Warner Chilcott end Femcon and Loestrin generic challenges

Warner Chilcott has been able to resovle a number of litigation cases against its proprietary oral contraceptives, Femcon Fe and Loestrin 24 Fe. Femcon was a chewable version of Ovcon 35, an oral contraceptive that has been on the market since before 1982. The chewable version was approved by the FDA in November 2003, and was the first chewable oral contraceptive, manufactured by Bristol-Myers Squibb and marketed by Warner Chilcott. The chewable version of Ovcon 35 was granted three years exclusivity in late 2003, to expire in November 2006, and a patent was granted for the drug which does not expire until 6th April 2019. In the case of Lostrin 24, Galen originally acquired the Loestrin brand from Pfizer, and in early 2006 was granted approval for Loestrin 24 Fe; that product is protected by a patent listed in the FDA’s Orange Book which is set to expire in July 2014.

Despite the long lead times left on the two patents protecting the two oral contraceptives, Warner Chilcott has faced generic challengers for both. Barr Laboratories filed an ANDA for a generic version of Femcon Fe in April 2007, leading to a patent challenge initiated that summer. Watson Pharmaceuticals also filed an ANDA for a generic version in 2007, leading to a lawsuit filed against it in October 2007. In the case of Loestrin 24 Fe, Warner Chilcott filed a lawsuit in the US District Court of New Jersey alleging patent infringement almost as son as the drug had entered the market, with a case against Berlex and Schering AG. Warner Chilcott alleged the firms were infringing Loestrin’s patent by marketing their YAZ oral contraceptive. A few months later, in June 2006, Warner Chilcott received an ANDA notice from Watson Laboratories notifying of an application to market a generic version of the oral contraceptive, leading to another lawsuit in the New Jersey court alleging patent infringement. The YAZ litigation was settled early, in November 2006, with Schering making payments to Warner Chilcott.

Now, in a series of agreements over December 2008 and January 2009, Warner Chilcott has settled the litigation with Barr and Watson (see p. 8). The settlement with Barr concerns Femcon Fe, and gives Barr the option to launch its generic version in 2012, seven years ahead of the 2019 patent expiration. Warner Chilcott also entered into a patent settlement agreement with Watson regarding Femcon Fe. Under the terms of this, Watson will have to wait until 180 days after Barr launches its version, or January 2013, whichever comes earlier. With regard to Loestrin 24 Fe, an agreement has been made with Watson whereby Watson will be able to commence marketing its version in January 2014, or earlier if another generic enters the market. It is interesting to note that once again, a settlement has been made which effectively allows a generic firm to launch its version as an authorised generic in order to sabotage sales from a third party.

Ian Platts - Editor, World Generic Markets

UK government announces new pricing plans

The UK government has announced a new deal with the pharmaceutical industry which will bring in a flexible pricing scheme. Although the announcement relates to the Pharmaceutical Price Regulation Scheme (PPRS), which in turn deals with the branded industry rather than generics, the news is of interest because the agreement further enshrines the place of generics in the NHS' spending plans. Of particular interest is the agreement covering pricing. In the original deal between government and industry announced in June 2008, a saving of 5% in the cost of drugs sold to the NHS was included, which was to be made up of a base price cut for all branded drugs of 2%, combined with measures to reduce the price of out of patent drugs where a generic exists and a further variable price cut. This has now been changed to include a 3.9% price cut and a plan for the Department of Health to introduce generic substitution, whereby pharmacists will be able to dispense a generic against a prescription for a branded drug unless the physician has specified the branded drug to be used. However, the measure will not be introduced before January 2010, a year after the rest of the agreement comes into force, because of the discussions and system changes that would be required. Further price adjustments will then come in each year with the aim of reaching the original 5% cut envisaged. However, the precise effect of generic substitution is unknown, and expected savings have been based on models, and so it is expected that a cut of exactly 5% is unlikely to be achieved; further discussions will therefore be undertaken to keep the scheme on track.

The agreement has been reached with the Association of the British Pharmaceutical Industry (ABPI), and on the face of it represents something of a change of heart for the organisation. Generic substitution - prescribing a generic without the specific consent of a doctor - has been illegal in the UK, and if a doctor has prescribed by a brand name, then the brand version must be dispensed. Not surprisingly, this is a stance that has been defended by the ABPI, which has previously argued that generic substitution would undermine doctors‟ relationships with their patients and could compromise patient health by disrupting the choice of medication selected by the doctor. Whilst the validity of such claims are clearly part of a much wider debate between generics and branded drugs, the stance will nonetheless have been very handy for the ABPI, given that prescribing of generics in Britain has been far higher than in other EU countries, and amongst the highest in the world, and is a trend that has continued to rise. As a result, the ABPI agreeing to at least discuss generic substitution would seem to be a significant change. However, on the other side of the coin, because over 80% of prescriptions are already written generically, it is questionable how much the branded industry would really stand to lose, as the rate suggests doctors already write generic prescriptions unless they specifically want a branded drug used.


Ian Platts - Editor, World Generic Markets