America-Israel Patent Law

"The Far Side" and Non-Obviousness/Inventive Step

There are a few Far Side cartoons that that are not only funny but useful for illustrating basic concepts in patent law.  One of those ran today on www.thefarside.com: it shows a group of cavemen with animals draped over their backs, and one caveman standing off to the side holding up a flint tool, saying "Yes, with the amazing new ‘knife,’ you only have to wear the skin of those dead animals". (I provide the description because the link will expire in three days.) This is an example of both novelty (previously unknown) and non-obviousness (as evidenced, e.g. by the fact that all the but huckster are wearing entire animals, some of them live - at the very least, this knife addresses a long-pelt, er, long-felt need).

Modeling Pandemics: An Illustration of Why Hindsight Reasoning Drives Patent Applicants Crazy

A friend shared this link to a comic-style presentation of the difficulties inherent in modeling a pandemic. In nutshell, lots of potential variables (not all of which are necessarily relevant in all contexts), and not enough data to populate those variables.  Ergo the predictions arising from those models may be wildly off.  

For many patent practitioners, there's a familiarity there, that comes from dealing with a prior art document that throws in everything but the kitchen sink.  It's not unusual for some patents or published applications to provide long lists of the potential identities of various components in a pharmaceutical or other formulation, or in a process for making a chemical compound or a formulation, or to provide long lists of potential substituents at various positions of a molecule.  Or maybe the patent recites broad ranges for the amounts of various components in a formulation or a process. 

When all those variables are taken into account, there may be millions or hundreds of millions of possible combinations.  Even the best-funded applicants can only provide a few hundred examples to illustrate those millions of possible combinations, and more often than not, the application will provide only a handful of examples.  And yet for a patent examiner - speaking, of course, for the hypothetical person of average skill in the art - when looking at that earlier publication as prior art, it was always obvious to pull out the much narrower group of combinations or the specific combination that's claimed in your client's own pending application. 

Sure. Just like it's easy to model a viral pandemic. 

The “Kosher Lamp” and the Redskins Trademark Saga: Reminding Us that “Patent” and “Successful Business” Are Not Synonyms

If the above title seems to be a non-sequitur, keep reading, because it’s not.

There’s been a lot of writing in the IP world recently about a US federal district court judge upholding the USPTO’s decision to revoke the trademark for “Redskins”, used in connection with the professional football franchise in DC.  The NFL, and Redskins team owner Dan Snyder, share the traits of deep pockets and dense skulls, so it will be shocking if an appeal isn’t filed. But even if sustained, the revocation of federal TM registration won’t stop the league from marketing Redskins apparel and, in all likelihood, profiting nicely in the process.  No less importantly for the league, the revocation won’t necessarily pave the path for knock-off artists to sell Redskins merchandise.  The team has been around for a long time, and it’s reasonable to say that the name “Redskins” and the team logo and colors have at this point in time acquired not only distinctiveness but goodwill.  So the NFL will likely still be able to avail itself of state trademark claims, including claims for infringement of unregistered marks (also known as “passing off”), and perhaps trade dress claims as well.  Whether it should continue to use “Redskins” as a team name is a separate question, as is whether the same arguments that led to revocation of the federal trademark registration would be good defenses against other claims that the NFL might bring.

The critical point is that, because the NFL is a strong, established business, it can use its existing market position to continue to profit from the Redskins mark, and to out-compete most nascent competition. 

This brings me to the connection between the Redskins’ situation and the second half of this blog post title.  A common fallacy among the uninitiated is that merely applying for a patent, let alone actually obtaining a patent, will make one rich.  I’ve lost track of the number of times I’ve had to disabuse potential clients of this notion.  As anyone who’s been in the patent law business long enough knows, a good idea, or even a good patent, isn’t sufficient.  Succeeding with a product in the marketplace depends on many, many factors; the procurement of a patent is just one of them. 

Sometimes, though, obtaining a patent isn’t even necessary. Case in point: the so-called “kosher lamp”.  By way of background, religiously observant Jews will use electric lights on Shabbat, but they’re prohibited by religious law from turning those lights on or off.  A common work-around to this issue is to use a timer to control the operation of the light. Sometimes, however this isn’t optimal: if you wake up in the middle of the night when the lights are off and you want to read until you fall asleep again, you’re out of luck.

Enter the “KosherLamp Max”.  This is a lamp in which the lighting element resides in a compartment having an opening in its side, through which the light can shine.  The twist, pun intended, is that there’s a shade that can be partially or fully rotated into place to cover the opening, thus reducing or completing blocking the light.  Judging from the testimonials, it appears that this product is doing well.  Yet as far I’ve been able to determine, there are no patents on this product.  Nor should there be: I recall a similar lamp in my parents’ in my childhood, and the lamp at right was evidently designed in 1967. 

The usefulness of patent protection doesn’t seem to have been lost on the proprietors of the KosherLamp: about 10 years ago, a US patent application was filed for an earlier version of the product, but was abandoned after the first Office Action. That version of the lamp utilized an incandescent bulb rather than a compact fluorescent bulb (which generates less heat), and the claims focused on the product features incorporated to dissipate the heat generated by the incandescent bulb. The same fate awaited the corresponding Israel patent application.  Nevertheless, the product is now out there, without the benefit of patent protection. 

It will be noted that there is a registered US trademark for a stylized “KosherLamp” logo.  So it’s possible that others may make a similar product and market it under a different name.  But having been first to market, and having now made something of a name for itself, I suspect that the KosherLamp will continue to be the leader in this particular niche market for some time.

In sum, IP can be a useful part of a business plan, but doesn’t sell products, and rarely will IP alone make anyone rich.  And sometimes, it’s not even necessary.

On Fields Medal Winners, Obviousness, and Patent-Eligibility

I came across this article about Manjul Bhargava, a Princeton professor who was recently awarded the Fields Medal, considered the Nobel Prize of mathematics.  What sets him apart from most mathematicians is not just the fact the he improved on Gauss (!) in an old branch of mathematics, number theory, but his passion for explaining his work clearly to the not-so-mathematically minded.  It was this paragraph, though, that caught my eye as a patent practitioner:

Elegance and simplicity are two of the highest goals of all mathematical expression. “A not-so-elegant proof would be like a corn maze, where you can’t see where you’re going,” explains Wood. “An elegant proof is like a road where you can see where you’re going.” Ng says: “When he explains his work to you, it seems like it’s obvious. And you think, ‘Oh well, there can’t be much to it because it’s so obvious.’ Then you realize that it’s actually very profound. There are problems that people have been working on for hundreds of years and have made no progress. Manjul somehow managed to see something no one else could.”

One the things that has bothered me almost since my first day in this profession is the unwillingness of many examiners to recognize the failure of others as evidence of non-obviousness.  I routinely have to tell clients (with a sigh) that the fact that no one before them solved the particular problem they've solved, let alone in the particular way they've solved it, is often insufficient to overcome an obviousness rejection.  Sure, examiners (and judges) aren't supposed to use hindsight in view of the invention itself, but when you present an elegant solution to a problem, you're sometimes inviting the assertion by lesser lights that your solution was obvious.

And according to recent US court decisions, if you're working in the area of algorithms, then you must be working with an abstract area or preempting someone else's research or something like that, so your invention shouldn't even be eligible for patenting.  Because, you know, you're just a Fields Medal winner, whose work has broad application to many number theory problems.

Sleep On That: Even When Trying to Help Hapless Pro Se Mattress Inventors, ILPTO Awards Excessive Fees to Well-Funded Opponent

Mr. and Mrs. Gabbai live in Ashdod. They developed a three-layer mattress, which they asserted helps prevent sudden infant death syndrome (SIDS). In 2007 they filed a US patent application on their mattress, which eventually issued as US 8065767. The corresponding Israel case, application no. 179840, didn’t fare as well: although allowed by the Examiner, the application was rejected by the Deputy Commissioner in pre-grant opposition proceedings instituted by Aminach, a well-established local mattress manufacturer. There are several aspects of the decision worth noting: first, the basis on which the application was (and was not) ultimately rejected; and second, the award of attorneys’ fees given to Aminach.

Aminach asserted that the patent shouldn’t be granted because (a) the Gabbais breached their duty of disclosure (by failing to provide the ILPTO with the publications cited by the USPTO examiner), (b) the claims were unclear, (c) the invention was neither novel nor inventive, and (d) the invention lacked utility.

Despite acting pro se (and, unsurprisingly, making numerous mistakes along the way as a result, e.g. attending the hearing at the ILPTO without being prepared to cross-examine one of Aminach’s witnesses), and despite the fact that Aminach was represented by one of the largest IP firms in Israel, the Gabbais managed to successfully parry most of these assertions. With respect to the non-disclosure of the references from the USPTO, the Deputy Commissioner noted that deliberate concealment is one of the requirements for sanctioning an applicant for non-disclosure, and she ruled that since Aminach hadn’t provided any evidence to show that the non-disclosure was deliberate, she had to find for the Gabbais on this point. Likewise, she found that the invention was novel and inventive over the prior art cited by Aminach.

What the Deputy Commissioner found lacking was utility. The Gabbais had asserted in their application that the mattress reduced the incidence of SIDS. Aminach’s expert witness, a physician, pointed out that there was no evidence in the application or even provided by the Gabbais later that showed that the mattress in fact achieved this result. Since the Gabbais were deemed not to have submitted their own evidence (because their evidence was filed as a letter rather than an affidavit), and their cross-examination of Aminach’s expert wasn’t terribly successful, the Deputy Commissioner ruled that that invention lacked utility and was therefore unpatentable.

The difficulty with that determination is, of course, that no one disputes that the mattress actually worked as a mattress. That alone is sufficient to qualify for utility under section 3 of the statute: “An invention, whether a product or process, in any technological field, which is new, useful, susceptible of industrial use and inventive, is a patentable invention.” Whether or not the mattress worked to reduce SIDS is (or should have been) immaterial. By stressing in their patent application that the mattress reduced in the incidence of SIDS, the Gabbais opened themselves to obfuscation of this point by Aminach’s attorneys. Had the application merely described what the invention is – viz., a mattress having a particular construction – without singing its praises, it is doubtful that the Deputy Commissioner would have been duped into agreeing that the invention lacked utility.

(Having determined that the invention lacked utility, the Deputy Commissioner didn’t rule on the clarity of the claims.)

No less remarkable was the awarding of 40,000 shekels (over US $10,000) in attorneys’ fees to Aminach. Aminach actually asked for over 140,000 shekels in fees, but refused to provide its attorneys’ billing sheets on the grounds that these were privileged. The Deputy Commissioner ruled that the billing sheets were not privileged documents, and that their non-production left the Gabbais without an opportunity to challenge the billings; nevertheless, she awarded 40,000 shekels on the basis of “the evidence and pleadings filed by the opponent, the fact that the applicants didn’t file their own evidence, and the great savings incurred by the fact that the summations were presented orally rather than in writing [as is the norm in Israeli legal proceedings – DJF]”.

Perhaps the Deputy Commissioner felt that she was doing the applicants a favor by awarding significantly lower fees than the prevailing party requested, but it’s still a slap in the face: you file a patent application on an invention which is novel and inventive, you nevertheless lose in an opposition, and then you have to pay the other side? It should also be borne in mind that just a few years ago, an award of 40,000 shekels was unthinkable – an award of just 5,000 shekels would have been considered sizeable. The request for 140,000, and the granting of 40,000, are clearly the result of the ILPTO’s trend to grant attorneys’ fees award far in excess of what real courts of law themselves actually award.

If anything, the fee award in this case will discourage inventors with little money from seeking to commercialize their inventions or otherwise disclose them in patent applications – why bother to do so if a better-funded competitor hire some good lawyers to sell the ILPTO a load of baloney not only to prevent you from getting a patent you deserve, but to also convince the ILPTO to tell you have to pay for your competitor’s lawyers?

(For those of you who read Hebrew, the transcript of the hearing before the Deputy Commissioner, as well as the letter the Gabbais sent to her the day after the hearing, both of which can be viewed on the ILPTO’s web site, make good reading if you’re looking to illustrate why acting pro se is usually a bad idea.)

Inherently Incomprehensible: Does the CAFC’s View of Inherency in In Re Kao Spell the End of Second Medical Use Patents in the USA?

The Federal Circuit’s May decision in In re Kao caught the attention of the patent prosecution community in general, and those of us working in pharma in particular, because it seemed to give some more contours to the obviousness doctrine post-KSR.  The decision involved three patent applications, all of which relate to aspects to Endo’s Opana ER^®, a commercially successful extended-release version of the opioid narcotic oxymorphone.  The Board of Patent Appeals and Interferences (BPAI) had rejected all three applications on grounds of obviousness; the CAFC reversed and remanded in one application (11/680,432) and sustained the Board’s rejections in the other two cases (12/167,859 and 11/766,740). 

It was the decision in the ‘432 application that grabbed the headlines.  Among other things, the CAFC said that it was wrong for the PTO to say that the dissolution profile recited in the claims of that application was obvious in view of the Maloney reference (WO 01/08661), since Maloney disclosed determining the dissolution profile using a test which was different from the test recited in the claims, and there was no evidence that the two tests were equivalent.  Interested readers can check the summaries in PatentDocs and PatentlyO for more information. 

What doesn’t seem to have attracted widespread attention, but did catch the eye of Endo’s attorneys (Jeff Lewis et al.), was the Board’s treatment of the ‘859 application and the CAFC’s upholding of that decision, in particular its application of the inherency doctrine.  Under the CAFC’s case law, this doctrine says that even if no one appreciated what the prior art taught, the fact that a product or process was inherent in the prior art means that the thing now being claimed is not new.   

The CAFC’s 2003 Schering v Geneva Pharmaceuticals decision provides a reasonable illustration of this doctrine.  In that case, the one and only claim of Schering’s patent application, a claim directed to a particular chemical chemical compound, was found to lack novelty: it was undisputed that the claimed compound, a metabolite, was formed in the human body whenever a person ingested a different, known compound, and that ingestion of that different, known compound by people had been taught in the prior art.  Thus, despite that fact that before Schering, no one had actually identified the metabolite, the claimed compound per se was inherently disclosed by the prior art (since the prior art taught how to make the compound – just administer the precursor compound to a person) and therefore the claim on the compound per se lacked novelty.  In that decision, the CAFC noted that Schering could have secured protection had its claims been worded differently, for example if it had claimed the compound in solid form or substantially pure form, neither of which were inherently disclosed by the prior art. 

Inherency is thus a basis for making a novelty rejection against a claim.  In contrast, a claim rejection on grounds of obviousness requires that, at the time that the invention was made, the claimed invention was obvious to one skilled in the art on the basis of the prior art.  Thus whereas a novelty rejection merely requires that the claimed thing existed, even if no one appreciated that existence – and therefore such a rejection can be based on grounds of inherent prior disclosure – an obviousness rejection requires that one of skill in the art appreciated what the prior art taught.  Without such appreciation, the claimed invention could not have been obvious at the time it was made.

Inherency came into play in that the claims at issue in the ‘859 application, claims 8 and 21, were found to be obvious – not anticipated – because a property recited in the claims was deemed to be an inherent property of oxymorphone.  Claim 8 reads,

8.         A method for treating pain in a human subject in need of acute or chronic pain relief, comprising the steps of:

(a) providing a solid oral dosage form comprising about 5 mg to about 80 mg oxymorphone or a pharmaceutically acceptable salt thereof in a controlled release delivery system with a release rate profile designed to provide an adequate blood plasma level over at least 12 hours to provide sustained pain relief over this same period, the system comprising a filer and a hydrophilic material, wherein oxymorphone is the sole active ingredient; and,

(b) administering the dosage form to the subject, wherein the oxymorphone C_max is at least about 50% higher when the dosage form is administered to the subject under fed versus fasted conditions.

It’s the last, emphasis-added clause which is critical. 

The only art relied upon by the BPAI and the CAFC in rejecting claim 8 was Maloney.  Both the USPTO and Endo agreed that Maloney does not actually teach that there is a different release profile for oxymorphone, or any other opioid, when the drug is administered to a fed patient versus when it is administered to a fasting patient.  And it’s uncontested that prior to the disclosure of this fact in Endo’s own patent application, one of skill in the art would not have recognized this different release profile.  Nevertheless, the CAFC found that this property was an inherent property of oxymorphone itself, and that since Maloney made it obvious to make and administer the composition recited in claim 8, the claimed method was obvious.  As explained by the CAFC,

The examiner rejected claims 8 and 21 as obvious in view of, among other references, Maloney. The examiner found that Maloney "teaches oral sustained release preparations of opioid analgesics" with the use of oxymorphone as a preferred opioid.

On appeal, the Board affirmed the examiner's rejection, relying exclusively on Maloney. The Board found that Maloney discloses a controlled release formulation with an opioid in amounts of 5- 100 mg and that oxymorphone is a preferred opioid. The Board found that Maloney further teaches using calcium sulfate (a cross linking agent), lactose (a filer), and hydrogenated vegetable oil (a hydrophobic material) in his formulation. Based on these disclosures, the Board determined that it would have been obvious to a person of ordinary skill in the art to formulate the claimed oral dosage form and to administer the form to the subject as claimed in the '859 Application.

* * *

Endo argues that Maloney does not expressly disclose the "food effect" limitation: "wherein the oxymorphone C_max is at least about 50% higher when the dosage form is administered to the subject under fed versus fasted conditions." Endo asserts that the Board erroneously relied on the teaching in the specification of the '859 Application that the claimed "food effect" was a property of oxymorphone and that Maloney inherently disclosed the limitation. Endo argues that an obviousness rejection can only be based on what is known by those of skill in the art at the time of the invention, and there is no evidence in the record that anyone recognized the claimed food effect at that time.

The Office responds that substantial evidence supports the Board's finding of inherency. The Office further responds that the Board's reliance upon the specification of the '859 Application to support this conclusion is entirely proper. Further, the Office responds that inherency is indeed a part of the obviousness inquiry.

This court agrees with the Office. Substantial evidence supports the Board's finding, based upon the specification, which confirms that the claimed "food effect" is an inherent property of oxymorphone itself, present both in controlled release and immediate release formulations of that drug. See In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009) (stating "(e)ven if no prior art of record explicitly discusses the (limitation), (applicant's) application itself instructs that (the limitation) is not an additional requirement imposed by the claims on the (claimed invention), but rather a property necessarily present in (the claimed invention)"); see also King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275-76 (Fed. Cir. 2010) (stating that "merely discovering and claiming a new benefit of an old process cannot render the process again patentable" (citations omitted)). This is not a case where the Board relied on an unknown property of prior art for a teaching. Rather, Maloney's express teachings render the claimed controlled release oxymorphone formulation obvious, and the claimed "food effect" adds nothing of patentable consequence.

[emphasis added]

In a petition for rehearing and en banc filed on June 23, Endo asserts that in dealing with Endo’s ‘859 application, the BPAI decision, and subsequently, the CAFC panel (Judges Linn, Moore and Rader) expanded the scope of the inherency doctrine to include not only anticipation but obviousness as well, in contrast to well-settled case law, the patent statute itself, and good public policy. 

In its petition, Endo argues that the BPAI and the CAFC erred, in that (a) the claim is not directed to a pharmaceutical composition per se, but to a method of treatment, (b) all parties agree that the “food effect” was not in the prior art and would not have been recognized by one of skill in the art prior to the applicants’ own disclosure of that effect, and therefore (c) in accordance with the CAFC’s own precedent, the claimed method cannot be deemed obvious, since inherency applies only with respect to novelty analyses, not obviousness analyses.

As the petition for rehearing notes, if the inherency doctrine is expanded to encompass obviousness as well, then

“The Panel's decision would bar claiming a new method of treatment using a known medicine (e.g., discovering that the proverbial cure for cancer is a new use of an old compound). Even if the use is novel and not what is expected by those of ordinary skill in the art at the time, the Panel decision would render it unpatentable because the effect would be inherent in the compound's use; although beneficial and previously unknown, the use would be deemed "inherent" to the compound.”

That’s clearly not a desirable result, and as the request notes, it’s a result that’s contrary to the constitutional mandate of promoting “the Progress of … useful Arts”.  

The petition also argues that under CAFC case law, obviousness, per 35 U.S.C. §103, is a question that must be decided with regard to the claimed subject matter as a whole, on the basis of what was understood by persons skilled in the art at the time the invention was made, and that prior to Endo’s own disclosure in the subject patent application, no one had taught or suggested that administering an oxymorphone sustained release formulation to a fed patient could yield significantly better results than administering the formulation to a fasting patient.  The request also explains why the cases relied upon by the CAFC in its decision do not support its position.

With regard to the application of the inherency doctrine, Endo’s arguments are compelling.  Suppose a compound is known for treating headaches; now it’s found that it can also be used as a chemotherapeutic agent.  But those anti-cancer properties are an inherent property of that compound, so under the CAFC’s logic in Kao, the fact that prior art taught administering the compound to a person, coupled with this inherent chemotherapeutic property, means that it was obvious to use the drug for chemotherapy – even though in point of fact it wasn’t obvious to anyone.  At any rate, apparently the USPTO thinks enough of this argument that it warrants further study – it has asked for an received an extension until August 12, 2011 to file its response to the petition for rehearing. 

Where I wonder about the propriety of Endo’s argument is not with regard to its observation about the proper scope of the inherency doctrine, but with regard to whether or not the doctrine has been misapplied with respect to the particular claims at issue, claims 8 and 21 of the ‘859 application.  That’s because although the “food effect” is recited in both claims, it’s open to interpretation if the recitation of the “food effect” constitutes a method step.  Suppose we left the “food effect” recitation out of claim 8.  Then it would read,

8.         A method for treating pain in a human subject in need of acute or chronic pain relief, comprising the steps of:

(a) providing a solid oral dosage form comprising about 5 mg to about 80 mg oxymorphone or a pharmaceutically acceptable salt thereof in a controlled release delivery system with a release rate profile designed to provide an adequate blood plasma level over at least 12 hours to provide sustained pain relief over this same period, the system comprising a filer and a hydrophilic material, wherein oxymorphone is the sole active ingredient; and,

(b) administering the dosage form to the subject.

In this instance, the argument for the obviousness of the claimed method on the basis of Maloney is much stronger, since Maloney teaches similar compositions using opioid analgesics (albeit not oxymorphone itself) and their administration to relieve pain.  If the clause “wherein the oxymorphone C_max is at least about 50% higher when the dosage form is administered to the subject under fed versus fasted conditions“ is viewed not as reciting a method step, but merely reciting what is an inherent property of the composition itself, then as the CAFC noted, that recitation doesn’t add patentable weight to the claim. 

Personally I’d feel that Endo was on better grounds had it recited the “food effect” limitation in part (a), as a functional feature along with the structural features of the composition being administered, for example,

8.         A method for treating pain in a human subject in need of acute or chronic pain relief, comprising the steps of:

(a) providing a solid oral dosage form comprising about 5 mg to about 80 mg oxymorphone or a pharmaceutically acceptable salt thereof in a controlled release delivery system with a release rate profile designed to provide an adequate blood plasma level over at least 12 hours to provide sustained pain relief over this same period, the system comprising a filer and a hydrophilic material, wherein oxymorphone is the sole active ingredient, and wherein the oxymorphone C_max is at least about 50% higher when the dosage form is administered to the subject under fed versus fasted conditions; and,

(b) administering the dosage form to the subject.

Here, since the fasted-vs.-fed release profile is recited as one of the limitations on the compositions that can be used in accordance with the claimed invention, it’s easier to assert that this limitation is part of the claimed method (though not a slam-dunk).  An even better route would have been to recite administering the composition to a patient within (or not within) a certain amount of time in relation to eating.  The prescribing information for OpanaER^® says that it should be administered “on an empty stomach, at least 1 hour prior to or 2 hours after eating”.  If such a recitation had been included in the claim 8, it clearly would have been part of the claimed method, not taught or suggested in the prior art, and, as Endo notes, therefore not subject to a finding of inherency.

Given the way the CAFC not once but twice bent over backward to construe the claims in Prometheus v Mayo as actually reciting a process, it’s possible that here too, if rehearing en banc is granted, the court will deem the last “wherein” clause of claim 8 to recite a process limitation.  In any event, I hope the CAFC takes this opportunity to correct itself and clarify the applicability of the inherency doctrine.  The way the panel decision is worded, Endo is right about this spelling the end of second medical use patents.