Don't Need Quality Patent Information? Think Again!
SummarySydney, Australia 29th September, 2008. A recent case heard in the Federal Court of Australia illustrates the need for comprehensive, accurate and regularly updated patent information to ensure that the planned launch of a generic pharmaceutical product is not delayed.
Sydney, Australia 29th September, 2008. A recent case heard in the Federal Court of Australia illustrates the need for comprehensive, accurate and regularly updated patent information to ensure that the planned launch of a generic pharmaceutical product is not delayed.
In Interpharma Pty Ltd v Commissioner of Patents  FCA 1283, the applicant was unsuccessful in seeking, among other things, an order setting aside the Commissioner’s decision to extend the term of the AU565856 patent. The patent in question describes and discloses a class of compounds having an anti-viral therapeutic effect and is the basis for the registration of the commercial product Gemzar (Gemcitabine hydrochloride). In one of the key aspects of the case the applicant was unaware of the existence of this Australian patent, and thus its subsequent extension, until August 2007 – more than 7 years after the grant of extension of term. The applicant had relied on information provided by a third part supplier of its generic drug product based in Austria to determine the possible launch date of the product. This failure to obtain comprehensive and accurate patent information in a timely manner, before making the commercial decision to register and market a generic product, led directly to the Court's dismissal of the proceedings.
What can we learn from this?
Reliance on basic or unproven sources of patent information can have major and far reaching consequences for generic companies. These include the loss of significant revenue from potential sales; paying financial compensation to a branded drug proprietor, if deciding to launch a generic equivalent at risk; and high litigation costs. It's clear that a small investment in the acquisition of reliable patent information is of great benefit to those seeking to manufacture non-infringing generics.
Leighton Howard, CEO of GenericsWeb stated that “too many generic firms spend time and money trying to secure indemnity against patent infringement proceedings from their overseas suppliers, rather than spending it more wisely making their own investigations regarding the patent protection surrounding a pharmaceutical product in their own market”.
In times when the active ingredient patent is merely the ‘tip of the iceberg’, in terms of patent protection of a pharmaceutical product, such practices are extremely risky. Even if costs are fully recoverable, patent litigation detracts from the core business of generic companies which is registering and marketing generic products.
“The patent situation varies significantly from country to country and no generic product can be developed with every potential market in mind”, Mr Howard continued, “Relying on overseas suppliers to advise on freedom to operate issues is akin to commercial suicide.”
What are the solutions?
Pipeline Scope is GenericsWeb’s latest product in the Pipeline Patent Intelligence suite and provides fast access to reliable key patent, SPC and data protection expiry information, for over 1400 drugs, covering 37 countries. This intuitive and user-friendly system is organised in patent families so you can find the information you need quickly and easily. The unfortunate case of Interpharma could have been avoided with a simple search across the Pipeline Scope database, which would have immediately revealed the Gemcitabine Australian patent as well as the matching extension, which expires in March 2009. Coupled with other products offered by GenericsWeb, a very fast and effective review of ‘second tier’ patents filed by the innovator and generic companies alike would also have been possible, not to mention prudent in this case.
Established in 1999, GenericsWeb has customers in over 30 countries including legal practices, government departments, consultants and generic manufacturers. GenericsWeb’s Pipeline Patent Intelligence provides the most comprehensive, relevant and accurate patent information available which stem from GenericsWeb’s 100% dedication to the industry, extensive experience and investment in customer research.
For further information about GenericsWeb’s Pipeline Patent Intelligence please call a GenericsWeb staff member in your nearest regional office:
AU: +61 (0)2 9262 7696 | UK: +44 (0)870 879 0081 | US: +1 888 3100774
Alternatively, please visit www.genericsweb.com or email us at email@example.com
The website www.genericsweb.com also hosts a web portal dedicated to serving the generic pharmaceutical industry. Resources found at GenericsWeb include regularly updated news and articles, careers, business intelligence, industry links and product development services. Receive our free monthly newsletter ‘INNsight’ by registering online.