Daiichi Sankyo v. Apotex (Fed. Cir. 2007).
Apotex filed an ANDA to begin making a generic version of Daiichi’s patented ear infection medication method – FLOXIN Otic. Daiichi sued and won a bench trial. On appeal, the CAFC reversed — finding the patented invention obvious.
Level of Skill: The nonobvousness doctrine requires an examination of what would be available to a person having ordinary skill in the art (PHOSITA). That inquiry is premised on a definition of the mythical PHOSITA. The general theory is that highly educated and trained PHOSITA know more and tend to think more inventions are obvious. On the other hand, a PHOSITA with little education or training would have more difficulty in making connections and finding obviousness.
The 1983 Orthopedic Equipment decision outlines factors for determining a PHOSITA – including education level of the inventor.
Here, the CAFC found that the lower court erred by picking a pediatrician as the PHOSITA in creation of compounds to treat ear infections without damaging a patient’s hearing. Rather, the skill level should be an otologist who is engaged in developing pharmaceutical formulations. The court primarily based its PHOSITA Skill Level on the inventors’ skill level and the skill level of their peers (which, almost by definition will be the same).
Obviousness: Based on the high level of skill in the art, the CAFC concluded that an otologist would have found the patented method obvious.
Reversed — Patented Invention is Obvious
DDC Comment: Although the education level of the inventor appears to be relevant to determining the PHOSITA skill level, there are a few reasons why that data point should be excluded from the list of factors. The common major mistake here is to search for a PHOSITA capable of making the invention rather than simply searching for the level of a skilled worker in the area. The PHOSITA skill level inquiry is not a search for what it takes to be a successful inventor. Rather, the PHOSITA is merely a skilled worker. The inventor’s biographical information may be indicative of a skill level for invention, but that is not the PHOSITA inquiry.
Under 35 USC 103(a), patentability of an invention “shall not be negatived by the manner in which the invention was made.” Of course, the process of inventing is intimately tied-in with the inventor’s skill and education level. In essence, use of the inventor’s biographical information in determing the PHOSITA skill level allows the court to ask whether the invention would have been obvious to someone standing in the shoes of the inventor. That methodology nothing more than a backdoor approach to asking whether any steps that the inventor took included non-obvous leaps — a legally impermissible question.
Notes:
- This case was originally decided in July 2007, but was recently republished as a precedential decision. The OrangeBookBlog covered the original release.
I don’t see the issue here. The level of ordinary skill for an ear treatment is that of people who make ear treatments, not people who administer ear treatments. To say otherwise would be similar to saying that the level of ordinary skill in circuit design is a computer technician. I don’t see how this is more than tangentially related to the level of skill of the inventors. Someone above stated that being below the level of ordinary skill gives you an advantage – I don’t see how that is the case. If a high schooler designed a microprocessor, you don’t use high schoolers as the PHOSITA – you use industry engineers.
Obviousness, though dangerous, is necessary. Easy example: computers executing software to perform some method. If someone claims a computer programmed to perform a certain task, could you come along and claim the same program stored on CD? No. Even though there is no explicit teaching of the CD (and, in fact, the CD isn’t even implied, because it makes more sense to store the program in memory or hard disk), storing the same program on CD is obvious. Contrary to what someone above posted, there is no admission of novelty here – everyone knows you can store software on CDs. The fact that there is no explicit disclosure of the CD frankly doesn’t mean a damn thing.
The way I see this issue is a sliding scale between only granting patents for revolutionary inventions vs. granting patents for everything that’s even slightly different, in any way. The question is which side of the scale is best for the economy.
I am not certain what one can learn from this decision, except that experts one brings to court must be carefully selected.
It seems that the case was lost and won only on the testimony of the paid experts.
As I understand from skimming the decision, Daiichi received a patent for providing humanity with an ear antibiotic (ofloxacin) that doesn’t damage hearing.
Apotex said the patent was invalid as the invention was obvious in light of a vague reference that said that a related drug (ciprofloxacin) did not damage the hearing.
Seemingly, the CAFC ultimately invalidated the patent because Apotex’s “expert” said it was obvious to use ofloxacin (interesting to know how many people’s hearing was saved by this expert’s inventions) while Daiichi’s expert said only that it wouldn’t be obvious for a doctor.
What would have happened if instead of arguing the level of a PHOSITA, Daiichi had offered the Apotex “expert” a swig of methanol-spiked moonshine instead of the chemically-related safe and effective Southern Comfort?
Dear BabelBoy,
You are a champion:
“Graham, in my opinion, is the Dred Scott decision of patent law.”
Malcolm said it perfect; please count me in, “I’ll have a bit of that” too.
What would you compare the USSC’s anti-injunction ebay decision too?
Here’s the skinny and I’m sticking to it:
Self-employed inventors have been busting their butts for years and decades inventing and patenting and, if/when successful, and after paying for the patent prosecution process and paying for the patent, the government finally grants you a patent.
The patent has printed on the red ribbon cover face* the government’s promise that you can stop infringement, but only if you first prevail at you own cost in a district court with a finding that your patent is valid and infringed.
So, with patent in hand, you tell Mr. Big Business infringer about your patent and ask for a royalty, but Mr. Big infringer only laughs and says:
“Pss off, you cannot stop me from infringing no matter what; sue me if you can, and if you actually prevail several years from now, then maybe I’ll pay you some piddling amount that may be awarded under the new big business anti-patentee damage guide-lines, or maybe not even that amount, maybe only a reduced amount set by a big business biased court.”
It is like asking soldiers to volunteer and enlist with the promise of loaded guns to defend and fight with, then, after he enlists, sending him into harm’s way, and then when he is under attack, saying, sorry, no bullets for you; try bluffing, and good luck.
The Patentees’ Settled Expectation
<>The Exclusive Right is a Settled Expectation<>
Another United States Supreme Court landmark ruling, “Connolly v. Pension Benefit Guaranty Corp. 457 U.S 1, 222, 106 S.Ct. 1018, 89 L.Ed.2d l66 (1986),” relates directly to every patentee’s well settled expectation of the “right to exclude others” from infringing his patent.
The USSC’s MercExchange v eBay decision lacks authority to change this historic and well settled expectation. Connolly held that:
“… legislation [e.g., 35 USC 283] readjusting rights and burdens is not unlawful SOLELY because it upsets otherwise settled expectations.” (emphasis added)
35 USC 283 and the USSC’s eBay decision based on35 USC 283, is not “unlawful SOLELY because it upsets” many patentees’ settled expectation of “the exclusive Right to their…Discoveries” (Article I, Section 8, Clause 8). THE EBAY RULING IS UNLAWFUL BECAUSE IT LACKS A REQUIRED PREREQUISITE AMENDMENT under Article V for authority to alter the Constitution which unequivocally provides for an Inventor to have the exclusive Right to his invention, traditionally and unequivocally meaning the right to exclude, just as the Director of the USPTO says on the red ribbon cover of every United States patent:
* “Therefore, this United States Patent
Grants to the person(s) having title to this patent THE RIGHT TO EXCLUDE OTHERS from making, using, offering for sale, or selling the invention throughout the United States of America …” (emphasis added)
The Supremes’ MercExchange v eBay ruling is a corruption of our Constitution. Article VI, the Supremacy Clause, mandates that it should not stand.
Constitutional corruption, as, for example, perpetrated by the USSC in its Constitutionally unlawful eBay decision, threatens our democratic way of life, our very freedom.
If We the People, IP people no less, let them big business bastards, in lobbying league with corrupt Congress, Court and Executive crooks, take away “Blessings of Liberty to ourselves and our Posterity” by inches, we will most assuredly lose by miles and miles.
Yours Truly,
Just an ordinary standup Constitutional philosopher(TM)
a/k/a
“Graham, in my opinion, is the Dred Scott decision of patent law.”
I’ll have a bit of that.
Many of these posts reflect confusion or disagreement over the issue of “skilled,” — what it means and what relevance it has to patentability. This is an excellent example of an outdated term properly used many generations ago but contorted by innumerable asinine judicial opinions until it has no meaning left.
Go back to Hotchkiss v. Greenwood (52 US 248, 1850) and even then there was disagreement as to question of “what’s skill got to do with it?” But back then skill and knowledge overlapped almost completely in all arts so the term could be accurately used to depict those who know the art. Knowing how to build wagon wheels was synonymous with being skilled in building wagon wheels. It was not necessary to distinguish between otologists, otolaryngologists, or otorhinolaryngologists.
Justice Woodbury’s dissent in Hotchkiss foretold many of today’s problems by 250 years. Woodbury’s point was that skill and obviousness have nothing to do with patentability — if there is any useful increment in utility over existing art (i.e., even de minimis novelty) then the inventor is entitled to the benefits of that incremental utility. Presumably the rewards will be commensurate with the magnitude of the increment. Although they didn’t have Section 103 back then, today every obviousness rejection contains within it the admission of novelty, otherwise the rejection would be anticipation.
BTW, Hotchkiss is a wonderful example of how much some things have not changed. Same issues; same arguments — just a more gentlemanly way of expressing them. Unfortunately, Graham v. Deere relied on the Hotchkiss majority and not the dissents. And KSR relies on Graham. Graham, in my opinion, is the Dred Scott decision of patent law.
Babel Boy
I read the opinion, and am forced to wonder what the district court was thinking when they made their original decision. It looks like a reference by Horst Ganz, which clearly renders the invention obvious, was ignored because of the determination that a PHOSITA was a general practitioner or pediatrician, not a specialist in ear treatments. It seems like a PHOSITA should be someone who would have the skill level to make the invention as well as use the invention, which means the specialist (otologist, otolaryngologist, or otorhinolaryngologist) would have to be the PHOSITA.
Even so, it does seem odd that an invention would be determined to be obvious by one job (specialist) and non-obvious by another job (general practitioner), and have that determination being the sole reason for patentability (as a reference is completely ignored as being beyond the skill level of the general pratitioner).
I’m also not seeing where the PHOSITA was correlated with the inventor, besides saying that one inventor was a professor specializing in otorhinoloaryngology, and another was a research scientist engaged in the research and development of antibiotics. The opinion than established that there were others working in the same fields as the inventor, and at the same skill level, and determined that those who develop the treatments (in positions similar to the inventors) would be the PHOSITA (the opinion specifically states that a general practitioner would not have performed the experimentation on guinea pigs, as the inventors had disclosed, or have the knowledge necessary to develop the treatments), however, others that are engaged in research and development in positions similar to the inventors would have the knowledge necessary to develop the treatments.
This result is risible. By definition, an “invention” is “obvious” to the “inventor.” Were it not, how could the inventor create it?
Ha-ha-ha…
Very troubling case!
This case suggests that, all else being equal, an invention is more likely patentable if the inventor has a lower educatation level.
A better rule would be that the PHOSITA is a person interested in PRACTICING THE SUBJECT MATTER OF (or INFRINGING) the claims at the time of invention. After all, the claims LIE AT THE HEART the art pertaining to the invention and should be the most important factor in determing what constitutes the pertinent art.
Everything that is simple is not obvious and vice versa.
Does anyone think simple and obvious are the same?
Is a simple invention patentable?
What bearing does the perception of an invention being complex or simple have on patentability?
The invention all admired, and each how he
To be the inventor missed; so easy it seemed,
Once found, which yet unfounded most would have thought,
Impossible!
Milton, John, “Paradise Lost”, Part VI, ll. 478-501 (1667)
Caveman, not “quickly”. Most of the revenue comes from maintenance fees, so that part won’t be largely affected for a decade or more. In the interim, they can just raise initial fees by (say) 80% to make up for the shortfall and cover their “costs”.
Yes, after that there will likely be reform (or revolution), if there is anything left.
So, if the inventor’s skill is relevant to the obviousness inquiry, a baker who invents a new rolling pin would argue that his invention must be non-obvious because, after all, he has less skill than ordinary skill in the art of carpentry. Were this not the case, the Court would be having its cake and eating it.
When the fees stop rolling in because of the new rules and proposed “reform” we will quickly see the new patent reform “reform.”
“The general theory is that highly educated and trained PHOSITA know more and tend to think more inventions are obvious” I don’t understand this statement and, with all due respect, its weasely. It’s like a USAToday oversimplified MacFactoid.
The key word in PHOSITA is “Ordinary.” Almost by definition, someone with incredibly high levels of skill in areas that are accessible to others, e.g. ear treatments, are not of “ordinary” skill.
Someone of ordinary skill in metal working could arrive at an invention that would be unobvious to those of ordinary skill in metal working, while, ex post facto, the invention might seem obvious to someone with an advanced degree in material science.
The suggestion embedded in the statement quoted above seems to cross the hindsight threshold. Sure EVERYTHING would be obvious in hindsight to those having extraordinary skill or even to the man on the street for that matter. That is not the test. The test is “ordinary” skill at the time the invention was made, e.g. without hindsight. If it would be so obvious to an Otologist, where is the art?
VCs are just lobbyists passing money to private parties instead of politicians:)
I just reviewed the new PCT search fees. I have f-ing had it. Is there any chance that DUDAS WILL BECOME THE NIFONG OF PATENT DIRECTORS?
Perhaps it goes without saying, but, I’ll say it anyway; Inventors please take note:
The difference between private investment and Vulture Capitalists (VCs) is this:
If private investors see that your life is dedicated to making a ROI for their and your investment, they will give you nothing but encouragement and maybe more money as you can justify, while, on the other hand, the VC will tear you down every chance they get to take more and more advantage of you and your angel investors.
The reason 95% of VC deals go south is because they de-motivate the entrepreneur. Generally speaking, VCs don’t have the brains of an ant (no offense to ants). VCs are PHOSITA of destroying motivation and entrepreneurial-ship.
I don’t know if youse guys think I am funny, but I do:
“I suspect a skilled educated physicist upon seeing Einstein’s new formula over cocktails for the first time might have slapped his forehead and said, Al, OF COURSE!, why didn’t I think of that!”
I bought myself an early cocktail on that one – the pause that refreshes.
Cheers! Happy New Year to all my Orthodox investors. Please keep the faith. I’ll fight till my dying breath to make your confidence in me amply rewarded.
Advice to my fellow Inventors (you know who you are):
If you have a really really great money-making invention, forgetta-bout Vulture Capitalists, they will eat you alive and lay off their bad judgment (19 times out of 20 their deals go south) on you via onerous terms; they will make you carry their bad investment luggage on your back. And if your ship does come in, they will screw you and your angel investors royally out of the well-deserved fruits of your labors and investments.
Remember this: Jesus saves, but Moses invests!
Einstein’s Theory Explained (please tell me if you heard this one):
Here’s a thought, logical thinking, maybe even obvious thinking:
<> When an object emits something it must become lighter.
It therefore follows that, when a flashlight emits light (“c”), it becomes lighter.
<> Lighter means, e.g., a decrease in mass (“m”).
<> The decrease would be equal to the amount of light energy radiated divided by the square of the speed of light (because the time tested and long-known rule is that light diminishes proportional to the square of the distance from the source).
<> Laws governing the conservation of mass and the conservation of energy are also time-tested and have been known for a long time.
Therefore, I ask, was the following obvious to “one skilled in the art”?:
“When an object emits light, say, a flashlight, it gets lighter.”
A) That’s only logical, even obvious;
B) In Einstein’s day, there were many PHOSITA physicists who knew that mass and energy were interrelated; and
C) The PHOSITA also knew that the brightness of light “c” decreased by the square of the distance from the light source.
Was m = E/c(squared) (same as E = mc(squared)) therefore obvious to PHOSITA physicists after it was formulated?
I suspect a skilled educated physicist upon seeing Einstein’s new formula over cocktails for the first time might have slapped his forehead and said, Al, OF COURSE!, why didn’t I think of that!
Here is a fascinating audio link that motivated my thinking about explaining Einstein’s formula in such obvious terms:
link to pbs.org
What is invention?
wordnet.princeton.edu/perl/webwn = “the creation of something in the mind”
Well, maybe that definition is a little too loose for the PTO.
I like this definition:
“Invention is what makes the non-obvious obvious,” with this clarification: “Everything is obvious after it has been invented.”
All this blogging works up a powerful thirst; only 48 minutes till 5 – – I can last …
…under this standard most Nobel Prizes and the Theory of Relativity are obvious…clearly not the standard intended by the drafters of the Patent Act – IMO.
Ya know, if we were all as smart as Einstein…
The discounting of creativity by courts is my general beef with obviousness law generally. It seems all to often that courts do not give inventors their due for creativity.
I’ve met some brilliant, highly educated, highly skilled in many different arts people that can’t create themselves out of a paper bag. This gives rise to the most essential patentability question: Does ordinary skill in the art mean:
(a) a creative person skilled in the art?, or
(b) merely an educated person skilled in the art?
If the answer is the former (a) then, potentially, nothing would ever be patentable – – and a lot would depend on the level of creativeness required, and then you’d really have a problem, because, how do you measure creativeness?
You might as well try to measure a cloud.
“Although the education level of the inventor appears to be relevant to determining the PHOSITA skill level … Of course, the process of inventing is intimately tied-in with the inventor’s skill and education level.”
I certainly agree. However, neither “skill” nor “education” does it for me when discussing PHOSITA; for me, the issue is “creativity.” Creativity as often as not has little relationship with skill or education.
Isn’t the essence of invention creativity?
So, please tell, how do you measure creativity?
Dennis wrote, “In essence, use of the inventor’s biographical information in determing the PHOSITA skill level allows the court to ask whether the invention would have been obvious to someone standing in the shoes of the inventor.”
The inventor’s biographical information is merely one factor to assess the level of ordinary skill. This factor is relevant at least because the inventor is working “in the art” of which the person of ordinary skill is also working.
Sure, there might be a risk that the finder of fact may erroneously consider the inventor’s level of skill to be ordinary. However, the plaintiff is free to submit evidence of other factors including: (1) type of problems encountered in the art; (2) prior art solutions to those problems; (3) rapidity with which innovations are made; (4) sophistication of the technology; and (5) educational level of active workers in the field. The plaintiff shoould be able to persuade the finder of fact that this last factor (the educational level of active workers in the field) is far more important than the educational level of the inventors themselves.
I think Dennis’s concern about blurring the line between the inventors’ skills and ordinary skill is largely overblown, but may be legitimate where the inventors have no peers to compare to. Here, however, there were “others working in the same field as the inventors of the ’741 patent were of the same skill level.” I have no problem with this result.
Well I have to thank the courts to shy away from 35 USC 112, first paragraph and inequitable conduct reasons for invalidating patents they want to invalidate. In addition this shows a level of creativity of the Federal Bench not seen since the days of Associate Justice Learned hand, Associate Justice Brandeis and Chief Justic Hughes. Way to go judges.
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