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from Breakingviews:

U.S. justices square the helix on gene patents

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By Reynolds Holding
The author is a Reuters Breakingviews columnist. The opinions expressed are his own.

The U.S. Supreme Court has managed to square the helix on human gene patents. The justices ruled on Thursday that companies can hold exclusive rights to synthetic DNA molecules but not naturally occurring ones. The unanimous decision should allow biotechnology companies to reap rewards for their work without stifling the research of others.

The controversial case involved Utah-based Myriad Genetics’ claim that isolating human genes linked to breast and ovarian cancer was a novel invention deserving of legal protection. The company’s research includes work on the BRCA1 and BRCA2 genes, recently in the news after a genetic test led Hollywood actress Angelina Jolie to decide to undergo a double mastectomy. Doctors, medical researchers and others argued that Myriad was attempting to monopolize natural substances crucial to finding cures for diseases.

The justices seemed on the critics’ side last year. They ruled in another case that observations of natural processes couldn’t be patented and asked the Federal Circuit Court of Appeals to reconsider its decision upholding Myriad’s patents. But the appeals court confounded expectations by again finding the patents valid, and the case landed back at the high court.

from Cancer in Context:

Does Researcher Turned Activist = No Funding?

Dr. Hagop Kantarjian, chairman of the leukemia department at the prestigious MD Anderson Cancer Center in Houston, has collaborated with drug makers for years to discover new ways to battle the disease.

Now, at age 59, he has become an activist protesting the high cost of the newest generation of life-saving drugs.

from Breakingviews:

Hostile drug deal gets too clever for its own good

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By Robert Cyran
The author is a Reuters Breakingviews columnist. The opinions expressed are his own.

Royalty Pharma is suffering from some self-inflicted wounds in its hostile pursuit of Elan. The finance firm tried to use the drug maker’s $1 billion stock buyback to swoop up the entire company. But it devised a puzzlingly complex tender offer that was too clever for its own good. The scheme ended up replacing a long-term shareholder with other investors far more likely to demand a chunkier premium.

from Breakingviews:

$6.6 bln won’t be enough to end Elan’s rash dreams

By Robert Cyran

The author is a Reuters Breakingviews columnist. The opinions expressed are his own.

Royalty Pharma’s $6.6 billion indicative offer for Elan probably won’t be enough to end the latter’s ambitious dreams. The biotechnology company has grand M&A plans after selling most of the rights to its blockbuster drug, Tysabri, for $3.25 billion earlier this month. Royalty Pharma may well use that cash more wisely than Elan’s current bosses, but a 4 percent premium won’t seal the deal.

from Alison Frankel:

FDA confirms: It’s considering rule change for generic labels

Last month, when I wrote about the Obama administration's apparent flip-flop on the question of federal pre-emption of product liability claims against generic drugmakers, I mentioned a curious footnote in the Justice Department's Supreme Court amicus brief in Mutual Pharmaceutical v. Barrett. All the wrangling over liability for generics, which are required by law to use the same labels as the brand-name drugs they replicate, could be unnecessary, Justice hinted. "This office has been informed that Food and Drug Administration is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances," the brief said. "If such a regulatory change is adopted, it could eliminate pre-emption of failure-to-warn claims against generic-drug manufacturers."

I should have given the footnote more attention. In the last couple of weeks, it has prompted speculation by a number of pharma websites about whether the FDA really intends to upend longstanding policy barring generics from altering their labels, and, if so, what that portends for their product liability exposure. On Wednesday, I emailed the FDA to ask. In an email response, an FDA representative confirmed what the Justice Department footnote suggested: "FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances," the agency said. "FDA intends to provide an opportunity for public comment with respect to any such proposed changes to its regulations."

from Breakingviews:

Pharma lands one-two punch on government finances

By Robert Cyran and Reynolds Holding

The authors are Reuters Breakingviews columnists. The opinions expressed are their own.

Pharma has landed a double blow against the American government. The U.S. Court of Appeals in New York has ruled that a drug salesman was exercising his right to free speech by pitching a narcolepsy drug as effective against insomnia, chronic fatigue and other conditions the Food and Drug Administration had not approved. If the Supreme Court upholds this decision, companies will pay fewer multi-billion dollar fines and useless healthcare spending will increase.

from The Great Debate:

Thalidomide’s big lie overshadows corporate apology

A lie wrapped in an apology is still a lie. It is a big lie, a particularly offensive lie, coming as it does from the German company Chemie Grünenthal responsible for inflicting its notorious drug thalidomide on hundreds of thousands of women in 52 countries. Some 90,000 babies are calculated to have died in spontaneous abortion, but at least 10,000 mothers are known to have given birth to malformed babies between 1958 and 1961; the most damaged survive today as limbless trunks, others whose legs and arms were reduced to digital “flipper” extrusions from the shoulder, and thousands have severe internal injuries as well.

Grünenthal (now GmbH) was a small private company set up after World War Two as an offshoot of an old family firm that made soaps and detergents. Its first pharmaceuticals were produced under foreign license, but thalidomide (which it called Contergan) was its own, a sedative discovered by accident in the spring of 1954 by a 32-year-old chemist and doctor, Heinrich Mückter. To exploit the postwar sleeping-pill boom, Grünenthal marketed it massively from October 1957 as “completely safe,” “completely atoxic,” and free of the unpleasant side effects of barbiturates. The sales department called it “the apple of our eye” because it was so profitable. From 1958 to 1961 they zeroed in on promoting it for use by expectant mothers.

from Breakingviews:

Purge likely after U.S. obesity drug binge

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By Robert Cyran
The author is a Reuters Breakingviews columnist. The opinions expressed are his own.

Two U.S. biotech firms are bingeing on obesity drugs. Their concoctions for weight loss have both been approved by the Food and Drug Administration in the last month. With American obesity rates rocketing, analysts are eyeing fat sales and bankers are weighing mergers.

from Breakingviews:

Bristol-Myers and Astra make fat bet on obesity

By Robert Cyran

The author is a Reuters Breakingviews columnist. The opinions expressed are his own.

Bristol-Myers Squibb and AstraZeneca have made a fat bet on obesity. The U.S. and UK drug giants are teaming up in the $7 billion purchase of Amylin Pharmaceuticals. Seven times estimated sales is a hefty price to pay for a biotech whose main drugs face stiff potential competition. But Amylin’s focus on diabetes, a sadly expanding market across the globe, makes this a healthier financial endeavor.

from Breakingviews:

KKR gets rich prescription for top-of-market LBO

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By Robert Cyran and Quentin Webb
The authors are Reuters Breakingviews columnists. The opinions expressed are their own.

KKR has found the right formula to exit Alliance Boots, its top-of-the-market drugstore deal. Walgreen’s two-stage acquisition of its European rival should more than double the investment KKR and its partners made at the peak of the leveraged buyout frenzy. What the U.S. drug chain’s investors will get for their money - as much as $16.2 billion - is harder to fathom.

The first stage sees Walgreen pay about $6.7 billion in cash and stock for 45 percent of Boots. The firm’s ownership is currently split fairly equally between KKR funds, Boots Executive Chairman Stefano Pessina and outside investors. Pessina, who will become a Walgreen director, takes proportionately more stock than the financial investors.

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