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Table 1 Marketed osteoporosis drugs
2007 sales ($)
The saga over the validity of Genentech’s widely licensed recombinant antibody patent, Cabilly 2, inched forward in late February when the US Patent and Trademark Office (USPTO) rejected it officially for the fourth time (though two were partially withdrawn). The patent covers a fundamental method of using host cell culture to make therapeutic antibodies; in 2007, it generated $133 million for Genentech, of San Francisco. Genentech can respond to the rejection, then appeal the decision to the patent office’s board of appeals and later to the courts. Cabilly 2 remains valid until the end of the proceedings, which could take up to a decade. The legal costs are trivial compared with the licensing revenue, so the company has every reason to continue fighting. The rejection may be Launched in the US in September 2007; limited European launch in October 2007. bNot approved in US figures for .com/naturebiotec
2005/2006 fiscal year. NA, not available.
the USPTO’s most thorough response to Cabilly 2 since the start of its re-examination in 2005, meaning that “Genentech has some work to do here to overcome this,” says Ivor Elrifi, co-chair Most osteoporosis therapies act by inhib- of intellectual property at Mintz Levin in Boston. iting osteoclast-mediated bone resorption “It’s relatively easy to prevent vertebral The USPTO argues that Cabilly 2 is a variation of (Table 1). Although they prevent further bone fracture,” says Javier San Martin, Amgen’s
the art described in a number of earlier patents, http://www
loss, they also inhibit new bone formation, as including Genentech’s Cabilly 1. While there are executive director of global development some in the industry who perceive Genentech osteoblasts fail to receive the correct activation for denosumab. The most potent bisphos- oup as having an unfair monopoly with its Cabilly
signals (Box 1; Table 2). Denosumab has the phonate, Zometa, reduces risk of vertebral
patents, others suggest the ruling is a sign same shortcoming, as it also works by reducing fracture by around 70%. “It’s going to be that the patent office is increasingly rejecting osteoclast activity. The therapeutic rationale, very difficult to go above that level,” he says. patents based on prior art. (Nat. Biotechnol, 25,
however, is that because in elderly patients new However, bisphosphonate therapy leads to 699–700, 2007.) For example, Alice Martin, lishing Gr a partner at Barnes & Thornburg in Chicago,
bone formation is minimal, it is less important reductions in nonvertebral fractures, rang- says the decision could “backfire on biotech ing from around 20–25%, he says, whereas Pitted against the dominant bisphosphonate Amgen hopes that denosumab will achieve class—and its latest generation of long-acting reductions of 25–40%. “We do have good rea-agents, such as Basel-based Roche’s Boniva sons to believe that will be the case,” he says.
Nature Pub India’s IP snub
(ibandronate) and Basel-based Novartis’ Even so, Eric Schmidt, analyst at SG Cowen The Indian government is challenging the patent Zometa (zolendroate)—denosumab, produced in New York, says that Fosamax, due to come 200 legitimacy of two more big-selling biotech
drugs. On February 28, the Indian patent office
off patent in the coming weeks, will continue began reviewing a plea from Natco Pharma of ogy licensed from Fremont, California–based to take “the lion’s share” of the osteoporosis Hyderabad, India to produce generic versions Abgenix, has a more precisely targeted mech- market, and Amgen will initially position of two patent-protected oncology drugs under anism of action. The mAb binds a soluble denosumab as a second-line therapy and as compulsory license (CL)— Tarceva (erlotinib) protein produced by osteoclasts, the recep- an alternative option for patients who are owned by Roche, of Basel, and partners OSI, of New York, and Sutent (sunitinib), produced tor activator of nuclear factor kappa B ligand unable to take bisphosphonates, which can by New York-based Pfizer. This has happened (RANKL), normally responsible for trigger- cause gastrointestinal side effects and severe before, as authorities refused in 2006 to uphold ing osteoclast differentiation, activation and musculoskeletal pain. Although the oncol- the patent on leukemia drug Glivec, held by survival. Preliminary evidence suggests this ogy patient population is smaller than that Novartis, also of Basel, on the grounds that small mechanism may have the upper hand over affected by osteoporosis, the opportunity for tweaks should not extend patent life. Roche has now lost its case against Cipla, of Mumbai, India: on March 19, the Delhi High Court ruled Cipla could continue to sell its generic version of Tarceva. “Being a tweaked version [-] Tarceva’s SELECTED research col aborations
patent is invalid and at $120 per tablet it is unaffordable. I can sell it for $20,” says Cipla managing director Yusuf Hamied. The Natco case Partner 1
Partner 2
$ (millions)
invokes recently introduced CL rules, granted for The Institute, Abbott and Genentech formed an alliance to discover new cancer compounds that target the apoptosis pathway. Abbott and Genentech will be respon- use in urgent or emergency situations, and Natco sible for developing, manufacturing and commercializing any drugs.
wants to produce the drugs for export to Nepal. Amgen paid Kyowa Hakko Kogyo $100 million initially and up to $520 million for rights to develop and commercialize a humanized monoclonal antibody KW-0761 If permission is granted, it may trigger a slew for all non-cancer indications outside of Japan, Korea, China and Taiwan, where Kyowa Hakko retains rights. The mAb targets CC chemokine receptor 4 (CCR4) of CL applications from other companies, says currently in phase 1 for lymphoma and with completed phase 1 trials for allergic rhinitis. Kyowa Hakko will continue oncology development through the end of phase Mohan Nair, Chennai-based patent consultant 2a testing, at which time Amgen has the oaption to reimburse Kyowa Hakko for the cancer-related development costs and expand its license to include oncology. to pharmaceutical companies. This will surely The companies formed a collaboration to identify fully human monoclonal antibodies against intractable disease targets. Pepscan will use its CLIPS technology to make multinational drug companies “think identify functional mimics of the essential parts of such intractable targets. Genmab will use the mimics to create and select therapeutic antibodies using its fully twice” before investing in India in research and human monoclonal antibody technology.


Microsoft word - solutions12.doc

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