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Patents, legal battles and R&D dominate drug delivery headlines

By Gareth Macdonald , 05-Dec-2011
Last updated the 05-Dec-2011 at 13:04 GMT

Legal battles, patent acquisitions and R&D dominate in-pharmatechnologist.com’s round up of developments in drug delivery this week with news from MonoSol, Acacia and a US University team working on GSK’s Relenza.

First up is New Jersey-based MonoSol Rx which will defend its drug delivery technology portfolio after the USPTO rejected its claims that BioDelivery Services International’s (BDSI) cancer pain patch Onsolis infringed on one of its patents.

Last month the US Patent and Trademark Office (USPTO) threw out all 191 of MonoSol’s claims that production methods for BSDI’s BioEdible MucoAdhesive (BEMA) broke patent number 7,824,588 covering the manufacture of active pharmaceutical ingredient (API) containing delivery films.

MonoSol, which has two months to respond to the USPTO’s decision, said it is preparing its response with CEO Mark Schobel adding that the firm is “Confident that, at the end of the process, the PTO will confirm the patentability of our claims.

To be clear, there has been no ruling on our '588 patent challenge and the patent and claims remain valid and enforceable until the USPTO rules otherwise on the case. The '588 patent is only a small part of MonoSol Rx's broad and robust patent portfolio.”

Delivery technology was also the focus of California-based Acacia Research Corporation this week, with the firm announcing it has bought 13 patents relating to an inhaler from a ‘major’ medical company.

Acacia declined to go into specifics on the technology or the medical company involved but did tell in-Pharmatechnologist.com that its “approach will be to license to all companies who want to use the technology.”

Patents also dominated the activities of a research team at the University of Hawaii, which is developing a new delivery system for GlaxoSmithKline’s (GSK) influenza treatment Relenza.

The team led by Eric Holmes, research director at the John A Burns School of Medicine, is basing the new delivery system on a patented method of improving the oral permeability of neuraminidase inhibitors and other polar agents.

Dr Holmes’ team claim that, using permeability enhancers, they can increase the amount of drug transported across cell membranes by 150 per cent.

In non-patent news Texan biopharma Heparinex has been granted $1.6m (EUR1.1m) by Oklahoma City’s Economic Development Generating Excellence program (EDGE) to help scale-up its sugar-polymer based delivery technology for assessment in clinical trials.

The technology, known as heparosan, is designed to boost the half-life of pharmaceutical actives by attaching polymers of the naturally-occurring sugar heparosan which prevent them the drug from being excreted too rapidly, therby boosting its therapeutic effects.

Heparinex, which claims its approach is superior existing PEGylation based methods in terms of safety and utility, said the grant will fund process development, documentation and characterisation of heparosan for delivery applications.

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