Is there possibly more than humanistic philanthropy behind Mr. Drosten’s steam chatter? Reprint of a strangely topical article by Erik R. Fisch and Jens Wernicke/Rubikon of July 27, 2020 on the entanglements between the PCR test manufacturer TIB Molbiol and Prof. Drosten.
The answers of the Charité to our press questions are here (1) and make the closer circumstances of the development and spread of the so-called Drosten test appear ever more dubious. According to information from the Charité, Prof. Christian Drosten developed the SARS-CoV-2 test on behalf of the Charité during his working hours. According to the technology transfer directive, the copyright is thus held by the Charité. The Charité claims it not even considered looking into a possible patent or other protection option because a “profit-oriented approach in connection with the pandemic is not necessary from (their) point of view”. A piquant point here: Drosten did not even bother notifying the Charité of the completed development of his test, the blueprint for the assay he submitted to the WHO in a flash, contrary to his obligation to report it under the law on employee inventions.
Again contrary, to its allegedly purely humanitarian approach, the Charité then allowed others, such as in particular the “small” Berlin-based company TIB Molbiol Syntheselabor GmbH, which was involved in the development of the SARS-CoV-2 test on a purely trustworthy basis on the initiative of Prof. Drosten “from the very beginning” and without any obligation of confidentiality or bound by a non-competition clause, to earn itself a golden nose with an annual profit before Corona of approximately 7.3 million euros. Their managing director, Olfert Landt, tells us that Prof. Drosten and he are no bosom buddies, even though the two of them have always been the very first to jointly come up with a new test for every new virus such as bird flu, swine flu, MERS, ZIKA etc. for the past 17 years.
A well-rehearsed double pack: Prof. Drosten as the scientific mouthpiece of his renowned employers, the Bernhard-Nocht-Institut and Charité, TIB Molbiol as the ready-made producer of the respective Drosten test kits. For the SARS-CoV-2 test kits, TIB Molbiol was even allowed to provide Charité with “logistical support” for deliveries to recipient laboratories in Thailand, Vietnam, Hong Kong, which Prof. Drosten had personally selected. This way, TIB Molbiol managend to be the first company in the world to send the Drosten test free of charge, a diagnostic goody bag, so to speak, with a letter of recommendation from the scientific Olympus. The door opener par excellence.
It is reasonable to assume that repeat orders have not been placed with Prof. Drosten but directly with TIB Molbiol, but, as the Charité hastens to assure us, this means that TIB Molbiol “has not been able to claim a competitive advantage“. Huh, never heard of the first-mover advantage? Is there something going on between Prof. Drosten, Charité and TIB Molbiol?
Professor Drosten, I have a few questions! Originally it was just one question, more like an exclamation: Wow, how do you manage to be always on the front line when a new virus finds its way into the ranks, with practically your gun – or rather your head – ready to fire, the little grey cells rattling, in exactly the same time interval as it takes us to sit on the sofa in front of the TV and reach over to grab our glass of beer, hurling a new test out of your mental cannon, which enables the precise identification of the new enemy virtually overnight?
You have not only succeeded in doing so with SARS and MERS, as your Wikipedia entry states, what an almost criminally sloppy research that is on their part (2). Why do they fail to mention that you achieved the same heroic feat many more times in the past? A total of at least seven times – and these are probably only the successes known to a wider public!
Since 2003, you have always been the first to track down all the following viruses with your clever test protocols: SARS-CoV (2003), bird flu (2005), swine flu (2009), Chikungunya virus (2009), MERS (2012), ZIKA (2016), yellow fever Brazil (2017) and SARS-CoV 2 (2020) (3).
When I realised this, I thought to myself that you had actually earned the Federal Cross of Merit on Ribbon (4) for this scientific ingenuity every time, and not just as in 2005 for the SARS CoV test. Plus your own weight balanced out in gold.
But somehow I got to thinking about this, about your inventive achievements. A patent attorney, whom I consulted on this matter out of sheer curiosity, said that your WHO test protocol basically showed a body of thought accessible to industrial property protection, in particular patent protection. And indeed, for example, the SARS-CoV test kit which you co-developed in 2003 got immediately patented for artus GmbH (5), a spin-off of your then employer, the Bernhard-Nocht-Institut (6).
The Charité is now informing us:
“Professor Drosten was commissioned by the Charité to develop the PCR test. He worked on it during his working hours at the Charité. The test development was financed with funds from the Federal Ministry of Education and Research and the European Union. These funds were explicitly earmarked for the development of tests for newly emerging viruses. “
In accordance with the German Employee Inventions Act and the Technology Transfer Directive, which details the general rules for the Charité, the copyright for employee inventions lies with the Charité, so that the lion’s share of the proceeds from the exploitation of your inventive performance would be due to the Charité. As a university lecturer, you would earn a 30 percent share of the proceeds generated by the Charité. Alternatively, you could of course exploit your invention yourself in consultation with your employer, for example in the context of a spin-off, but would then have to pay a licence fee to the Charité (7).
Publications prior to the filing of a patent application are fatal because the invention is then no longer considered new.
You have to be able to control yourself, even when you’re boasting to your comrades-in-gin at the bar of a hotel where traveling salesmen in the brush business hang out, otherwise you’ll soon be out of luck with your invention.
Against this background, I wondered what the current protection status of the very protectable and worthy aspects of their latest and most important Drosten test is.
Did you secure your industrial property rights in good time before submitting the test protocol to the WHO, for example by filing a patent application or an application for a utility model, so that all your intellectual effort, all your scientific craftsmanship could and can be reflected in ringing coins for you personally and, of course, your employer, the Charité? And/or has the Charité, by securing industrial property rights in good time, possibly even put itself in the humanitarian position of being able to spit in the soup of money-hungry synthesis companies by obliging them to sell the test kits developed on your blueprint at particularly favourable prices, possibly even at cost price?
At present, it is not known whether a patent application has been filed, by the Charité or by someone else. The Charité denies this and nothing has been seen at the patent office so far, but patents do not have to be disclosed until after 18 months.
In response to our question about your cooperation, Prof. Drosten, with the “small” Berlin company TIB Molbiol Syntheselabor GmbH in the context of test development, the Charité wrote to us:
“There is no agreement; it is not intended by any party to claim or protect rights. Cooperation on both sides is exclusively on humanitarian grounds. “
Renunciation of legal protection out of humanity? That would be something. But humanity seems to be rather one-sided on the part of the Charité, if you consider the undisguised joy of TIB Molbiol managing director Olfert Landt over the SARS-CoV-2 test kits sold millions of times. His son now spends 60 hours a week sticking labels on the packaging of his test kits because of the sheer unbelievable number of orders, the co-presenter of the Drosten test protocol with the WHO tells us (8).
Well, it’s a “small” company, so you can be very happy when the ruble finally rolls in. Of course, “small” is of course extremely relative, the Tempelhof company already had a turnover of 16.5 million euros in pre-Corona times and with its approx. 40 employees, a profit of about 7.3 million euros. It has retained earnings of a sensational 55 million euros. The “small” company was obviously a real cash cow even before Corona! For 2020, sole shareholder Olfert Landt now expects a fifty-fold increase in turnover (9), provided of course that the Corona wave continues to spill over a little further. It’s hard to imagine how turnover could develop in the event of a – this time, however, a real – corona tsunami, for example in the fall!
Prof. Drosten, you have been working with Olfert Landt for a long time. Not only have you developed each of your tests together with him over the last 17 years, you also publish diligently with him, at least 11 joint publications have been produced over the years.
It somehow saddens me that despite this long and extremely successful collaboration, Olfert Landt feels it necessary to stress that you are not bosom buddies and that he just happened to be at the Charité in early January 2020 when you were working on the development of the SARS CoV-2 test (10). God-given coincidence? Or was Olfert Landt’s story just a little embellishment to make the dry story of a test development with an old scientific companion a little more lively?
“From the beginning”, on the other hand, is the Charité‘s answer to our question:
“At what time and for what reasons was the company TIB Molbiol or its managing director Olfert Landt from the Charité or Prof. Drosten involved in the test development? “
This sounds more like the targeted involvement of a professional in an important development process. This is how it would have been desirable, after so many years of productive cooperation, that it was not just chance that was at work.
But let’s get back to the question of patent or legal protection: The company TIB Molbiol now makes millions and you get nothing. But somehow someone else is not getting anything out of it, yes, exactly the Charité. Has the Charité approved the immediate publication, has it released it? Why can it simply do without such assets?
The Charité is a corporation under public law and, according to § 10 of its statutes, is subject to the obligation of good corporate governance (11) and of course also to the budgetary principles of proper business management. If the Charité were to simply give away a house, for example to Olfert Landt, so that he and his small company could finally reside elegantly at the pulse of time in Berlin-Mitte instead of staying in the sleepy Tempelhof area, I suspect that this would not go down so terribly well, at least not with the Federal Audit Office. The renunciation of a patent or other property right worth millions or even billions is of course less conspicuous than the giving away of a house, but the content is the same. In this respect, I do not quite understand what the Charité would like to tell us when it makes the following statement:
Question:
“Has the submission of the above-mentioned test protocol to the WHO been approved in advance? “
Answer:
“The question is based on an incorrect assumption; no such submission has been made. “
Question:
“If prior clearance was given: Who has given whom this clearance? Has it been checked before release whether a submission/publication would prevent patenting by the Charité? When deciding on the approval, was it taken into account that the Charité might give up a large asset? On what grounds, if any, was such waiver granted? “
Answer:
“The time conditions for this were not met, especially as the loss of an asset of the Charité was not and is not to be assumed. “
Further question:
“Has it been examined in advance whether a waiver of a patent or other rights to the ‘Drosten test‘ is compatible with the principle of ‘good corporate governance‘ as laid down in § 10 of the Charité’s statutes? What was the result of the examination? Were any other budgetary constraints examined that might prevent the waiver of a patent or other rights? If so, what budgetary requirements were examined? With what result? “
Answer:
“The profit-oriented approach to the fight against the pandemic you asked for was not appropriate from the point of view of the Charité. “
Well, that’s a bit surprising. Of course, everything had to be done quickly, and of course there was a humanitarian aspect at the forefront. But the same aspect did not prevent artus GmbH, the Bernhard-Nocht-Institute spin-off, from applying for a patent for SARS-CoV. And patent ownership, it should be mentioned again here, does not automatically mean – from a purely legal point of view – squeezing out the highest possible revenues. Patent ownership means first and foremost control over the exploitation of the invention. It also enables, for example, the selection of reputable licensing partners and the dictation of low prices for humanitarian reasons.
Could there be a further guideline or a legally sanctioned practice at the Charité outside the technology transfer directive that inventions with a humanitarian aspect should never be considered from a profit-oriented perspective? However, almost every invention by a scientist in the medical field is likely to have some humanitarian aspect. So should the Charité‘s technology transfer directive actually be without any purpose? It is hard to imagine, but we will continue to investigate the matter at the Charité.
Unfortunately, the Charité does not tell us which specific individuals have voted for a non-profit approach to the matter. However: According to the information provided, the Charité had no knowledge of the completed test development and your publication plans prior to your Blitz publication with the WHO, because you, Prof. Drosten, contrary to § 5, paragraph 2, sentences 1 and 3 of the ArbErfG, had not reported your service invention at all.
Question:
“Prof. Drosten has submitted test protocol to the WHO for evaluation. When and in what form did Prof. Drosten notify the Charité of the development of this test? “
Answer:
“There was no corresponding notification. “
But wait, wasn’t that a finished test that you developed? Have I misunderstood something? At least that’s how you could interpret this answer from Charité:
Question:
“Has the Charité applied for or is directly or indirectly involved in an application for patent, utility model, trademark or other protective rights with regard to the so-called ‘Drosten Test‘, individual components, primers, etc., or other related aspects? “
Answer:
“No. Professor Drosten has not developed a test kit, but has published the crucial information for laboratories to carry out a test in the form of a procedure protocol. Companies have developed test kits from this. Professor Drosten does not earn any income from this. “
Okay, so supposedly not a test kit. But a blueprint, a very concrete instruction for the laboratories, that’s what it is. Well, I don’t know, that sounds a bit like circumvention. If an employee at VW were to put the construction manual for a new type of particulate filter on the Internet and then tell the VW legal department that he hadn’t invented or developed anything, but had written a process protocol for the production of a filter, perhaps even for humanitarian reasons, to rid the world of particulate matter, then the legal department would probably not like that very much. In the case of the SARS-CoV-2 test, your procedural instructions already contain everything a laboratory needs to know in order to be able to produce in-house test kits and possibly even sell them to third parties.
The representation that you could have only produced a process protocol that is irrelevant from a patent law point of view is also biting with the alleged mere logistical support of TIB Molbiol shipping the test kits to your selected laboratories in Thailand, Vietnam and Hong Kong – and maybe also to other places later on? Obviously, a test kit already developed by you and your team must have been available at this point, for which TIB Molbiol then one took care of the shipping details for reasons of practicability, in particular to save time.
The Charité writes to us in this respect:
“The logistical support of the company TIB Molbiol was called upon to save time: The reagents were available at TIB Molbiol ready for shipment and could be sent using the logistics available there; Charité does not have the appropriate logistics for filling and packaging the reagents. All information on the production of the reagents was disclosed and was available to other synthesis companies, so that TIB Molbiol could not claim any competitive advantage. “
Hm, but unlike the Charité, Olfert Landt seems to see the pole position itself as a competitive advantage. He has no need to acquire customers, he does not have to place ads, his company is simply fast and thorough, as the Tagesspiegel will tell us on 6 March 2020.
At that time, according to Olfert Landt, TIB Molbiol had already produced three million tests and shipped them to more than 60 countries. The first ones were already sent to Hong Kong by airmail on 10 January. At that time the package insert was not even finished. “We sent it by e-mail afterwards”, Olfert Landt is quoted as saying (12). But you, Prof. Drosten, were actually the one who was “quick and thorough”. With regards to TIB Molbiol I was wondering whether the services it provided according to the Charité – delivery of special reagents for the development of the test technology, technical pre-validation – could not have been provided just as well by one of the highly professional laboratories at the Charité. I am already very curious about the Charité‘s response to our next round of press requests.
Perhaps Prof. Drosten’s friendship with Olfert Landt is not so close because you have always been so unhappy about the fact that you develop the test, make it available very quickly and unselfishly, inspired by the desire to help, and then it is always TIB Molbiol who is makes a fortune with your test – uh actually the tests of the Bernhard-Nocht-Institute and the Charité.
Prof. Drosten, one could really become jealous. If I were you, I admit quite openly that I would have thought up something else after one or two such experiences. I would have set up a little spin-off company or kicked my employer to set up one. And then I would have either laughed the whole way to the bank or donated the bulk of the proceeds to a good cause.
You are not openly involved in TIB Molbiol and I sincerely hope that there are no fiduciary or other agreements of any kind. I appreciate your independence and, how should one call it, attitude of staying away from the big money or perhaps your naivety, which has led to you now making the same “mistake” at least eight times, to throw your invention onto the market so quickly that you no longer had a chance to profit from it, but rather had to watch the till ringing loudly at one of your co-developers. Somehow, I think this is already strange for you. But maybe I’m just too caught up in the old-normal thinking patterns and the rapid application of your test all over the world is enough of a reward for you.
However, it is also a very odd result for the Charité, which has to deal with all kinds of problems. According to a report by the Federal Audit Office, it is unable to invoice hospital services worth 100 to 300 million euros to the health insurance funds because its employees do not correctly document the course of treatment and the invoices are therefore not accepted by the funds (13). Instead, the Charité does such strange things as inventing cost units and billing them via institutes that do not even exist (14).
In addition, it maintains a well-established system of cross-financing of its hospital operations from research funds of the Berlin Institute for Health Research, which has been highly problematic from a budgetary point of view for many years, and which has been criticised by the Federal Court of Auditors yet has also been benevolently tolerated by the Federal Ministry of Finance (15). For example, the Charité likes to bill its scientists for disproportionately high electricity costs by allocating a proportion of hospital electricity costs to sparsely illuminated scientific pauses for thought.
One can only hope that the Charité is not threatened with insolvency in all this accounting muddle, otherwise a renunciation of a lavish asset such as a patent for the SARS-CoV-2 test might even be seen as a disadvantage for its creditors.
First published at Rubikon
Sources and notes:
(1) http://schlussjetzt.org/Antwortschreiben%20Charite%20auf%20Pressefragen%20Jens%20Wernicke%20vom%2018.06.2020.pdf
(2) https://de.wikipedia.org/wiki/Christian_Drosten#Wissenschaftliche_Laufbahn
(3) http://www.corodok.de/drosten-landt-connection-1/, http://www.corodok.de/drosten-landt-connection-2/, http://www.corodok.de/drosten-landt-connection-3/
(4) https://de.wikipedia.org/wiki/Christian_Drosten#Ehrungen
(5) http://www.corodok.de/wirtschaftliche-interessen-des-prof-drosten/
(6) https://patents.google.com/patent/DE20315159U1/de
(7) https://technologietransfer.charite.de/fileadmin/user_upload/microsites/sonstige/technologietransfer/RiLiCharité-TT-Fassung_28-01-2016.pdf
(8) https://taz.de/Produzent-von-Corona-Tests/!5671485/
(9) https://www.deutschlandfunk.de/coronakrise-virentester-tib-molbiol-coronatests-fuer-die.1197.de.html?dram:article_id=477239
(10) https://www.sueddeutsche.de/wissen/coronavirus-covid-19-test-jens-spahn-1.4865919?reduced=true
(11) https://www.tagesspiegel.de/berlin/tib-molbiol-berliner-firma-produziert-coronavirus-tests-fuer-die-ganze-welt/25602142.html
(12) https://frauenbeauftragte.charite.de/fileadmin/user_upload/microsites/beauftragte/frauenbeauftragte/Gleichstellung/Gesetze/Satzung_der_Charite_Lesefassung_2019-12-18.pdf
(13) https://www.morgenpost.de/berlin/article216725117/Abrechnungsprobleme-setzen-Charite-finanziell-unter-Druck.html
(14) https://www.morgenpost.de/berlin/article216654635/Erfundene-Charite-Institute-Senat-schaltet-Innenrevison-ein.html
(15) https://www.bundesrechnungshof.de/de/veroeffentlichungen/produkte/beratungsberichte/langfassungen/langfassungen-2019/2019-bericht-risiken-einer-integration-des-berliner-instituts-fuer-gesundheitsforschung-in-die-charite-pdf/view
