Patent

J&J win in patent suit

Christe Bruderlin-Nelson — Wed, 01 Oct 2008 04:14:05 -0400

Johnson and Johnson received some happy news yesterday when a federal judge awarded its cardiac device unit $1.2 billion in a longstanding battle between the megacompany, Boston Scientific and Medtronic over a stent device.

The U.S. District Court in Delaware entered a final judgment benefiting Cordis Corporation, a Johnson & Johnson company, for patent infringements by Boston Scientific and Medtronic from cases from 2000 and 2005 involving the Palmaz balloon expandable stent. In all, the battle has been raging for just over a decade. Previous juries found that Boston Scientific's and Medtronic's stent products and ordered them to pay $703 million and $521 million, respectively.

The final amount includes accrued interest. The best part? The stent the companies were fighting over is no longer on the market.

- read the Wall Street Journal story
- find out more at MSN Money
- see MarketWatch's article

EU commissioner widens pharma probe

Thu, 15 May 2008 06:59:55 -0400

Europe's competition commissioner is casting a wide net in her pharma-market antitrust probe. After questioning some 100 companies--including Pfizer, GlaxoSmithKline, and Sanofi-Aventis--investigators are now scrutinizing medical organizations and associations and government agencies.

At issue: Whether brand-name drugmakers are unfairly blocking generics makers from the market--and now, whether those patent fights are getting in the way of R&D. Generics don't get to market as quickly in Europe as in the U.S., and they make up only 42 percent of Euro pharma sales, compared with 63 percent in the United States.

- check out the item at PharmaGossip
- see the International Herald Tribune article

GSK accused of monopolizing Wellbutrin

Thu, 08 May 2008 06:59:57 -0400

Did GlaxoSmithKline try to monopolize the Wellbutrin market? A lawsuit now certified as class-action says so. The plaintiffs accuse GSK of artificially boosting Wellbutrin prices by fibbing to the U.S. Patent Office and engaging in "sham" patent litigation against generics makers. The patent lawsuits delayed copycat versions of the drug, the class action alleges, forcing purchasers to pay unnecessarily high prices. GSK didn't comment on the allegations, and so far its court defense has focused on class certification, rather than the lawsuit's specific claims.

Meanwhile, Glaxo is working to downgrade competitors to its Alli weight-loss med. The drugmaker filed a citizen's petition with the FDA, attempting to persuade the agency to change the rules on dietary supplements that claim to aid weight loss. Being overweight is a risk factor for disease, GSK reasons, so supplement makers should be required to get the FDA to sign off on their effectiveness claims before their products can be sold. That would be quite a change: FDA has long held that weight-loss claims don't imply disease treatment or prevention. If the FDA considers changing that, the fur will fly in the weight-loss market.

- see the story at Legal Intelligencer
- check out the Pharmalot item
- read GSK's petition
- get Pharmalot's take

ALSO: Yesterday we reported on GlaxoSmithKline's protest letter to Massachusetts officials. Today, some legislators say that letter may backfire, inspiring state lawmakers to "dig in their heels" on banning gifts to doctors, rather than leading them to reconsider the move. Report

Drugmakers resist U.K. price goals

Mon, 05 May 2008 06:59:54 -0400

Drug companies are standing their ground in price negotiations with the U.K. government. Pharma is offering to cut the U.K.'s drug bill by roughly half the government's goal, The Daily Telegraph reports. Industry negotiators said they'd reduce the prices of patented drugs by less than 5 percent, when the government was reported to be seeking a 10 percent to 12 percent reduction. To make up some of the difference, drugmakers are saying they'll cut the price of drugs that come off patent but still have little generic competition.

Apparently, the negotiators are at odds over predicted increases in drug costs. Pharma is predicting just 3 percent annual growth, but the government is expecting something like 8 percent, an "insider" told the newspaper.

- read the Telegraph article

Wyeth discounts Pristiq for big sales push

Wed, 23 Apr 2008 06:59:54 -0400

Think the latest-and-greatest drug would naturally be the most expensive? Think again. Now that its Pristiq antidepressant is finally approved, Wyeth is offering a cut-rate price to woo patients over from Effexor XR. And these hip-to-Effexor XR patients might just buy, because Pristiq is essentially a "new-and-improved" version of that drug.

Effexor XR, remember, will be vulnerable to generic competition in 2010--so it behooves Wyeth to switch patients to Pristiq, even at a 20 percent discount off the older antidepressant. And to switch as many as possible, Wyeth plans to make Pristiq the main focus of its primary-care sales force, a Wyeth SVP told Dow Jones.

Of course this pricing tactic is nothing new: Other pharma companies use it, especially now that so many blockbuster drugs are approaching the patent cliff. Seems counterintuitive to undercut your own drug, but unusual times call for unusual measures.

- see the story at the WSJ Health Blog
- check out Pharmalot's coverage

Neurontin fails bipolar med review

Fri, 18 Apr 2008 06:59:54 -0400

Review the research on epilepsy meds, and what do you find? Neurontin (gabapentin), is no better than placebo for bipolar disorder, according to the Prescribing for Better Outcomes center at the University of North Carolina.

A bunch of "very poor quality articles," however, seemed to support a positive effect--and those articles were cited and re-cited in the scientific literature, creating an "echo chamber effect." Hearing it over and over, doctors were led to believe that Neurontin worked for bipolar patients, and prescribed it to lots and lots of them.

Ironically, the epilepsy-med review came courtesy of the 2004 Neurontin marketing settlement, under which Pfizer paid $430 million to settle off-label allegations. Some 94 percent of the drug's sales in 2002 were off-label, the government said at the time.

- see the item in the WSJ Health Blog
- check out one of the center's new papers from their drug review

Related Articles:
Pfizer might be liable for generic Neurontin. Pfizer report
Court: Pfizer can defend Neurontin patent. Report

Pfizer might be liable for generic Neurontin

Mon, 24 Mar 2008 07:59:54 -0400

You may pay the fine though you never collected the revenue. That's what a Philadelphia judge told Pfizer and Warner-Lambert last week in a trial over off-label marketing of Neurontin. If the plaintiffs prove that the companies did promote Neurontin and its copycat form gabapentin for uses not approved by the FDA, then the companies may be held liable for money spent on the generics, even though the generics were sold by another company altogether. Legal experts said it was the first legal opinion to state that a brand-name manufacturer could be liable for money spent on generics made by a third party.

- read the article in Legal Intelligencer
- see the Pharmalot item

Related Article:
Court: Pfizer can defend Neurontin patent. Report

BBC: Reckitt schemed against generics

Fri, 07 Mar 2008 06:59:55 -0500

Reckitt Benckiser execs bragged in internal documents that they'd blocked generic competition for their Gaviscon stomach med for years--even after the drug went off patent. According to the BBC, The company blocked generic competition by citing health and patient safety, but documents show the execs were conspiring to throw up obstacles to the generics so they could preserve their Gaviscon revenue. In one document, an executive wrote, "Should we not drag it out as long as possible...nine million pounds of business is at stake."

One former exec told the network that Reckitt sold Gaviscon to the National Health Service for three times the cost of generics. The company had "cheated the NHS" and could have saved the state healthcare provider "millions of pounds," the former official said.

- read the BBC story

Related Article:
The specter of generic competition grows. Report
Analysts get bullish on generics makers. Report
Patent 'cliff' looms for Big Pharma. Report

Bayer loses Yasmin patent fight

Tue, 04 Mar 2008 06:59:57 -0500

Bayer had the Yasmin rug pulled out from under it yesterday. A U.S. court voided the contraceptive's key patent, leading the German conglomerate to revise its 2008 profit expectations downward. Until now, Yasmin and related meds were Bayer's top sellers, just ahead of its MS treatment Betaseron.

The ruling opens the door for Barr Pharmaceuticals to sell a Yasmin copycat in the U.S. The product sold $487 million worth here last year; including other, sister meds such as the lower-dose version Yaz, the franchise is worth about €1 billion, or $1.5 billion. Bayer is mulling an appeal; regardless of the ruling, it holds exclusivity on the drug till 2009.

It's just the latest in a series of blows for Bayer, which last month saw its drug Nexavar fail a lung cancer trial. Last fall, the company suspended sales of its anti-bleeding med Trasylol because of side effects.

- see Barr's release
- read the report from Forbes
- check out the BusinessWeek coverage

Related Articles:
Yasmin sales spur earnings at Bayer. Report
Bayer lower 2008 expectations. Report

Teva abstains from Protonix fray

Mon, 04 Feb 2008 06:59:55 -0500

Teva Pharmaceuticals' dilemma: A rival generic drugmaker is ready to flood the market with a copycat Protonix, and Wyeth is set on nabbing at least some generic revenue by selling its own copycat. So what does Teva do?

Nothing, at least for now. The company announced Friday that it has no plans to relaunch the generic Protonix that got it to the negotiating table with Wyeth late last year.

Here's the background: Teva and Wyeth had been fighting over Protonix's patent. Seemingly confident of its position, Teva launched its copycat version. Wait a minute, Wyeth said; we'll talk. Then talks broke down, and last week Wyeth said it would sell its own generic Protonix. India's Sun Pharma chimed in, saying it was planning to launch its copycat, too.

So why would Teva abstain? An analyst tells the WSJ Health Blog that if Teva relaunched, it would have to cut the price because of additional generic competition, and the it would have to rebate customers that bought in December. So maybe it's just holding back for now.

- check out Teva's press release
- read the item in the WSJ Health Blog

Related Articles:
Wyeth makes its own Protonix copy. Report
Wyeth loses a round to Protonix knockoffs. Report
Sun copycat to cut $500M off Wyeth sales. Report

FDA shoots down Mevacor OTC

Mon, 28 Jan 2008 06:59:56 -0500

It's official: Merck's off-patent statin drug Mevacor can't go over-the-counter. About a month after an advisory panel said "nay" to the idea, the FDA sent Merck a not approvable letter. It's the third time the agency has denied Merck's request to sell Mevacor without a prescription.

This time, there was an added wrinkle: GlaxoSmithKline had inked a deal with Merck for the over-the-counter rights to Mevacor in the U.S. So Merck was asking the FDA for an OK on GSK's behalf. The panel's chief concern: that even Merck's own patient survey showed some who shouldn't be taking statins would choose to do so.

Merck's OTC group is now "evaluating the conditions outlined in the agency's response" to see where to tack next. The FDA asked for a revised label--and, most importantly, for additional data. We'll see what Merck can pull out of its hat.

- see the release
- read the report from CNN Money
- here's a PharmaTimes article

Related Articles:
FDA panel: No can do on Mevacor OTC. Report
FDA unsure consumers can self-Mevacor. Report
Merck faces fierce debate on OTC statin. Report
GSK buys OTC rights to Merck statin. Report
Switching to generic statins not so healthy. Report

It's Crestor vs. Lipitor in AZ trial

Tue, 15 Jan 2008 06:59:55 -0500

If GlaxoSmithKline can challenge Merck to a head-to-head trial (Cervarix versus Gardasil), then AstraZeneca can throw down the gauntlet before Pfizer. In this case, the products in question are statins--AstraZeneca's Crestor and Pfizer's Lipitor. And the study, dubbed Saturn, will compare the two for their ability to decrease progression or induce regression of atherosclerosis over a two-year period. By the time the results are in, Lipitor will be going off patent, and the still-protected Crestor will need a performance edge to tout against cheap, copycat Lipitors.

Who knows, maybe the gamble will pay off. Maybe Crestor will trounce Lipitor and everyone at AstraZeneca will dance joyfully around the exec who came up with the idea for this trial. But the risks are considerable. For a cautionary tale, just consider Merck and Schering-Plough's roll of the Vytorin dice. Presumably, however, AstraZeneca won't hold back the trial results if they don't look good. At least we hope not.

- see this release from AstraZeneca
- read the article at MarketWatch

Related Articles:
Lipitor patent gets U.S. thumbs-down. Report
Lipitor is No. 1, but faces generic threat. Report
AZ hits back at Crestor imitators. Report

Merck joins Fosamax copycats

Mon, 14 Jan 2008 06:59:55 -0500

Merck won't be outdone on Fosamax. The company has struck a deal with an unidentified generics supplier for an authorized, copycat form of the osteoporosis drug. The Merck-blessed generic could go on sale as early as next month.

You'll recall that Fosamax's key patent is due to expire Feb. 6, and two generics makers--Teva Pharmaceutical Industries and Barr Pharmaceuticals--are first in line. Because they were first to ask the FDA for approval for their versions of Fosamax, they have six-month exclusivity. But that exclusivity doesn't apply to Merck itself, which could sell its own generic form or do so with a partner.

This type of arrangement--for an authorized generic--has come under fire as more and more pharma companies have begun to engage. Critics say they destroy the competitive advantage that six-month exclusivity is designed to confer; now, the Federal Trade Commission is studying the deals

- read the Wall Street Journal article

Related Articles:
US Senate to take on authorized generics. Report
Merck expects $1.8B hit on Fosamax. Report
Merck touts Fosamax data. Report
Merck profits jump by 62 percent. Report

FDA reforms lack cash backup

Wed, 02 Jan 2008 06:59:54 -0500

Everyone's favorite shooting target, the FDA, will continue to come under fire in 2008. Congress may have revamped the agency, but legislators didn't address its primary problem--funding--at least not in any material way. Congress gave the agency $1.73 billion for fiscal 2008, just $145 million over 2007's funding level. That's far short of the double-or-nothing called for by many FDA critics and friends alike.

You'll recall that in September, legislators passed a sweeping FDA overhaul, giving the agency power to order recalls, requiring drug makers to disclose clinical trial data, incentivizing studies of off-patent meds and meds for kids, and more. Two months later, a committee of FDA advisors said the agency is ill-equipped to deal with today's drug industry. Science is lacking, staff is lacking, money is lacking. Unless FDA commissioner Andrew von Eschenbach wins a few lotteries, we'll expect more of the same.

- here's the article about the FDA's 2008 funding
- read about the FDA reauthorization bill
- get more on the FDA's shortfalls

Related Articles:
FDA: Hyper-cautious or simply vigilant? Report
FDA badly needs more money, staff. Report
The FDA: Caught between a rock and a hard place. Report
FDA can't guarantee drug safety. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report

BMS offloads imaging unit for $525M

Mon, 17 Dec 2007 06:59:54 -0500

Bristol-Myers Squibb said it was going to retrench, and so it is. The company announced this morning that it would sell its medical imaging unit to the private equity firm Avista Capital Partners for about $525 million. BMS says it wants to focus more narrowly on biopharma, which doesn't include medical imaging. Plus, the unit's biggest product, Cardiolite, faces generic competition after its key patent expires next year.

The sale is part of a company-wide restructuring that includes 4,300 layoffs; BMS hopes to save $1.5 billion a year from cuts in jobs and manufacturing.

- take a look a this release from BMS
- read this article for more

Related Articles:
BMS cuts 4,800 jobs. Report
BMS starts laying off workers. Report
BMS to unveil (big?) layoffs. Report
Bristol CEO: Job cuts, shutdowns continue. Report

Mylan CEO intent on new global biz

Mon, 10 Dec 2007 06:59:55 -0500

The rise of generic drugs has been bad news for Big Pharma, but not so bad for copycat makers like Mylan, which gets the profile treatment today from its hometown newspaper, the Pittsburgh Tribune-Review. Since Labor Day five stock analysts have upgraded their ratings on the company, which bought Merck KGaA's worldwide generics unit in October for $7.4 billion. And that deal followed January's big investment in India's Matrix Pharmaceutical Laboratories. With those buys, Mylan became the world's third-largest generics maker. "I thought global from day one," CEO Robert J. Coury told the newspaper.

One interesting note: To embark on his growth plan, Coury had to squeeze out one of the company's big investors, none other than Carl Icahn. Might some Icahn-burdened biopharmas do the same?

- read more from Mylan's CEO in the Tribune-Review

Related Articles:
Pharma faces "tidal wave" of generics. Report
Patent 'cliff' looms for Big Pharma. Report
Glaxo to let Mylan make generic Paxil. Report

The top 15 R&D budgets

Mon, 10 Dec 2007 06:59:54 -0500

In the world of drug development, you're only as good as your pipeline. As many companies' older blockbuster drugs go off-patent, analysts are looking at pipelines to see who'll have what it takes to survive and grow, and which companies will fall behind in the race to develop new drugs.

A recent EU report ranked the world's largest R&D budgets, and Pfizer took the lead--not just among drug developers but among all industries--with a staggering $8.34 billion budget in 2006. But as this report shows, spending more money doesn't necessarily make for a better pipeline. Take a look at this list of the top 15 pharmaceutical R&D budgets to find out how they're spending all those billions of dollars.

- see this special report for more

ALSO NOTED: Byetta data backs stand-alone app; Watson, Novartis settle suit;

Fri, 07 Dec 2007 06:59:50 -0500

> Amylin Pharmaceuticals says it has the data to back an application to make Byetta a stand-alone therapy for diabetes. Report

> Watson and Novartis have settled their patent wrangle over the Alzheimer's drug Exelon. Report

> We're happy the way we are, thank you very much. That's what Genzyme CEO Henri Termeer (photo) has to say to rumors that the company could be next on the list of Big pharma biotech buyouts. Report

> In yet another sign of monoclonal antibodies' popularity among big drug developers, Wyeth has extend its evaluation of selected Raven Biotechnologies MAb antibodies. Report

And Finally…. Stand and deliver…smiles. A new survey shows parents prefer teachers who make their children happy over teachers with high achievement ratings. Release

Say goodbye to Big Pharma's gilded age

Thu, 06 Dec 2007 06:59:58 -0500

Yes, generic competition has become something of a mantra in the drug industry. But we're going to start the chant again, because The Wall Street Journal took a close look at just how much revenue the industry will lose over the next few years--and posits that Big Pharma's gilded age will soon be history.

Generics are expected to cut $67 billion from top drug makers' annual U.S. sales between 2007 and 2012. Sound sustainable? Not if you know that $67 billion amounts to half those companies' total U.S. revenues. Overall, industry revenue is expected to drop between 2011 and 2012, the first decrease in 40 years.

Meanwhile, as we know, the number of new drugs coming online has slowed. Between 2002 and 2006, pharma launched 43 percent fewer meds based on new chemicals, compared with the last five years of the 1990s. Development in some areas has all but stopped.

And with widespread restructuring, Big Pharma won't look like Big Pharma anymore, analysts say: "The era that created the modern pharmaceutical industry is in fact over," one predicted. Even pharma's own executives are speaking in eulogistic tones. Says Sidney Taurel (photo), chairman of Eli Lilly, "I think the industry is doomed if we don't change."

- read the report from The Wall Street Journal

Related Articles:
PwC to pharma: Adapt and invest or die. Report
Patent 'cliff' looms for Big Pharma. Report
New drug approval lags in 2007. Report
Lines blur as Big Pharma crosses borders into biotech. Report

ALSO NOTED: Merck cleared to sell Isentress in Canada; Sanofi, Astellas restructure Japanese venture;

Fri, 30 Nov 2007 06:59:50 -0500

> Merck's new, first-in-class HIV treatment Isentress won approval from Canadian regulators for patients resistant to other AIDS drugs. Report

> Sanofi-Aventis and Astellas Pharma say they're restructuring their joint venture by splitting up the rights to market various drugs. Report

> Teva Pharmaceutical Industries got the FDA's tentative nod to market a generic version of GlaxoSmithKline's Parkinson's drug Requip when its patent expires in May. Report

> Walgreen's has stopped filling prescriptions for four CVS Caremark drug plans, saying the reimbursement levels are too low. Report

> Lifecycle Pharma has tapped Hans Christian Teisen as its new chief financial officer; Teisen most recently served as CFO of the drug maker Bavarian Nordic. Report

> A Friedman Billings Ramsey analyst downgraded MGI Pharma's stock, joining market watchers skeptical that the up-for-sale biotech will attract suitors anytime soon. Report

> Questcor Pharmaceuticals upgraded its interim president Don M. Bailey to permanent president and chief executive. Report

> Canada's Axcan Pharma is being bought out for $1.3 billion by the private equity group TPG Capital. Report

> Regeneron is feeling the warm embrace of Sanofi-Aventis, France's acquisition-hungry pharma giant. Sanofi has upped its stake in Regeneron from 4 percent to 19 percent while putting up $85 million in an up-front fee to seal a development deal covering therapeutic antibodies. Report

> The latest survey from the National Venture Capital Association shows that biotechnology is still on a roll with investors. Report

And Finally... What's good for the gander isn't for the goose: A genetic variation puts women at risk of depression from chronic stress, but protects stressed-out men from the same mood disorder. Report