The European Court of Justice today ruled that biological procedures cannot be patented if they are based on the prior destruction of human embryos, with “human embryo” defined in the broadest possible sense.
Background of the ruling is a patent filed by German stem cell researcher Oliver Bruestle in 1997. The patent covers isolated and purified neural precursor cells produced from human embryonic stem cells and used for the treatment of neurological diseases. The cells are already being used clinically for the treatment of patients suffering from Parkinson`s disease.
Greenpeace filed an opposition to the patent and after the Federal Patent Court, Germany, ruled that the patent was invalid in so far as it covers processes for obtaining precursor cells from human embryonic stem cells, Bruestle appealed to the Federal Court of Justice, Germany, which referred the case to the European Court of Justice, saying the concept of ‘human embryo’ was not defined in EU Directive 98/44/EC on the legal protection of biotechnological inventions. The question was whether the exclusion from patentability of the human embryo covers all stages of life from fertilization of the egg or whether other conditions must be met, for example that a certain stage of development is reached.
Today, the European Court of Justice stated that its decision was not about ethical or moral questions, but solely on the legal interpretation of the EU Directive, adding that the Directive defines “human embryo” in the widest possible sense, i.e. every human egg able to divide must be classified as a “human embryo”. This even comprises enucleated eggs, into which the cell nucleus of a human body cell has been transplanted, as well as non-fertilized human eggs, in which cell division and further development have been stimulated without fertilization, e.g. by parthenogenesis. Taking the definition even further, it adds that all inventions that are based on the prior destruction of human embryos or their prior use as base material are excluded from patentability.
Greenpeace hailed the decision as a “landmark case”, stating the ruling was protecting humans from being commercially exploited. The press release was illustrated by the picture of a baby carrying a “patent clip” in its earlobes.
Oliver Bruestle, who was placed under police protection together with his family when the campaign against his patent application was started, commented that fundamental research on human embryonic stem cells can still take place in Europe – however, it means that “others will pick the fruits in the U.S. and in Asia.”
The ruling is the result of the EU’s Directive, which was adopted in 1998 after a decade of debates and compromises between the EU member states, the EU parliament and the EU Commission.
Germany’s new Law on the Reorganization of the Pharmaceutical Market (AMNOG), which came into force January 1 this year, has substantially changed the rules for the introduction of new medicines on the German market. The akampioneer already has reported on the novel regulations and procedures – now it is time to look at the consequences AMNOG has had already.
Since the beginning of 2011, 18 dossiers for the required benefit assessment have been filed with the Federal Joint Committee G-BA, the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. G-BA is then assessing the “additional patient-related benefit” of a novel drug, either itself or by assigning Germany’s Institute for Quality and Efficacy in Health Care (IQWiG). If G-BA identifies an additional benefit, the umbrella organization for the statutory health insurance funds and the pharmaceutical company negotiate the reimbursement price as a discount on the original selling price within six months. If negotiations fail to reach an agreement, an arbitration commission defines the reimbursement price using the European price level as a standard.
Most cases are still pending. In one of the 18 cases (the statin pitavastatin marketed by Merckle Recordati in Germany) , the manufacturer itself requested the drug to become reimbursed under the fixed price system. In two cases, marketing was halted in Germany by the manufacturer following a negative G-BA assessment: Boehringer Ingelheim and Eli Lilly decided not to market linagliptin, a DPP4 inhibitor for the treatment of type II diabetes; the companies think G-BA chose the wrong therapy for comparison and assessment of the additional benefit.
Novartis removed Rasilamlo from the market, effective September 1. The oral drug is a combination of aliskiren and amlodipine, which was approved in April this year for the treatment of high blood pressure patients not adequately controlled by either aliskiren or amlodipine alone. The company could not get to terms with G-BA on the data required for the assessment of the additional patient-related benefit.
The decision not to market a drug in Germany if the assessment is negative and the setting of a low price is imminent certainly reduces sales; on the other hand it prevents the setting of a lower price in other European countries that use Germany’s drug prices as reference.
The first completed assessment regards AstraZeneca’s platelet aggregation inhibitor ticagrelor, which was approved in December 2010 for the prevention of thrombotic events in patients with acute coronary syndrome or myocardial infarction with ST elevation, and is intended to be used in combination with acetyl salicylic acid (ASS). G-BA had assigned IQWiG with an assessment that deviated from the design of the studies used for approval and from the comparator therapy G-BA originally had agreed upon with the manufacturer. For approval, the drug had been compared to clopidogrel (plus ASS). IQWiG, however, defined subgroups and compared ticagrelor plus ASS with clopidogrel plus ASS in patients with unstable angina pectoris and myocardial infarction (with and without ST elevation) and prasugrel plus ASS as a comparator for patients with ST elevation, which had received a coronary bypass or a percutaneous coronary intervention (PCI) .
As a result, G-BA ruled that the drug has an additional benefit only in patients with myocardial infarction without ST elevation and in patients with unstable angina pectoris. In these cases, G-BA sees a moderate additional benefit. IQWiG had stated that the data provided by the manufacturer to support efficacy in patients with ST elevation did not sufficiently prove additional benefit in this subgroup.
While it certainly is a good idea to ask whether a novel drug not only meets regulatory requirements but also translates into patient benefit, the process of assessing this benefit and the degree of improvement as compared to existing therapies is a mess in Germany.
One important point is transparency. The crucial selection of the comparative therapy for the assessment takes place behind closed doors in G-BA’s pharmaceutical subcommittee. G-BA does not even disclose the subcommittee’s members – however, it is known that the members are picked from the National Association of Statutory Health Insurance Physicians and from the Statutory Healthcare System. The cheaper the comparative therapy chosen, the bigger is the hurdle to meet the cost/benefit ratio.
Second, as compared to the NICE procedure in the UK as an example, manufacturers are not involved in the process once it has started (except that they may be asked to submit more data), and if they are not happy with a decision the only possible procedural intervention is taking G-BA to court. Otherwise, they may wait for a year after which they can file an application for submitting novel data – which may be granted by G-BA or not.
Third, it is often very difficult to prove an additional benefit of an innovative medication immediately – except maybe for an antibiotic. Therapies for chronic diseases lead to measurable improvements often in the long or medium run only, and regulatory studies often are not large or long enough to meet the strict “evidence-based” criteria of IQWiG and G-BA. In addition, elderly patients often suffer from multiple diseases, making an assessment even more difficult.
Last not least, for the reference price system the devil is in the details. Will all European countries, including the poor economies of the former communist countries in Southeastern Europe, be included – or only the richer economies of the old European heartland?
All in all, the new regulations already have led to a slowing-down of novel drugs reaching the German market – a development that IQWiG’s new director Juergen Windeler in a recent interview declared as “expected”. He might as well have said “welcomed” as he added that of the about 60,000 drugs on the market in Germany, 95% were dispensable: “Experience shows that good medical care is possible with 2,000 to 3,000 drugs only.”
Dieter Durand and Susanne Kutter in Wirtschaftswoche feature a disputation between Alzheimer-researcher Konrad Beyreuther and author Cornelia Stolze, who has written a book claiming Alzheimer’s disease does not exist as an exactly defined disease.
While Beyreuther maintains the disease is real and can be clinically separated from other forms of dementia, he concedes that current medications are useless and that diagnosis often is inadequate. Stolze in her book “Vergiss Alzheimer” (“Forget About Alzheimer’s”) states that patients with signs of dementia often are labeled as Alzheimer’s disease patients although they are not, that they receive useless medications, that the real causes of their respective dementias, such as diabetes, depression, stroke, or dehydration, are overlooked and not treated, and that medical doctors make money with unreliable early diagnostic tests. A review of the book is to follow soon – please regularly check the akampioneer.
Joachim Müller-Jung in Frankfurter Allgemeine Zeitung (FAZ) comments on a proposal by several US stem cell researchers in the “Cell Stem Cell” journal. The manifesto calls for establishing a market for human donor egg cells so that scientists can use these cells for cloning experiments. While the purpose is not cloning humans but generating pluripotent human stem cells, Müller-Jung warns that the push will once again put the “cloning humans” debate on the table – a discussion he thinks is needed like a hole in the head. He states there are plenty of experiments already demonstrating that sooner or later it will be possible to generate pluripotent human stem cells for regenerative medicine by reprogramming human body cells.
Martina Lenzen-Schulte, also in FAZ, features the first attempts to use the mirror neuron concept for clinical purposes, e.g. for the rehabilitation of stroke patients to support regain of movement control.
Hildegard Kaulen in FAZ reminds her readers that a substantial part of the research crowned by nobel prizes never received third-party funds. She expresses sympathy with the proposal put forward in “Nature” by Stanford University’s John Ioannidis to either allocate research grants by lottery, by dividing up the money so that each applicant receives the same amount, or simply by handing out money to outstanding scientists with the only specification to use it for research. He criticizes that it has never been investigated which method to allocate research grants is the best and that the current practice consumes too much valuable time that should be spent more creatively on research.
Die Welt reports in a feature by dpa on material scientists of the Technical University Dresden who use wood for pipes that are as strong and resilient as pipes made from concrete. Wood is cut to rectangular blocks, which are heated to 140°C and compressed. Subsequently, all air – which amounts to up to two third of the wood’s volume – is removed. The resulting panels are then bonded and formed by applying steam. The team led by Peer Haller of the university’s Institute for Steel and Wood Construction calculates that a post carrying 50 tons of weight needs 155 kg of steel but only 28 kg of wood treated with the new procedure.
Katrin Blawat in Süddeutsche Zeitung (SZ) reports that Umckaloabo, an alcoholic extract of Pelargonium sidoides roots, is under investigation by Germany’s Federal Institute for Drugs and Medical Devices (BfArM). The medication, which is sold as OTC in Germany for the treatment of acute bronchitis (with annual sales of about € 40 million), is suspected to cause inflammation of the liver, with six cases reported in 2011.
The New York Times (NYT) this week deals in-depth with the recommendation of the United States Preventive Services Task Force that men no longer should have an annual prostate-specific antigen (PSA) test. Gardiner Harris interviewed the experts involved in reviewing PSA testing, citing Dr. Roger Chou, an associate professor of medicine at the University of Oregon, as saying “the idea that knowing you have a cancer isn’t always a good thing is a very difficult concept for many people.” Chou states that the vast majority of men who have prostate cancer will never be bothered by it. Urologists however view the issue differently, stating the task force chose to focus on the wrong studies and it was wrong to throw PSA testing away.
Last not least, in preparation of the coming common cold season, Ulrike Gebhard in Neue Zürcher Zeitung (NZZ) explains that men suffer from the common cold more often than women. Reason is – according to researchers from Belgian Gent University – that women often carry extra portions of genes from the toll-like receptor (TLR) gene family. As a result, they produce more of the so-called miRNA molecules that support the body in fending off viral infections. The downside of women’s more powerful immune system is increased susceptibility to autoimmune diseases and a more violent reaction to certain vaccines.
There are a lot of service providers offering Search Engine Optimization (SEO). But what do biotech and medtech companies really need to increase their online visibility? Three things are essential in our view:
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The rest of SEO is negligible for biotech and medtech companies as they are not selling consumer goods. Did you ever meet a potential collaboration partner who has screened thousands of Google hits related to your company? Probably not. If you are lucky, he may have read about your company in one of the important trade publications and already has you on his radar. If you are not so lucky, he may wonder why he has never read anything about your company in one of those important trade publications – despite your leading-edge technology and thousands of Google hits.
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SEO success is based on carefully crafted key messages on your company, a bit of HTML editing and constant work to keep your website up-to-date, presenting new and interesting and – above all – relevant content.
The main task is to carefully think about the keywords important for your business. These need to be presented on your website in a way that Google’s earch engine can see and recognize them. This requires basic knowledge of HTML – not a lot more. The most important task is continuous communication – keep the world updated by adding news and novel information and by providing useful links, e.g. to pharma and academic partners, articles, patents, wikipedia entries relevant for your business, official statistics, market data, etc.
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