Spanish Supreme Court confirms Bexal and Uso Racional victory over Pfizer (Amlodipine)

On January 3, 2013 the Spanish Supreme Court has dismissed the Cassation appeal filed by Pfizer in its action against Bexal Farmeceutica and Uso Racional.

Court action was filed by Pfizer on 28 October 2005 against Kern Pharma, Bexal Farmaceutica and Uso Racional.

On 26 May 2006 Commercial Court no. 2 of Barcelona approved the agreement reached by Pfizer and Kern Pharma.

On 31 July 2008 Commercial Court of Barcelona recognised patent (product and procedure) infringement and condemned Bexal Farmaceutica and Uso Racional to pay a total amount of Euro 4,681,520.74.

On 24 February 2010 Appeal Court of Barcelona granted the appeal filed by Bexal Farmaceutica and Uso Racional and rejected Pfizer’s action.

The Appeal Court pointed out that:

.- Pfizer’s Product Patent expired on 19 March 2004 while Bexal Farmeceutica and Uso Racional started producing their (Amlodipine) products not before 1 March 2005.

.- Bexal Farmeceutica and Uso Racional proved that the Amlodopine salt was produced by Adamed

.- Procedure used by Adamed was panteted by means of European Patent no. EP 993,447.

.- Pfizer filed an opposition to EP 993,447, based in its procedure patent (EP 244,944) that was rejected by the EPO.

.- An expert who travelled to Adamed premises in Poland confirmed that procedure used by Adamed was the one described in EP 993,447.

Appeal Court concludes that procedure of EP 993,447 is not equivalent to Pfizer’s.

Pfizer called in its Cassation appeal Art. 69 of European Patent Convention and its modification on 29 November 2000, that entered into force on 13 December 2007.

The Spanish Supreme Court rejects now the Cassation appeal filed by Pfizer since Pfizer didn’t use that argument during the first instance or the appeal.

Furthermore, Pfizer’s Spanish Patent over the procedure expired on 31 March 2007 and Appeal Court couldn’t therefore apply the modification, even if the argument was used during the Court procedure (that it wasn’t).

Some questions came to my mind while reading the rulings. The first may be answered by our readers: Has Pfizer started an action against Adamed as producer of the Salt? If so, when and which was the result? 

Other questions are connected with pay for delay agreements, use or abuse of patent system and enforcement…

Those interested in a copy of Appeal Court and Spanish Supreme Court decisions (in Spanish) just have to ask.

Italy: Pfizer fined 10.6 M (abuse of dominant position)

We finally have a decision in the Xalatan case, started in October 2010 (reported here and here).

In a 33 page decision (here), the Italian Competition Authority concludes that Pfizer artificially extended patent protection of the active ingredient latanoprost (used to treat eye glaucoma) to prevent or delay generics entering the market.

I find of particular interest the following paragraphs of the decision (fast translation):

"74. The documentation inspection revealed the existence of a complex strategy - developed by a working group of Pfizer (the so-called "LOE group") - for the defense of the drugs after the expiry of patent protection, primarily designed to protect their share market entrance of equivalent drugs. The latter, in fact, are retained by Pfizer a particularly serious threat.

75. Among the strategies designed, beside those purely commercial or promotional, special emphasis is given to the use of "legal strategies" to change the date of expiration of patent protection.

76. … Pfizer appears to have full knowledge of the peculiarities of the Italian situation and the risk of a possible entry in the market of equivalents to Xalatan in advance of the rest of Europe.

84. Additional documentation shows Pfizer’s knowledge about the violation of antitrust law in the case concerning the release of the new SPC in Italy and the extension of patent protection in September 2009 to July 2011, in view of the doubts of the company regarding the validity of the SPC obtained.

89. Fears about possible actions by Pfizer to prevent access to the market for generic drugs were confirmed in the letter, sent in July 2009 by an attorney of Pfizer to Ratiopharm, requesting not to introduce its drug in commerce…

90. The documents included in the file show that similar communications were sent to other producers of Xalatan equivalents. The purpose of these letters was to prevent latanoprost generics entering the market before the patent expiration in July 2011.

91. However, comments from employees of the company suggest that sending warning letters to generic companies before placing their drugs in the market has been practiced successfully by Pfizer in other circumstances… (should we expect new investigations?)

The effectiveness of this strategy appears to support Pfizer’s choice to use the same even with regard to drugs whose patents where to expire. In particular, with reference to four blockbuster products, the company aimed to further prolong the patent rights from two to three years.

113. … Following the listing of Ratiopharm and Sifi (May 2010) the sales of Xalatan have suffered a drastic reduction in volume of approximately 70%. This share has been gradually acquired a 50% to Sifi and the remaining 20% from Ratiopharm.

138. The evidence acquired during the procedure, described in detail above, fully confirm Pfizer's abusive behaviour.

139. This documentation proves the existence of Pfizer's strategy to artificially extend the patent protection of Xalatan in Italy from September 2009 to July 2011, in order to align it with other European countries, by requests - solely to this end - both the EP168 divisional patent in 2002 and the following SPC, requested in Italy in 2009.

144. Pfizer's exclusionary conduct aimed not only to defend the sales of Xalatan in the Italian market, but also to those made in the entire European market as a price reduction to the public in Italy (to effectively combat the entrance of genericis) would inevitably risk a drastic decrease in revenues from sales of Xalatan in other Member States due to import from Italy, via parallel trade.

198. Again demonstrating the exclusionary nature of Pfizer's request (reference is made to the SPC), is relevant to make reference to the absence of a new drug, which normally follows the divisional application. This shows that the company had no intention to launch a new drug, but only to exclude prostaglandin generics from the Italian market - regardless of the absence of a statutory obligation in this regard, a fact underlined by Pfizer –.

212. The exclusionary nature of Pfizer’s overall strategy can be also seen in the request made in January 2011, to obtain a further term of protection extension based on pediatric trials of Xalatan (up to January 2012).

With the release of the extension of patent protection, Pfizer appears to have obtained a new extension of patent rights on their drug, this time not only in Italy but in all EU countries (should the European Commission start an investigation?)

214. … testing for pediatric use of a drug, like Xalatan, used to treat a disease that typically affects old people, appears only as seeking further extension of patent coverage of the drug.

As evidence, the documents in the case shows that the pediatric trial is held by Pfizer a tool to use for all drugs for which patent is near expiration, not just those intended primarily for the treatment of diseases that may also cover the children.

217 It should be emphasized that the request to extend patent protection for pediatric use has been made by Pfizer in January 2011, after the revocation of the divisional application by the EPO in October 2010 - which led to the annulment of the SPC - and, then, after disappearing in Italy the legal basis on which that request was based.

225. … Finally it appears Pfizer’s intention to use the same strategy to defend next drugs to “expire” … (will the Italian Authority start new investigations regarding those drugs?)

231. Finally, it should be noted that despite the huge estimated losses from the decrease in sales of Xalatan on the Italian market, Pfizer believes that it can not lower the price in Italy. Such a choice, in fact, is considered extremely dangerous because, as a result of parallel trade, a price cut in Italy would inevitably be forced to adjust the price of Pfizer's Xalatan on other European markets with "high price", where the patent protection was guaranteed by the SPC until July 2011 (and subsequently extended to January 2012).

233 Pfizer's strategy has produced significant effects on the market.
First to mention is the delay with which generics have entered the market ... (will now companies affected file damages actions? And the Italian Government, taking in to account the excess paid through the national health system?)

245 Direct result of the Pfizer’s strategy is the damage suffered by the NHS in terms of lost savings on drug reimbursement prices as a result of delaying the entry of generics in the market. The data reported by Pfizer itself confirms that the amount of Xalatan sold in the period following the expiration of the patent in September 2009, was approximately 1.4 million units.
In view of the price difference of the reimbursement price by the NHS of drugs based on latanoprost before and after the entry of generics in the market, the lack of savings for the NHS can be estimated around Euro 14 million.

251. According to the Commission Communication 2004 / C 101/07 - Guidelines on the effect on trade between Member States concept contained in Articles 81 and 82 of the Treaty on OJ C 101/81 of 27 April 2004, the concept of effect on trade between Member States must be interpreted taking into account the influence, direct or indirect, actual or potential, on the pattern of trade between Member States.

252. In light of that legal framework the case falls under Article 102 TFEU - and integrates many cases of violation - given the fact that the conduct engaged in by Pfizer were eligible to restrict trade between Member States. In particular, the conduct in question has produced its effects on the entire Italian territory, which is significant part of the Community market and on which there are many multinational companies and international operators.

255… the conduct in question - delaying, for about seven months, the entry of generics on the market - has enabled Pfizer to continue enjoying a monopoly rent quantifiable up to about Euro 17 million - in view of the market share gained by generics in the first seven months of their entry on the market -".

Pfizer: Abuse of dominant position? (2)

In November we made reference to the investigation started by the Italian Autorità Garante della Concorrenza e del Mercato (here).

It is investigated if Pfizer has tried to artificially extend the protection over EP0364417 until January 2012, trough Divisional Application no. EP1225168 (Latanoprost). The arguments used by the Italian Authority to start the investigation can be read here.

According to the Italian Law (art. 14 ter of Law no. 287/90), companies investigated can offer commitments to exclude anticompetitive effects. If those commitments are accepted by the Italian Authority, the case can be closed.

In this case Pfizer has offered the following commitments:

1.- An open and free non exclusive licence in Italy, Spain and Luxemburg over EP 1225168. Interested parties may become licensees by just submitting a letter of acceptance to Pfizer.

2.- Renounce to actions brought against AIFA e Sifi spa and others at Regional Amministrative Court of Lazio.

3.- Accept claims (legal and administrative costs excluded) filed at Courts of Milan and Rome against Pfizer by following plaintiffs.

• Tubilux Phrama spa

• Alapis sa

• Ratiopharm Italia srl

• Ratiopharm Gmbh

• Mylan spa

• Idustriale Chimica srl

• EG spa

4.- Renounce to preliminary injunction requested by Pfizer against Sifi spa at the Court of Milan

5.- Renounce to the extension requested on January 10, 2011 over the paediatric use.

6.- Inform the consumers though its website (during 3 years) about alternative Latanaprost products available in the market. Inform doctors and pharmaceutics (during 6 months) about available products in the market.

The Italian Authority will take a decision regarding Pfizer's offer before 29 July 2011.

Full text submited by Pfizer here

Never ending patents?

Some interesting “pills”

Monday The New York Times published Drug Firms Face Billions in Losses in ’11 as Patents End.

"At the end of November, Pfizer stands to lose a $10-billion-a-year revenue stream when the patent on its blockbuster cholesterol drug Lipitor expires and cheaper generics begin to cut into the company’s huge sales".

"The loss poses a daunting challenge for Pfizer, one shared by nearly every major pharmaceutical company. This year alone, because of patent expirations, the drug industry will lose control over more than 10 megamedicines whose combined annual sales have neared $50 billion".

"... the industry faces intense pressure from generic competition and has tried every tactic to ward it off, including extended-release versions of the same medicine and new pills that combine two ingredients".

Reading the reference to expiration this year of Lipitor patent, the actions started against Dr Reddy (the last one at the beginning of the year) came to my mind. As announced for example in ibtimes on January 4, 2011, “Pfizer moves court against Dr Reddy's launch of Lipitor in US market”. As there reported, "The drug maker, which rakes in over $12 billion in global sales from Lipitor, has asked the court to withhold approval of the drug until one of its patents for Lipitor expires in January 2017".

On January 5, 2011, Claire Bowie wrote on Pharma Times:

"Though Pfizer’s central patent for the crystalline form of atorvastatin expires in July 2016, and it retains paediatric exclusivity through to January 2017, it came to an out of court agreement with Ranbaxy in 2008 that will see the Indian firm sell a low priced version of the enantiomer version of the drug from November this year.

The two firms have been fighting over the validity of patents covering Lipitor all over the world since 2003 and a number of analysts thought that Ranbaxy could possibly launch its generic version of the drug as soon as March 2010 in the USA, when Pfizer’s basic patent was set to expire. The enantiomer patent expires in the USA in 2011, while various process and crystalline form patents are valid until 2016 and 2017".

Bringing our attention back to the days when the agreement was signed, we find Release of Generic Lipitor Is Delayed, published on June 19, 2008, where we read:

"For people with high cholesterol, the wait for a cheaper version of Lipitor just got longer. Pfizer announced an agreement Wednesday to head off generic competition for its flagship drug until November 2011 — up to 20 months later than many analysts had been expecting.
…
By delaying Ranbaxy’s generic version of Lipitor, which might have been sold as early as March 2010, Pfizer has won extra time for exclusive sales of Lipitor, potentially totaling billions of additional dollars.
…
As part of the agreement, Pfizer granted licenses to Ranbaxy authorizing the company to sell generic Lipitor in seven other important pharmaceutical markets: Australia, Canada, Belgium, Germany, Italy, the Netherlands and Sweden.

The deal will let Ranbaxy sell its drug in those seven countries two to four months before patents expire, according to Chuck Caprariello, a spokesman for Ranbaxy".

Will the actions started against Dr Reddy end with an agreement? When will this company start selling its product? Which product will it finally sale? Will we get answers to these and many other questions before first patent expires?.