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Fordham Conference 2015 – Biosimilars

Penny Gilbert from Powell Gilbert LLP explains the position of biosimilars in the pharmaceutical industry. Biosimilars are essentially generic versions of biologics. Traditional generic compounds are  chemical reproductions of the patented compound which makes regulatory approval more straightforward. Biological compounds (proteins or antibodies which are produced from genes) are not identical with one another and have higher hurdles in terms of achieving regulatory approval. The cost of bringing it to market is significant. Doctors may be less willing to prescribe biosimilars as compared to generic chemical compounds when considering the alternatives to the originator’s product. Undertakin [...]

Monopoly on Test Results? Protection of Immaterial Products as “Fruits” of a Patented Method under Sec. 9 (3) German Patent Act

Based on method claims, German Patent Law does not only grant the patentee an exclusive right to exercise the method on the German territory, but also a monopoly to offer, bring into circulation or to use in Germany a “fruit” that is the immediate result of the patented method (Sec. 9 (3) German Patent Act). This is true even if the method has been carried out, and the “fruit” has therefore been “picked”, in another – not designated – country and has then been imported into Germany.

Following a 2012 decision of the Federal Supreme Court (“MPEG-2 Videosignalcodierung”), which specifies how this rule applies to immaterial products like data, the District Court Munich now ha [...]

EPO: T 1729/06, Enhanced pollenizer and method for increasing seedless watermelon yield, European Patent Office (EPO), Board of Appeal, EP1487256, 17 September 2014

Inventions regarding a method of improving the yield of triploid seedless watermelons by pollination with a specific type of diploid water melon are not to be regarded as an essentially biological process for the production of plants and are therefore not excluded from patentability under Article 53(b) EPC. These biotechnological inventions according to Rule 26(2), (3) EPC are therefore in principle patentable under Article 52(1) EPC and Rule 27 EPC.

A full summary of this case has been published on Kluwer IP Law.

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A Little German Christmas Present and some Year’s End Reflections

Thanks to Miquel Montaña’s brilliant Christmas post, we have learnt a lot about the lucina sine (aut cum) concubitu and the legal impact her involvement may have had for the application of Directive 98/44/EC to the event leading to the holidays that we have just been celebrating. While I must admit that even after having read Miquel’s lucid post, I am still not a hundred percent clear on whether Jesus in statu embryonis would have fallen under article 6(2) of Directive 98/44/EC, I can at least confidently say that I am satisfied with the fact that certain questions are probably unanswerable and that the CJEU has generously left this one for the national courts to decide.

Which brings us [...]

Herceptin Round 2: Hospira enjoys the sweet smell of success once more

By Brian Cordery and Steven Willis

Regular readers of the Kluwer patent blog may recall that in April 2014, the English Patents Court revoked two patents relating to trastuzumab, the active ingredient in Herceptin, which is marketed outside of the US by Roche. One patent was for a dosage regimen and the other related to a composition of trastuzumab containing certain levels of impurities. The SPC for trastuzumab itself subsequently expired in July 2014, but as yet, Hospira has not launched its competing medicine in the UK. As part of its campaign to clear the way for launch, Hospira challenged two further related divisional patents – this time relating to lyophilised formulations of tra [...]

Patentability of biotechnology inventions: “O time thou must untangle this, not I. It is too hard a knot for me to untie”

Although Brian Cordery will try to have you believe that the title of this blog is borrowed from William Shakespeare’s Twelfth Night, it may well have been taken from the Report from the Commission to the Council and the European Parliament dated 14 July 2005 on Development and implications of patent law in the field of biotechnology and genetic engineering, where the Commission wrote that:

There is no immediate answer to the question of the patentability of embryonic pluripotent stem cells and indeed at this stage it would appear premature to come to a definitive conclusion. The Commission will continue to monitor developments in this area.”

No additional progress appears to have been made [...]

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