Tech Law Reporter Andrew Noyes today reports on rumors that Duke University Law Professor and occasional Patently-O contributor Arti Rai will be joining the USPTO executive suite as head of external affairs. That position typically leads both intra– and inter-governmental relations.
Professor Rai’s primary research focus over the past decade has been on the administrative powers of the USPTO and regulatory methods of promoting regulation especially in the areas of health care and biotechnology. In a 2009 article, Professor Rai suggests that the PTO should continue to use the courts to secure additional control over its own rulemaking and procedural authority.
Given the difficulties of securing congressional action—particularly when Congress may be unwilling or unable to separate relatively simple administrative reform from highly contentious issues like damage awards in litigation—the judiciary is probably the more promising venue for conferring such control.
Additionally, Rai argues that the PTO should move forward with inequitable conduct reform.
The progress that could be achieved through inequitable-conduct reform is difficult to overstate. With such reform, interactions with applicants could be regulated in a much more rational manner. In addition to accelerated examination, inequitable-conduct reform could also create opportunities (where appropriate) for more intensive, on-the-record engagement between the examiner and the applicant. For example, in appropriate cases, on-the-record pre-first-office-action interviews that obviate the need for multiple subsequent rounds of negotiation between examiner and applicant might be possible.
Professor Rai has long ties with President Obama. They were law school classmates at Harvard Law School and she worked tirelessly on the campaign. Prior to becoming a law professor, Rai clerked for Judge Patel (N.D. Cal.) and was an associate at Jenner & Block.
Her patent law expertise and close ties to President Obama also place her on a short list of Federal Circuit nominees should a vacancy arise.
“The comments on this website are often nasty, juvenile, petty, unproductive..” Agreed.
“It is embarrassing.” Is it really? What is embarrassing for this onlooker from outside the USA is when poisonous comments from a few warped minds inexplicably go unchallenged, and unrefuted. At least on this blog, however, that’s not the case. Far from embarrassed, one is left feeling grateful for the existence of this blog, as a particularly effective and destructive means that more clearly thinking communicators can use, to expose prejudice whenever it pops up. One of the pleasures of this blog (quite apart from keeping up with the news) is to see reasoned written logic exposing bigotry for what it is.
The comments on this website are often nasty, juvenile, petty, unproductive, and so forth. It is embarrassing.
This thread has gotten pretty nasty and a bit off point. It started with the idea that Professor Arti Rai would join the administration for awhile. I have known her for at least fifteen years, and have had her as a colleague and collaborator for the last seven. I find her brilliant, sensible, kind, and an amazingly productive colleague. She will take those qualities to Washington.
A few specific points. It is simply unfair to say she “dropped out” of medical school. Having gotten her history of science baccalaureate from the largest and one of the best departments in the world, she switched from Harvard Med to Harvard Law because her interests shifted. We should all have such an intellectual pedigree. It’s not a minus but a plus. I guess we could ding Harold Varmus for dropping out of his grad program in English to go to med school, en route to getting the Nobel Prize and directing the NIH.
The arguments that she is unqualified to help the patent office think through some policy decisions are highly unpersuasive, given what I have watched her do at close range for the past seven years. Those who are sure of themselves about her lack of qualifications will simply be proven wrong. Given the tone of the comments, I’m not sure they’ll admit it, but they won’t win their case.
“burden of proof is on the advocate of any policy change;”
Is that a matter of lawl or personal opinion? Sometimes I get confuzzled about these kinds of things.
“in this case the good professor Rai has failed to provide evidence to support her claim, this is generally viewed as evidence of pre-conceived positions, aka ideology;”
So, in this case, Ms. Finston has failed to provide evidence to support her claim, but you don’t believe that this would also be generally viewed as evidence of pre-conceived positions, aka ideology? I think I understand your point. But it doesn’t seem like your point makes much sense.
“2) documentation was provided for the CONVERSE, which is that patents are not/not shown to deter university scientists in conducting their research.”
I’m sorry, I missed that documentation. I also missed the independent review of that “documentation”.
Perhaps you have links directly to both?
“Here is the direct link to that discussion, based on well regarded NBER research: link to bayhdole25.org, in case the more general link challenged your attention span.”
To be 100% honest with you, your “more specific” link seems just as overly general as any general link you may have previously provided would be. Perhaps when I cite my references in my next OA I should just point them to the class where each reference is found and leave out patent num., page/line numbers etc.
And let’s be clear Susan, this discussion is all about you.
Oh, and you’re welcome.
However, the exact same conversation could be had in reference to the rest of your buddies.
Let’s also be clear on another matter, I don’t have a position either way in this particular debate. I’m just saying, if you want me to believe she’s unpersuasive then you need to be somewhat persuasive yourself. I can see the potential for her views to be correct, and I can also see the potential for your own to be correct. I also see the overwhelming likelihood that reality lies somewhere between the two positions.
re 6 –
I prefer logic to your “famoosity”.
1) burden of proof is on the advocate of any policy change; in this case the good professor Rai has failed to provide evidence to support her claim, this is generally viewed as evidence of pre-conceived positions, aka ideology;
2) documentation was provided for the CONVERSE, which is that patents are not/not shown to deter university scientists in conducting their research.
Here is the direct link to that discussion, based on well regarded NBER research: link to bayhdole25.org, in case the more general link challenged your attention span.
3) the proposition that patents have promoted R&D is a different statement altogether, and one I would support, but not at issue here.
Thanks anyway for trying to make it all about me.
Regards,
SKFinston
(disclosure: I am a pharmaceutical brand side lawyer who once worked at the same firm). I like Shashank Upadhye for the Federal Circuit. He has practiced in big and small firms, has a PTO reg number, worked in corporations and is global head of IP for a company. He did brand pharma and now does generic work. He litigates alot (although now in-house). He is a great speaker at seminars, is very fair and open minded. He has written lots of law reviews and a whole treatise on FDA and patents law. So he has what Rai lacks, practical work experience over a long term. He has published just like an academic too.
While I note the various criticisms of Professor Rai, and I may be preaching to the converted, at least Rai’s point regarding the unique suitability of the courts in resolving issues regarding PTO authority is well taken.
For more on patent litigation: GeneralPatent.com.
I didn’t say that it was.
But I will say that the attorneys who I’m famoose with are tickled right clear pink. You wouldn’t believe the phone calls I get. I know how celebrities feel.
6,
Don’t confuse “famoosity” for a good thing.
It is not.
Let’s review.
1. I like Rai.
2. Old Timer is old.
3. ????
She’s in.
“As Prof. Rai has not provided any compelling evidence that this patenting actually has “retarded” subsequent R&D”
As you have not provided any compelling evidence that any patenting actually has promoted subsequent R&D is this evidence that your position is based purely upon your ideological position as opposed to a pragmatic weighing of the available data and facts?
“Your famoosity preceeds you.”
You would not believe how true this actually is.
Re: Susan K Finston | Sep 11, 2009 at 08:51 AM
Having taken a look at the cited article, apparently the author has not paid much heed to Sections 202 and 203 of the B-D Act.
“Her patent law expertise . . . place her on a short list of Federal Circuit nominees should a vacancy arise.”
Surely you jest, Dennis. I can’t tell whether this is just academic a** kissing, or if you’ve completely lost your marbles. Let’s review:
Her degree is a BA in History and Science (Biochemistry). It is not apparent from her background whether she even has the requisite credentials to sit for the patent bar. Strike one.
It looks like she dropped out of med school. I’ll call that a foul ball, strike two.
She does not have a PTO registration number. Strike three.
She has never spent any time practicing in front of the PTO. Strike four. Huge strike four.
She clerked for one year on the district court for the Northern District of CA. It is highly unlikely that she saw a patent case from start to finish in one year. She may have written a few opinions in patent cases, but she would have only caught a snippet of the case. Strike five.
She then worked for Jenner and Block for two years, “focusing on patent cases.” Again, two years as a newbie associate–give me a break. She’s never seen a patent case from start to finish, much less the business issues and pre-litigation disputes that lead up to a patent lawsuit. Strike six.
She left Jenner & Block in 1994 to go to the Justice Department, and has had no substantive involvement in patent law since 1994–that’s FIFTEEN YEARS ago. Strike seven.
She’s never worked a day in the private sector, period, much less in an industry that relies on the patent system as part of its business model. Strike eight.
At best, her writings demonstrate a lukewarm support for the patent system, and a clear bias in favor of using the courts to vest rulemaking authority in the PTO that Congress has explicitly declined to grant. Strike nine.
Nine strikes–that’s the whole inning right there.
This is a classic example of a manufactured expert. Ms. Rai has a total of three years of litigation experience, including some patent litigation. This experience was gathered fifteen years ago. It is simply not credible to assert that Ms. Rai possesses some modicum of “patent law expertise.”
It’s far more credible to assert that she is under consideration because she is a FOB (Friend of Barak) and because she shares his lukewarm support for intellectual property rights, particularly in bio and pharma related fields.
Musick – Thank you for this clarification.
Again, this demonstrates an interesting indication of Prof. Rai’s temperament or ideology on patents because empirically biotech patents are weaker, relatively, than patents for small molecules.
This makes sense when you consider other barriers to entry that the industry has enjoyed including difficulty of manufacturing processes (where the process is the product), regulatory protection, etc.
And fundamentally, small companies that act as R&D pipelines for biopharmaceuticals don’t have the deep pockets of a larger company to invest as much in patent drafting, either in terms of breadth or in the number of jurisdictions (ie through PCT filings).
This is a very real issue for the folks who have to bring these drugs to market.
Regards,
Susan
S. Question–the context was a brief discussion earlier this year following a presentation by Ann Witt, advisor to Senator Waxman, about the appropriate term of exclusivity in the follow-on biologics legislation. Ms. Witt was saying that one reason advanced by biotech companies for longer exclusivity was that biotech patents are not adequate to protect investment because they are often narrower than pharma patents, and Ms. Rai’s comment was a response to that–in context, essentially an out of hand dismissal that that might be true. I found the link to Ms. Witt’s slides at link to dukeipcs.org, but could not find any video online, although the talks were to have been recorded. If you get hold of the video, IIRC the discussion happened near the end of Ms. Witt’s presentation.
Professor Rai is on record as opposing expansive patent rights for publicly funded biotech research. See Conclusions from an article written with Prof. Rebecca Eisenberg (U-M), another “industry expert” who has never worked at a pharma or biotech company:
“As proprietary claims have proliferated in biomedical research, the costs that patents impose on R&D have become more salient. At the same time, patents on biomedical research discoveries plainly offer important social benefits in the form of motivating further private investment in product development. The presumption that patent incentives are necessary to promote research and development has less force for inventions arising from government-sponsored research than for inventions arising from purely private funding. It is therefore important that decisions about patenting the results of government-sponsored research be made on the basis of a careful balancing of the costs and benefits that they entail for future R&D. Current law entrusts these decisions to the unbridled discretion of institutions, such as universities, that receive federal funds, but these institutions are inadequately motivated to take the social costs of their proprietary claims into account in deciding what to patent. A more sensible approach would give research sponsors, such as NIH, [*pg 314] more authority to restrict patenting of publicly-funded research when such patenting is more likely to retard than promote subsequent R&D.”
link to law.duke.edu
As Prof. Rai has not provided any compelling evidence that this patenting actually has “retarded” subsequent R&D, this is at least some evidence of an ideological position, not a pragmatic weighing of the available data and facts.
In fact, reliable data from a paper presented at a recent NBER seminar showed the converse, e.g. that academics do not actually closely follow patent filings and so are not chilled in their research by patent status. A much more important factor is availability of proprietary research materials, ie immuno-compromised (or ‘nude’ rats), and/or other expensive or specialized equipment or resources needed to advance research in a particular field. For more details and documentation, see the BayhDole25 website at http://www.bayhdole25.org.
Regards,
Susan K Finston
Academicians is exactly what the USPTO does not need right now. When she becomes a registered patent attorney AND has prosecuted 50 – 100 apps before the USPTO, then she will be ready to assume a leadership role.
“Another sockpuppet, and again with boring name-calling.”
LOL.
I guess it’s much more creative name calling when an examiner like yourself calls practitioners sleaze bags.
Wow, talk about an official statement from the redundant department of statements of official redundancy, or something like that:
“…it’s a worthless anecdote without any evidence to back it up.” – Malcolm Mooney.
quite the synonym, given the content and the source.
6,
I’m sure that Ms Rai is aware of the type of “help” you can offer. Your famoosity preceeds you.
“So, did Professor Rai say “I can’t believe that biotech patents are EVER narrower than pharmaceutical patents”? I don’t know the context of the statement”
Nobody does because it’s a worthless anecdote without any evidence to back it up.
“”Why doesn’t the PTO hire searchers who can help the examiners, and then charge a larger filing fee?””
We already have them, but we don’t charge you extra.
They are useful. Sometimes.
Mark, the issue is sometimes searching. But not always.
You guys need to lay up offa Rai, she’s teh awesomz and that’s all there is to it.
The only question we need to ask is: does she need help moving anything in?
“They certainly can be…”
So, did Professor Rai say “I can’t believe that biotech patents are EVER narrower than pharmaceutical patents”? I don’t know the context of the statement but it appears to me that she was simply reacting to a suggestion that biotech patents as a category are narrower than pharmaceutical patents. Such a suggestion would appear to be nonsense, as you seem to agree – it’s an apples-to-oranges comparison. So what nuance did Professor Rai miss?
***********it’s only a matter of time before everyone will have to file an ESD of some sort. either the courts will say the USPTO has the authority to ask for an ESD or the USPTO will ask congress to give them that authority. there is no constitutional right to remain silent, at least with respect to the merits of your claims**********
It used to be a requirement that Applicants file an ESD for every reference submitted in an IDS. The CAFC in Tafas said that the PTO can require an ESD for references submitted after the first 20. What they struck down were the Continuation rules.
If the USPTO were to start requiring ESDs again in all cases (whcich the CAFC apparently confirmed they have the power to do), I could see Accellerated Examination becoming much more attractive, as the risk of PHEBA and Inequitable Conduct (IE) will already be present. However, the requirement to perform a search of impossibly large scope is still an obstacle. Moreover, even if the required scope of search were decreased, performing such a search would increase the risk of PHEBA and IE. So, if the ESD becomes mandatory, I predict that patent prefiling searches will become taboo much more so than AE will become a viable option.
There is one scenario that I can think of in which AE would become attractive. Patent Offices of some other countries allow themselves to be used as search services for a modest fee. Other countries also lack a duty of candor. The USPTO could offer the same type of service. If the requirement for the search could be completely met by purchasing such a search, and if the duty of candor were eliminated, then Applicants could look at the search results and decide whether to go the AE route. Once the application is filed with the ESD, the Examiner can update the search at the 1 year mark or 18 month mark and then proceed from there. If the AE route is not selected, then the Applicant need not submit an ESD, but can indicate that a search was performed and provide a reference number to the search in order to receive a reduction in the search fee. Then, those results are still of record at the PTO for the Examiner’s reference upon taking up the application for examination.
I think that if Applicant’s are saddled with a duty of candor and a requirement for an ESD, then Examiner’s ought to have a reciprocal duty to read the specification and identify subject matter that, if claimed, would be allowable.
“Biotech patents are narrower than pharmaceutical patents?”
They certainly can be–for example, a claim to a sequence limited to SEQ ID NO:1 versus a claim to a small molecule where even one substitution is allowed. I’m sure there are examples in the other direction, and there are apples-to-oranges issues, but that’s kind of the point–it’s going to depend on the claims and the exact subject matter, and on how you categorize the subject matter. Presidential advisers on patents should be familiar with such nuances.
**********”Examination Support Document = Prosecution History Estoppel by Argument”
Shouldn’t the latter expression be “prosecution disclaimer”. The ESD does not normally include amendments.***********
No. I did not say Prosecution History Estippel by Amendment. I said Prosecution History Estoppel by Argument (PHEBA). Tehre are two ways to create estoppel. One is by amendment of claims. The otgher is by arguments that clear disclaim subject matter, and need not be accompanied by an amendment. The ESD requires Applicants to distinguish the claims in detail over the teachings of the cited prior art references. Loads of PHEBA are inevitable under these circumstances.
“…blurting out statements along the lines of ‘I can’t believe that biotech patents are narrower than pharmaceutical patents’ at a CLE as she did recently should disqualify her from holding any advisory or PTO position…”
Biotech patents are narrower than pharmaceutical patents?
Dear JAOI ™,
I suggest that you re-read Prof. Rai’s writing. Your statement that she is against strong IP rights is completely erroneous and contrary to my reading of her writings.
I also hope this does not happen. In addition to supporting the rules, Ms. Rai seems to have a strong anti-pharma bias. Plus, blurting out statements along the lines of ‘I can’t believe that biotech patents are narrower than pharmaceutical patents’ at a CLE as she did recently should disqualify her from holding any advisory or PTO position, except perhaps on Obama’s next political campaign. One would hope that a celebrated academic would try to gather information (or specifics, or anything) first and come to conclusions later, but one would be disappointed here. Maybe the PTO is hoping to have Ms. Rai continue John Doll’s function of antagonizing the patent bar.
“Why doesn’t the PTO hire searchers who can help the examiners, and then charge a larger filing fee?”
The issue isn’t searching, but interpretation of what has been found.
“it’s only a matter of time before everyone will have to file an ESD of some sort. either the courts will say the USPTO has the authority to ask for an ESD or the USPTO will ask congress to give them that authority. there is no constitutional right to remain silent, at least with respect to the merits of your claims.”
Why doesn’t the PTO hire searchers who can help the examiners, and then charge a larger filing fee?
Ms. Rai is probably a fine academician. But my colleagues and I recommend that the PTO passes on her appointment. Pragmatic improvements in the U.S. Patent System and the Examination process require more than an understanding of legal theory. The Office of External Affairs interfaces with Congress, foreign governments and IP offices, the State Dept., and US trade reps for negotiating treaties w/r/t IP. We need a Champion of U.S. intellectual property rights, not one diminishes the rights of US inventors.
“Examination Support Document = Prosecution History Estoppel by Argument”
Shouldn’t the latter expression be “prosecution disclaimer”. The ESD does not normally include amendments.
“Examination Support Document = Prosecution History Estoppel by Argument = No Way Will I Ever Do Unless it Forced at the Point of a Gun”
it’s only a matter of time before everyone will have to file an ESD of some sort. either the courts will say the USPTO has the authority to ask for an ESD or the USPTO will ask congress to give them that authority. there is no constitutional right to remain silent, at least with respect to the merits of your claims.
” No Way Will I Ever Do Unless it Forced at the Point of a Gun”
I understand, but suppose you didn’t have to do any of that. All you had to do was pay a large fee (e.g. $20k) comparable to what the cost of the current requirements were?
Just what the USPTO needs…an academic with no experience beyond waxing poetic about Title 35 and caselaw.
Oh, my bad. A couple of years as a new associate in a general practice firm shuffling discovery papers makes up the difference for likely never having studied in infinite detail the contents of 37 CFR and the MPEP.
Rai might be a qualified individual, but based on her support for the “rules” it will take a strong effort by her to rehabilitate her image to the patent bar. I think its impossible.
Dear saddle,
She is opposed to strong IP rights. Please pull your head out and smell the coffee.
******How many of you have a case right now where you would file a petition to make special if it were not for the inequitable conduct exposure*********
Examination Support Document = Prosecution History Estoppel by Argument = No Way Will I Ever Do Unless it Forced at the Point of a Gun
I’m also factoring in the requirement that the Applicant perform a perfect and complete search of every library and database in the world in every language and all kinds of impossible stuff that even PTO Examiners are not required to do, even though they have superior search tools.
Boy, I have no idea where all of this apprehension about Prof. Rai arises.
Prof. Rai was my lawschool professor in 1998-1999. I am impressed by her intellect, reasoning, and common sense. Contrary to some academicians, she is not intransigent about her positions on patent law.
Therefore, I think that she would be an excellent person for this role.
A funny comic
link to techdirt.com
Isn’t she the loon who thinks the PTO has the power to promulgate the “final rules”, which say you can’t place allowable dependent claims in independent form if there are more than 5 of them (assuming you didn’t file an ESD because you didn’t file more than 5/25 claims)?
Yeah, adding her to PTO administration will do wonders.
This is a good appointment and I hope it goes well. Her background seems to be very well suited for a policy role. Depending on how much impact she’s able to have, the PTO Solicitor’s office might be busier and more interesting for her influence.
The CAFC angle isn’t very interesting for the moment. The next CAFC judge should be someone with experience as a district judge. There are already several judges who’ve prosecuted patents and at least one who’s been a full-time academic.
of all people who should not be allowed anywhere near the PTO… 🙁
Fleeing the douchiest law school!
link to abovethelaw.com
Hello prof Rai!
🙂
“on-the-record pre-first-office-action interviews that obviate the need for multiple subsequent rounds of negotiation between examiner and applicant might be possible.”
Great idea, assuming “on-the-record” means “recorded, verbatim.”
Interesting thoughts on inequitable conduct reform.
Quick show of hands. How many of you have a case right now where you would file a petition to make special if it were not for the inequitable conduct exposure.
(Feel free to contact me privately at mark.nowotarski@gmail.com if this forum is a bit too open for candor.)
I would favor someone with a patent bar number who has prepared/prosecuted for a number of years as a Federal Circuit judge.
I’m establishing the over/under at 16 months before she leaves Alexandria screaming something to the effect “burn it … burn it all down.”
EG,
Hear!, hear! You got that right.
Arti Rai discussing gold-plated patents at the presidential campaign debate last August:
link to gtk8d.rmxpres.com
With all due respect, I sure hope that Professor Rai is not on the short list of Federal Circuit judges. We need more Judge Newmans, not Judge Moores, on the Federal Circuit.
Arti Rai has patent law expertise? Since when?
Please do not equate “patent law experience” with writing about administrative law that just happens to tangentially involve the USPTO.
There goes the neighborhood.
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