Article One Looks to Review Singulair Patent

Teva Pharmaceuticals and Merck & Co. are currently tied up in a lawsuit over Merck’s blockbuster drug, Singulair.  While the two are busy battling it out in the court room, and independent firm has just made the case a little more interesting.

According to CNN Money, Article One Partners LLC, an independent firm, specializes in challenging the validity of patents.  Article One has requested that the USPTO review a patent for Singulair, because their online community found two pieces of prior art that suggest the key ingredient in Singulair isn’t novel.

We’ll have to wait and see what impact, if any, this news will have on the case.  Teva had applied to the U.S. Food and Drug Administration for a generic version of Singulair, but Merck responded in 2007 by filing a lawsuit.  The mandatory stay on Teva’s generic Singulair launch is due to expire in the summer, making the current trial even more important.

Singulair generated $4.3 billion last year which accounted for 18% of all Merck sales.

Merck & Teva Sparring Over Singulair

Singulair, a popular asthma medication, rang up $4.3 billion in sales last year and is currently Merck’s biggest seller.  Although the patent on Singulair doesn’t expire until 2012, Merck is facing a looming patent challenge from Teva Pharmaceuticals.  As reported by The Wall Street Journal, Teva is seeking to release a generic version of Singulair as early as August, and is challenging the validity of Singulair’s patent.

The two are set to face off in court this month, but some analysts told Dow Jones that they think Merck has the stronger case.  However, it’s always possible that the two companies could reach a settlement outside the courtroom. 

This legal battle has become very important to Merck, as sales of Gardasil already slipped 3% in the 4th quarter of 2008.  Sales of Merck’s other blockbuster drug, Gardasil, have fallen as well.

Merck to buy Insmed Biosimilars for $130 Million

Merck has just announced that they will buy Insmed’s portfolio of follow-on biologic therapeutic candidates, as well as a manufacturing facility, for $130 million.  As reported on Forbes.com, Insmed agreed to sell its pipeline of “biosimilars” which are drugs that are attempted copies of biotech drugs made from living cells.

The new drugs will be managed by Merck’s new BioVentures business.  Also, the deal is expected to speed up Merck’s entry into making follow-on biologic products.  Examples of follow-on biologic products are Insmed’s INS-19 and INS-20, which are intended to prevent infections in patients recovering from chemotherapy.  Merck gains control of both products, which are currently in early-stage testing.

The manufacturing plant included in the deal is a 50,000 square-foot facility in Boulder, Colorado.  The plant is used to make and analyze biologic drugs.

Merck will pay Insmed $10 million upfront, and will make the rest of the payment when the deal is closed.  Merck will not owe any additional milestone or royalty payments.

Pfizer-Wyeth Merger a Preview of Things to Come?

Pfizer’s recent move to buy Wyeth should not have come as any major surprise.  With patents expiring in the near future, and revenue pools drying up, such a move made sense.  But according to Pharmafocus, more pharmaceutical mergers may be on the horizon.

One such company that is speculated to make a move is Merck, which still hasn’t found a product that equals the amount of revenue generated by Vioxx.  In 2004, Vioxx was withdrawn after concerns that the drug increased the risk of heart attacks.  Chief executive Richard Clark recently said, “I don’t think in today’s world any CEO can categorically rule out any type of transaction.”  Some speculate that Merck could potentially merge with Schering-Plough, after the two forged a successful partnership for the marketing of cholesterol drug, Vytorin.

Another potential merger could involve Sanofi and Bristol-Myers Squibb.  The two recently gained legal protection against any further attacks on their co-marketed drug, Plavix.  But with the patent for Plavix expiring in 2011, both will see a huge loss in earnings.

At the same time, GlaxoSmithKline has made it clear that they are not interested in any mega-merger.  Chief executive Andrew Witty recently said he would “not be distracted by large-scale M&A.”  Some believe that the company’s recent moves into emerging markets supports Witty’s statement.

While merging companies may cut costs, it may only buy time.  The real cure for big pharma is to continue innovating and diversifying their research.