The Golden Boy

Could it be that Mr Drosten's steamy chatter conceals something other than humanistic philanthropy?

Saturday, 27. June 2020, 15:55

The answers of the Charité to our press questions are here (1) and make the closer circumstances of the development and distribution of the so-called Drosten test appear more and 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 copyrights are thus held by the Charité. The Charité does not even want to have examined a possible patent or other protection 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 notify the Charité of the completed development of his test, the blueprint for which he submitted to the WHO in a flash, contrary to his obligation to notify the WHO in accordance with the Employee Invention Act.

Contrary to its allegedly purely humanitarian approach, the Charité then allows 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 "from the very beginning" on a purely trustworthy basis - without any obligation of secrecy or non-competition clause - with an annual profit before Corona of approximately 7.3 million euros, to earn a golden nose. 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 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 "broadcast technical support" for deliveries to recipient laboratories in Thailand, Vietnam, Hong Kong, which Prof. Drosten had personally selected, i.e. 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.

One may assume that repeat orders are not placed with Prof. Drosten, but directly with TIB Molbiol, but, as the Charité hastens to assure, 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, practically gun to gun, or rather head to toe, rattling the little grey cells, in exactly the same time interval as it takes us, sitting on the sofa in front of the TV, reaching for his beer glass, hurling a new test out of your mental cannon, which enables the targeted identification of the new enemy practically overnight?

You have not only succeeded in doing this with SARS and MERS, as your Wikipedia entry says, which is a criminal sloppy research (2). Why is it not mentioned here that you have achieved the same heroic feat many more times? 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 face all the following viruses with their clever tests: 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 realized that, 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 like in 2005 for the SARS-CoV test. And this was balanced out by your weight in gold.

But somehow I got to thinking about this, about your inventive achievements. A patent attorney, whom I consulted in this matter out of sheer curiosity, said that your WHO test protocol basically shows a body of thought that is accessible to industrial property protection, in particular patent protection. And indeed, for example, the SARS-CoV test kit that you co-developed in 2003 was immediately patented for artus GmbH (5), a spin-off of your then employer, the Bernhard-Nocht-Institut (6).

The Charité is now telling 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 expressly earmarked for the development of tests for newly emerging viruses."

According to the German Employee Inventions Act and the Technology Transfer Directive, which defines this in more detail 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 have a 30 percent share in the exploitation 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 license 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.

One must still have oneself under control even when boasting to one's wine-loving comrades at the bar of a hotel with a brush salesman, otherwise the luck of the inventor can quickly be over.

Against this background, I wondered what the current protection status of the protectable and protection-worthy aspects of their latest, extremely important Drosten test actually 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 low prices, possibly even at cost price?

At the moment we do not know whether a patent application has been filed, by the Charité or someone else. The Charité denies this and nothing has been seen at the patent office so far, but patents must be disclosed after 18 months.

In response to our question about your collaboration, Prof. Drosten, with the "small" Berlin company TIB Molbiol Syntheselabor GmbH in the context of test development, the Charité wrote to us:

"There are no agreements; it is not the intention of any party to claim or protect rights. The cooperation is being carried out by both sides exclusively for humanitarian reasons"

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 informs us (8).

Well, it is also a "small" company, so you can be very happy when the ruble finally rolls. Whereby, "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 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 is hard to imagine how turnover could develop in the event of a - this time, however, a real - corona tsunami, for example in autumn!

You have been working with Olfert Landt, Professor Drosten, 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 emphasize 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 providence? Or was that of Olfert Landt 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 point in 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. That's how it would have been desirable, after so many years of productive cooperation, that it wasn't just chance that was at work.

But let's get back to the question of patent or legal protection: TIB Molbiol now makes millions and you get nothing. But somehow someone else is left empty-handed, yes, exactly the Charité. Has Charité approved the immediate publication, has it released it? Why can they simply do without such assets?

The Charité is a corporation under public law and, according to Article 10 of its statutes, is subject to the obligation of good corporate governance (11 ) and, of course, to the budgetary principles of proper management of its business. If the Charité would now 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, 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 wants to tell us when it makes the following statement:

Question:

"Has the aforementioned test protocol been pre-approved for submission to the WHO?"

Answer:

"The question assumes incorrect facts; no such submission has been made."

Question:

"If a prior release was made: Who gave whom this clearance? Has it been checked before the release whether a submission/publication would prevent a patenting by the Charité? When deciding on the approval, was it taken into account that the Charité might be faced with a large asset in this respect? On what grounds, if any, was a waiver granted?"

Answer:

"The time conditions for this were not given, especially since the loss of an asset of Charité was not and is not to be assumed."

Another question:

"Has it been checked in advance whether a waiver of a patent or other rights to the 'Drosten Test' is compatible with the principle of 'good corporate governance' according to § 10 of the Charité statutes? What was the result of the examination? Were other budgetary requirements examined that might conflict with a waiver of a patent or other rights? If so, which budgetary requirements were examined? With what result?"

Answer:

"The profit-oriented approach in connection with the fight against the pandemic, which you questioned, was not appropriate from the point of view of the Charité."

Well, that's a little surprising. Of course, everything had to be done quickly here and of course a humanitarian aspect was in the foreground. 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 primarily means control over the exploitation of the invention. It also enables, for example, the selection of reputable license 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 of the technology transfer guideline with which we are familiar that inventions with a humanitarian aspect must never be considered from the perspective of profit orientation? 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 purpose? It is hard to imagine, but we will continue to look into the matter at the Charité.

Unfortunately, the Charité does not inform us which specific individuals have voted for a non-profit approach to the matter. However: According to information provided, Charité had no knowledge of the completed test development and your publication plans before your Blitz publication at the WHO, because you, Prof. Drosten, contrary to § 5 paragraph 2 sentence 1 and 3 ArbErfG (employee invention), did not report your service invention at all.

Question:

"Professor Drosten has submitted a test to the WHO for evaluation. When and in what form did Prof. Drosten inform the Charité about the development of this test?"

Answer:

"No such notification was given."

But wait, wasn't that a finished test that you developed? Did I misunderstand something? At least that's how you could interpret this answer from the Charité:

Question:

"Has the Charité applied for or is directly or indirectly involved in the application for patent, utility model, trademark or other protective rights with regard to the so-called 'Drosten Test', with regard to individual components, primers, etc., or other related aspects?"

Answer:

"No. Professor Drosten has not developed a test kit, but has published the decisive information for laboratories to carry out a test in the form of a procedure protocol. Companies have used this information to develop test kits. Professor Drosten makes no profit whatsoever from this."

Okay, so supposedly not a test kit. But a blueprint, a very specific set of instructions for the labs. I don't know, that sounds a little 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 manufacture of a filter, perhaps even for humanitarian reasons, in order 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 achieved a process protocol in your development that is irrelevant from a patent law point of view is also biting with the mere broadcast technical support of TIB Molbiol in sending the data to the laboratories you selected in Thailand, Vietnam and Hong Kong - and perhaps to other places in the further course of the project? Obviously, a test kit already developed by you and your team was available here, for which TIB Molbiol then only took over the dispatch for reasons of practicability, especially to save time.

The Charité writes us in this respect:

"The broadcast technical support of the company TIB Molbiol was called upon for reasons of time saving: 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 about the production of the reagents was disclosed and was available to other synthesis companies, so that TIB Molbiol was not able to claim any competitive advantage".

Hm, but unlike the Charité, Olfert Landt seems to see his pole position itself as a competitive advantage. He has no need to acquire customers, he doesn't have to place any advertisements, 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 of these 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). However, "fast and thorough" was actually mainly you, Prof. Drosten, and at TIB Molbiol the question arises whether the services it provides according to Charité - delivery of special reagents in 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 Charité. I am already very excited about the Charité's response to our inquiry.

Perhaps Prof. Drosten's friendship with Olfert Landt is not so close because it has always been so unfortunate for you that you develop the test, make it available very quickly and very unselfishly, inspired by the desire to help, and then it is always TIB Molbiol who makes a fortune from the tests - 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 frankly, I would have thought of something else after one or two such experiences. I would have founded a collecting society or kicked my employer to found one. And then I would have either laughed all the way to the bank or donated the majority of the proceeds to a good cause.

Frankly, you are not involved with TIB Molbiol and I sincerely hope that there are no fiduciary or other agreements of any kind. I value you in your independence and, how should one call it, money-removed or perhaps naivety, which has led to the fact that you have now made the same "mistake" at least eight times, to throw your invention onto the market so quickly that you no longer had any chance to profit from it, but rather had to watch the till ringing loudly at one of your co-developers. Somehow, I think that's a bit weird 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 reward enough for you.

However, it is also a very strange result for the Charité, which has to fight with all kinds of problems. According to the report of the Federal Court of Auditors, it is not able to invoice hospital services worth 100 to 300 million euros to the health insurance companies every year because its employees do not correctly document the course of treatment and the invoices are therefore not accepted by the insurance companies (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 system of cross-financing of its hospital operations from research funds of the Berlin Institute for Health Research, which has been well established for many years and is highly problematic from a budgetary point of view; it has been criticised by the Federal Court of Auditors and benevolently tolerated by the Federal Ministry of Finance (15). For example, it likes to bill its scientists for disproportionately high electricity costs by allocating a proportion of hospital electricity costs to sparsely illuminated scientific pauses in thought.

One can only hope that the Charité is not threatened by 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 considered a disadvantage for creditors.

Sources and notes (not translated):

(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