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Early entry
comes at a price
Without an early entry license, generic drug makers may
not promote their wares before expiry of the pertaining
patent or SPC protection in Germany – even if the offers
relate to a time after the protective right expires find
Dr Paul Tauchner and Dr Niels Hölder of Vossius & Partner

For the owner ofa pharmaceutical German physician’s journal, the defendant
be worth several million euros – also at the Simvastatin. Further, the defendant had its called “Lauer-Taxe”, a database informing place, line up for the rush into the market.
availability and prices of pharmaceuticals Whoever enters first will secure for himself the biggest chunk of the market and can, in In their defence, the defendants had relied addition, profit from the comparatively high on their opinion that an offer could only infringe a protective right if it relates to a content themselves with considerably lower delivery during the term of such right. The defendant further argued that as the early advertisements had not literally mentioned “early entry” of the drug whose patent the still protected Simvastatin, they could In the recent Simvastatin case decided by agents whose protection expired at around defendant had offered, during the term of (SPC) in dispute, to deliver the patented product after the expiry of the SPC. In its decision the BGH1, ruled that the defendant material, press releases, ads or the like which had gone too far. In remarkable contrast to lack any direct relation to the protected Dr Paul Tauchner (left) is a senior partner at
the English position (to which we refer in product, the offer must be interpreted from Vossius & Partner. He is a German and European the perspective of an objective and informed Patent Attorney and holds a PhD in chemistry. He thereby strictly reserved the last days of a (fictive) reader rather than on the basis of works mainly on opposition and litigation cases, as well as freedom-to-operate and validity opinions.
Merck Sharp & Dohme (“MSD”) market words, while the defendant has presented a Dr Niels Hölder (right) is an Attorney at Law at
containing the active agent Simvastatin.
Vossius & Partner. He received his PhD in law and MSD’s SPC covering Simvastatin expired on that they had not recognized the link to the his LL M degree in the field of intellectual patented product, this was held irrelevant to property. His practice focuses on patent litigation, the BGH. In its view it is the court’s task to determine, on a legal basis, what the offer protection certificates and licensing.
promotional materials disclose all features being realised by the offered product. The such license, started promoting its “new” cholesterol lowering drug as being available 2003, i.e. the first day after the expiry of the advertisements, which were also placed in a www.ipworld.com
May 2007 | Patent World Issue # 192 | 11
infringed MSD’s patent rights although the recognizably pointing to Simvastatin rather that the same view is taken by the Courts of database is run by a third party because the than to other cholesterol lowering agents Switzerland and Austria. While it could be thereby assumed liability, for such listing.
patent protection for which also expired at This finding is in line with another recent automatically apply to offers that are made was held liable for inducing the entry of the defendant’s uncontested intention to draw the physicians’ attention to his product SPC in order to safeguard its share in the legislator has prohibited also the mere offer generic market. The BGH thereby also took of products which make use of the protective and rightfully allows innovative enterprises, the defendant’s subjective intention into right in order to convey to the patentee the in particular in the pharmaceutical sector, to account, which of course is unknown to the full protection against all restricted activities objective reader, when interpreting the offer.
during the term of the patent. The purpose unrestricted protection over the full lifetime The result is just a matter of common sense: English practice
On the European level, the legal
“The defendant clearly intended to offer Simvastatin,
and the trade circles concerned are likely to have
uncertainty still remains, in particularhaving regard to the differences between understood the message. A defendant cannot get
away with such an artful pretension
practice, according to which “infringing” products may be offered before the expiry ofa relevant protective right for the time effectively protect the patentee against any Simvastatin, and the trade circles concerned impairment of his exclusive right without possible explanation for the deviation might are likely to have understood the message. A differentiating between actual infringements be found in the reference to the protection “in the strict sense” and activities in the run- being linked to the lifetime of the patent up thereto. In this respect, the Düsseldorf contained in the UK Patents Act 1977. This court of appeal had rightfully pointed out related to deliveries to be made after expiry convincing. According to Sec. 60(1) of the impact on the patentee’s turnover during the UK Patents Act 1977, a restricted activity lifetime of his patent (or SPC), the patentee such as making or offering only infringes Inconsistent
may, from an economic perspective, sustain The question whether an offer to deliver a losses, because by offering to deliver the patent is in force”. The same requirement product after expiry of the protective right, (of course) applies under German law even protective right, even if the offer relates to without being expressly mentioned in Sec. 9 deliveries after the expiry of the protective product and could thereby safeguard sales to purchasers who are prepared to wait until offers can only infringe the patent if they well as in other European countries for quite the expiry of the exclusive right, and who are made during the lifetime of the patent.
might have otherwise ordered the patented indication as to the time of the delivery to question in the affirmative, there has been lifetime of the right, if they had not received which the offer relates. To this end, the the infringer’s offer2. For that reason, a German courts: while the Düsseldorf courts infringements, the Hamburg courts did not.
defendant had received prior to the expiry of prohibition of infringing offers could be impact on the patentee’s market position, preferably along the lines of the Simvastatin that “offering” per se is an activity which is defendant was in principle liable for damages inhibited by the patent, independently of any (through market confusion) even though the defendant made its deliveries only after the delivering which may or may not follow the offer. It also mentions that the treatment of District Court Düsseldorf, InstGE 1, 19.
the “offer for sale” use form as a separate and of the advertisements, the listing in the bi-weekly German database “Lauer-Taxe”, Patents Court, Gerber Garment Technology Inc also laid down in Art.25 of the still not v. Lectra Systems Ltd, [1995] R.P.C. 383 [412].
12 | Patent World Issue # 192 | May 2007

Source: http://www.vossiusundpartner.ch/pdf/011-012-PW-May07-CC.pdf

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