Archive for the ‘Pharmaceuticals’ Category

Pharma Industry Challenges Drug Take-Back Law

Monday, December 17th, 2012

The pharmaceutical industry – represented by the Pharmaceutical Research and Manufacturers of America, (“PhRMA”), the Generic Pharmaceutical Association and the Biotechnology Industry Organization - is challenging an Alameda County, California ordinance that requires the pharma industry to  be  responsible for running — and paying for — a program that would allow consumers to turn in unused medicines for proper disposal.   Drug companies have to submit plans for accomplishing it by July 1, 2013.  The pharma industry filed its lawsuit on December 7, 2012.

Such take-back programs exist; however, most existing programs are run and paid for by local or other government agencies.

Supporters of the ordinance argue that the industry that profits from the sales of these products should have the financial responsibility for proper management and disposal.  In other words, this law does not really enact new programs.  Rather, it shifts the burden of these programs from taxpayers to the pharmaceutical companies.

The pharma industry counters that the law is unconstitutional.   PhRMA’s general counsel, James Spears, asserts, ““They are telling a company in New Jersey that you have to come in and design and implement and pay for a municipal service in California.  This program is one where the cost is shifted to companies and individuals who are not located in Alameda County and who won’t be served by it.”

Mr. Spears said it would be best left to sanitation departments and law enforcement agencies, which must be involved if narcotics, like pain pills, were to be transported.

Alameda’s ordinance is based in part on on the system in British Columbia and two other Canadian provinces.

This should be an interesting case to watch.  On balance, we suspect the ordinance will ultimately be upheld.  From our perspective, there is really nothing unconstitutional about the law.   If a company based in New Jersey can sell its products in Alameda county there is really no hardship is operated a disposal program there.

The original complaint may be found here.

FDA Approves first flu vaccine using mammal cell cultures

Wednesday, November 21st, 2012

On Tuesday, the FDA announced that it approved the first flu vaccine comprising animal cell cultures.   The vaccine, to be marketed under the trademark FLUCELVAX, is a Novartis product.  FLUCELVAX will be manufactured in Novartis’ brand new North Carolina plant.

The vaccine is produced with virus strains that are grown in animal cell cultures derived from mammals instead of in chicken eggs. Similar cell culture technology has long been used to produce other types of vaccines, FDA said.

FDA press release here.

Top Drugs Since 2000

Thursday, November 15th, 2012

Based on Genetic Engineering & Biotechnology News’ list of best-selling drugs between 2000 and 2011, Pfizer’s LIPITOR topped the list with $121.4 billion in sales.  Sanofi/Bristol-Myers Squibb’s PLAVIX was number two with $74.6 billion in sales.

Sanofi’s LOVENOX also appeared in the top 10.

Source

Mathew Lombard Publishes Article on Biotech Start-Up

Tuesday, November 6th, 2012

Lombard & Geliebter partner, Mathew Lombard, has published an article about the importance of trademarks at the Biotech Start-up Blog. You may access the article here.

Congratulations to Mathew. We look forward to seeing future articles.

What is the Cost to Bring One New Drug to Market?

Thursday, February 16th, 2012

Forbes.com looks at this question here.

FDA Approves New Sunscreen Rules, Finally

Tuesday, June 14th, 2011

After 30 years in bureaucratic limbo, the FDA has approved new rules, published today, intended to alleviate consumer confusion about sunscreen effectiveness.

In order to claim they protect against skin cancer, sunscreen manufacturers will have to prove they filter out bothultraviolet B rays and ultraviolet A rays.  Additionally, any sunscreen with an SPF of 15 or less will have to bear the following warning:  ”This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

The key takeaway for consumers: Look for a sun protection factor, or SPF, of 15 and above that also says “broad spectrum.” That’s the new buzzword from the Food and Drug Administration to describe a product that does an acceptable job blocking both types of damaging rays.

The new regulations require that sunscreens be tested for the ability to block the more dangerous ultraviolet A rays, which can penetrate glass and pose the greatest risk of skin cancer and premature aging. Currently, the FDA requires testing for only ultraviolet B rays that cause sunburn. The current SPF labeling system only deals with ultraviolet B rays.

Under the new rules:

• The FDA will prohibit sunscreen marketing claims like “waterproof” and “sweatproof,” which the agency said “are exaggerations of performance.”

• The FDA also proposes capping the highest SPF value at 50, unless companies can provide results of further testing that support a higher number.

• FDA says manufacturers must phase out a four-star system currently used by some companies to rate UVA protection.

After reviewing more than 3,000 public comments, the agency concluded the star system was too confusing for consumers. Instead, protection against UVA should be proportional to protection against UVB, which is already measured using SPF.

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.