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.