PHARMACEUTICAL PATENT PROCEEDINGS JURISDICTION REPORT: FINLAND
Petri Eskola and Markus Lampinen Backström & Co Attorneys
In Finland, patent litigation proceedings are handled in the first instance by the District Court of Helsinki. Each month only a few cases are filed with the court, most of which to date have related to pharmaceutical patents. Te primary reason for the high number of pharmaceutical cases is that patent protection of pharmaceuticals has been relatively weak since most of the best-selling products are protected by so-called ‘analogous process patents’. Tis special type of patent only provides protection for certain manufacturing methods mentioned in patent claims, instead of the end product or invention. Tis means that a generic manufacturer can, in principle, enter the market with a competing generic product using the same active product ingredient manufactured by a different and non-infringing process. For analogous process patents, a reversed burden of proof is applied, which means that during the infringement proceedings, the defendant has to present proof that the patented method has not been used.
Competition on the Finnish market has also become attractive for generic pharmaceutical products due to the mandatory substitution system and the recent implementation of the reference price system. Te core essence of the system is that the pharmacies automatically substitute an original product for a cheaper generic one, while the customer usually gets reimbursement only according to the price of the cheapest product.
If a cheaper generic product enters the market, it will rapidly gain considerable market share, unless the original manufacturer lowers its prices as well. To prevent losing market share, the original manufacturers usually try to prevent the generic launch by applying for preliminary injunctions before the District Court of Helsinki. Such injunction proceedings constitute a crucial part of the parties’ process strategy.
Procedural features
In pharmaceutical patent matters, the doctrine of equivalence usually plays an important role. According to the doctrine, which is acknowledged in the European Patent Convention, literal infringement may not be the only grounds for a case. Te argument may end up being over what was obvious to a person skilled in the art at a certain time.
To assess these technical questions of pharmaceutical chemistry, the District Court uses two independent, court-appointed experts. Teir opinions on the technical questions have considerable importance, even though the experts are not officially members of the panel of judges. An interesting detail is that if the case proceeds to appeal stage, the appeal courts do not use court-appointed technical experts.
Written evidence brought forward by the parties can be very chemistry- specific and fact-based. For instance, the original manufacturer could carry
“ THE PRIMARY REASON FOR THE HIGH NUMBER OF PHARMACEUTICAL CASES IS THAT PATENT PROTECTION OF PHARMACEUTICALS HAS BEEN RELATIVELY WEAK SINCE MOST OF THE BEST-SELLING PRODUCTS ARE PROTECTED BY SO- CALLED ‘ANALOGOUS PROCESS PATENTS’. THIS SPECIAL TYPE OF PATENT ONLY PROVIDES PROTECTION FOR CERTAIN MANUFACTURING METHODS MENTIONED IN PATENT CLAIMS, INSTEAD OF THE END PRODUCT OR INVENTION.”
out laboratory tests to prove that the generic’s manufacturing process yields impurities that are characteristic of the patented process. Written opinions and declarations of independent experts in the field of chemistry are also used.
As mentioned above, the doctrine of equivalence can contain an imaginary conception of a person skilled in the art and the general knowledge that existed in the field. To support their arguments, the parties usually appoint expert witnesses to cover the technical questions. Tese expert witnesses may represent the highest academic skill in the field, and foreign experts are frequently appointed as well as local scientists.
If the court finds that a patent infringement has been established, the defendant is obligated to pay a reasonable royalty for exploiting the patented invention and other damages sufficiently proven by the patent holder. Te damages issue, which contains very complex argumentation as well, can be decided in separate proceedings aſter the infringement has been held to exist, should the parties agree to this two-stage procedure.
Petri Eskola is a partner at Backström & Co Attorneys. He can be contacted at:
petri.eskola@
backstrom.fi
Markus Lampinen is an attorney at Backström & Co Attorneys. He can be contacted at:
markus.lampinen@
backstrom.fi
82 World Intellectual Property Review November/December 2010
www.worldipreview.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108