by Dennis Crouch
The U.S. Supreme Court is weighing whether to grant certiorari in Vanda Pharmaceuticals v. Teva Pharmaceuticals. I have been closely watching this obviousness case that could have significant implications beyond the pharmaceutical industry. The following essay provides an overview of the key legal issues at stake and introduces Teva’s recent briefing.
The case centers on the proper legal standard for determining when an invention is “obvious” and therefore unpatentable under 35 U.S.C. § 103. In particular, Vanda argues that the Federal Circuit has unduly raised the non-obviousness hurdle — barring patents based upon a “mere reasonable expectation of success” or that certain experiments would have been obvious to try, even though the result was not known.
The patentee argues that obviousness requires that the claimed solution was “predictable.”
The question presented is: Whether obviousness requires a showing of “predictable” results, as this Court held in KSR, or a mere “reasonable expectation of success,” as the Federal Circuit has held both before and after KSR?
In KSR v. Teleflex (2007), the Supreme Court stated that a “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Later, the Court elaborated on this principle, stating that “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” At the same time, the decision is clear that the KSR Court did not intend to limit the doctrine in a way inconsistent with the flexible, more nuanced understanding of obviousness discussed elsewhere in the case. Although KSR does not literally discuss a “reasonable expectation of success” but the case does indicate that a combination of known elements is obvious when it “yields no more than one would expect from such an arrangement.” In my mind, all this begs the question of whether we are simply fighting over meaningless semantics: whether a “reasonable expectation of success” is the same as “yield[ing] predictable results?” KSR (quoting Sakraida). The briefing cites to other statements from the court about the meaning of obviousness, including:
- Dow Chem. Co. v. Halliburton Oil Well Cementing Co., 324 U.S. 320 (1945)(“perfectly plain to an expert”)
- Textile Mach. Works v. Louis Hirsch, 302 U.S. 490 (1938) (“plainly foreshadowed”)
- De Forest Radio Co. v. General Elec. Co., 283 U.S. 664 (1931) (“immediately recognized”)
- Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45, 62 (1923) (non-obvious because “there [was] no means, short of actual experiment, to enable one to anticipate results.”)
- Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945) (obvious because “not the product of long and difficult experimentation” rather by “selecting a known compound to meet known requirements.”)
- Atlantic Works v. Brady, 107 U.S. 192 (1883) (a “slight advance” of “ordinary mechanical or engineering skill” is not enough)
The successful patent challengers (Teva and Apotex) recently filed their responsive brief–complying with a request from the Supreme Court. As is now quite common, the responsive brief substantially rewrote the question to focus on the evidence presented in the litigation rather than the more abstract legal question:
Question as Re-presented by Teva and Apotex: Whether the district court and the court of appeals erred in holding the asserted patent claims invalid as obvious based on evidence that all of the elements of the asserted claims were known in the prior art and that a person having ordinary skill in the art not only would have been motivated to combine those previously known elements to arrive at the claimed inventions but also would have reasonably expected to succeed in doing so.
As I discuss below, the responsive brief does an excellent job of responding to Vanda’s arguments and suggesting that this case is not the right “vehicle” for SCOTUS review. Vanda will now have the opportunity to file its reply brief. If the case is moving forward beyond that, next step is for the court to either (1) grant the writ of certiorari or (2) call for the views of the solicitor general (CVSG), asking for an amicus filing from the U.S. Government.
Teva & Apotex’s Arguments Against Certiorari
- Vanda forfeited its “predictability” argument by not raising it below. The lower courts cannot be faulted for not adopting a standard Vanda never proposed.
- The Federal Circuit applied the correct standard consistent with Supreme Court precedent, including KSR and Deere, focusing on the knowledge and capabilities of a person of ordinary skill in the art.
- There is no circuit split – Vanda mischaracterizes old regional circuit cases that predated key Supreme Court rulings and the Federal Circuit’s creation.
- This case is a poor vehicle because Vanda’s patents are likely invalid even under its proposed “predictability” standard. The prior art provided ample reason to expect the claimed dosing regimen and drug interactions.
- Vanda overstates the importance of the question presented. If a genuine problem existed with the long-standing obviousness framework, it would have been raised before now.
I have more on the case in prior posts:
Obviousness: Is a Reasonable Expectation of Success Sufficient
Vanda Seeks Supreme Court Review on Lower Standard for Obviousness
The obvious to try standard – i.e., if you arrive at a result that was not predictable, the combination is not obvious, but if the result was predictable it is obvious – a curious one. You do not know if the combination is obvious until after you try it and see what happens. In other words, we need to determine obviousness from the point of view of one of ordinary skill only after the invention was invented and not from the point of view of one of ordinary skill in the art prior to the invention being invented. Isn’t that the dictionary definition of hindsight? Shouldn’t the standard look make the determination of obviousness from the point of view of one ordinary skill prior to making the invention?
I don’t see what is wrong, in a First to File jurisdiction, with the proposition that: “You do not know if the combination is obvious until after you try it and see what happens”. A patentable invention is a non-obvious technical solution to a technical problem. If you “try it” and all that happens is that you get exactly what everybody was expecting, and nothing more, then you ain’t got something patentable. But if you do get more than POSA would have expected, write it up, in a patent application, as the story of a problem addressed and surprisingly solved, and ask the PTO for a grant certificate.
In a FtF jurisdiction, the determination of patentability is made after you wrote up your valuable and surprising contribution to the useful arts. And that determination is based on your write-up. Go ahead, sell your patentability to the PTO and let them judge you on your own work product.
What’s not to like in that? What criticism is valid?
DL,
I see your point.
Prior art is… prior.
State of the art is the state… prior.
> from the point of view of one ordinary skill prior to making the invention
Yes, and just to add on…that should include recognizing the source of a problem*, not just the solution itself. Consider the old Eibel Process case. Once the inventor realized that the problem limiting the speed of paper machines was a speed mismatch, the solution was trivial (and nowadays, also conventional). But… the paper industry had been trying to solve that problem for decades, as speed ~= profitability in that field.
*or, imho, that a problem exists i.e., the old Steve Jobs line that “People don’t know what they want until you show it to them.”
+ 1
Billion
who was it that concluded Snowfake was do confused he called himself a liar?
You mean the first time ever or the most recent example?
Snowflake is confusing himself. He is going to call himself a liar again. Watch.
nice try to sneak one by on a analogous post that was only 22 days old.
So in addition to the choice of subject that gets me coin, your 0bsess10n of last (omitting best) is a multiplier.
Thank$$
“try to sneak one by”.
See? we told you he’s getting so confused soon he will call himself a liar. Again.
Watch.
Yet another multiplier post of your choosing.
My oh my, that notion of “comments closed” rather makes you the
L
I
A
R
doesn’t it?
See?
Anyone can “see” that this is not going well for you.
How many times did you state that you were closing comments (and still are commenting?
Please Pardon Potential re(P)eat…
Your comment is awaiting moderation.
March 28, 2024 at 7:37 am
Well Shifty, when you find Malcolm agreeing with you, you know that you are in trouble.
> As is now quite common, the responsive brief substantially rewrote the question to focus on the evidence presented in the litigation rather than the more abstract legal question
So would you say that the content of the reply brief was predictable, or that one could reasonably have expected it?
Dennis also noted the typical arguments against cert that the cert petitioner would loose under Either “obvious to try” success predictability version under the facts of this case. So, no good basis for deciding that more abstract question in this case.
Before the UK signed up to the European Patent Convention, in 1977, its Patent Office examined for clarity and novelty but not for obviousness. Why? Because to make a determination of obviousness one needs the evidence of what was the common general knowledge in the art (field of endeavour) and what the POSA would have found plausible/predictable/likely to succeed, and the PTO, ex Parte, was not in a position to gather and assess such evidence, and the legislator duly provided in 1949 a statute to fit.
For mainland Europe, Japan, Korea, China, it’s totally different, for in such civil law jurisdictions the technically tribunal tasked with the determination is empowered to determine such matters of fact by itself.
Good luck with the petition but I cannot see how SCOTUS can help to streamline the obviousness enquiry in an English law jurisdiction, or render it any less of a lottery than it already is, in the USA.
But the court needs wiggle room to do justice between litigants. For obviousness currently, there is all the subjective wiggle room any judge could need. Legal certainty, and confidence when giving an FTO opinion, just has to take a back seat, I suppose. Can you live with that, I wonder?
Wiggle room…?
MaxDrei is the epitome of wanting such an “open mind” that one’s brains fall out.
so if people stop “engaging” with your nonsense you do not get paid.
we got it.
Thank$ again for your choice.
“Whether obviousness requires a showing of “predictable” results, as this Court held in KSR”
Non-starter. KSR didn’t held that. They didn’t say obviousness requires such. They said that is one way to show that obviousness is present. A world of difference there.
GL to them, but they’re not going to get review.
“In my mind, all this begs the question of whether we are simply fighting over meaningless semantics: whether a “reasonable expectation of success” is the same as “yield[ing] predictable results?” ”
No they’re different bro and will make a meaningful difference in allowable claims/valid claims. Though yes, in an avg case the difference would be meaningless.
What is the analysis that deems something to be predictable or unpredictable?
How do you determine when something requires “undue experimentation”?
It seems to come down to “I know it when I see it”.
“It seems to come down to ‘I know it when I see it.'”
Reminds one of “abstract.”
Snowflake still does not understand that comments are closed?
Picking a sub thread almost a month old in your 0bsess10n over me with the attempt to have “last” while contradicting your own declaration is a choice of yours with multiplier payouts to me.
Yummy.
Sounds like the Descartes Youth League is really taking off.
link to youtu.be
Idk, how does it work with enablement? You have to do some fact finding and get expert testimony. What were POSAs capable of, what did they think was promising/not promising, how long would it have taken to achieve the claimed invention, how many decent alternatives were in play?
It’s been over two weeks since an AI or 101 article has appeared, so this:
link to rev-vbrick.uspto.gov
Is a little off-topic.
But after watching this, I am wondering if anyone (still) disagrees with the points that I have provided in regards to AI as co-inventor NOT being allowed (and leading to my Hobson’s choice position).
don’t know what that is supposed to mean but how much you got paid for that?
We both know that I enterprise off of your 0bsess10n with me and your choices — just like this one here.
So you are saying to some reasonably bright people that your business model is getting paid if and only if somebody “engages” with your nonsense.
What did your designated expert Boundy conclude about that?
ahh yes. he said Snowflake was an incredibly sloppy reader, writer, and thinker. probably does not comprehend that comments are closed.
You’ve tried this trick of inserting a comment in a long unused sub thread before.
It has never worked for you.
Still trying for “last,” when I have informed you that it is last AND best?
Thank$.
I had to see it for myself. i thought you were exaggerating.
That is not what “exaggerating” means.
Should you tell him or should I?
lol – thank$
(is ‘telling’ exempt from the ‘comments are closed?)
You mean no one’s told him yet?
oh now we remember. incredibly sloppy reader, writer, and thinker.
You know better, as I have explained it to you many times now.
It is not engagement – it is in the choices of your 0bsess10n that show that you are 0bsess1ng as opposed to engaging in a meaningful manner.
As an example – the reference to Boundy when you are aware of the context, but still insist on misrepresenting the picture. You are quite 0bsessed with somehow showing me to be in error, and yet – over your several thousand attempts, you have yet to be successful in even a single time.
i agree. Boundy nailed it. you are an incredibly sloppy reader, writer, and thinker.
how much you got paid for this “engagement.”. in Yuan
really Snowfake? Can’t you get a real job after how many years?
several thousand, Snowfake? can you identify 943 of the several thousands? such a small per centage of the several thousands we know you can do it!!!
^^^ wow – a nice 8X multiplier.
Cha-Ching!
once again you run away, Snowflake.
we are closing comments.
Run away? Why? Your choices are making me a mint.
can’t identify even one.
Comments are closed.
Perhaps if you would like to have an actual conversation, you can make an actual point.
As it is, this is only cyber-sta1king.
It’s English, Snowflake. Comments. Closed.
Still trying for “last,” when I have informed you that it is last AND best?
Thank$.
can not comprehend that comments are closed.
I am quite certain that there well may be quite a lot that you have trouble comprehending.
But yet another attempt at “last,” which certainly falls well short of “best” – as a post of your choosing – earns me coin.
Again.
Thank$.
And proves time and time again that he is, as concluded by his own designated expert, an incredibly sloppy reader, writer, and thinker.
Thank$$$$
And he thanks you for the reminder. Because he is, after all is said and done and comments closed, an incredibly sloppy reader, writer, and thinker. Once to the extent he got so confused he called himself a liar.
But boy can the boy he cut and paste fromWikipedia!!
A 5X multiplier payout from YOUR choices.
How many times are you going to show your 0bsess10n over me by posting after you declare that you are closing comments?
Whatever you do! Do not imply Snowflake is not capable of cutting and pasting from Wikipedia!
Yay – haven’t seen this slice of you in awhile.
Thank$
No! I tell you I’ve seen him do it!! He Can Cut And Paste FromWikipedia!!!
You are going somewhere here – it’s a circle, but it is somewhere, and you certainly are going.