Replies to post #45888 on Biotech Values

[gofishmarko]

Re : Patent ‘Obviousness’


>>This is an excellent ruling that was long overdue, IMHO.<<


Agreed. Is there now a basis for challenge of patents on isomer drugs like Lexapro , which is a pretty obvious improvement of Celexa ?

Hopefully this ruling will spur some real innovation and decrease the amount of research dollars wasted on me-too drugs.

[DewDiligence]

Re: Supreme Court patent ruling

In the Lotrel case, I think the recent KSR vs Teleflex decision (#msg-19250528) played at least some role in the judge’s denial of NVS’ request for an injunction as well as in TEVA’s decision to launch generic Lotrel at-risk.

[DewDiligence]

KSR Patent Ruling Already Affecting Court Cases

[To date the KSR ruling has not explicitly affected any drug-related patent case, but it’s only a matter of time until it does.]

http://online.wsj.com/article/SB118584454182682899.html

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By PETER LATTMAN
July 31, 2007

Three months after the Supreme Court handed down what many called a landmark patent decision, judges have begun to rule in favor of companies defending themselves against infringement lawsuits -- in one case dismissing a suit and in another ordering a review.

Last week, a federal judge in San Francisco who previously had allowed a patent-infringement lawsuit to proceed against RealNetworks Inc. changed course and dismissed the case, citing the Supreme Court's April ruling in KSR v. Teleflex. The case is believed to be the first in which a trial-court judge has reversed his position and dismissed a case in the defendant's favor, citing the KSR decision.

RealNetworks was sued in 2003 by Friskit Inc., a patent-licensing company based in San Francisco, over technology for organizing and playing video and audio files. The judge ruled that Friskit's patent claims were nothing more than obvious combinations of elements publicly available, including RealNetworks' own Internet products. Judge William Schwarzer concluded that "the idea of integrating these different components was not novel."

"The Supreme Court has made it clear what it thinks," the judge said at a hearing in the case. "Patents are being issued on obvious inventions, and it tightened the reins." A lawyer for Friskit says the company is reviewing its options for appeal and was confident it could prevail.

The KSR decision turned on the notion of "obviousness," one of the bedrock doctrines of patent law. The Supreme Court laid out the obviousness doctrine in 1851, saying that a patent requires more "skill and ingenuity" than that of "an ordinary mechanic acquainted with the business." Since virtually every litigated patent case includes an assertion of obviousness, and since the U.S. patent office examines patent applications for obviousness, many legal commentators have called KSR the most important patent case in decades.

"Patentees have long had the upper hand in patent litigation but the KSR case has shifted that balance of power back to defendants," said Dennis Crouch, a law professor at the University of Missouri.

In KSR, the Supreme Court rejected a "rigid" application of existing tests for obviousness in favor of a more "expansive and flexible approach" that would give judges more discretion. If a person of ordinary skill in the relevant subject area would "be able to fit the teaching of multiple patents together like pieces of a puzzle" then the patent is obvious, the Supreme Court ruled.

Some experts in law and economics think affording judges discretion in analyzing an obviousness defense is not a good thing. "Flexibility has an Achilles' heel, which is that people with the biggest lobbying and litigation budgets, and the best public relations, win," said Scott Kieff, a law professor at Washington University in St. Louis, who has argued for predictable rules in the patent system. "Flexibility really means that the company that can fight the hardest and shout the loudest wins the attention of the person with the flexibility to use his own discretion."

Technology and financial services companies were particularly hopeful after the Supreme Court ruling. These companies in recent years have faced a flood of costly patent-infringement lawsuits, often brought by patent-licensing and -holding companies often derisively called "patent trolls" -- that buy up patents with the aim of obtaining royalties from alleged infringers. These companies and other patent holders argue that courts should vigorously protect ownership rights or companies will be unwilling to take the risks necessary for innovation.

More decisions like the RealNetworks case could give companies leverage against patent-holding firms and pressure those firms to settle disputes rather than risk a court ruling invalidating their patents outright. Though only one case at the trial-court level, it was handed down in the San Francisco Bay Area, where many patent-infringement disputes are heard because of the heavy concentration of technology companies. The court is known as being more defendant friendly in these cases as opposed to, say, the Eastern District of Texas, which has become famous for big plaintiff-friendly jury verdicts.

The KSR ruling has also affected the U.S. Patent and Trademark Office, whose examiners review every patent application for obviousness. After KSR, the patent office issued a short memorandum to its examiners suggesting that the decision wouldn't have a major impact on the examination process. Still, an appeals panel at the patent office has cited KSR in at least three recent rulings upholding an examiner's rejection of a patent on the grounds of obviousness.

Meanwhile, companies defending patent lawsuits are invoking KSR with mixed results, and it's still too early to tell whether the RealNetworks case will be a forerunner to similar decisions.

Vonage Holdings Corp. asked a federal appeals court to send its patent case against Verizon Communications Inc. back to a lower court, arguing that KSR calls into question the validity of some Verizon patents at issue in the case. In April, a jury ruled Vonage had infringed on several key Verizon patents related to Internet calling. The U.S. Court of Appeals for the Federal Circuit, a specialized court in Washington for patent appeals, hasn't yet ruled on Vonage's request.

A panel of judges from the International Trade Commission, an independent agency that serves as another forum for adjudicating patent disputes, last month agreed in the wake of KSR to review a finding that 24 companies violated patents for ink cartridges manufactured by Seiko Epson Corp.

A federal judge in Manhattan ruled earlier this month that a patent at issue held by McNeil-PPC Inc. was invalid based on obviousness and discussed KSR extensively. The court, though, said even without the KSR decision it would have ruled the same way. In June a federal judge in San Diego relied on KSR in dismissing one of several patent-infringement claims on obviousness grounds in a case involving Single Chip Systems Corp., a technology company in San Diego. But the judge allowed the case to proceed on three other claims, found to be not obvious under KSR.

Cellphone chip maker Qualcomm Inc. tried to use the KSR decision to its advantage in an escalating battle at the International Trade Commission with Broadcom Corp., a smaller chip maker that says it holds key patents related to advanced "3G" cellphones. Qualcomm argued that the ITC should have to follow the precedent set by the Supreme Court's ruling and dismiss Broadcom's inventions as obvious. But the agency ultimately sided with Broadcom, banning the importation of Qualcomm chips and cellphones that include them. The Federal Circuit upheld the ITC decision earlier this month. Qualcomm is now hoping for a presidential veto of the ITC ruling by Aug. 6.
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[DewDiligence]

FDA Approves Generic Yasmin from BRL

http://biz.yahoo.com/prnews/080509/nyf078.html

[Yasmin is a patent case where BRL undoubtedly benefited from the new “non-obviousness” standard in the Supreme Court’s KSR ruling (#msg-19250528). The patent in question pertains to the formulation of drospirenone (one of the two active ingredients in Yasmin) in which the particle size was reduced to increase bioavailability. Branded Yasmin from Bayer sells about $600M annually in the US.

Yasmin should not be confused with Yaz, a newer, lower-dose oral contraceptive from Bayer that BRL hopes to market as a generic. Yaz is vulnerable on the same formulation patent that failed to protect Yasmin; however, Bayer has H-W marketing exclusivity for Yaz until Mar 2009, so there can’t be any generic on the market until then.]

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Friday May 9, 3:35 pm ET

MONTVALE, N.J., May 9 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin® (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.

On March 3, 2008 Barr announced that the U.S. District Court for the District of New Jersey had ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG for its Yasmin product. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, 2008, Bayer Schering appealed this ruling to the U.S. Court of Appeals for the Federal Circuit.

Yasmin is a 28-day oral contraceptive consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $575 million for the twelve months ended February 2008, based on IMS sales data.
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