Durante mucho tiempo no había principios uniformes para la Atribución de nombres a los antibióticos https://antibioticos-wiki.es . Más a menudo se les llama por el nombre genérico o especie del producto, con menos frecuencia-de acuerdo con la estructura química. Algunos antibióticos se nombran de acuerdo con el lugar donde se asignó el producto.
News_nbt0408.indd
Table 1 Marketed osteoporosis drugs Marketer Indications 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were partially withdrawn).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.
VOLUME 26 NUMBER 4 APRIL 2008 NATURE BIOTECHNOLOGY
From: Don Drinko Sent: Wed Apr 15 16:12:40 2009 Gallagher Sharp Shop Talk: Workers’ Compensation Question: Do injured workers have a “right” to receive brand name prescription The Supreme Court of Ohio recently considered this question, and concluded that injured workers are not entitled to receive full payment for brand name prescription drugs, even when specific brand names are
HOJA INFORMATIVA PARA LOS INVERSORES SOBRE BIRMANIA Última actualización: 6 de diciembre de 2007 Datos clave sobre Birmania Birmania es un estado internacional paria, gobernado por un régimen militar que no tolera ninguna disensión, reprime a sus minorías étnicas y ejerce un poder absoluto pese a las condenas y sanciones internacionales. El país es notorio por sus violacion