PharmExec Blog

With Botanicals, No Patent, No Expiry, says Sanofi Exec

Sanofi-Aventis' Ray Jupp, next to a mixture derived from botanical ingredients

Sanofi-Aventis' Ray Jupp, next to a mixture derived from botanical ingredients

What if a new drug could be trademarked instead of patented, keeping generics companies at bay for the life of the trademark, i.e., forever?

That was one of the ideas floated to reporters yesterday by Sanofi-Aventis’ Ray Jupp, VP of the fibrosis and wound repair therapeutic strategic unit, an early-stage research division created as part of Chris Viehbacher’s R&D restructuring in February 2010. Jupp said botanicals are typically patented by process, meaning it’s not the active ingredient or constituent that is proprietary, but the way those chemical constituents are extracted from the plant, and processed.

Since it’s nearly impossible to “back-engineer” a copycat from a finished botanical drug without understanding the extraction and processing methodology, Jupp wondered if there was a way to trademark a plant-derived drug “without giving everything away” during FDA’s drug approval process, which requires public disclosures detailing manufacturing processes. If so, a brand could conceivably retain its trademark forever, and shrug off patent expiry anxiety.

Ann Lamport Hammitte, an attorney focusing on intellectual property law at law firm Lando & Anastasi, said a trademark would protect what a product is called, but it doesn’t protect “what the product is underneath.” In the case of Sanofi, if the process methodology is the trade secret, that wouldn’t need to be disclosed to receive a trademark, but it would have to be disclosed for a patent, said Hammitte.

Jupp said botanical drug research in the past has focused on isolating single chemical constituents, but in many cases, efficacy is lost when plant extracts are fractionated out. In fact, plants themselves “can synthesize molecules in ways scientists can’t,” he said. Using different solvents to make extractions yields different groups of chemical constituents; those combinations mean that botanicals have the potential to impact multiple pathways, according to Ashfaq Parkar, director, transformational sciences, at Sanofi. The company is currently studying 12 unnamed botanicals, at 50 extracts each.

If it’s hard to know exactly what chemicals are at work in a botanical drug combination, wouldn’t that be problematic with respect to approval and commercialization? Well, not according to FDA’s guidance on botanical drugs, from 2004:

In many cases, the active constituent in a botanical drug is not identified, nor is its biological activity well characterized. Therefore, the [Chemistry, Manufacturing and Controls] documentation that should be provided for botanical drugs will often be different from that for synthetic or highly purified drugs, whose active constituents can be more readily chemically identified and quantified. For example, FDA would expect an NDA for a synthetic or highly purified drug to identify the active ingredient. However, it would not be essential for the sponsor of a botanical drug to identify the active constituents (although FDA recommends that this be done if feasible).

Currently, one in four drugs on the market comes from a plant, including Sanofi’s Taxotere injection (from taxus brevifolia, or the Pacific yew tree), said Jupp, adding that new applications for botanical-based drugs require new delivery solutions, since orally formulated products place inherent restrictions on chemists. Fibrosis (which is excessive scarring) and wound repair are therapeutic areas sorely lacking in treatments, said Jupp, using as an example diabetic ulcers; 12% of diabetics get ulcers, which can be debilitating, he said.

In a search through the trademark listings, no large pharmaceutical companies had products listed, though the Italian company Indena S.p.A. had nearly two dozen trademarks for botanicals trademarked for use in the preparation of pharmaceuticals products. Spectrum Pharmaceuticals licensed Indena’s ortataxel in 2007, a third generation taxane for solid tumors, but the drug hasn’t completed phase 2 trials, according to Spectrum’s website.

If Sanofi does end up developing a plant-based treatment for fibrosis, and they do try out the trademark route (and forgo a patent), they most likely won’t be letting reporters back into their research lab to observe the extraction process.

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3 Comments

  1. Posted May 25, 2011 at 3:34 am | Permalink

    The first 20 year patent was granted by King Henry VI in 1449. They were originally intended to protect the inventor for the remainder of their working life. In the 21st century the use of patents in the development of medicines has become an anachronism. The duration of protection is too short to allow development of a drug and give a sufficient period of market exclusivity to recoup costs. Instead companies waste hugh amounts of money and R&D resource developing follow on formulations to ‘tweak’ the original product solely with the intention of extending the patent. Lawyers make fortunes from creating and then negotiating through patent minefields, created to deliberately stifle innovation and competition and venture capitalist use patent portfolios as a lazy shorthand to value inventions (and thus companies) they do not understand. Regulatory bodies should be able to see details of compounds without public disclosure and drug companies should be allowed to use proprietary knowledge to protect their inventions over the long term. If Coca Cola had taken out a patent on their product the exact formulation would have become public property over a century ago. If that had happened how likely is it that the Coca Cola Company would still even exist in the 21st century?

  2. Posted May 25, 2011 at 7:49 pm | Permalink

    Hi Ben – Nice article. There’s a company already doing this work closer to home than Italy. Bionovo (NASDAQ: BNVI, incorporated in 2002) follows the FDA botanical guidelines to develop new drugs for menopausal hot flashes, breast cancer, pancreatic cancer, and other ailments. All of their drug candidates are derived from single or multiple botanical products with centuries of efficacy. According to their website, “We isolate, purify and test potent active ingredients from herbs and other botanicals, then formulate them into novel drug products which can be packaged as powders or pills for easy use by patients. We have identified the active chemical components underpinning the mechanism of action for all of our drug candidates, and in some cases, we have developed synthetic methods of production.”

  3. J. Bossart
    Posted May 25, 2011 at 8:29 pm | Permalink

    It should be noted that many of the “one in four drugs on the market comes from a plant” are derivatives of natural products, and are not found as such in nature. This is true of Taxotere (docetaxel), a semi-synthetic derivative of an intermediate extracted from the European Yew, a renewable resource.

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