Archive for the ‘Pharmaceuticals’ Category

Sanofi-Aventis Launches New Cancer Treatment

Tuesday, August 3rd, 2010

We congratulate our client, Sanofi-Aventis, on the launch of its new prostate cancer treatment, JEVTANA.  The FDA approved JEVTANA (cabazitaxel) on June 17, 2010 for use in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-based treatment regimen.  Jevtana is administered intravenously.

Subsequently, Sanofi-Aventis launched JEVTANA in the United States on July 19, 2010.  Jevtana in combination with prednisone is the only FDA approved regimen to significantly improve overall survival in patients previously treated with docetaxel-based chemotherapy regimen."  Studies have shown that JEVTANA can increase survival by 30%.

We are proud to have played a role in helping Sanofi-Aventis bring this innovative and exciting treatment – and trademark – to market.

Pharmaceutical Trademark Law: Some Tips & Considerations To Keep In Mind

Thursday, July 8th, 2010

Clearing and obtaining rights to pharmaceutical trademarks presents unique challenges unlike those associated with trademarks used in other fields. In addition to navigating the U.S. Patent & Trademark Office, the pharmaceutical trademark lawyer must counsel his or her client regarding the FDA regulatory hurdles that go along with securing a chosen product name.  After all, it does the client no good to successfully secure a Notice of Allowance if the FDA ultimately rejects the trademark during its drug name review process.  And the FDA gives no deference to U.S. Patent & Trademark Office decisions on registrability of trademarks. This is why it is critical to be mindful of both the U.S. Patent & Trademark Office’s approach and the FDA’s approach to approving chosen pharmaceutical trademarks.

Here are some quick points and tips (not by any means an exhaustive list) to keep in mind as you navigate the pharmaceutical trademark minefield:

  • You may submit up to two trademark names at a time to the FDA for approval, a process which takes approximately 3 years
  • Be careful about names that imply efficacy, risk, indication, superiority, or that are overly fanciful
  • Handwriting Analysis: Be mindful of potential confusing similarity between trademarks when they are handwritten, even if they are otherwise visually different when typewritten, or phonetically different; we all know that doctors are not known for having the best penmanship!
  • Verbal pronunciation analysis: even if 2 respective trademarks are visually distinguishable, if they sound the same when spoken verbally, this will weigh against ultimate approval
  • You may very well need to consider the trademark registration process and drug approval process in a foreign country if the product will be marketed and sold internationally; for example, the regulatory agency for the evaluation of medicinal products  in the European Union is EMEA (European Medicines Agency).  EMEA has its own process and rejects approximately 50% of proposed trademark names

Our team here at Lombard & Geliebter LLP has extensive experience representing pharmaceutical companies in connection with their trademark matters. If you have any questions relating to the pharmaceutical trademark law, please call Mathew Lombard or Darren Geliebter at 212-551-1755 or reach us by email: mail@lgtrademark.com.

FDA Nominee Faces Senate

Thursday, May 7th, 2009

fdalogoMargaret Hamburg, President Obama’s selection to head the U.S. Food & Drug Administration (“FDA”) is scheduled to face senators today as they consider her nomination.

Hamburg is a physician and a bioterrorism expert who has served as Commissioner for Health of New York City. 

The Senate is expected to grill Hamburg in light of some notable FDA failures such as salmonella outbreak in peanut products early this year, tomatoes and peppers in 2008 and spinach in 2006.

BMS to Sell Unit

Saturday, May 3rd, 2008

My former employer, Bristol-Myers Squibb Co., has announced it is selling its ConvaTec unit for $4.1 billion to two private equity firms:  Nordic Capital and Avista Capital Partners.  ConvaTec had been Bristol-Myers’ ostomy and surgical equipment.

Apparently, cash will be used to help finance Bristol-Myers’s strategy to shift its focus to biopharmaceuticals.  

Wyeth Sues Over Patent

Monday, December 24th, 2007

Following Teva Pharmaceuticals USA’s announcement that it would launch a pantoprazole tablet, Wyeth Pharmaceuticals, a division of Wyeth, said that it would pursue a patent infringement claim for lost profits and other damages against Teva.

P&G Gets Warning Letter

Wednesday, September 19th, 2007

Yesterday, the FDA ordered Procter & Gamble to stop advertising that its Vicks foaming sanitizer for hands (product here) prevents the spread of viruses (that cause colds.

The FDA is reviewing health claims for over-the-counter antiseptics made by P& G, Johnson & Johnson and other companies. While the active ingredient in the Vicks product, triclosan, is covered under FDA. regulations for certain antiseptic uses, that does not include P& G’s directions that users should leave the sanitizer on their hands, without rinsing with water, according to the letter.

“We believe we’re within the FDA guidelines, and we’re going to work with the FDA to clear up any misunderstandings,” said David Bernens, a spokesman for P&G.

FDA Wants Avandia Off the Market

Monday, July 30th, 2007

A Food and Drug Administration panelist said Monday that the diabetes drug Avandia should be taken off the market because it increases cardiovascular risk, but GlaxoSmithKline, the maker of the drug, disputed the comments.

“Rosiglitazone should be removed from the market,” said FDA advisor Dr. David Graham at the meeting, using the scientific name from Avandia.

Graham said studies suggested that Avandia increased cardiovascular risk, a relatively broad medical condition that is the leading cause of death in diabetics – the patients who are prescribed to take the drug.

ASPRINA: Unregistrable, but Why?

Thursday, May 31st, 2007

As trademark practitioners know, in the United States, “aspirin” is considered generic for the analgesic acetylsalicylic acid.  Although Bayer continues to own valid registrations of ASPIRIN as a trademark elsewhere in the world, “aspirin” has been generic in the United States for many years.

Nonetheless, Bayer uses the mark ASPIRINA elsewhere in the world and sought to obtain a trademark registration of ASPIRINA in the United States.  The USPTO Examining Attorney refused registration of ASPIRINA on the grounds that the mark is “merely descriptive” of aspirin.  After a motion to reconsider was denied by the Examining Attorney, Bayer appealed the decision to the Trademark Trial & Appeal Board (“TTAB”), which upheld the Examining Attorney’s refusal on the grounds that the mark was merely descriptive.

Bayer appealed the decision to the Federal Court of Appeals Second Circuit.  On May 24, 2007, the court released its opinion.

The Second Circuit upheld the Board’s decision.   However, the Second Circuit went to great lengths to make clear that it was a close call in light of the various conflicting bits of evidence.  Nonetheless, the dissent makes some interesting points.  Among them, Judge Newman writes, “Although the panel majority acknowledges that the issue of whether ASPIRINA is a generic word was not before the Board and is not before this court, the majority holds it unregistrable because it is similar in ‘appearance, sound, and meaning’ to the generic English word ‘aspirin.’”

On this point, he concludes:

Thus the court holds that because “aspirin” is generic, so is ASPIRINA. There was no hearing on the issue of genericness. See In re Merrill Lynch, Pierce, Fenner, and Smith, Inc., 828 F.2d 1567, 1571 (Fed. Cir. 1987) (“The burden of showing that a proposed mark is generic remains with the Patent and Trademark Office [and requires a] ’substantial showing by the Examining Attorney . . . .’” (quoting The Trademark Manual of Examining Procedure ‘1305.04 (1974, rev. 1983))).

Based on Judge Newman’s analysis, it seems that the Second Circuit has in fact decided an issue which was not before it.

Nonetheless, in concluding, the majority switches gears saying, “We find that there is sufficient evidence as a reasonable mind might accept as adequate to support the Board’s finding that ASPIRINA is merely descriptive.”

Without commenting on merits of registration of ASPIRINA, the rationale of the majority seems a bit tenuous as it confounds a genericness and merely descriptive.

I am wondering whether Bayer will appeal this decision to the Supreme Court or, at least, request a rehearing en banc at the Second Circuit.

AstraZeneca To Acquire MedImmune

Tuesday, April 24th, 2007

az.gifAccording to news reports, AstraZeneca announced Monday that it was buying U.S. drug maker MedImmune in a $15.6 billion deal that would allow the British company to enter the growing human vaccine market. (To compete with GlaxoSmithKline?)

AstraZeneca says it will pay $58 a share for MedImmune, which is a 21 percent premium over MedImmune’s April 20 closing price of $48.01.

Pharma Consolidation

Monday, March 12th, 2007

Schering-Plough has announced that it will buy Akzo  Nobel N.V.’s drug unit N.V. Organon for $14.4 billion.

Akzo was expected to publish details of a plan to sell Organon shares today. Instead, this morning, the board signed the agreement with Schering-Plough. Talks began one and a half weeks ago, Chief Executive Hans Wijers told reporters on a conference call.

The transaction will boost Schering-Plough’s earnings per share by about 10 cents in the first year and close before the end of 2007, the U.S. drugmaker said.