Medinol Ltd v Abbott Ireland & Abbott Vascular International BVBA and Others
| Jurisdiction | Ireland |
| Judge | Mr. Justice Brain J. McGovern |
| Judgment Date | 10 March 2011 |
| Neutral Citation | [2011] IEHC 128 |
| Court | High Court |
| Date | 10 March 2011 |
[2011] IEHC 128
THE HIGH COURT
BETWEEN
AND
AND
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RANBAXY LABORATORIES LTD & ORS v WARNER-LAMBERT CO 2009 4 IR 584 2007/53/11270 2007 IEHC 256
KIRIN-AMGEN INC v HOECHST MARION ROUSSEL LTD 2005 1 AER 667 2005 RPC 9 2004 UKHL 46
EUROPEAN PATENT CONVENTION ART 69
EUROPEAN PATENT CONVENTION ART 69(1)
PROTOCOL ON THE INTERPRETATION OF ARTICLE 69 EPC ART 1
PROTOCOL ON THE INTERPRETATION OF ARTICLE 69 EPC ART 2
PATENTS ACT 1992 S45
VIRGIN ATLANTIC AIRWAYS LTD v PREMIUM AIRCRAFT INTERIORS UK LTD 2010 RPC 8 2009 EWCA CIV 1062
CATNIC COMPONENTS LTD & ANOR v HILL & SMITH LTD (NO 1) 1981 FSR 60 1982 RPC 183
GLAXO GROUP LTD, IN RE UNREP CHARLETON 26.6.2009 2009/23/5599 2009 IEHC 277
GENERAL TIRE & RUBBER CO LTD v FIRESTONE TYRE & RUBBER CO LTD (NO 1) 1971 FSR 417 1972 RPC 457
SYNTHON BV v SMITHKLINE BEECHAM PLC 2006 1 AER 685 2006 RPC 10 2005 UKHL 59
Commercial law - Intellectual Property - Alleged infringement of patent - Patent proceedings in other jurisdictions - Whether stents infringed patent - European Patent Convention, Article 69 - Patents Act 1992 - Patents (Amendment) Act 2006.
Facts The plaintiff alleged that the defendants had infringed one of their patents. The defendants denied the infringement and counterclaimed for revocation of the patent on three bases: obviousness, lack of novelty and added matter. The products in question were coronary stents. The plaintiff also brought a contingent application to amend the patent. The plaintiff contended that claimed that their stent design was novel and inventive in that there were longitudinally opening loops in the second (or horizontal) meander patterns. These loops provided additional flexibility to the stent and also the ability to compensate for foreshortening of the stent, which might otherwise occur when the stent was expanded. The defendants claimed non-infringement because the undulating rings of their stents were not first meander patterns; they were not periodic patterns about a centreline and intentionally contained a combination of long and short crests. It was also contended on behalf of the defendants that the same situation had arisen in other jurisdictions and regard should be had to those decisions (which had found in their favour).
Held by McGovern J in dismissing the claim. The patent in suit must be construed from the perspective of a person skilled in the art to whom the patent was addressed. The addressee, in this case, was a team consisting of a biomedical engineer and an interventional cardiologist. What was obvious about the Abbott stents was that the patterns contained therein were not periodic about a centreline. They were not symmetrical and were intentionally asymmetric, containing a combination of long and short crests in order to create a pocket in the ring for the "U-shaped" portion of the link. What the plaintiff suggested was a second meander pattern in the stents alleged to infringe were not meander patterns according to the teaching of the patent in suit. The Abbott stents did not infringe the Patent in suit.
Reporter: R.F.
JUDGMENT of Mr. Justice Brain J. McGovern delivered on the 10th day of March, 2011
1. In this action, the plaintiff alleges that the defendants have infringed European Patent (IE) No. 181 902 ("the Patent"). The defendants deny infringement and counterclaim for revocation of the patent on three bases: obviousness, lack of novelty and added matter.
2. This is one of a series of actions taken in Europe in relation to this Patent. To date, proceedings have been heard in Germany, the Netherlands and the United Kingdom as well as before the European Patent Office. There have also been proceedings in the United States between the parties in respect of the same products at issue in these proceedings.
3. The products at issue in this case are manufactured in Galway and are sold by the defendants. They are coronary stents known as Vision, Multi-link 8, Xience and Xience Prime.
4. Stents are cylindrical-shaped devices, usually made of metal, that are inserted into the coronary arteries, typically after balloon angioplasty. An expanded coronary stent provides support to keep the blood vessel open.
5. In 1977, balloon angioplasty was first used. This procedure involved inserting a balloon tipped catheter into an artery (usually the femoral artery or brachial artery and guiding it to the narrowed, diseased coronary artery). The balloon is then inflated to dilate the artery before being removed. This procedure has three main potential drawbacks, namely:
(i) immediate abrupt closure;
(ii) early recoil; and
(iii) late recurrence of stenosis (re-stenosis).
6. These potential problems could be overcome by the use of stents, inserted into the coronary arteries and designed to provide sufficient support to keep the blood vessel open. There are two types of stents, namely, balloon expandable stents and self-expanding stents. A balloon expandable stent is crimped onto a balloon catheter and inserted into a femoral or brachial artery via a guiding catheter or wire. The stent and balloon are manoeuvred into position via the vasculature, and once in place, the balloon is expanded. This causes the stent itself to expand. The balloon is then removed leaving the stent in place. The self-expanding stent is inserted in a similar fashion. The stent has a sheath over it to prevent expansion until it is in the desired location.
7. In considering the issues that arise in this case, it is important to bear in mind the priority date of the Patent which is July 1994. There is little or no disagreement between the parties as to the evolution of stent design and the desirable characteristics for a stent as at the priority date. In July 1994, there were two types of stents available for use, namely, those made of wire and those made from metal tubes, which had slots and various patterns cut into them. The wire stents, because of their nature, were very flexible, but it was found that when they were delivered to the desired location, they did not provide sufficient scaffolding strength to keep the lumen open when they expanded. The stents made from cylindrical tubes had excellent scaffolding properties but were insufficiently flexible. This posed a serious problem with deliverability to the lesion which required treatment. In 1994, stents were predominantly used in emergency bail-out procedures in case of abrupt closure of coronary arteries. Therefore, the ability to reach the site of placement quickly was very important. If the stent could not be delivered in time, an emergency by-pass operation was needed.
8. Stent thrombosis was also a significant problem in 1994. It was widely believed that metal within the artery was thrombogenic and that stents containing multiple crossed wires increased the risk of thrombosis. This danger decreased in 1995, with the introduction of anti-platelet drugs.
9. Another significant issue concerned the radial strength of the stent, that is, the ability of the stent to support the vessel wall and not suffer too much recoil which might hasten re-stenosis. A balance had to be struck between providing enough material to provide radial strength but not so much as to increase the perceived risk of thrombosis. While these matters were the most important, given the use of stents in bail-out situations, there were other considerations in the minds of parties involved in the design and/or use of stents in 1994. These may be summarised as follows:
(a) Scaffolding. The stent ought to provide sufficient scaffolding so that parts of the artery wall do not prolapse between the gaps in the stent.
(b) Conformability. The stent should take the shape of the vessel upon expansion. In 1994, a degree of straightening was deemed acceptable.
(c) Foreshortening. It was known that when stents expanded many of them shortened longitudinally. While a small amount of foreshortening was acceptable, it was undesirable to have significant foreshortening because the stent might not cover the entire lesion.
(d) Maintenance of side branch artery opening upon expansion. The stent struts should not be so close together that they would obstruct any side branch arteries.
(e) Crimping onto the balloons. The stent would be pre-crimped onto the balloon and should be securely held there until it reached the site where it was to be deployed.
(f) Radiopacity. It was important that the stent could be visualised properly once inserted so that the cardiologist could see if the whole lesion was covered and exactly where to try to implant a second stent if required.
10. These were the issues known to biomedical engineers and cardiologists who were involved in the design and/or use of stents in July 1994.
11. In assessing what comprised the common general knowledge of a person skilled in the art at the priority date, it is necessary to examine the stents available on the market at that date. A skilled person would have been aware of those stents. At the time, there were five stents available. These were:
(a) Strecker. The Strecker stent was a balloon expandable tantalum woven wire stent. Its main drawback was that it did not crimp satisfactorily on to the balloon and it also had a lot of metal protruding into the lumen which was thought to increase the risk of thrombosis.
(b) Wallstent. The Wallstent was a stainless steel self-expanding wire mesh stent. It suffered from unacceptable...
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...might be taken into account 153 Ranbaxy (n 3) [4.4], [4.9]. 154 ibid [3.9], [3.13]. 155 ibid [6.72]. 156 Medinol Ltd v Abbott Ireland [2011] IEHC 128. 157 ibid [17], [19], [21]. 158 ibid [46]. 159 ibid [48]. 160 David Brophy, ‘Irish “Lipitor” litigation: High Court favours broad claim const......