Hi and welcome back to The Pharmaceutical News. We have a corker to round off this afternoon, continuing on with the World Generic Markets, please read on…
Teva and Pfizer in Court…
Teva UK launched its generic atorvastatin in the United Kingdom on 20th June 2011; the launch of the product, a generic equivalent of Pfizer’s anti-cholesterol product, Lipitor, sparked a legal battle. In a letter to customers on 29th June, Teva reported that Pfizer had been granted a temporary injunction against Teva, along with the pharmacies Phoenix Healthcare Distribution and AAH Pharmaceuticals which prevented the three parties from accepting any more orders at least until a full hearing scheduled for 11th July. However, Teva noted that on 27th June, a further hearing in the High Court was held to decide certain points of the case. Teva reported that:
- Pfizer sought and failed to obtain an injunction against Rowlands Pharmacy. Teva commented that at this time, the application was refused and therefore the situation remained that no retail pharmacy was currently the subject of an injunction in the case;
- The judge had expressly clarified that Teva was not prevented from offering an indemnity to dispensing pharmacies to cover them in the event of action being taken against them in relation to the case.
Teva commented in its letter that it felt that it was acting in the interests of sustainable and affordable healthcare delivered via the pharmacy and would support its customers. To that end, should any action be taken against any more dispensing chemists, the firm would provide full legal assistance and support.
On 11th July 2011, Pfizer issued a statement in which it noted that Teva, along with AAH, Phoenix and a third wholesaler, Trident, had submitted to an injunction to prohibit the supply and sale by each of them of generic atorvastatin in the UK. Pfizer commented that the injunction would run between 11th July and the expiry of Pfizer’s UK patent protection on 6th May 2012, or the decision after a full trial on the patent. Pfizer added that the question of an interim (emergency) injunction against the pharmacy chain Rowlands, which had been scheduled to be considered in court on 11th July would not now proceed. Pfizer noted that the issue remained untested before the court; Rowlands was a defendant to the litigation and Pfizer would now pursue its claims against Rowlands and the other defendants for a permanent injunction and full financial recompense.
Pfizer commented that it was sympathetic to the position that a number of pharmacies had found themselves in having purchased generic atorvastatin from Teva / AAH / Phoenix in good faith, but maintained that the situation was the responsibility of the defendants, having made what it called a surreptitious launch of Teva’s generic. Pfizer added that it refuted Teva’s claim to be acting in the interest of ‘sustainable and affordable healthcare’, claiming instead that Teva’s actions had caused disruption and concern in the pharmacy community. The branded firm further commented that it had no desire to pursue individual pharmacies which continued to act in good faith over the supply of generic atorvastatin, noting that it could reassure any pharmacy which confirms that they would not dispense any generic atorvastatin during the injunction period that Pfizer would be satisfied that its rights would not be infringed and would not pursue claims for damages against them. However, Pfizer intended to join as defendants other pharmacies which continued to dispense the generic. The firm added that offers of indemnities by Teva would not protect pharmacies from Pfizer taking these steps.
Teva stands firm
For its part, on 11th July, Teva repeated its offer that it would support and indemnify any retail pharmacy taken to court by Pfizer as part of the current infringement case that started shortly after Teva launched generic atorvastatin. The generic firm noted that as the dispute around the interim injunction had been resolved following an agreement between the parties, there was no court hearing that day and added that the case would go straight to trial to examine the validity of Pfizer’s patent. As a result, Teva confirmed that there was no change around the existing status with the supply and dispensing of generic atorvastatin:
- Pharmacies are not prevented from dispensing generic atorvastatin that they had already purchased;
- No retail pharmacy was subject to an injunction;
- Should Pfizer take action against dispensing pharmacists, Teva stood by its promise to provide full legal assistance and support;
- Teva and the wholesalers could not ship any further generic atorvastatin orders.
Teva maintained its view that Pfizer’s patent protection for the drug in the UK was invalid. The firm expressed its disappointment with Pfizer’s continuing attempts to, in its words, ‘frighten individual pharmacies by threatening to drag them into the patent litigation system.’ Teva’s spokesperson added, “The choice whether to dispense generic atorvastatin is yours and yours alone to make. But, one question you must ask yourself is why Pfizer is attempting to act in this way and whether succumbing to this sort of bullying tactic is in the best interests of pharmacy in the long-term. We’d like to underline what Mr Justice Floyd said on 27th June, which was that ‘the actual dispensing of the product is not the basis of the harm to the claimants’”.
On 22nd July, Pfizer reported that the High Court of Justice in London had decided to allow Pfizer’s request to add Day Lewis Ltd as a defendant in the action, adding that Pfizer would not pursue an injunction and full financial recompense from Day Lewis. Pfizer noted that in open court Asda Stores Ltd had agreed to not deal or dispense generic atorvastatin between now and the expiry of the patent protection or any judgement of the Patents Court that atorvastatin was not protected by valid patent protection. Asda also undertook to comply with the outcome of the full trial; in return, Pfizer agreed not to join Asda as a defendant.
On 25th July 2011, Teva reported that the trial in the atorvastatin case would be heard in November 2011; Pfizer added that it would be in late November. The firm noted that the trial will take place at the High Court of Justice in London, with a decision expected a few weeks later. Should Teva win, all of its stocks of generic atorvastatin currently being held at wholesalers would be released for sale, ending Lipitor’s exclusivity in the UK. Teva commented that the trial would come some six months before the current UK patent expiry date for Lipitor.
According to figures in the Prescription Cost Analysis England 2010 report published by the NHS’ Health and Social Care Information Centre Prescribing Support Unit, sales of all atorvastatin products in England in 2010 were worth £305.9 million (US$473.0 million). Nearly all of this came from sales of 10 mg, 20 mg, 40 mg and 80 mg Lipitor Tablets, which were worth a combined total of £305.3 million (US$472.1 million).
British Generic Markets Association comments
In a side note to the case, on 12th July 2011, the British Generic Manufacturers Association (BGMA) weighed in with a comment about Pfizer gaining an additional six months’ effective patent protection for Lipitor. Warwick Smith, Director-General of the BGMA, commented, “This is the latest example of a pharmaceutical company being granted an extension of patent in exchange for a paediatric testing of a drug … and it raises important questions about the EU’s Paediatric Regulation and its current parameters.” Mr Smith continued, “We estimate that the work to produce a version of a medicine for children may cost around £1 million (US$1.6 million). This ‘reward’ to the company for carrying out this work under the EU’s Paediatric Regulation is a further six months of overall patent protection from generic competition for the medicine as a whole, not just that used for children. We estimate that this could net the company in this case some additional £150 million (US$243.2 million) of sales in the UK alone – all paid for by the NHS and the UK tax-payer.” Mr Smith argued, “It is morally right that paediatric uses of medicines should be researched and licensed. We do not object to there being a financial incentive, if one is needed, to encourage companies to do this work. It just seems that such a high return on such comparatively low investment is beyond all reasonable scale and proportionality. This is particularly true at a time when the NHS needs to use medicines as cost effectively as possible. Delaying the use of generics at this sort of cost makes no sense.”
Mr Smith noted that in January 2017, the European Commission is scheduled to provide an economic impact report, including analysis of rewards, incentives and consequences for public health, as a result of the Paediatric Regulation, which was introduced in 2007. However, Mr Smith commented that the report could be brought forward to 2013 together with proposals for amendments if sufficient evidence of the Regulation’s impact becomes available. Mr Smith urged that this must be done in the interests of patients, the NHS and tax payers.
Background to the case
According to the court documents from 20th June, the interim injunction request was with regard to Supplementary Protection Certificate (SPC) number SPC/GB97/011; the underlying patent being European Patent UK number 0,247,633. The SPC is set to expire on 6th November 2011, although the court noted that there was an application in progress for a paediatric extension of six months. With regard to the patent, the court noted that this had been the subject of an application for a declaration of non-infringement by two generic firms, Arrow Generics and Ranbaxy UK. The Court of Appeal gave judgement in these cases in June 2006, noting that the relevant compound fell within the claims of the patent. At that time, neither generic firm attacked the validity of the patent.
With regard to the current situation, Teva’s position was taken up in correspondence during the course of 2010; a letter from Teva’s solicitors on 25th June 2010 informed Warner Lambert that Teva was preparing to launch a generic version of Lipitor in the UK in November 2011 on expiry of the SPC. The letter added that Teva did not believe its launch would infringe the patent. Pfizer responded on 12th July 2010, noting that there had been approval for the paediatric use of atorvastatin, and as a result the firm was seeking a six month extension to the SPC.
The court papers noted that the matter remained at that point until the injunction proceedings. These were initiated after Pfizer discovered that AAH was offering generic atorvastatin, as was Phoenix. In addition, the firms Superdrug and Co-operative Pharmacy, were being offered generic atorvastatin by AAH. It was therefore clear that there had been a launch of generic atorvastatin, which was being sourced from Teva. Teva was acting on the belief that the patent is invalid.