What`s in the Biotech Pipeline? - 500 Beiträge pro Seite

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July 12, 2000
What`s in the Biotech Pipeline?
By Anna Snider


PIPE DREAMS

BLOCKBUSTER DRUGS from the biotech industry may be far in the future, but investors don`t like to hear that earnings will be too. And as second-quarter earnings announcements begin trickling in, the news isn`t all that bad.

Biogen (BGEN), the industry`s third largest player, Tuesday reported second-quarter earnings of 43 cents, beating estimates by a penny, on strong sales of Avonex, its only drug on the market. The sector`s other leading players, Genentech (DNA) and Amgen (AMGN), are also expected to announce strong earnings when they report in the coming weeks.

Biogen (BGEN) fell on the news largely because investors are worried about what`s in its pipeline. It reported that quarterly sales of Avonex, its drug to treat multiple sclerosis, came in at a robust $190 million, 30% above the same period last year. So what`s after Avonex? Well, as it turns out, more Avonex — and that`s what investors are concerned about. Biogen is looking for ways to expand the use of the drug in patients with both earlier and later stages of multiple sclerosis. The company has also been testing an inhalable version of the drug.

The biggest potential lies with later-stage patients, since they comprise about half of all those with MS. If the drug is approved for those patients, sales of the drug could grow more than 20% in 2001, Biogen says. If not, sales could drop to 10% to 15% next year.

Approval is not a sure thing. "While we hope for compelling results...interferon therapies have not performed well in the treatment of secondary progressive MS," says Dain Rauscher Wessels analyst Andrew Milne.

Beyond Avonex, Biogen has a couple of other drugs that may be potential earnings drivers. One is a psoriasis drug called Amevive, which is in late-stage Phase III clinical trials. Analysts haven`t started modeling the potential revenues, but some 2.5 million people suffer from psoriasis, and Biogen would likely be first to market with an effective treatment. Still, even if approved, Amevive wouldn`t launch until mid-2002 and wouldn`t contribute meaningfully to Biogen`s bottom line until 2003.

Management didn`t say anything about the status of Antova, a drug for immune disorders pulled from clinical trials in late 1999 after some patients developed blood clots. David Molowa, an analyst with Chase H&Q, says he doesn`t hold out much hope for the resuscitation of the program, but Prudential Vector Healthcare analyst Peter Drake says the drug "may not be dead."

After the Antova setback and signs in the first quarter that Avonex sales might slow, Biogen shares took a beating. The stock fell from a high of $129 in February to a low of $48.50 in May. It`s back up again to about $70.

The good news is that James Mullen, Biogen`s new chief executive, said in a conference call yesterday that the company would make it a top priority to shore up the pipeline. The company will spend $300 million on research and development, one of the biggest budgets for R&D in the biotech industry. Mullen also said he expects to pour 15% of Biogen`s research budget into functional genomics research.

According to Robertson Stephens analyst Jay Silverman, despite Biogen`s research setbacks and slow drug development, it`s still the "cheapest" stock among the top biotech companies, trading at about 35 times 2001 earnings. The average top-tier biotech trades at 80 times next year`s earnings forecasts, Silverman says.

The next big biotech company to report earnings will be Genentech on July 17. The First Call/Thomson Financial consensus earnings estimate is for 29 cents per share, up a penny over the same quarter last year.

Analysts won`t be quibbling about the company`s pipeline. Instead, they`ll be celebrating it. With 18 products (mostly focused on treating heart disease and cancer) in active clinical trials, Genentech`s pipeline is often called the best in the industry.

Sales of its breakthrough cancer drugs, Herceptin, for breast cancer, and Rituxan, for non-Hodgkin`s lymphoma, continue to fuel strong earnings. Herceptin sales are expected to rise about 60% to $74 million in the second quarter, and Rituxan sales should be up about 30% to $98 million in the second quarter of 1999, Molowa says.

But analysts will keep a special look out for sales of TNKase, a new drug approved by the Food and Drug Administration in June that is faster than any other at fighting blood clots during a heart attack. They`ll also be scoping for early indications of the performance of Nutropin Depot, an advanced form of human growth hormone that requires only monthly or semi-monthly, rather than daily, injections.

"With a stable core business, a growing oncology franchise, a burgeoning pipeline and improving margins, Genentech is clearly in a sweet spot," said Chase H&Q`s Molowa in a recent research note.

Still, he warned, the stock`s valuation might be a bit rich. Genentech`s P/E ratio is 116 times 2001 earnings and the stock has a PEG of 5.1. By contrast, the average large-cap biotech company has a P/E ratio of 83 times 2001 earnings and a PEG of 4, he said.

Amgen, which boasts the two biggest products derived from biotech research — Epogen for anemia and Neupogen for cancer — reports on July 26. Analysts are expecting earnings of 27 cents per share in the second quarter, up two cents from the year-ago period.

Earnings might be suppressed slightly because Amgen is increasing spending in advance of new product launches, says Robertson Stephens analyst Gregory Miliotes. But that spending should pay off in accelerating EPS growth beginning in 2001, he says.

Once criticized for a weak pipeline, Amgen has four new products expected to hit the market in the next two years, with a combined commercial potential of $5 billion. These include: NESP, a more powerful version of Epogen; Kineret, a treatment for rheumatoid arthritis; Abarelix, which can be used to treat both prostate cancer in men and endometriosis in women, and SD-01, an advanced form of Neupogen.

And those are drugs both patients, and investors, can benefit from.


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Sunday July 16 3:27 PM ET

Now Celera Plans to Win Proteomics Race

By Ben Hirschler

BIRMINGHAM, England (Reuters) - Craig Venter, head of U.S. firm Celera Genomics which last month finished the race to map the human genome, said on Sunday his new goal was to map the proteins which drive all chemical reactions in the body.

The president and chief scientific officer of the Maryland firm, attending a scientific conference here, said Celera would spend heavily on a new class of mass spectrometry machines for its drive into proteomics.

Proteomics involves identifying the function and inter-relationship between proteins, and their role in disease.

This new avenue could eventually see Celera move from the simple provision of information to drug discovery.

``A big part of the business is the straightforward providing of information -- but I`m not complacent just to do that,`` Venter told reporters.

Mapping of the ``book of life,`` or genome, was only the start for Celera which now aimed to work down the biochemical chain from gene to protein to help indentify diagnostic tests or treatments for disease, he said.

``We will be moving toward therapeutics but whether we ever do a clinical trial ourselves or not is another matter,`` he added.

Celera`s near-term business plan is to make money by charging drug makers and researchers subscriptions to giant databases detailing the genetic makeup of humans and other organisms. Venter expects to finished sequencing the mouse genome by December.

So far his company has signed up six pharmaceutical companies plus research institutions around the world and Venter said it had committed revenues of more than $200 million.

He declined to say when he expected Celera to make a profit.

The company had revenues of $12.4 million in the year to June 1999 but reported a loss of $43.5 million, reflecting its heavy expenditure on computers and analytical machines.

Celera`s stock hit an all-time high of $252 a share on February 25 -- valuing it at some $14 billion -- but has retreated sharply since then amid some concerns about how fast its business model will start delivering results. It closed on Friday at $92-5/16.

Most industry analysts do not see Celera turning a profit for around five years.

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July 18, 2000


Drug War Awaits Attack of Killer Fungus
By JIM ROBBINS


Jim Robbins for The New York Times, top; Dr. David C. Sands, bottom

Dr. David C. Sands says a fungus called Fusarium, middle, can be an effective killer of plants used to make illicit drugs. Bottom, a healthy row of coca plants grows beside a row of dead plants killed by the fungus.

OZEMAN, Mont. -- Dr. David C. Sands holds out a clear plastic petri dish filled with a white fuzzy fungus growing across the bottom. This substance, he believes, is the key to ending much of the world`s production of illicit drugs.

Members of Congress also believe that Dr. Sands and other researchers may be on to a powerful and environmentally safe method of killing not only coca plants, but also marijuana and poppy plants. The members have asked the government of Colombia to test a strain of Fusarium oxysporum over the next two years. If it proves effective, the disease will be sprayed on vast fields of coca plants there, and experts say it could wipe out much of the coca crop within a year.

The research holds such promise that officials at Montana State University ended it two years ago, fearing it could make the university a target of drug cartels. But the technique had already been developed.

Others are not sure that fusarium will be effective against the the cartels. "Efficacy is high on my list of concerns," said Eric Rosenquist, a United States Department of Agriculture official involved with international research programs.

"You can put a lot of energy into this and get nothing out in the end." Mr. Rosenquist said a naturally occurring fusarium coca virus in Peru had killed only 40 percent of the crop there.

An attack on coca plants may be only a first salvo in the attack of the fusarium fungus. Dr. Sands and others believe that the use of fungal disease is an ideal way to kill a broad range of undesirable plants. Research on fusarium has been under way for years, and Dr. Sands and other scientists say the research is about to usher in an era of effective and environmentally safe controls that would be alternatives to chemical herbicides and genetically modified organisms.

Biological controls, the use of a pest`s enemies against it, are old: centuries ago, the Chinese built bridges between trees so predatory ants could find and destroy aphids. But biological control is not yet proven as a viable alternative to chemicals. Most diseases and predatory insects, for example, are not especially deadly; they "farm" a plant, attacking it but not wiping it out, so they can keep consuming it.

"They live in total coexistence, like real estate agents," Dr. Sands said. "They take a percentage. If they took too much they would be out of business."

But some diseases are especially virulent, wiping out most or all of the host. Phytophtora, a fungus that destroyed potatoes in 19th-century Ireland and caused the great famine there, is one. Fusarium, Dr. Sands said, is another of the "Attila the Hun" diseases, and there are strains of fusarium for virtually every cultivated plant and many wild ones.

A plant pathologist, Dr. Sands came to the field of bioherbicides in his search for a way to treat exotic plants from Asia that run rampant through Western range land because they are unchecked by native enemies. Some diseases found in Montana are being tested on these weeds. But a much more effective approach, Dr. Sands said, may be to bring back the fungal diseases that the weeds evolved with in Central Asia and elsewhere and use them as herbicides.

He has had collaborators scouring Kazakhstan and Russia for diseases that evolved with two especially difficult species, spotted knapweed and leafy spurge, and some have been shipped to the United States where they remain in a containment facility in Maryland awaiting approval to be used in testing.

In 1987, while working with weeds, Dr. Sands got a call from the department of agriculture. Worried about a revolution in Peru, Coca-Cola had established a coca plantation in Hawaii to assure a supply of the plant for its soft drinks. (The stimulating components of the plant are not included in the product.)

When the plantation was abandoned, the department used the plants to test herbicides that might be used in the drug war. But something killed many of the plants in a control plot that was not being sprayed. Dr. Sands discovered that it was a strain of fusarium.

Dr. Sands cultured the fungus and spread it as granules on a three-acre plot. It killed nearly all of the coca plants.

Fusarium is especially virulent on plants that dominate a landscape, he said. Dutch elm disease and chestnut blight are both fungal diseases similar to fusarium. They destroyed trees across America because those trees were the only ones that many cities planted.

While Dr. Sands believes that importing diseases can be an effective approach to combating exotic weeds in Montana, officials in Colombia say they will use an indigenous fungus, a strategy Dr. Sands also advocates, because coca is a native plant. But because politics as well as biology is involved, the outcome in Colombia remains in question.

Conservationists generally favor substitutes for chemicals in killing weeds, but some are not sure that de facto biological warfare is the answer. They worry about "mission drift"; a disease may start as an effective enemy of coca but somehow change hosts and kill important nontarget plants, like bananas, or attack wild relatives of the coca plant and threaten biodiversity.

Dr. Peter Stiling, a professor of biology at the University of South Florida who has studied introduced species, says possible unintended effects have not been sufficiently examined. "I am not prepared to come down on one side of the fence." Dr. Stiling said. "But I think we should be careful. It`s difficult enough to find the nontarget effects of insects, and it`s even more difficult for nontarget effects of fungi and bacteria."

Such problems are often subtle at first and might not be found for a long time, Dr. Stiling said. A study in Oregon has indicated that the use of Btk, a bacterial pesticide for control of the western spruce budworm, may have reduced the abundance and diversity of butterfly larvae.

"There are 500 people working on fusarium," Dr. Sands responded, "and we don`t see it changing its host species."

So far, no environmental problems have been blamed on fusarium, largely because it has not been widely used in the United States.,

The use of fungal disease as a herbicide was studied before by the Agricultural Research Service, but the agency determined that it wasn`t viable as a biological control primarily because it required a great deal of the product to cover the vast areas involved.

To make fusarium economical, Dr. Sands and other researchers have discovered they can use a native grass seed to culture the fungus. In a patented process, they spray fusarium on the seed and drop it; when it hits the ground the fungus multiplies. Once the fungus kills the coca plants, the theory goes, the grass seed or whatever seed officials choose to use, takes over for the dead plants.

What`s more, the fungus lasts in the soil. "They kill and they survive the nongrowing season perhaps for as long as five years," Dr. Sands said.

Another advantage to fungal defoliants is that while chemicals must be sprayed on coca plants from very low altitudes during daylight, fusarium can be dropped from thousands of feet above the fields at night.

Although the university ended the fungus research, Dr. Sands said that others could easily follow his formula for making fungus-based bioherbicides.

Culturing fungus is fairly simple and can be taught in a couple of weeks, he said.

The coca producers could respond with a fungicide or disease-resistant plants, but Dr. Sands said that could take many years.

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July 18, 2000


Agriculture Takes Its Turn in the Genome Spotlight
By CAROL KAESUK YOON


Xylella Fastidiosa Genome Project
An electron micrograph of the bacterium Xylella fastidiosa.

In a scientific first, and a coup for science in Brazil, a team of more than 200 researchers there has for the first time deciphered the complete DNA sequence of an organism that causes a plant disease.

Though other genome sequencing efforts -- for example, in humans or the laboratory staple fruit fly -- have attracted more attention, the Brazilian target, an odd little bacterium known as Xylella fastidiosa, distinguishes itself as the first to be decoded of the countless nasty species that together cost farmers and foresters many billions of dollars each year. This particular organism can cause diseases in oranges, grapes, almonds, plums, peaches, alfalfa, oaks, elms and other plants.

"Everyone is quite thrilled," said Dr. Andrew Simpson, a molecular biologist at the Ludwig Institute for Cancer Research in São Paulo, Brazil, and one of the team leaders. "It`s probably the biggest ever scientific project in Brazil."

The team has been feted by the president of Brazil and serenaded by orchestras, and a new scientific prize was invented just to be given to the team. It was an achievement for developing nations` science as well, Dr. Simpson said, as this was the first complete sequence to come from outside the United States, the United Kingdom or Japan.

The consortium of scientists unveiled the full genome sequence of this bacterium in the current issue of the journal Nature.

Scientists said xylella`s genome has already begun teaching biologists lessons about how pathogens evolve and about the destruction they cause. By revealing exactly which proteins this bacterium enlists to build itself and live its life, the complete sequence has also begun pointing the way toward methods for curbing this particular strain of the bacterium that attacks orange trees.

The report contains surprises, including the presence of genes thought to be peculiar to animal pathogens and a complete lack of some genes thought to be essential to plant disease organisms.

"It`s going to be the standard against which all subsequent studies will be compared," said Dr. Edwin Civerolo, a plant pathologist with the U.S.D.A. Agricultural Research Service at the University of California at Davis. "It gives you the basis for designing novel and unique strategies for dealing with the disease, things we`d never thought of before."

Perhaps most surprising is that all this insight has come from an organism about which almost nothing was previously known.

Dr. Alan Collmer, a plant pathologist at Cornell University, called the new study "a big deal," adding: "This is a complete parts inventory for the bacterium. It`s a remarkable demonstration of the power of genomics to give you an instant insight into an organism like this that was previously a black box. It`s a revolutionary first step to take."

Scientists have typically sequenced the genomes of organisms that had already been intensively studied. But researchers said the new work illustrates the power of genome sequencing as the first step, rather than the last, in the path of knowledge, particularly for organisms whose biology is largely a mystery.

While designated a single species, Xylella fastidiosa is made up of numerous strains, each of which specializes in victimizing a different kind of plant. Researchers in Brazil, financed in part by the $4 billion a year orange juice industry, studied a strain that attacks orange trees after being injected into the plant by insects known as sharpshooter leafhoppers.

Once injected, xylella lives hidden in the plant`s circulatory system, a network of water-conducting tissues known as the xylem. Hard to observe or collect and happiest inside a leafhopper or a plant, the bacterium is fastidious and hard to grow in the laboratory -- hence its name, fastidiosa. So though the diseases caused by xylella can be severe -- in California, vineyards lose tens of millions of dollars each year to the bacterium -- little was known about the biology of this bug.

Much has been learned now that the sequences of xylella`s 2,800 genes are in hand.

Dr. Simpson said one of the biggest surprises was finding genes like those in animal pathogens, in particular three that were very similar to those in the bacterium that causes meningitis in humans, genes that help bacteria to gain a foothold in their host.

"Nobody suspected they`d be in these bacteria," said Dr. Simpson, who said the finding suggests that there may be common themes in disease-causing bacteria, irrespective of who the bacteria are attacking.

Other curious interlopers are the 83 genes from viruses that came in, infected the bacterium and left their DNA behind. These viruses also left DNA they had stolen from bacteria that cause diseases in animals, including humans. Dr. Simpson suggested that such wholesale importation of genes from other pathogens might be what turned xylella from benign to disease-causing.

The researchers also discovered that xylella has a penchant for sequestering iron, something that may explain the anemic, yellowing leaves symptomatic of the disease. One possibility for curbing the disease, said Dr. Simpson, was changing irrigation regimes to decrease the amount of iron available in these plants.

Any hint of a cure will be welcomed as farmers have few weapons against this class of diseases.

"Take, for example, citrus canker," another bacterial disease of orange trees, Dr. Collmer said. "It`s the year 2000 and they handle that by burning the orchard. That is a brutal indicator of just how much at the mercy we are of these bacteria."

The most surprising discovery, however, has been what is not there. All other disease-causing bacteria share a complex of genes that allows them to inject specialized proteins that determine what kind of host species a bacterium can successfully attack. But while this system has been considered fundamental to causing disease, xylella wreaks havoc just fine without it.

In fact xylella`s sequence is small, a mere one-thousandth the size of the human genome, and 24 bacteria (not causing plant disease) had already beat it to the finish line with little fanfare in their respective countries. But researchers said xylella`s completion was worth a bit of hoopla as it marks not only the revelation of a new genome, but the entry of a surprising new player in a field dominated by developed nations.

"This enabled them to launch a genomics industry in Brazil," Dr. Collmer said. "I think they should celebrate."

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Manipulating Simple Interactions To Create Artificial Bacteria

By manipulating simple and nonspecific interactions, researchers have discovered a way to make chemicals spontaneously self-assemble into ribbon-like tubules that resemble bacterial cell walls.
The micrometer-sized tubules have potential applications in drug delivery systems and as templates for the synthesis of inorganic nanostructured materials.

"The `artificial bacteria` consist of the biopolymer actin attached to charged lipid membranes," said Gerard Wong, a professor of materials science and of physics at the University of Illinois. Wong was the lead author of a paper published in the June 16 issue of the journal Science that described the assembly process. "The resulting actin-membrane capsules are fairly rigid and quite stable," he said.

Actin is a protein that provides the structural framework in eukaryotic cells and forms the molecular basis for biological functions as diverse as hearing, muscle contraction and cell division.

When mixed with special liposomes, the researchers found, actin immediately undergoes a hierarchical self-assembly process that results in the formation of nano-scale tubular capsules.

"The composite membrane is organized into three layers," Wong said. "A middle lipid layer, similar to the plasma membrane that surrounds most cells, is sandwiched between two layers of actin filaments. The filaments first arrange themselves into two-dimensional parallel arrays on both sides of the lipid layer, and then they spontaneously wrap into tubules."

The spaces between the layers are filled with water and could be used for a variety of applications, including the packaging of certain drugs that would be slowly released to the body. The nano-capsules also could be used as miniature templates in novel inorganic nanofabrication techniques.

While the structures have no real analog in nature, this type of spontaneous organization is reminiscent of multi-layered bacterial cell walls, Wong said. The protein-membrane interactions in living cell walls, however, exist far from equilibrium and require the hydrolysis of ATP (adenosine triphosphate) -- the biological energy storage molecule ­ to maintain their shape and structure.

"And that`s a crucial difference," Wong said. "Our actin-membrane capsules are in equilibrium and do not require energy to remain stable."

The work was performed while Wong was a postdoctoral associate at the University of California at Santa Barbara. Wong`s collaborators in the study were materials science professor Cyrus Safinya, staff scientist Youli Li and graduate student Alison Lin at the University of California at Santa Barbara, and physiology professor Paul Janmey (now at the University of Pennsylvania) and postdoctoral researcher Jay Tang at Harvard University.

Funding was provided by the National Institutes of Health, the National Science Foundation and the University of California Biotechnology Research and Education Program. - By James E. Kloeppel

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Owning DNA
by Jenna Greene
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Criticized for issuing gene-related patents that seem to describe discoveries more than inventions, the U.S. Patent and Trademark Office is on the verge of releasing new examination guidelines that raise the bar for patentability.

While the new guidelines will make it more difficult to patent genes, PTO Director Q. Todd Dickinson has also stressed that his office awards such patents based on solid legal precedent - despite the objections from medical groups and others who say patenting genes is unethical and not in the public`s best interest.

The new guidelines are largely supported by the biotech community and will require applicants to be more specific in describing what a gene actually does.

"One simply cannot patent a gene itself without also clearly disclosing a use to which that gene can be put," Dickinson told the House Judiciary Subcommittee on Courts and Intellectual Property on July 13. "As a result, we believe that hundreds of genomic patent applications may be rejected by the U.S. PTO, particularly those that only disclose theoretical utilities."

For the past six months, interim guidelines on genomic patenting have been in place. Dickinson said the final version, expected to be released this fall, is unlikely to differ significantly.

As for the 6,000-odd gene patents already issued - 1,000 of them for human genes - Dickinson told Rep. Zoe Lofgren, D-Calif., "If there is a problem here - and it`s not clear if there is or is not - it`s the courts` job to look at the patents."

Some of the first patents on human genes, which date back to the late 1970s, aroused little controversy because they were so clearly linked to the cause or treatment of specific diseases, such as anemia, and involved years of laboratory work.

But with the expansion of efforts to clone and sequence human DNA, a rush for patents ensued. Currently, more than 20,000 applications related to genes are pending at the PTO.

To meet the utility standard, the PTO in the past required only that DNA serve as a molecular probe - a property attributable to most human DNA, according to Harold Varmus, president of Memorial Sloan-Kettering Cancer Center and director of the National Institutes of Health from 1993 to 1999.

The result?

"Some of the issued patents have seemed very broad in their claims," he told the IP subcommittee. "Other issued patents appear to cover many possible gene functions that were only speculative at the time of submission, thereby allowing the patent holder to claim title to applications that became known only after extensive additional studies by others."

Earlier this year, for example, Human Genome Sciences Inc. was granted a patent on a gene that was later discovered to be the entryway for the AIDS virus to infect cells.

While Varmus said the revised guidelines are "an improvement," he argued that the bar still may not be high enough.

"Overly enthusiastic protection of intellectual property, too early in the process of product development, can impede the delivery of public health benefits," he said.

But biotech industry representatives staunchly defended the importance of patents to their companies and future medical advances.

"Patents are an absolutely fundamental requirement for commercial success in our industry," testified Dennis Henner, senior vice president of research for Genentech Inc. "We feel the PTO has done a good job walking this tightrope."

Neither Celera Genomics Group nor the publicly funded Human Genome Project, which jointly announced the completion of a "rough draft" of the human genome in June, has sought to patent the genome itself. Celera, however, has filed provisional applications for thousands of individual genes.

As for the IP subcommittee, its members had nothing but praise for the PTO and made it clear that Congress - for the time being, at least - has no plans to tackle legislation on such a sensitive subject.

Yet in the 50 public comments received by the agency on revising the utility guidelines, many writers found the practice deeply objectionable.

"Genes are not inventions so we do not understand why the PTO is issuing patents for human genes and sequences," wrote Abbey Meyers, president of the National Organization for Rare Disorders, a federation of 140 nonprofit health groups. "How can the PTO allow a person or company to patent genes that have existed since the beginning of time?"

The College of American Pathologists also opposes the patenting of genes.

"Because information about gene sequences is so fundamental to understanding specific diseases," the group argues, "patent holders can essentially gain ownership of diseases through patents."

But as Dickinson testified, courts have held for half a century that isolated and purified products of nature may be patented, culminating with the Supreme Court`s 1980 decision, Diamond v. Chakrabarty. The high court found that genetically engineered bacteria were patentable, ruling that the inventor`s discovery "is not nature`s handiwork, but his own; accordingly, it is patentable subject matter."

Genentech`s Henner told the committee that increased PTO scrutiny is the best way to regulate the burgeoning industry.

"In our opinion, the question of whether patents should be made available for gene inventions is not an issue that needs to be revisited," he said. "The proper focus for discussions on gene patenting is not on the question of whether patents should be granted on genes, but rather the question of when it is appropriate to grant such rights."

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