by Dennis Crouch
Senju v. Lupin (Fed. Cir. 2015)
In a split decision, the Federal Circuit has affirmed a district court judgment that Senju’sU.S. Patent No. 6,333,045 is invalid as obvious. The patent covers an eye-drop formulation that is mixture gatifloxacin and EDTA (sold as Zymar) and has an interesting litigation history. In particular, this case represents the fourth time that the patent has been asserted in a lawsuit before Judge Sue Robinson (D.Del.). That history includes a prior finding by Judge Robinson that the claims were invalid as obvious. Following that original obviousness decision, Senju successfully shepherded the claims through an ex parte reexamination. In that process, the PTO confirmed the patentability of the claims once amended to include a specified concentrations of the aforementioned ingredients (e.g., “about 0.3 to about 0.8 w/v%” of gatifloxacin and “about 0.01 w/v%” of EDTA). Following reexamination, the court blocked Senju from asserting the reexamined claims against the same party (Apotex) who won the first obviousness decision — finding that claim to be precluded. However, the court did allow assertion of the new claims against new parties – here Lupin and Hi-Tech Pharma. However, after considering the same prior art as the USPTO, Judge Robinson found the revised claims still obvious based upon -again – the same prior art.
On appeal, the Federal Circuit affirms – holding that the district court’s conclusion of obviousness was correct. In the process the Federal Circuit appeared to give no deference to the USPTO reexamination determinations other than to require clear and convincing proof of the factual underpinnings of the obviousness determination. See Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1260 (Fed. Cir. 2012) (“Whether a reference was previously considered by the PTO, the burden is the same: clear and convincing evidence of invalidity.”). The appellate court did agree that the amendments during reexamination did refresh the patent claims so as to reestablish the presumption of validity in the face of the prior invalidity ruling.
Regarding the added concentration limitation of “0.01 w/v% EDTA,” the two sides fought over whether that concentration level was suggested by the prior art studies. The court writes:
At bottom, the district court’s analysis rests largely on a determination that Lupin’s experts were more credible than Senju’s experts. Based on this determination, the district court found that [the Prior Art] Grass 1988-I, along with the other cited references, taught that 0.01 w/v% EDTA would be effective to increase corneal permeability. On the evidence before us, that determination by the district court falls well within the wide discretion the court has to weigh expert credibility. Ordinarily, and absent compelling reason otherwise, an appellate court defers to such credibility determinations.
With that (and some further analysis), the court affirmed the obviousness finding.
= = = = =
Judge Plager drafted the majority opinion that was joined by Judge Moore. Writing in dissent, Judge Newman argued that the courts should “give deference” to the PTO’s review of the narrowed claim scope and its conclusions regarding the unexpected results associated with the newly narrowed claims. Judge Newman further writes:
The prior art is crowded. . . . However, no combination of prior art references shows or suggests the use of very low concentrations of EDTA to enhance the corneal permeability of antibiotic formulations of gatifloxacin, or of any other quinolone. . . . The panel majority relies on the unsupported opinion of Lupin’s expert witness, and gives that unsupported opinion greater weight than the experimental data.
= = = = =
Although PTO reexamination decisions are not given deference in this type of third-party challenge, there are some reasons to think that IPR/PGR decisions should be given deference under the APA. However, it is unlikely that the Federal Circuit would come to that conclusion without first being led by either Congress or the Supreme Court.
New Patent Law Would Trash Disease Cures
link to forbes.com
US 6,795,918 is today’s atrocity for a dozen odd tech companies to defend, thus increasing costs and decreasing actual innovation for rest of us. Firewall software whose “novelty” is that a user can’t configure it. Which flavor of obviousness do we have here?
Test.
Cannot find the filter-tripping word, sorry Mr. Snyder.
Ned, since your Fed. Cir. pending legal challenge re the unconstitutionality of IPRs* also must apply to all reexaminations rendered since the option of de novo D.C. review was removed, let us know when your oral argument date, if any, is provided?
*MCM Portfolio Company v. Hewlett Packard Company Fed. Cir. Case No. 15-1091 filed 1/21/15.
That would be fun. Come and watch him anonymously as possible.
just fyi:
Halo Electronics v. Pulse Electronics
Petition for en banc rehearing denied
O’Malley’s dissent (joined by Hughes):
[T]he structure for assessing willfulness set forth in Bard and our old § 285 Brooks Furniture test were both predicated on our interpretation of the Supreme Court’s decision in Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc. (“PRE”), 508 U.S. 49 (1993), which we believed required a two-step objective/subjective inquiry before either enhanced damages or attorneys’ fees could be awarded. We have gone so far, moreover, to require that an evidentiary wall be erected between the objective and subjective portions of the inquiry. We preclude considerations of subjective bad faith—no matter how egregious—from informing our inquiry of the objective baselessness of a claim and preclude the weakness a claim or defense from being indicative of a parties’ subjective bad faith….
We now know that the artificial and awkward construct we had established for § 285 claims is not appropriate. We should assess whether the same is true with respect to the structure we continue to employ under § 284.
Write up re the original case and the petition here: link to patentlyo.com
Paul, will do.
FYI, the HP brief was filed today and is available thru Pacer. The Director has to file a corrected brief. I will let you know when that too is available.
The HP Brief did not raise de novo review as a potential savior. It might behoove folks trying to save their collective a’s to file amicus briefs arguing Patlex district court (de novo review solves Art. III, 7th Amendment problems) coupled with Executive Benefits Ins. Agency v. Arkison, 134 S. Ct. 2165, 573 U.S., 189 L. Ed. 2d 83 (2014)(de novo review solves Art. III, 7th Amendment problems) is a solution to this. Combine that with a legislative effort to restore de novo review — with respect to all pending reexaminations and IPRs, and the potential damage will be limited. It may also rescue the AIA as a whole, because if any provision of the AIA is held unconstitutional, it all goes done. Urgent action by the movers and shakers is necessary.
Still, with respect to final reexaminations with claims cancelled from the patent, I think folks trying to recover will confront another problem: waiver. If one does not assert their constitutional rights, one waives them.
Ned: if any provision of the AIA is held unconstitutional, it all goes done.
And then what?
Here’s an idea: we can stick a big fork in the functional claiming of junky information processing garbage and re-pass the AIA with more reforms, including more opportunities for review of improvidently granted patents and greater restrictions on patent assertion by “patent monetizer” types.
Bring it on.
Where was that fork while the AIA was being drafted?
Methinks you have an opposite-Teddy thing going on: speak loudly to compensate for your little stick.
MM, good idea.
For one, repeal 112(f). No savings clause. If a claim is functional at the PON, it cannot be rescued by 112(f). It is invalid.
This is a long sought goal of mine.
“This is a long sought goal of mine.”
I have to chuckle at the implicit admission in this statement.
If Ned’s goal is to change the law, then by default the current law is not what he wants (or often, how he attempts to portray the law to be).
Of course, the next step on this little logical journey is to realize what Congress actually did in 1952 – and what Federico actually said about the use of language sounding in function, especially in combination claims.
The prohibition that is so often sought to be over-applied is against TOTALLY or PURELY claims of function.
As a certain blog master once indicated, there is a Vast Middle Ground of claims with some physical structure AND functional language (even at Ned’s version of PON) that is completely acceptable under 35 USC 112 – with or without the option of section (f), as I have demonstrated with case law such as In re Orthokinetics – tellingly, a case none of my proponents have even dared comment upon (and that case is not even a “software” case)…
Anon,
Do you think Orthokinetics? Seems like the ‘problem’ with the claims in both instances were fairly similar.
Hah, to clarify, do you think Orthokinetics survives Nautilus?
I do not recognize what it is that you think comes from the Nautilus decision, so I do not have a frame of reference for your comment or the comparison to the Orthokinetics case – a case that remains solid law.
Or are you saying that the Supreme Court sub silento has thrown out Orthokinetics?
case law such as In re Orthokinetics
ROTFLMAO
…and the mindless drivel continues…
link to nytimes.com
The article above is a great example of how far we have fallen. Facts don’t matter. Only what people feel.
Anon, the problem is with the latest “functional” judicial activism is that people don’t understand how to map a claim to real world inventions. That is the problem. Funny too the way it is so similar to “abstract.” Lemley figured out that people don’t understand these terms well particularly layman like the new Google judges and the SCOTUS. They are terms that ripe for being categorized as witches.
I think the way to counter this is to ask for real world examples. What solutions would a person skilled in the art people able to come up with given the spec and claims at the time of the invention?
Note the way the judicial activist never answer this question. They never tie the claims to real inventions. This is very much like the “abstract” witch.
>>a big fork in the functional claiming of junky information processing garbage
Except that this is a made up problem that isn’t real. Thanks Lemley.
(You notice too, Dennis, the pushing of the agenda constantly from MM. Gee, I wonder who pays for that?)
The Director’s corrected brief is now filed and available on pacer.
Why not hotlink it here? It is a Government written publicly filed document.
Paul, perhaps Dennis will link the briefs as they are filed.
In the absence of the pending atrocities fora, I give you today’s example. A quiver of energy companies sued, costing anyone who uses energy some miniscule amount….I ask: obvious, abstract, not adequately described, anticipated, or all of the above?
link to google.com
link to deathpenaltyinfo.org
Another prisoner has been set free. We need to end all criminal prosecutions.
There’s no way that wasn’t anticipated or obvious in 2000. Controlling devices which use different net protocols via a website. CSS came out in 1998, so creating a “gui” by a series of instructions was well established as standard practice. Even using HTML tables for formatting is arguably a GUI by instruction and that was happening since Mosaic.
Even if theres no art which anticipates this, which I would highly doubt, this is completely lacking enablement without undue experimentation. The spec keeps harping on allowing the user to issue standard device commands which get interpreted into vendor specific commands. Fig 9, 906. Except that if that is the point of novelty (which from my quick read it seems to be) there’s absolutely no direction that would enable a practicioner to make those routines.
It’s just a conclusory: “Translate them.” Uh, okay, except if you’re claiming that’s the useful non-anticipated function of your patented technology you should describe how the commands are translated. Do you have a database (this is unclearly implied) containing the rules? So the idea is to store translations and pull them out — e.g. store data in a database then access the data e.g. exactly what databases have done since the first ones were written in the 50s and 60s. Storing data in a database then retrieving it is not novel or nonobvious. If its some sort of intelligent on-the-fly translation (which might actually be novel) it isn’t described and certainly isn’t enabled.
I’m not going to go into a full analysis on this thing as nobodies paying me to. This is no legal opinion, by a personal opinion: the system ought not allow this type of patent as insufficiently described/not enabled. A practitioner who had this same idea would save literally no time at all reading through the spec, it doesn’t enable anything. It just says configure off the shelf DB, Web Server, connect to Internet, and write some translations. Uh okay, so “I had this idea, but you have to do all the work.” What exactly is the public gaining from this disclosure?
Patenting is a trade off of gov’t granted monopoly in return for the public gaining the knowledge in order to practice an invention after that grant is done. The public gains nothing from this because it tells you “Here’s a loose idea, but you have to do all the work.” Gee thanks. They don’t even list the devices — how can this guy possibly claim possession of translating ALL possible networked device commands when he doesn’t list what devices he’s actually implemented this on?? Commanding a loudspeaker, a router, and a camera are not equivalents
Properly enabled pharma patents greatly reduce or eliminate the time to discover the compound. Mechanical patents elaborate and diagram in actual enabling images (e.g. the image shows the design and utility in one swoop by showing the structure of the thing) how to make/do the thing. Software patents like this one loosely describe a result and show you some garbage Waterfall design diagrams that would be the barest minimum starting point to start coding from. If you brought this to a software company this wouldn’t even function as a spec document. You’d need the list of devices, at the very minimum…
note: this is incomplete analysis based on a quick scan through. don’t consider this legal advice…
>>lacking enablement without undue experimentation.
No. According to Lemley all information processing/EE is automatically enabled no matter what you write. In fact, I don’t see why Lemley doesn’t write “A computer to perform the working functions of Mark Lemley,” and then pass it off to a clerk with a a pizza to get it done.
Hi guys,
I’m a registered patent attorney looking to start my own patent prosecution firm with one other attorney. I’ve worked for various other law firms (both large and small) for about 7 years. I know many seasoned patent practitioners frequent this blog, and I was just wondering if anyone out there had any recommendations, (e.g., billing software, docketing software, malpractice carriers) or practice tips for someone going into business for the first time. I would also like to ask: whenever you get a thorny legal question, and the statutes and case law are unclear, I’m wondering if there is some kind of online resource where patent attorneys go to maybe throw some questions out there and consult with other patent attorneys. Thanks in advance.
Joe,
I highly recommend you look into the National Association of Patent Practitioners.
That’s an interesting Association. How are the forums? Are they as bad as this one?
“I’m wondering if there is some kind of online resource where patent attorneys go to maybe throw some questions out there and consult with other patent attorneys.”
Welcome to PatentlyO. Ned’s around if you need to consult. There’s a few others around that claim to be attorneys, and at least a few that appear to be.
Great questions. I’ve been told that pretty much all billing and docketing software perform similar functions. The difference maker is the person you hire to use the software. Make sure the person has enough experience that you can reasonably rely on him or her, because you aren’t going to have a lot of time to oversee the workflow. Also, I like to keep my own docket as a back up by having my assistant add important dates to a calendar. If you get the docket situation well-tuned, you won’t need to worry as much about the customer service side of the malpractice carrier, in my experience. If you get the billing situation well-tuned, you won’t have to eat ramen noodles (for long).
Good luck!
Jamison for reasonably priced insurance.
FlexTrac for reasonably priced docketing software.
I just used Quicken for billing and accounting/taxes. My tax guy just took the end-of-year data from Quicken to determine my taxes.
The most recent stats from the Federal Patents Court in Germany is that 95% of all petitions for revocation were successful, in whole or in part. Only 5% of patents were upheld as granted.
Two points. First, we are not looking at equity or unenforceability in this civil law court. Second, there is nothing new about “nullity proceedings” before the German Federal Patents Court.
To me, this demonstrates 1) the pressure on Patent Offices to grant on very dubious subject matter and claims at the limit of patentable width, 2) the death squad at the USPTO is not the only one,and 3) inter partes proceedings explore validity far more effectively than ex parte proceedings at the PTO.
In view of this, should we:
a) scrap the current system immediately,
b) move to a pure registration system and let “those that care” – being far less than 2% by today’s standards – worry and “pay into” the cost of “examination” – as opposed to the Billions currently paid into in the US alone,
c) a combination of both, or
d) some other option
Of course, an option not listed is to simply carry on as is.
I’m curious as to this ecosystem’s examiner contingent’s views. This type of statistic cannot be very comforting as it appears to be a criticism far more severe than what I could “get away with” posting.
There is a very good argument that we have already moved to a registration system. $5-$30K for the registration. $500 PGR/IPR phase.
I think one order of magnitude of expense pretty much nulls out the registration fee. I think there is a very good argument to let all the examiners goo and focus on the PGR/IPR phase. Probably the money the PTO is extorting for registration is not well spent. The money would be better spent on the attorneys/agents that prepare the patent [application].
The attorneys could charge twice the fee to prepare the registration in preparation for the IPR/PGR (or PRegistrationR).
The IPR/PGR could be made more of a district court litigation and if you come out of it alive then the presumption should be almost impossible to break. Of course, the problem is standing and the fact anyone can file an IPR against you, which means there is no theoretical limit on the cost of maintaining a patent.
Really poorly thought out. Only a group with an intent to burn down the system would have come up with the AIA.
In my mind its as simple as this:
Either the PTO needs to be willing to spend the time to come at least 75% of the way of the completeness of a prior art search /obviousness analysis as it would receive in litigation, or we acknowledge that the PTO is doing a preliminary check that misses a great deal of art and stop requiring clear and convincing evidence when the evidence is art not previously considered by the PTO. This is basically the de-facto standard now in the post grant procedure AIA world.
I’m fine with either outcome.
“I’m fine with either outcome.”
Except that you are not per your very own comments above (posted minutes before this one).
Point to consider: while I do not want a registration system, it appears that we are at a point that ANYTHING other than what we have now would be better.
Keep in mind just how much the current AIA system costs the innovation community: several Billion dollars in user fees alone annually in the way of the USPTO budget.
Are you really fine with that?
That’s sad.
>>art not previously considered by the PTO.
This is wrong. An expert in a field does not have to consider each piece of art, but know the most relevant art. What you wrote actually is one of the great anti-patent wins that this is even written with opprobrium raining down on the writer. We can thank Lemley for this too. Gee, makes you want to get rid of all academics. They have nothing to do but sit around and come up with judicial activism ways of burning the patent system down.
“In view of this, should we:
a) scrap the current system immediately,
b) move to a pure registration system and let “those that care” – being far less than 2% by today’s standards – worry and “pay into” the cost of “examination” – as opposed to the Billions currently paid into in the US alone,
c) a combination of both, or
d) some other option”
I see no particular problem with business as usual except for the current inclusion of non-useful arts in the patent system as we have today.
You’ve become redundant 6.
Perhaps for the non-useful arts.
Over here in the useful arts we’re still weeding out plenty of non-meritorious claims and getting applications a decent search.
You mean the non-useful arts like the computer that helped you drive your car to work, that you are using to type comments, that evens out the power in the power grid, etc.
That non-useful stuff?
“You mean the non-useful arts like the computer that helped you drive your car to work,”
The only thing the computers in my car do is make my repairs more expensive. I don’t drive a fancy new car with a million tom gizmos.
“That non-useful stuff?”
Nah the computers themselves are fine. It’s the authoring of instructions for those computers that’s the part we’re discussing today.
The notion of ‘functionally related’ is lost upon 6.
The irony, of course, is delicious.
(I wonder if he is still trying to get his Britney Spears CD to act like a Windows operating disc…)
Why do you use “non-useful” things?
The oft purposefully mischaracterized reference to the Amish fits here.
For the likes of certain individuals that refuse to ascribe utility (as in, their Belieb that software is not in the Useful Arts), they should simply put their money where their mouths are and stop using what they consider ‘non-useful’ art items.
After all, there is an entire Belieb system that inculcates that type of exclusion.
“anon” stop using what they consider ‘non-useful’ art items.
It must be difficult to pretend to be a patent attorney, as you do, and not understand the difference between a junky functional patent claim and actual software that might fall within the scope of that claim.
Of course, this lame business about the Amish comes from the same self-styled referee who likes to pretend that the ineligibility of useful non-obvious books is somehow “off limits” when discussing instructions for computers.
Brush aside the ad hominem and (once again) you have said nothing.
Maybe you want to make your point using those short declarative sentences you are always on about…
link to slate.com
Everyone should re-read this article along with the recent article in the WSJ about Google manipulating search results to favor their products even when they were less relevant.
And, Google is number one in lobbying Congress, and Google doesn’t want software patents, and now we have a Google Fed. Cir. and Google Director.
Seriously, read those two article (and the one from ft.com) and tell me that all this anti-patent stuff doesn’t have the same feel.
“Seriously, read those two article (and the one from ft.com) and tell me that all this anti-patent stuff doesn’t have the same feel.”
When you define things with that feel as “anti-patent” then I’m sure they do.
You appear to miss the point that the same feel is there by paying too much attention to the label for that feeling.
Nah I got that point anon, I just don’t care about that feeling.
“I just don’t care”
An attribute that you have projected onto me…
(Another try)
“I just don’t care”
An attribute that you have projected onto me…
Seriously 6? You want to stand up for Google. The mob speaks.
The mindset that 6 presents in his “Bro” comments (which oddly do not make it past the censor when I point this out), exemplifies the inability of 6 to employ critical thinking.
This is why 6 is the postcard of the non-thinking lemming, having quaffed prodigious quantities of the anti’s koolaid, and pretending that the aspect of software that deserves patent protection does not exist and instead wanting only to portray a different aspect of software.
He seems completely unwilling to recognize the reality that software simply has multiple aspects, each of which can earn protection under the different realms of intellectual property law.
Sadly, attorneys who should know better (and some who do, but still act otherwise), are permitted (and at times the perception is there of being encouraged) to obfuscate the reality that different intellectual property laws provide different protections for different aspects of those things manufactured by the hands of man.
America’s leading source of something other than patent law is a bane to actual patent law.
And that is an inconvenient fact for many of a certain philosophical leaning.
>America’s leading source of something other than patent law >is a bane to actual patent law.
I think you are right. It is impossible to discuss real issues on here unless they fit the paid bloggers agenda. It is impossible to compete with someone that is being paid to blog full-time. If you post something that doesn’t fit the agenda, you are blasted into obscurity with dozens of posts are attacked.
I would ask Dennis –again–to do just one thing: verify that the frequent contributors are real people and simply check out their employer.
I would distinguish your comment in a nuanced – but important – way:
Competition.
In a “battle for thought” competition is affected by all the rules of “rhetoric,” including the arts of sophistry and propaganda.
As my friend Anon2 so subtlety pointed out, this is not an objective forum.
One of the “tricks” then is to simply not fully engage in a true dialogue.
As I have pointed out, there are several paths to this method often employed here.
You have the “blast” method. You have the ever-polite-but-disappearing-at-critical-points method, you have the won’t-acknowledge-counterpoints method. You have the pure-ad hominem-attempt-to-discredit-Med (or ‘can’t understand English version) method.
These are methods ployed time and again – and without reference to the paid or not status of the sAme ones (to draw a clear distinction from the mere sOmeones).
It is not a matter of “competing” as much as it is a matter of how that competing unfolds.
The ability to engage in an internet style shout down by merely repeating old positions ad nauseum no matter what counterpoints are raised in any one discussion is the key driver why there is no improvement in “the ecosystem” over the course of nine years. And this is why there will be NO improvement.
I “get” that different viewpoints being expressed is a desirable thing. The problem comes when those different viewpoints wanting to be “preserved” comes at the expense of actually arriving at conclusions necessitated by logic, critical thinking, and real law and history that simply do not support certain philosophical stands.
The merry-go-round continues. This forum is a bully pulpit for incompatible views – and the battle is not over.
That’s basically right anon. My big point, though, is that paid bloggers really tip the scales.
It is a bigger issue than this blog. It is happening all over the Internet. I posed an article a while back about paid bloggers. One point are the odds that the anti-patent groups haven’t hired paid bloggers? Zero.
People really should read these articles because they illustrate the tactics used by Google and the fact that Google has effected epic change.
If you care about our patent system, then you should take a look at these.
Also, if there is any truth to the proposition that executives of corporations become like their corporations, then these articles also go to what we can expect from Director Lee.
Perhaps I should qualify my remarks above.
About one third of oppositions at the EPO end in the patent being “maintained in amended form”. A high proportion of the German Federal Patent Court invalidity cases end in the patent surviving with a narrower claim.
When this is the outcome, should it be counted as a win for the patent owner or for the petitioner for revocation? Most commentators put it at 50:50. In about half the cases, the narrower claims are still potent. So, in Europe, a fair proportion of cases where the patent does not survive as issued do constitute a “win” for the patent owner. And of course, a patent whose validity has been through the fire of such proceedings does of course carry an enhanced presumption of validity.
“does of course carry an enhanced presumption of validity”
Is that a legal statement?
Is that only for the particular art?
How does that wash in a system without state decisis?
I think rather that such was what is called “a throw away” comment.
In England, if you see off the validity attack you can ask for a Certificate of Contested Validity. Challenge the validity of a patent so certificated and, if you lose, you pay legal costs to the patent owner at a higher-rated scale.
Regardless of jurisdiction, if the best prior art just failed, and so did the new matter and enablement attacks, and you are next up, to attack validity, what are you going to do, to bring the patent down?
You have managed to both dodge the questions I put to you and assume that any first “attacker” actually had the “best” art.
Please try again to answer the questions without such self-serving assumptions.
Might I add, Max, that in Europe generally speaking if a claim narrowed in a postgrant proceedings still covers products still sold within the statute of limits, that one can still collect damages. Not so in the United States.
Couple that with no reliability of injunctions as opposed to Europe and our postgrant proceedings are caused substantial damages to patent owners who must amend their claims.