America-Israel Patent Law

A Good Explanation of the Problem with "Progressive" Views of Big Pharma

James Meigs has a piece in the newest edition of Commentary entitled "Thank God For Big Pharma".  It doesn't say anything that's not already familiar to people involved in the pharmaceutical development process, but it's still a good read.  My only criticism: he doesn't mention Bayh-Dole, but he does discuss what would happen if the private sector were taken out of the drug development process, which is what some politicians seem to be angling for (by depriving drug companies of profits).  As I've said more than once before, I'd rather someone make huge profits and there be new drugs (or in the past year, new coronavirus vaccines) than no one make huge profits and there be no new drugs; and I'm glad there's a generic drug industry to make sure that, in nearly all cases, those drugs eventually become generic, at which point their prices drop precipitously. Together those two things drive new drug development.

When Science Professors Opine on IP Matters Without Good Legal Advice

The letter below came to my attention recently.  It was sent out by two professors in administrative positions at one of Israel’s institution of higher education.  Can you spot the errors?

Greetings All, 

Maintaining records of laboratory work is important for the day-to-day activities of collaborative research within a group or Department. Moreover, it is a legal requirement for securing Intellectual Property (IP) rights in cases where patents are involved and the novelty of an invention might be contested.

Traditionally, hardbound notebooks were the standard method for recording and saving laboratory data. With widespread and advanced use of lab computers and digital information processing, the use of paper records is no longer adequate. Researchers around the world use various well-known digital document sharing solutions such as Dropbox, GoogleDocs, or OneDrive, which were not specifically designed for this purpose and therefore not legally recognized. .   

In order to keep up with the growing needs of labs, [name of institution] selected [Vendor/System] for electronic data management. This system was first implemented at [name of institution] in May 2018 and includes the following features:

• • Organize and manage laboratory data in a flexible multi-disciplinary environment
  • Protect intellectual property
  • Collaborate safely and securely
  • Data compliant with funding agency requirements
  • Works on multiple platforms including iOS and android
  • Recognized by funding agencies

The system is currently being used at [institution] by 53 research labs who have created 400 Digital Notebooks.

Dr. WW from the Department of XX was among the pioneers who initiated the project at [institution] and has been using [System] from the beginning.  We encourage you to contact him and learn about his experience with the product.

[Vendor] will be offering an informational webinar this week on Thursday, October 22, 2020, at 14:00.  A group of researchers will speak about their experience with the product, give advice, and present workflows that they have created with the tool.  The event is open to anyone who registers:  [url]

We invite you to take research storage and collaboration in your lab to the next level with this advanced data management system.

Click here for more information about [Vendor] and how to register [link disabled] 

Professor YY                                                                   Professor YY

In case you missed them:

1. Saying that “Maintaining records of laboratory work … is a legal requirement for securing Intellectual Property (IP) rights in cases where patents are involved and the novelty of an invention might be contested” is misleading at best and in some case just wrong, in two respects.

First, you normally don’t need to prove when you conducted experiments (if you did conduct experiments) in order to secure IP rights – the patent application, if it is properly drafted, speaks for itself. 

Second, in the old days, in the USA, when there was a first-to-invent system, proving initial conception and diligence in reduction to practice could be important, and well-maintained lab notebooks could come into play in situations where precedence of conception was in question.  And yes, proving an early conception date could in some cases be used to disqualify an otherwise novelty-destroying publication as a reference.  Nowadays, though, even the USA has abandoned first-to-invent.  By and large, the first party to file wins (no more interferences in the USA), and the question of priority of inventorship, if it arises, will only arise if the later-filing party asserts that the earlier-filing party derived (or in less flowery language, stole) the invention from the later-filing party.  There’s no more establishing an earlier conception date to overcome a prior art rejection.

2. Paper records may be a cumbersome way to share data, but to say they’re inadequate is a bit much. And to say that Dropbox, GoogleDocs, and OneDrive “are not legally recognized”, whether because they were not specifically designed to share lab information or for any other reason, is, again, just wrong. Can one imagine a system designed specifically to record and share lab data, that clearly records the dates and times on which information was entered and modified, and by whom, and that is protected in such a way as to serve as a good source of evidence in court?  Sure.  But that doesn’t mean that paper is per se inadequate for that task.  It may require a lot more work at trial to prove the veracity of paper records than records generated in a specifically-designed electronic system, but if the researcher is meticulous and diligent about documenting her work, paper can be fine.  Ditto for general document sharing services.

So how did these errors enter into this letter? I have a friend who works in the tech transfer office of this particular institution, who explained that the professors involved (neither of whom, to the best of my knowledge, has been involved in IP litigation) were advised by the office of general counsel rather than by the IP specialists at the TTO.  It’s a shame, because the result is the professors sound like they’re pitchmen for the particular service, rather than the accomplished scientists that they are.

How Not To Encourage Tech Transfer From Universities

Once upon a time, universities didn’t pay much attention to IP. That has changed over the years.  When I was a kid growing up in Ann Arbor in the late 1970’s, the athletic director at the University of Michigan was considered a pioneer and a marketing genius, but it wasn’t until 1985 that the block “M”, which had been in use since at least the 1890’s, was registered as a trademark.  Now every university with even a moderately successful football or basketball program will register and assert copyrights and trademarks for logos and mascots to go on clothing, shot glasses, wall clocks and just about anything else one can think of.  (Some universities with not-so-great athletic programs but with a few Nobel prizes to their credit do the same.) 

Universities now also seek patents.  In the USA that’s directly attributable the passage of the Bayh-Dole act in 1980, which allowed universities to profit from the IP generated by federally-funded research.  I blogged a number of years ago about the chemistry building at Princeton, that was completely funded by royalties from a molecule initially synthesized in a Princeton lab and eventually brought to market by Eli Lilly.

In Israel too, there was a time when universities and research institutes didn’t pay attention to patents; the notorious story around Rehovot is that of the Weizmann Institute professor who discovered the strong bond between avidin and biotin and didn’t think to patent it.  Now all the institutes of higher education in Israel have tech transfer offices. 

That doesn’t mean that drafting patent applications for professors, or commercializing the underlying technology, is easy for the patent attorney or TT office.  Professors are used to telling others how what to do, so it can be a tricky thing to tell Professor X that his one example that he thinks will get paper published in Nature is insufficient to support broad patent claims.  And although professors today tend to be more IP-aware than their predecessors a generation or two ago, most professors are still focused on publishing papers, not commercializing products or supporting the patent applications that facilitate such commercialization. 

Tech transfer offices have limited budgets, which means that, often, patent applications don’t get filed in many countries, or even as a PCT application, unless a strategic partner to fund the patenting has been found.  Hitherto, though, I viewed finding that strategic partner to be part of the tech transfer office’s job.  This week I heard about one Israeli TTO that recently adopted a new scheme: it puts the onus on the inventor to be the salesman. 

Basically, if the prof doesn’t provide the TTO with enough proven examples of possible uses of technology, it won’t file anything beyond a provisional.  That’s a great deal for a prof who’s not interested in commercializing her work, and just wants to concentrate on publishing.  But for the TTO and the university, given professors’ general reticence toward the patenting process and general lack of business sense, this doesn’t sound like a winning formula to securing outside funding and eventually making profits for the institution in question.  At a minimum, it would take a promise of a very large percentage of the profits, should any be realized, to entice a professor to do this, and there’s no reason to think that most professors would do a better job than the business-minded people employed by the TTOs at identifying possible partners.  One would think that trying to work with faculty, instead of making them responsible for something they may not care about in the first place, would be a better route to success.

We’ll check back in a few years and see if this institution’s PCT and overall patent filings drop as a result of this new policy.

"All Our Patents Are Belong To You"

Yesterday Elon Musk of Tesla Motors put up this blog post, in which he is apparently trying to say that as long as he's in charge, Telsa won't enforce any of its patents, because he wants to encourage others to develop sustainable transportation.  (That reading of it seems to be consensus among tech business writers, such as Will Oremus at Slate.)

Inasmuch as none of the big automakers are trying to copy Tesla or even make a serious run at the non-hydrocarbon burning vehicle market, a point that Musk makes in his post, there seems to be little downside to taking this stance, and far be it for me to second guess his business strategy.  As a lawyer, however, I ask myself if his promise is backed up by action.  For example, by dedicating Tesla's patents to the public, something that can be done through the USPTO. 

A quick, non-exhaustive sample out of the over 100 US patents issued to Tesla Motors indicates that so far, such a step hasn't been taken.  For instance, as of this writing, US 8421469 is still listed in the assignment listings as being owned by Tesla Motors, and there is nothing in PAIR showing that the patent has been dedicated to the public.  Same thing for US 7741750, which was renewed last year, (and along with ownership by Tesla Motors shows with a security interest on record to Midland Loan Services, Inc.)  Ditto for US 7404720.  The same attorney, with his address given as Tesla's Palo Alto addressm, is listed as the contact person for all three patents.  

 

I do not doubt Mr. Musk's sincerity, and perhaps his online statements would be construed by a court as constituting a dedication the public, or an offer for a non-royalty bearing license, or a covenant not to sue.  But until there's something in the record of the patents themselves to corroborate his statements, it's hard not to advise a client thinking of using technology covered by Tesla's patents to obtain written permission to do so before proceeding.  Then again, as my brother the US patent litigator noted, the announcement says "Tesla will not *initiate* lawsuits against anyone who, in good faith, wants to use our technology", language which implies that Tesla wants to reserve the right to sue if sued, or if it feels someone is using the technology for purposes that Tesla doesn't approve of.  So this statement may be all that we see from Tesla on the matter.  

 

On the humorous side, for those of you who remember Highland Applicance (of blessed memory), the title of his post, "All Our Patent Are Belong To You", reminds me of this classic commercial:

 

Four Israeli Universities Among Top 100 Patentees in USA in 2012

Today Don Zuhn at PatentDocs posted about a report from the National Academy of Inventors and the Intellectual Property Owners Association, which lists the universities worldwide that received the most U.S. utility patents in 2012.  The University of California tops the list with 357 patents; last on the list is Seoul National University Industry Foundation with 18 patents.  Of the top 100, most of the non-US universities are located in the Far East (27).  There is only one entry for a European university (Ecole Polytechnique, Federale de Lausanne, coming at 94th place with 20 patents) and one entry for the King Fahd University of Petroleum and Minerals in Saudi Arabia with 57 patents.  The tech transfer companies of the Technion, Weizmann Institute, Hebrew University and Tel-Aviv University all made the list, with 30, 35, 30 and 37 patents, respectively. 

While numbers of patents per se aren’t necessarily a measure of the patentee’s successful contributions to commerce, it’s nevertheless impressive that Israel, with a population significantly smaller than those of any of the other countries represented on the list (unless one counts Hong Kong as separate from China), and which has to devote a larger proportion of its budget to defense than the other countries, has four universities on the list (out of seven Israeli universities total).  And according to this slideshow, and this news article, and this publication, Hebrew U. (Yissum), Weizmann (Yeda) and Technion have licensing revenues on par with those of the leading US universities.