Australian Pharmaceutical Extensions of Term Expiries for July 2014
Rodney Cruise, Principal
Below is a report from IP Organisers (an independent service company of Phillips Ormonde Fitzpatrick) detailing Australian Pharmaceutical Patents (that have been granted extensions) and that are due to expire in the coming month.
This report covers Australian patents whose Extension of Term expires in July 2014.
A method for substantially reducing the range in daily dosages required to control pain in approximately 80 % of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated “ql2h” (i.e., every 12 hours) administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients. The figure is a graph showing the mean plasma oxycodone concentration for a 10 mg controlled release oxycodone formulation prepared in accordance with the present invention and a study reference standard
The invention provides antifungal agents of the formula:- <CHEM> and their pharmaceutically acceptable salts, wherein R is phenyl optionally substituted by 1 to 3 substituents each independently selected from halo and CF3; R<1> is C1-C4 alkyl; R<2> is H or C1-C4 alkyl; and “Het”, which is attached to the adjacent carbon atom by a ring carbon atom, is selected from pyridinyl, pyridazinyl, pyrimidinyl, pyrazinyl and triazinyl, “Het” being optionally substituted by C1-C4 alkyl, C1-C4 alkoxy, halo, CF3, CN, NO2, NH2, -NH(C1-C4 alkanoyl) or -NHCO2(C1-C4 alkyl).
[Global] Availability of Biosimilar Pathways and Data/Marketing Exclusivity Globally“This is a follow-up to our post of September 27, 2013 in which we reviewed the availability of biosimilar pathways and data and/or marketing exclusivity for innovator biologics in Asia, Latin America and Eastern European countries.During the last several months, we at the BRIC Wall expanded our research to gain a broader understanding of which countries provide biosimilar pathways and data and/or marketing exclusivity for innovator biologics.”Read More
[Canada] CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs“On a per capita basis, Canadian drug costs are already the second highest in the world after the United States and are among the fastest rising in the Organization for Economic Co-Operation and Development. The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada will further exacerbate the rise in costs by:• Committing Canada to creating a new system of patent term restoration thereby delaying entry of generic medicines by up to two years;• Locking in Canada’s current term of data protection, and creating barriers for future governments wanting to reverse it;• Implementing a new right of appeal under the patent linkage system that will create further delays for the entry of generics.”
[Italy] Pfizer’s misuse of patent/SPC rights results in an abuse of dominant position“The highest Italian administrative tribunal held that the instrumental use of a divisional patent and of a related supplementary protection certificate (SPC), even if legitimate from a civil/administrative point of view, may be considered abusive under competition law if put in place by a company in a dominant position.”Read More
[Vietnam] Vietnam’s Pharma Market “to Rocket” Over Next Six Years“Vietnam’s pharma market in Vietnam is set to increase by $5 billion over the next six years, reaching a net worth of $8 billion by 2020 and representing a Compound Annual Growth Rate (CAGR) of 15.4%, says research firm GlobalData.”Read More
[Global] Restructuring the Pharmaceutical Industry“The global pharmaceutical industry is facing pressure from multiple fronts, including patent expiries, poor R&D productivity, payer pushbacks, tough regulatory oversight, etc. But pharmaceutical is not a declining industry. According to IMS Health, the global pharmaceutical market was worth $962bn in 2012 and is expected to grow at 5.3% CAGR to reach $1.25 trillion in 2017. Therefore as a whole the market has decent growth prospects.”Read More
[Definitions] Supplementary Protection Certificate“In Europe, a Supplementary Protection Certificate (SPC) is a unique intellectual property (IP) right that extends the duration of the exclusive right. It enters into force after expiry of a patent upon which it is based. This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products (e.g. insecticides, and herbicides). Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products (i.e. authorisation to put these products on the market).A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum lifetime of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006).Supplementary protection certificates in the European Union are based primarily upon two regulations. Although all countries in the EU are required to provide supplementary protection certificates, no unified cross-recognition exist. Applications must be filed and approved on a country-by-country basis”.Read More
[Definitions] Data Exclusivity“Data exclusivity is a “quasi” – intellectual property right which prevents health authorities responsible for granting marketing authorizations from relying on the original data submitted by the first market entrant as well as preventing subsequent applicants from cross-referring to the original data. Data exclusivity should be distinguished from market exclusivity. Market exclusivity means that a subsequent market entrant may not market a particular product on which a marketing authorization has been issued, irrespective of the fact whether he refers to data submitted by the first market entrant or he has generated the data himself. Data exclusivity should neither be confused with data protection, as there are other legal instruments, such as trade secrets, which serve to protect undisclosed, confidential know-how. Complex relationships between SPCs, data exclusivity and market exclusivity may occur i.e. the scope and period of protection conferred by them may overlap or complement each other. In the latter case they enhance the overall protection for a given medicinal product. They are even more important during the period when no other type of protection is available, and there is only data exclusivity or SPC protection. Due to the interesting interrelations between SPCs and data exclusivity they are both worth a profound analysis. The paper aims to touch upon the importance of data exclusivity in the light of other legal protection instruments available, such as an SPC”.“In Europe, “Data exclusivity” refers to the period during which the data of the original marketing authorisation holder relating to (pre-) clinical testing is protected. Accordingly, in relation to marketing authorisation applications submitted after 30 October 2005 for the applications filed in the framework of national procedures or 20 November 2005 for applications filed in the framework of the centralised procedure, ‘data exclusivity’ refers to the eight-year protection period during which generic applicant may not refer to the information of the original marketing authorisation holder and ‘marketing exclusivity’ refers to the ten-year period after which generic products can be placed on the market. However, in relation to marketing authorisation applications submitted before the above mentioned dates, the wording ‘data exclusivity’ refers to the six or ten-year protection period granted to the original marketing authorisation (MA) holder before generic applicants can file their applications for marketing authorisation”.Read More
