Patents

Barr, Bayer clinch generic Yasmin deal

Tracy Staton — Tue, 24 Jun 2008 09:24:06 -0400

Another generic deal that antitrust watchdogs love to hate: Barr Pharmaceuticals inked a deal to sell an "authorized generic" version of Bayer's birth control pill Yasmin by July 1, several years before the product's last patent expires. Barr also will launch an authorized copycat of Bayer's Yaz product on July 1, 2011. In both instances, Barr gets exclusive rights to sell the meds in the U.S., and Bayer will supply the pills. In return, Bayer will get a share of the sales.

You'll recall that in March, a federal court deemed one of Yasmin's key patents invalid. Bayer is appealing that decision. Even if Bayer wins, though, Barr will still get to sell generic Yasmin. It will just have to pay a larger share of sales to Bayer for the privilege.

- check out the release
- read the Associated Press story
- see the coverage in Forbes

Docs back Viread for hepatitis B

Tracy Staton — Thu, 29 May 2008 10:47:38 -0400

Analysts are chatting up Gilead Science's HIV drug Viread as a treatment for hepatitis B. Currently under FDA review for that indication, Viread already has the backing of four out of five doctors, said Thomas Wei, a Piper Jaffray analyst."Feedback from this survey leads us to believe that Viread could enter the market with the best combination of efficacy, safety and resistance data, and coupled with a lower cost, could win the majority market share of the class," Wei wrote in a note to clients.

This is good news for Gilead, which has been fighting off Viread competitors lately. In November, the FDA gave tentative approval for the first generic version of Viread under the President's Emergency Plan for AIDS Relief, and in January, the Public Patent Foundation challenged four patents on the drug. The U.S. Patent Office has since upheld one of those patents, but there's been no ruling yet on the others.

- see the story in Forbes

AZ stock leaps on Seroquel hearing news

Tracy Staton — Tue, 20 May 2008 09:53:43 -0400

Color AstraZeneca hopeful. A U.S. court hearing over Seroquel's patents has been bumped forward to today from June 4, boosting speculation that the drugmaker might just come out on top in the high-stakes case. (It hasn't hurt AstraZeneca's stock, either.) Today's hearing is to consider AstraZeneca's request for summary judgment in the case; a decision might not be handed down today, though.

Back in February, AstraZeneca announced it would seek an early decision in its Seroquel patent fight with generics giant Teva Pharmaceutical Industries. At risk: AstraZeneca's $4 billion antipsychotic drug, the company's second-biggest seller, accounting for an expected 28 percent of 2008 earnings. If the judge decides not to grant summary judgment, the Seroquel fight is set to go to trial in August.

- read the article at MarketWatch
- see the Forbes piece
- check out The Guardian's take

Sanofi's Lovenox patents 'unenforceable'

Thu, 15 May 2008 06:59:56 -0400

Will the way soon be clear for a generic form of Lovenox? Sanofi-Aventis just lost a bid to save its patents on the anticlotting med, as a U.S. appeals court upheld a lower-court ruling that called the patents unenforceable. That court found that Sanofi failed to disclose certain info on its patent applications--"inequitable conduct" that negated their protection.

The ruling is a win for Teva Pharmaceutical Industries and Amphastar Pharmaceuticals, which originally challenged the patents. They both applied for FDA approval for copycat forms of the med back in 2003. Lovenox's key patent was set to expire in 2012; Sanofi says it's "considering its legal options."

- read the Wall Street Journal news

New Canadian rules to delay big generics

Tue, 06 May 2008 06:59:56 -0400

Generics makers are up in arms over proposed patent rules in Canada. The drug copycats say the rules will delay generic Lipitor and several other blockbusters by as much as two years. (Can you hear Pfizer cheering that idea?) And they say the new rules are nothing but a sop to brand-name drugmakers.

The government says it's simply trying to put the worms back into the can after two court rulings unexpectedly curbed the practice of "evergreening," otherwise known as "filing new patents on a drug to keep generics away." Canada's Industry Minister's office says that the new regulations would uphold government policy as it was before the court rulings. "We need predictable and stable intellectual property laws" to remain attractive to international investment, a spokeswoman said.

- read the story in the National Post

Roche appeals Mircera injunction

Thu, 10 Apr 2008 06:59:56 -0400

Roche is appealing to a higher power on Mircera. The Swiss drugmaker is appealing a lower court ruling barring U.S. sales of the anemia med, claiming that Mircera doesn't infringe on Amgen's patents after all. Saying that a judge in federal court encouraged the appeal, Roche said it "maintains its position that all of Amgen's patents...asserted against Roche are invalid and not infringed."

Apparently, Roche got tired of waiting for Judge William Young to decide whether to let it sell Mircera in the States. You'll recall that, in giving Amgen its injunction against Mircera, Young said he might let the drug onto the market under certain conditions, including price controls and royalty payments. Roche agreed to the conditions, but Amgen balked--and so Young is appointing a special master to help sift through the technical issues.

Then--as now--Amgen simply said it thinks a permanent injunction against Mircera is the only correct answer. We'll see what the various judges decide.

- check out the item at Pharmalot

Related Articles:
Mircera judge seeks expert guidance
Court sends Mircera case to ITC
Roche accepts judge's deal on Mircera
Mircera gets FDA nod, but blocked by patent case
Amgen wins patent fight with Roche

Dems back compulsory licensing

Thu, 10 Apr 2008 06:59:55 -0400

Now Rep. Henry Waxman and 26 of his Congressional counterparts are wading into the compulsory licensing fray. They're questioning U.S. Trade Rep Susan Schwab for her downgrading of Thailand after it issued patent-breaking licenses for three drugs. Though Schwab gave various reasons for putting Thailand on the trade watch list, the reps' letter says the move appears to be a condemnation of compulsory licensing itself. So they're asking Schwab to "reaffirm" the World Trade Organization agreement that allows for those compulsory licenses in public health emergencies at each Member country's discretion.

Can you hear the howling already? As you know, compulsory licensing is controversial in the drug industry; after all, it lets countries bypass the patents on brand-name meds so they can buy cheap copycats. Drugmakers are understandably reluctant. But proponents say that otherwise, patients in poor countries might never get access to the lifesaving meds they need. It's a complex issue, and a contentious one, so you can expect the debate to intensify--especially if Congress decides to get more involved.

- see the House Democrats' letter to the U.S. Trade Rep (.pdf)
- read the item at Eye on FDA
- check out Pharmalot's coverage

Related Articles:
Thai official backs off licensing fight
Thailand reconsiders compulsory licenses
Thailand skirts Plavix patent
Thailand may bust cancer patents

SPOTLIGHT: Thais to make their own generics

Thu, 13 Mar 2008 07:59:52 -0400

After announcing that it would bust the patents on four cancer meds, Thailand now says it's building a plant to make local versions of several anti-AIDS meds and the heart drug Clopidogrel. The government's health agency had already been distributing low-cost generics of the AIDS meds made in India. Report

Novartis, Novo sue Bayer over patent

Thu, 21 Feb 2008 06:59:54 -0500

Novartis and Novo Nordisk are ganging up on Bayer, alleging that the German company's hemophilia treatment Kogenate infringes on one of their joint patents. In a statement, Bayer said it would "vigorously defend itself" against the complaint, and that it doesn't believe it has overstepped the bounds of any patents. The company's stock fell on the news. Meanwhile, other news reports said the suit, filed in federal court in Texas, names Wyeth as well. The New Jersey-based firm has not yet commented.

- see Bayer's release
- read the article at CNN Money
- check out reports of the Wyeth connection at CNN Money

Fearing sanction, Thais may pay for drugs

Wed, 13 Feb 2008 06:59:54 -0500

Thailand may be running scared. Remember, the new health minister promised last week to review the country's compulsory licenses--which essentially break patent rules so that cheap meds can be had during health emergencies. Now, Chaiya Sasomsa says he'd rather buy the expensive cancer drugs his predecessor co-opted, because the alternative may be trade sanctions.

The World Trade Organization allows compulsory licenses if public health demands it. But apparently, Thailand officials are worried that the policy could undermine relations with trading partners. The U.S. Trade Rep, for one, put Thailand on its Priority Watch list because of the patent-breaking.

- read the item at Pharmalot

Related Articles:
Thailand reconsiders compulsory licenses. Report
Thailand may bust cancer patents. Report
Thailand skirts Plavix patent. Report