Monday, June 29, 2009

More on the "Trouble for Temodar", Today -- Post-Trial Patent-Challenge Briefs Filed

"An Egregious Misuse of the Patent System. . . ."

After clearing a madatory one-week delay, to allow the redaction of trade secret material, Barr/Teva, Schering-Plough's opponents in the Temodar patent litigation (Cancer Research Technologies, et al. v. Barr Laboratories, et al., Case 07-457 (SLR), US Dist. Ct., Del. -- trial complete April 2, 2009 -- awaiting decision) have laid waste to one of Schering-Plough's central patent protection strategies in this challenge to the exclusivity for Temodar. Do click it to enlarge [a massive 2.6 Mb PDF File of the 60-page brief, full text]:

Background, from earlier SEC Form 10-Q, and federal District Court filings:

. . . .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. . . .

[Much more on Schering-Plough's "In Substance" Patent Cliffs, more generally, here.]

[From the Delaware 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. . . .

With so much focus on health care reform in the United States, this case may well become the "poster child" for Big Pharma's more-than-occasional alleged abuse of the United States patent system -- to (in this case) delay the start date of patent protection, until the manufacturer (Schering-Plough) is in the best position to keep any potential generic competitors (Barr/Teva) off the US market-shelves for the longest period of time imaginable. Once again, pressing too hard -- torturing the facts, and the law -- Schering-Plough may yet reap the exact opposite of the result it originally sought. We shall see.


Anonymous said...

Just to open a debate:

Cost-Effectiveness of Cancer Drugs Is Questioned-

A very difficult subject that no-one really wants to talk about. But, has implications for our health care costs.

Condor said...

Indeed. Extending life by only a few weeks -- in terminal cancer cases -- at a very high per-dose price.

I am not sure that I buy the WSJ's view that this was born of the "Baby Boomers" going gray. . . .

I think Americans have long felt entitled to consume ALL of anything they feel they can possibly afford to buy.

They rarely ask "Should I?"

A large part of the problem here (as you have implied, as well) is that the person demanding it, and consuming it (the patient; the family), is not (directly) the person PAYING the bill, and the person authorizing the treatment (the oncologist) is not PRIMARILY driven to make decisions based on the economic utlity of these trade-offs. . . . the oncologist is primarily concerned with extending the time-line.

It takes a family intervention, or a patient refusal, to say "that's enough" -- and let cellular biology take its inevitable course, in those cases.

Yep -- health care delivery in the US is surely broken.

Candidly, I think this all points to a government-funded option -- and rationing -- by economic disincentives.