep -- 'tis going to be entertaining.
Namaste
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