- Seven pharma-related patents expire the week of August 10, 2014.
- One patent relates to Novartis/Noven/Novogyne's CombiPatch, as well as two other transdermal hormone therapies for post-menopausal women.
- A third relates to Pfizer's Nicotrol nasal spray to help stop smoking.
This week's patent expirations are related to estradiol products belonging to Novartis (NYSE:NVS) and other companies, as well as Pfizer's (NYSE:PFE) Nicotrol, as well as several other pharma industry players.
Nicotrol, Pfizer's prescription nicotine inhaler/insufflation device for smoking cessation, also saw a patent expire this week. A report citing IMS Health data indicates that as of 2011, Nicotrol sales were in the $6 million range, well behind then-market leader Chantix, which has since encountered a fair amount of legal turbulence thanks to claims about negative psychological side effects associated with that drug.
The FDA had granted approval for marketing of Nicotrol to Pharmacia and Upjohn Co. - a precursor to Pfizer - in 1997.
The loss of IP related to Nicotrol appears to be a small one; Pfizer reported 2013 revenue of $51.6 billion.
This week's expiration
U.S. patent number 5,656,255, titled "Composition to help stop smoking," relates to "compositions and methods useful for subjects who wish to reduce tobacco smoking or to find a socially acceptable substitute."
The acceptable smoking alternative, filed in 1993, was a "nicotine-containing spray for administration to the nasal mucosa."
The application lists several other smoking replaiacement technologies, like chewing gum and the patch, as well as their downsides.
CombiPatch, Vivelle-Dot, and Minivelle
A patent relating to use of female sex hormone estradiol in three separate marketed products expired this week. One product governed by the patent is CombiPatch, a drug for which French pharmacuetical company Rhone-Poulenc Rorer secured FDA approval in August 1998 to treat:
- "moderate to severe vasomotor symptoms associated with menopause"
- "vulvar and vaginal atrophy"
- "hypoestrogenism due to hypogonadism, castration or primary ovarian failure"
(Rhone-Poulenc Rorer eventually, through mergers, became a part of Sanofi-Aventis.)
Novartis has shared in global marketing rights for CombiPatch, and in 2001, Novogyne Pharmaceuticals, a privately held joint venture between Noven and Novartis, acquired the rights to CombiPatch for a series of payments totaling $65 million. From 2010 to 2011, global sales of CombiPatch fell 20% to $5 million, per Evaluate Pharma. That performance meaningfully lags that of Novogyne's Vivelle-Dot/Estradot, which took in $199 million in 2011 sales.
Patents related to Vivelle-Dot and Minivelle, which are also Noven/Novartis-affiliated transdermal hormone patches, are also expiring this week.
This week's expiration
U.S. patent number 5,656,286, titled "Solubility parameter based drug delivery system and method for altering drug saturation concentration," relates to "to transdermal drug delivery systems, and more particularly, to a transdermal drug delivery composition wherein a blend of polymers is utilized to affect the rate of drug delivery from the composition. More specifically, a plurality of polymers including a soluble polyvinylpyrrolidone having differing solubility parameters, preferably immiscible with each other, adjusts the solubility of the drug in a polymeric adhesive system formed by the blend, affects the maximum concentration of the drug in the system, and modulates the delivery of the drug from the composition and through the dermis."
The objects of the patent, filed Jan 7, 1994, included:
- "Provide a transdermal drug delivery system wherein the rate of drug delivery from the transdermal composition may be selectably modulated."
- "Provide a transdermal drug delivery system wherein the rate of drug delivery from the transdermal composition may be selectably modulated by adjusting the solubility and/or diffusivity of the drug in the multiple polymer adhesive system."
- "Provide a transdermal drug delivery system wherein the multiple polymer adhesive system is simple to manufacture."
Here is a table of this week's patent expirations. This table of patent expirations and additional biotech-related IP information is available at DrugPatentWatch.com.
Additional Disclosure: Additional editorial support provided by Seeking Alpha staff.