Merck has vowed to stay the course on its legal strategy as it continues to face setbacks in court over cases involving Vioxx (rofecoxib).

The company is defending its game plan as it releases the first set of safety data for its next generation painkiller Arcoxia (etoricoxib).

A federal jury in New Orleans earlier this month found that Vioxx had caused a heart attack in a 58 year-old South Carolina man. Then, in a separate New Jersey case, a judge set aside a previous Merck victory after reading an "expression of concern" in The New England Journal of Medicine (NEJM).

The cases were Barnett v. Merck and Humeston v. Merck, respectively.

"We remain confident in the strength of our defense, and we remain committed to the fight and to the strategy of defending these cases on an individual basis," said Ted Meyer, an attorney at Hughes Hubbard & Reed and a member of Merck's litigation team.

"We are going to have losses along the way," added Phil Beck, one of Merck's lead litigators and founder of firm Barlit, Beck, Herman, Palenchar & Scott. "We recognize that that's part of the vagaries of the legal system and the company is committed to going forward and defending each case on the merits as it comes."

Members of Merck's legal team addressed analysts and the media on a conference call. They reiterated that they expect to wage a long legal battle, and explained the necessity behind it.

"Our message is resonating with juries in a lot of places and in a lot of situations," Meyer said. "You're going to have different results depending on your jury, depending on the facts of your individual case, and so on. And that's why we have to continue to look of these cases individually."

James Etscorn, a partner at Baker Hostetler who is not working with Merck's legal team, noted that Merck is taking a "somewhat unforeseen strategy."

Most companies that faced a recall in the past have opted to settle cases, rather than fight them individually. But he noted that the nuances in the published data--as well as the larger question of whether Merck adequately warned the medical community of heart risks--separates the Vioxx cases from others.

"People want to second-guess Merck's legal strategy, but it's too early to tell how this will play out," Etscorn said, adding that the appeals courts will have the final word on these cases. "I think their strategy has seen some success. These are not the type of cases that can be decided through class action status."

Merck has now litigated nine cases, lost four, and had one victory set aside.

Separately, Merck has released preliminary Arcoxia data suggesting that the drug's cardiovascular risk profile is similar to the non-steroidal anti-inflammatory drug diclofenac.

The company was guarded about the details of the data, saying that the full results of the MEDAL trial would be released in a peer-reviewed paper and at medical meetings.

Articles

Company faces two Vioxx setbacks in court as it prepares to reveal safety data on its cox-2 successor.

Merck Defends Vioxx Strategy, Releases Arcoxia Data

In today's legal environment, no drug patent goes unchallenged.

Companies are seeing a spike in cases that invalidate brand name patents partially or completely, a recent analysis found. Patent attorneys believe the trend is driven, at least in part, by generics makers challenging secondary patents that are harder to defend, but which pharma companies obtain in a desperate attempt to extend patent life.

The Federal Circuit has invalidated some or all of the patent claims in all of the 25 to 30 cases published since December 2004, according to calculations done by Robert Schulman, a partner and co-chair of the life sciences group at law firm Hunton & Williams.

Between 2000 and 2004, in contrast, patents were upheld in about 50 percent of 27 published patent challenges.

"If you put it to the judges, they'd probably say it's a coincidence," Schulman said. "But there was clearly a change that occurred."

Schulman's analysis also compared the pharmaceutical industry to other fields, and found that the trend appears to be isolated.  He noted that there seems to be a change in the way judges are applying patent law, and pointed to Pfizer's Lipitor (atorvastatin) as an example.

Earlier this month, the US Court of Appeals for the Federal Circuit invalidated one of Lipitor's secondary patents, cutting its marketing exclusivity by one year. Ranbaxy Labs brought the patent challenge.

"To most of us, [the decision] seemed quite extraordinary," Schulman said.

He noted that the case hinged on a legal formality, and industry executives "absolutely should be concerned about this."

The US Appeals court similarly issued a split ruling on five patents for Amgen's Epogen (erythropoietin) this month.

Tim Murphy, a partner at Bromberg & Sunstein, noted that the trend is being seen both in the courts as well as the Patent and Trademark Office. 

"Pharmaceutical companies have been very aggressive in extending the life of a patent," he said. "When you're really aggressive, you're bound to have some pushback."

"The court has been subjecting pharma patents to a great degree of scrutiny," agreed Nicholas Groombridge, a partner at Weil, Gotshal & Manges. "My sense is that there have been more challenges to basic patents."

But Groombridge noted that pharma companies are winning more of these cases that involve the core compound. Where patent challengers have been successful, however, is in picking off the "low-hanging fruit," or so-called secondary patents.

Most of the successful cases have involved not the core compound, but an element of its formulation or administration, noted Judy Mohr, a partner at Perkins Coie. "When the claim isn't directed at the core compound, it probably is more open to challenge," she said.

And the growth of the generics industry means that every patent is at risk of being challenged.

"Five, six years ago, there were fewer generic makers with the wherewithal to challenge Big Pharma," Mohr said.

Murphy of Bromberg & Sunstein sees the trend continuing. "Even though the successes may be limited [in winning a secondary patent case] there's so much money at stake."

Recent analysis shows partial or complete invalidation of all pharma patents challenged since December 2004.

Federal Courts Get Tough on Patents

Schering-Plough is working with BBDO to update its successful Nasonex (mometasone furoate) campaign for the end of the summer, according to sources familiar with the changes. Nasonex is one of the top 10 most advertised brands.

The new look still relies on the animated Nasonex Bee as its centerpiece, but a revised message will now emphasize the nasal spray's ability to treat multiple allergy symptoms. Nasonex is approved to treat symptoms caused by both indoor and outdoor allergens.

The new television spots will run during episodes of "Extreme Makeover," "CSI New York," and "Super Nanny." The print spots will run in magazines including 

The ads depict an animated couple facing a host of allergens including pollen, dust, and pet dander--and getting relief from Nasonex. The Bee narrates the TV spot in its signature voice.

Schering-Plough declined to comment on the new campaign, citing company policy. BBDO referred all calls to the client.

In its second quarter earnings report, Schering-Plough cited Nasonex as one of its top brand performers. Sales rose 21 percent to $242 million over the same period last year.

But competition is fierce in the crowded allergy market, and creating a brand presence is key.

The company also reported higher overall promotional expenditures for the first half of 2006, but the figures weren't broken down by brand.

Nasonex was the sixth most advertised brand in 2005 based on its direct to consumer expenditures, according to Verispan's DTC audit, which was released this summer.

The latest campaign evolution comes roughly a year after Schering-Plough poured about $100 million into its DTC budget for Nasonex to catch up to GlaxoSmithKline's consumer spending on competitor product Flonase (fluticasone).

Advertising expenditures for the two brands ran neck in neck in 2005, with Flonase coming in at number seven on Verispan's list of most advertised brands.

The top three most advertised brands in 2005 were Nexium (esomeprazole), Lunesta (eszopiclone), and Vytorin (ezetimibe, simvastatin).

Schering-Plough's successful allergy medication gets an updated ad campaign.

Pharmaceutical Executive-08-30-2006

Merck Defends Vioxx Strategy, Releases Arcoxia Data

Federal Courts Get Tough on Patents

Nasonex Bee Buzzes New Message