Tag Archives: reasonable expectation of success

Obviousness and Chemical Compounds

Patent,

By Jason Rantanen

Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc. (Fed. Cir. 2012) Download 11-1126
Panel: Lourie (author), Moore, Reyna

This opinion addresses the appropriateness of using a "lead compound" analytical framework for evaluating the obviousness of chemical compounds, reaffirming and refining the approach taken in Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007). 

The defendants in Otsuka consist of a group of ANDA applicants who contended that the compound claimed in Patent No. 5,006,528, aripiprazole (marketed under the brand name Abilify®), was obvious in light of three prior art carbostyril derivative compounds.  Prior to aripiprazole (itself a carbostyril derivative), the only atypical antipsychotic compounds approved by the FDA for the treament of schizophrenia were those that possessed structures related to the antipsychotics clozapine and risperidone, neither of which were the basis for the obviousness challenge.  Following a bench trial, the district court concluded that the asserted claims were not obvious in light of the three "lead compounds" identified by defendants, nor was the patent invalid due to nonstatutory double patenting.

Obviousness: In rejecting defendants' appeal of the district court's determination of nonobviousness, the CAFC endorsed the two-step framework of Takeda (also authored by Judge Lourie). In Takeda, the CAFC addressed the defendant's argument that "the prior art would have led one of ordinary skill in the art to select compound b as a lead compound," with "lead compound" referring "to a compound in the prior art that would be most promising to modify in order to improve upon its antidiabetic activity and obtain a compound with better activity."  Takeda, 492 F.3d at 1357.  The court then analyzed whether a PHOSITA would have both selected and modified the prior art compounds identified by the defendant, an approach applied by the district court in Otsuka and challenged by the defendants on appeal as the type of rigid analysis precluded by KSR.

The CAFC disagreed, holding that the Takeda approach was permissible:

Our case law demonstrates that whether a new chemical compound would have been prima facie obvious over particular prior art compounds ordinarily follows a two-part inquiry. First, the court determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts….The second inquiry in the analysis is whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead com-pound to make the claimed compound with a reasonable expectation of success. 

Slip Op. at 17, 19.

Of course, aspects of KSR do impact this conclusion.  For example, the reason or motivation for a PHOSITA to modify a lead compound may come from a variety of sources, or not even be explicit in the prior art. Slip Op. at 19-20.  And the CAFC's approval of the Takeda approach may have been guided in part by the parties' decision to focus their arguments on selecting and modifying particular prior art compounds, rather than approaching obviousness from another direction.  Id. at 17. 

Examining the two steps, the CAFC concluded that the district court did not err when it found that a PHOSITA would not have selected the prior art compounds for use as lead compounds for further antipsychotic research or made the modifications necessary to arrive at the claimed compound. 

Obviousness-type double patenting: The CAFC also rejected defendants' nonstatutory obviousness-type double patenting argument, using the opportunity to clear up an apparent ambiguity about the differences between obviousness and obviousness-type double patenting.  Although analogous, the two differ in several respects.  The patent principally underlying the double patenting rejection need not be prior art (which makes sense given that the purpose of the double patenting doctrine is to prevent one person from obtaining more than one valid patent for the same invention or an obvious modification of the same invention).  More notably, "when analyzing obviousness-type double patenting in cases involving claimed chemical compounds, the issue is not whether a skilled artisan would have selected the earlier compound as a lead compound."  Slip Op. at 28 (emphasis added).  Rather, selection of the earlier compound as a lead compound is presumably automatic under the court's language.  However, it is still necessary to identify some reason that would have led the PHOSITA "to modify the earlier compound to make the later compound with a reasonable expectation of success." Id. at 29.  This is mandatory: "There is no other way to consider the obviousness of compound B over compound A without considering whether one of ordinary skill would have had reason to modify A to make B. That is traditional obviousness analysis."  Id. at 30 (emphasis added). 

As with the obviousness inquiry generally, the CAFC declined to find clear error in the district court's determination that no such reason existed in this case.

WARNING: Appellate lawyers often feel compelled to make sub-arguments in footnotes, as Otsuka's counsel did here in contending that a PHOSITA would not have consulted an unindexed file history of a patent.  Although Otsuka ultimately prevailed, this practice is strongly discouraged by the court: "Arguments raised only in footnotes, however, are waived…Although we may exercise our discretion to consider improperly raised arguments, we decline to do so here."  Slip Op. at 22.

The Path Forward for Intervening Rights: Presaging the En Banc Decision in Marine Polymer v. Hemcon

Patent, , ,

Guest Post by Scott McKeown, Greg Gardella, and Lisa M. Mandrusiak all of OBLON, SPIVAK, MCCLELLAND, MAIER & NEUSTADT, L.L.P.[1]

The Court of Appeals for the Federal Circuit is currently considering en banc the panel decision in Marine Polymer Technologies, Inc. v. Hemcon, Inc. The panel decision can be interpreted as suggesting that intervening rights can arise from an argument made during a post grant patent proceeding, such as a patent reexamination proceeding,[2] even if the patent owner is merely urging a claim interpretation that is consistent with the manner in which the term would have been understood at the time the underlying patent application was filed. In cases where the post grant record simply clarifies the way in which a skilled artisan would have understood a claim term at the time of filing, or reiterates the positions of the previous intrinsic record, the scope of the claims cannot properly be said to have been altered during the subsequent proceeding.

Post grant PTO patent proceedings often focus on the meaning of different aspects of originally issued claim language than were considered during the earlier application prosecution. Therefore, much of the argument made by the patent owner during the subsequent PTO proceeding is directed to new issues not previously considered by the PTO. It is to be expected that re-opening the intrinsic record via post grant file histories will often include substantively new discussion of various claim terms.

For example, during post grant proceedings patent claims are accorded the broadest reasonable interpretation ("BRI"). Determining the BRI requires a different analysis than carried out in a district court during claim construction, and notably, there is no requirement that the PTO consider the earlier prosecution record in ascertaining the BRI and meaning of an originally issued patent claim. This often places patent owners in the position of having to re-argue distinctions which were implicitly or explicitly accepted by the previous patent examiner. When the PTO requires amendment of a claim in post grant proceedings the amendment may in fact be a simple restatement of previously agreed upon claim scope, which should not give rise to intervening rights.

The rule adopted by the Court should be flexible so as to accommodate the foregoing situations and permit intervening rights only in the appropriate circumstances. The application of argument-based intervening rights should be limited to situations in which the patent owner clearly and unambiguously revises the issued claim scope by urging that a limitation has a meaning that is plainly at odds with the interpretation a court would have given the originally issued claim language.

(more…)

Wyers v. Master Lock

Obviousness, Patent, Patent Cases 2010, Prior Art, , ,

Is "obviousness" a question of law or fact?  The rote answer is that it's both: it's a question of law based on underlying findings of fact.  Drawing that line, however, can be tricky, especially when the jury issues a general verdict.  In addition to addressing this issue, the case discussed below is also noteworthy due to its commentary on KSR on the subject of  motivation to combine. 

Wyers v. Master Lock Co. (Fed. Cir. July 22, 2010)
Wyers involved three patents relating to trailer hitch locks.  Trailer hitch locks are mechanisms used to secure trailers to towing vehicles.  It was undisputed that the prior art disclosed the use of dumbbell-shaped locks for this purpose, so the case turned on the the patentee's modifications to these types of locks.  The following images illustrate the prior art:

Wyers 1 Wyers 2

Wyers' patents claimed dumbbell-shaped locks with two additional elements: a series of sleeves that could be placed over the center section (the "shank") in order to increase its diameter, and an external seal designed to keep dirt out of the locking mechanism.  The only issue before the jury was whether it was obvious to add these two elements to the prior art locks.

The jury concluded that it was not, and issued a general verdict of nonobviousness. After the district court denied Master Lock's motion for Judgment as a Matter of Law, Master Lock appealed. 

Opinion of the Court
Drawing heavily on KSR, the Federal Circuit concluded that the patents were obvious as a matter of law.  The court considered each of the factual questions before it: whether the art was analogous, whether there was sufficient motivation to combine the reference, and the secondary considerations of nonobvious, and concluded that none favored the patentee.

In reaching this conclusion, the Federal Circuit gave no deference to the jury.  On each issue of fact, the panel found that no evidence supported nonobviousness.  For example, when addressing the issue of whether the prior art was analogous, the court reasoned that it was "clearly within the same field of endeavor as the sleeve patents," and was pertinent as a matter of law.

Particularly interesting, however, were the panel's views on motivation to combine.  While recognizing this as an important aspect of the obviousness inquiry, the panel applied the "common sense" approach outlined in KSR:

"We conclude that it was a matter of common sense to combine the Down patent with the prior art barbell locks in order to arrive at the invention claimed in the ’115 and ’426 patents, and that one of ordinary skill in the art would have had a reasonable expectation of success in doing so."

Slip Op. at 23. Furthermore, "where all the limitations of the patent were present in the prior art references, and the invention was addressed to a 'known problem,' 'KSR … compels the grant of summary judgment ofobviousness.'"  Id. at 17.  Such an approach is particularly appropriate when the technology is "easily understandable." 

Finally, on the issue of secondary considerations, the court concluded that, even if Wyers had established the requisite nexus, it would have been insufficient:

Moreover, secondary considerations of nonobviousness—considered here by the district court—simply cannot overcome a strong prima facie case of obviousness.

Slip Op. at 28

Concurrence
Judge Linn concurred with the opinion, but wrote separately to warn parties of the dangers of general verdicts.  He noted that although the law permits general verdicts, verdicts involving special interrogatories are encouraged in the obviousness context due to the mixed question of law and fact.  He further noted that, while the court must presume that the jury resolved the underlying factual disputes in favor of the verdict winner when there are no special interrogatories,

"[b]ecause there is no way to determine from a general verdict on obviousness the specific findings of fact made by a jury on the factual questions underlying its verdict, the court in examining the first part of the obviousness question is left to infer whether substantial evidence existed from which the jury could have made the factual findings necessary to support the verdict. Here, the majority examined the record and after considering the factual inferences concluded that support was lacking and that the claims at issue would have been obvious as a matter of law."

Slip op., concurrence at 4-5.  In other words, when a general verdict is give, the Federal Circuit has to attempt to reconstruct the underlying findings of fact.  Here, it could not discern anything that might reasonably have been in dispute, and thus judgment as a matter of law was appropriate. 

Actonel Patent Validity Affirmed: Nonobviousness of Positional Isomer

Obviousness, Patent, Patent Cases 2009,

Procter & Gamble (P&G) v. Teva Pharmaceuticals (Fed. Cir. 2009)

P&G’s osteoporosis drug Actonel reportedly has $1.5 billion in annual sales. Hoping to manufacture a generic version, Teva challenged P&G’s patent – arguing obviousness in light of a prior P&G patent (the ‘406 patent) and obviousness-type double patenting. The district court rejected those challenges, and on appeal the Federal Circuit affirmed the patent’s validity. The patent is set to expire in 2013.

New Compound is Nonobvious: The claimed active compound – risedronate – is a bisphosphonate. In arguing obviousness, Teva pointed to P&G’s ‘406 patent which listed “central problems” in using bisphosphonates to treat osteoporosis. Although the prior art patent does not list risedronate, it does suggest the use of thirty-six similar molecules in the same class including one a positional isomer of the claimed risedronate. The positional isomer (2-pyr EHDP) includes the same atoms as risedronate, but those atoms are arranged in a somewhat different order.

In risedronate, the hydroxy-ethane-diphosphonate group is connected to the #3 carbon of a pyridine ring, while in 2-pyr EHDP, the hydroxy-ethane-diphosphonate group is connected to the #2 carbon. Because the nitrogen atom is in a different position in the two molecules, they differ in three dimensional shape, charge distribution and hydrogen bonding properties.

In addition to these structural differences, P&G pointed to “contemporaneous writings from Herbert Fleisch, the preeminent authority on bisphosphonates during the relevant time period.” Fleisch wrote that “every … bisphosphonate, exhibits its own physical-chemical, biological and therapeutic characteristics, so that each bisphosphonate has to be considered on its own. To infer from one compound the effects in another is dangerous and can be misleading.”

On appeal, the Federal Circuit agreed that these differences were sufficient to push development of the new compound beyond the obvious – additionally noting that Teva had not shown that a PHOSITA would have had a “‘reasonable expectation of success’ in synthesizing and testing risedronate.” Here, the court quoted its 1988 O’Farrell decision: “Patents are not barred just because it was obvious ‘to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.'”

This holding further supports the conventional wisdom that the KSR case will have much less impact in the area of pharmaceutical research.

Secondary Factors: In arguing secondary considerations of nonobviousness, TEVA argued that the element of long-felt but unmet need could not be proven because another drug (aledronate) was available prior to risedronate. The Federal Circuit rejected that argument – holding that the need may still have existed because the P&G patent application was filed before the other drug was on the market. “Under Monarch, we look to the filing date of the challenged invention to assess the presence of a long-felt and unmet need.”

Swearing Behind Not Allowed: P&G’s researcher had evidence that it had invented risedronate prior to the filing of the ‘406 patent. In particular, the inventor submitted a lab notebook with detailing the structure of risedronate and the procedure for its synthesis. However, the Federal Circuit rejected the evidence because the entry “was unwitnessed and was not corroborated by any other evidence.”

Double Patenting: “Having concluded that risedronate was not obvious under 35 U.S.C. § 103, we similarly conclude that the [risedronate] patent is not invalid for obviousness-type double patenting … [because] the claims of the [risedronate] patent are distinct from the claims of the ‘406 patent.”

Further Discussion:

In re Kubin: Federal Circuit Expands Obvious-to-Try Jurisprudence

Patent, , ,

In re Kubin (Fed. Cir. 2009), 08-1184.pdf (Opinion by Judge Rader)

In a much anticipated biotech case, the Federal Circuit has affirmed a BPAI obviousness decision and in the process expanded the court’s obvious to try jurisprudence. The Kubin opinion found that the Supreme Court’s KSR decision overturned In re Deuel and its admonition against an “obvious to try” test for obviousness.

To be clear, Kubin does not hold that an invention that was “obvious to try” was necessarily obvious under Section 103(a). Going forward, however, the question in this long-running debate will be “when is an invention that was obvious to try nevertheless nonobvious?” (quoting In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988).

Kubin revives the O’Farrell analysis of obvious to try and carves-out two factual situations where obvious-to-try analysis should not apply.

(1) Throwing darts versus a finite number of Identified, predictable known options:

In such circumstances, where a defendant merely throws metaphorical darts at a board filled with combinatorial prior art possibilities, courts should not succumb to hindsight claims of obviousness. The inverse of this proposition is succinctly encapsulated by the Supreme Court’s statement in KSR that where a skilled artisan merely pursues “known options” from a “finite number of identified, predictable solutions,” obviousness under § 103 arises. 550 U.S. at 421.

(2) Exploring new technology versus improving known and predictable technology:

[An] impermissible “obvious to try” situations occurs where ‘what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.’ (Quoting O’Farrell).

Again, KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless “the improvement is more than the predictable use of prior art elements according to their established functions.”

Application: In this case, the court finds that neither of the O’Farrell exceptions apply. The invention is old-school biotech: isolating and sequencing a human gene that encodes for a protein. People do this in high school now, and the application explicitly states that the DNA and Protein sequence may be obtained through “conventional methodologies known to one of skill in the art.” Likewise, the protein in question had already been identified and the prior art suggested that the protein plays an role in human immune response.

KSR moves to Non-Predictable Arts: Biotech has traditionally been thought of as unpredictable. Here, Judge Rader may have dismantled the art-level distinction in holding that KSR applies to the unpredictable arts. The issue rather is if the particular invention in question was predictable.

Therefore this court cannot deem irrelevant the ease and predictability of cloning the gene that codes for that protein. This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests for specific scientific fields in ways that deem entire classes of prior art teachings irrelevant, or discount the significant abilities of artisans of ordinary skill in an advanced area of art.

Affirmed.

Notes:

  • Kevin Noonan provides an important critique of the case – focusing primarily on the court’s mishandling of the factual issues. [Link].
  • I should note here that the PTO is well ahead of the Federal Circuit. MPEP 2141 indicates that being “obvious to try” is a proper rationale to “to support a conclusion of obviousness.” The big book does hint that such an application would only be proper if the “trying” means “choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.”
  • This case makes clear that the level of enablement of the prior art is very important to any obviousness conclusion. That result is in contrast to the recent Gleave case that found anticipation absent known utility.

Obvious to Try? BIO Challenges Ex Parte Kubin

Amicus Brief, BPAI, Obviousness, Patent, Patent Cases 2008,

In re Kubin (Fed. Cir. 2008)

Immunex (a subsidiary of Amgen) is hoping to patent its a DNA sequence coding for a NK (Natural Killer) cell regulator protein. The BPAI rejected the “nucleic acid molecule” claim — finding it obvious over the prior art. [BPAI Decision]. This decision is one of only three precedential BPAI decisions in 2007.

Just looking at the claimed sequence, it would not seem obvious — its structure is not overly similar to other regulator proteins, and the unpredictable nature of protein folding makes it virtually impossible to predict whether a particular sequence would code for an appropriate protein.

Despite the structural uniqueness, the BPAI found the claim obvious because it could have been isolated and verified simply by following conventional laboratory techniques — thus, making it obvious to try.

Although the CAFC has previously warned the BPAI away from using “obvious to try” analysis in its 1995 In re Deuel case. There, the appellate court held that obviousness analysis of a structure should focus on the structure itself as compared to prior art structures.

In Kubin, the BPAI rejected Deuel as limited by the Supreme Court’s KSR decision. That case focused on combination claims, but included the stray quote that “the fact that a combination was obvious to try might show that it was obvious under Section 103.”

Here, the BPAI argued, the inventor wanted to isolate the NK Regulator and simply used known methods to do so. “Thus, isolating NAIL cDNA was ‘the product not of innovation but of ordinary skill and common sense.’” (again quoting KSR).

The case is now on appeal at the the CAFC. On June 10, the Biotechnology Industry Organization filed an amicus brief asking the court to cabin in the scope of KSR and hold that its obvious to try dicta does not abrogate the Deuel standard. Briefing is ongoing and a decision is not expected until the end of the year.

  • Download kubin.amicus.pdf
  • The PTO’s Obviousness Guidelines have the following rules for making an obviousness rejection based on the obvious to try reasoning:
    • (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
    • (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
    • (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
    • (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.The BPAI decision is notable for a few reasons, including the following two: (1) It was written by Nancy Linck, former PTO Solicitor, Newman law clerk, & PhD Chemist. Soon after authoring the decision, Linck left the firm to join the Rothwell Figg firm. (2) It is a unanimous opinion.
  • Thanks to Hal Wegner for providing a copy of the brief which his firm filed on behalf of BIO.

    • (more…)

    CAFC: Proving Utility Is Not Inventive

    Patent, ,

    PharmaStem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007)

    PharmaStem sued six defendants for infringement of its broadly written patents covering cryopreserved umbilical cord stem cells useful for hematopoietic reconstitution. The defendants offer cryopreservation of umbilical cord blood to serve the donor later in life. A jury found infringement and validity, but the district court set aside the verdict — holding that the patents were not infringed.

    Defendant’s Ads Not Specific Enough: The defendants advertised that their product would aid in hematopoietic reconstitution. However, the district court found (and the CAFC agreed) that the ads were insufficient to serve as an admission that the stem cells were “in an amount sufficient to effect hematopoietic reconstitution of a human adult” as required by the claims. This decision stands to reinforce the principle that a patentee must prove infringement of every limitation of every element of any asserted claim.

    Infringe the Whole Claim: PharmaStem’s method claims include collecting, preserving, and using the stem cells .  The defendants, however, are only responsible for collecting and preserving the cells. Transplant physicians do the rest.

    PharmaStem argued contributory infringement under 271(c) — alleging that the defendants sold or offered to sell a component of a patented method especially adapted for infringement. Of course, the defendants do not sell stem cell blood — rather they are “merely bailees”. Because 271(c) requires sale of a product, there is no infringement here.

    Invention is Obvious: When asserting obviousness based on a combination of prior art references, the patent challenger must show that a PHOSITA “[1] would have had reason to attempt to … carry out the claimed process, and [2] would have had a reasonable expectation of success in doing so.”

    Reason to attempt:

    In view of the prior art references, the first part of that test is plainly satisfied here. The idea of using cryopreserved cord blood to effect hematopoietic reconstitution was not new at the time [of filing]. Two of the prior art references…suggest using cord blood for that purpose. Two others…suggest cryopreservation and storage of the cord blood until needed. Accordingly, this is not a case in which there is any serious question whether there was a suggestion or motivation to devise the patented composition or process.

    Expectation of Success: The inventors appear to have conclusively proven that umbilical cord blood is capable of hematopoietic reconstitution.  Unfortunately for them, completing a proof is not necessarily inventive. Rather, prior scientists strong suspicion of the capability creates an expectation of success so strong that “no reasonable jury” could find the patent valid.

    While the inventors may have proved conclusively what was strongly suspected before—that umbilical cord blood is capable of hematopoietic reconstitution—and while their work may have significantly advanced the state of the science of hematopoietic transplantations by eliminating any doubt as to the presence of stem cells in cord blood, the mouse experiments and the conclusions drawn from them were not inventive in nature. Instead, the inventors merely used routine research methods to prove what was already believed to be the case. Scientific confirmation of what was already believed to be true may be a valuable contribution, but it does not give rise to a patentable invention.

    Holding: Patent is invalid and not infringed.

    [More to come on this case]

    Impact of KSR v. Teleflex on Pharmaceutical Industry

    Patent, ,

    For the past 30 years, Cal has been a litigation analyst serving the investment community. He is member of the New York Bar and a graduate of Northwestern law School. www.litigationnotes.com.

    =====================

    By Cal Crary:

    We do not believe that too much guessing is needed to see what the new patent environment will be like, since we already have the benefit of Chief Judge Michel’s March 23, 2007 decision in the Norvasc case, in which he identified the likely changes in the court’s obviousness jurisprudence. . . . A few of the principles reflected in Judge Michel’s opinion are as follows:

    1. routine testing to optimize a single parameter, rather than numerous parameters, is obvious;
    2. an approach that is obvious to try is also obvious where normal trial and error procedures will lead to the result;
    3. unexpected results cannot overcome an obviousness challenge unless the patentee proves what results would have been expected;
    4. a reasonable expectation of success does not have to be a predictable certainty but rather it can be an expectation that can be satisfied by routine experimentation; and
    5. motivation can be found in common knowledge, the prior art as a whole or the nature of the problem itself.

    ….

    [T]here are certain types of patents in the pharmaceutical industry that will have to be looked at, or looked at again, in light of the Supreme Court’s opinion. We happen to believe that enantiomer patents are especially vulnerable, at least in cases in which the technology to separate them was available in the public domain at the time the separation was made. However, we do not believe that the courts will permit a massive extermination of drug industry patents or that a meat-axe approach to them will be used. Rather, we think the Supreme Court’s only demand is that common sense be injected into the determination of what a person of ordinary creative skill in the art would do. The primary examples of enantiomer patents that we regard as vulnerable include Forest Labs’ Lexapro, Bristol-Myers’ Plavix, AstraZeneca’s Nexium and Johnson & Johnson’s Levaquin. We think that all four of these drugs are especially vulnerable now, in light of the new, broader scope of obviousness. In the case of Levaquin, Mylan Labs lost at the district court level in a case that it should have won, even under the law as it existed at the time, and then it was affirmed by Judge Pauline Newman, a pro-industry Federal Circuit judge, in a non-precedential decision without opinion. In a new case, if obviousness is in the mix and if Judge Newman is avoided on appeal, then Levaquin will be a generic drug.

    (more…)

    Routine Experimentation -> Obvious

    Patent,

    Pfizer v. Apotex (Fed. Cir. 2007).

    Norvasc® is Pfizer’s patented blockbuster drugs for treating hypertension and angina.  The Court of Appeals for the Federal Circuit (CAFC) has invalidated Pfizer’s patent — finding it obvious. Generics are already on the market.  

    Background: Apotex, a generic manufacturer, filed a notice with the FDA — certifying its belief that Pfizer’s patent covering Norvasc was invalid and unenforceable. The trial court upheld Pfizer’s patent and issued an injunction stopping Apotex from making a generic version.

    Courts and the PTO: In its appellate opinion, the CAFC began with a strong repudiation of any reliance on Examiner’s findings during prosecution of a patent: “Our case law consistently provides that a court is never bound by an examiner’s finding in an ex parte patent application proceeding.”  Applying this boundary, the panel found that “it can never be the case that an examiner’s interim finding of prima facie obviousness renders the claims of an issued patent prima facie obvious.” 

    Unpredictably Obvious: Norvasc is amlodipine besylate.  At the time of the invention, amlodipine was known as was the use of besylate anions.  Pfizer argued that the results of combining these would have been unpredictable and therefore non-obvious.  The CAFC disagreed, finding that unpredictability does not result in nonobviousness.

    [A] rule of law equating unpredictability to patentability, applied in this case, would mean that any new salt … would be separately patentable, simply because the formation and properties of each salt must be verified through testing. This cannot be the proper standard since the expectation of success need only be reasonable, not absolute.

    Here, the court found plenty of evidence to believe that a PHOSITA would have had a reasonable expectation of success.

    Obvious to try: A combination can be “obvious to try” but still be nonobvious.  This is may be true, for instance, in cases where there are many potential parameters or where the art merely suggests a “general approach that seemed to be a promising field of experimentation.” The court distinguished those situations from the present case — finding that a PHOSITA would have been able to narrow the group of potential salt-formers to fewer than 53 anions, which would be an acceptable number to form “a reasonable expectation of success.”

    Routine Experimentation: Start telling your story!!  It is axiomatically true that patentability is not negated by the manner in which the invention was made.  The exception, found here, is that “routine testing” can be considered a reason to invalidate the patent.

    [T]he prior art provided not only the means of creating acid addition salts but also predicted the results, which Pfizer merely had to verify through routine testing.

    Secondary Factors: On appeal, the CAFC also held that it was an error to consider Pfizer’s switch from a different form of amlodipine to amlodipine besylate as a secondary factor of obviousness.  Furthermore, comparison of unexpected results must compare the invention to the closest prior art — not to the closest commercial product.

    Orange Book Issues: Mylan was first to challenge the patent and lost.  Under the Orange Book rules, Mylan still qualifies for six-months as the exclusive generic seller.  Apotex, which won this case, claims that it also has rights to begin selling a generic version as soon as the FDA gives its approval. Apotex, however, has not presented its legal claim.

    Expiration: When $2.4 billion per year are at stake, every day counts.  The patent was set to expire on Sunday, although Pfizer claimed six additional months of exclusivity based on its testing of childhood eficacy.

    Notes:

    • The patent had previously been upheld by three separate district courts.

    In its first post-eBay injunction decision, CAFC vacated Abbott’s preliminary injunction

    Patent, Patent Cases 2006,

    Macrolides (Clarithromycin)Abbott Labs v. Andrx Pharma (Fed. Cir. 2006, 05–1433).

    Abbot was awarded a preliminary injunction (PI) against Teva to stop alleged infringement of its patents relating to extended release clarithromycin. The CAFC reviewed that holding for abuse of discretion or clear error. 

    Looking at the prior art, the lower court found no motivation to combine several prior art references that discussed azithromycin rather than clarithromycin.  On appeal, the CAFC found the motivation in the form of an implicit admission made by Abbott in one of its prior patents.  In that prior patent, the specification discussed only clarithromycin, but the claims were directed at both azithromycin and clarithromycin. 

    Because the [earlier Abbott] patent explicitly discloses only clarithromycin controlled release compositions, yet claims azithromycin compositions, we conclude that Abbott has represented to the U.S. Patent and Trademark Office ("PTO") that the differences between clarithromycin and azithromycin were such that azithromycin could be substituted into a controlled release clarithromycin composition by a person of ordinary skill in the art without undue experimentation.

    Based on the earlier Abbott patent, the CAFC found a substantial argument that a jury could find a motivation to combine the references with a reasonable expectation of success.

    Regarding potential irreparable harm, the CAFC held that direct competition “alone does not establish that Abbott’s harm will be irreparable.” 

    And, on the question of public interest, the appellate panel “agree[d] with the district court that the public is best served by enforcing patents that are likely valid and infringed.”  But, because of the chance that Abbott’s patents are invalid, the panel concluded “that the public interest is best served by denying the preliminary injunction.”

    In dissent, Judge Newman argued that the majority opinion constituted de novo rule and did not give significant deference to the lower court — as is required by law.

    My colleagues do not discuss the trial judge’s careful explanations, but, upon finding that Teva has raised a "substantial question" about patent validity, they hold that Teva should be permitted to practice the Abbott invention before patent validity is decided. With all respect to my colleagues’ concerns, they misapply not only the criteria of the preliminary injunction but also the standard of appellate review.

    Newman argues that the criteria used by the majority for determining likelihood of success on the merits were not correct:

    Thus my colleagues conclude that claim 4 of the ‘718 patent is "vulnerable to allegations of invalidity," and find "a substantial argument" as to other claims. These are not the criteria of likelihood of success.

    Ex-Post Figures Allowed in Hypothetical Royalty Calculation

    Patent,

    ScreenShot017Honeywell v. Hamilton Sundstrand (HSC) (D. Del. 2005).

    Conflicts between these two companies have already generated Federal Circuit precedent.  Now, in a case involving Honeywell’s patented power supply, the Delaware District Court has determined that HSC’s ex-post sales figures should be used in the calculation of a reasonable royalty.

    Once infringement is found, a patentee is entitled to damages that are “in no event less than a reasonable royalty for the use made of the invention by the infringer.” 35 USC 284. The reasonable royalty is generally calculated through a legal fiction known as a “hypothetical negotiation” that would have occurred at a time before infringing activity began.

    In this case, the patent issued in 2000, after HSC was already selling its allegedly infringing product. Demand changes due in part to the 9/11 tragedy caused product sales to increase dramatically in 2004 and 2005.  Honeywell argued that, despite their later date, these sales projections could not be ignored in the hypothetical negotiation.  HSC disagreed, arguing that post-negotiation sales projections should be rejected in the context of the hypothetical negotiation construct — particularly where pre-negotiation projections exist.

    The court, noting a direct conflict between Fromson v. Western Litho (Fed. Cir. 1998) (later figures may be used) and the 2003 CAFC’s decision in Integra v. Merck KGaA (post-negation figures excluded because they change “risks and expectations of the parties”), sided with Honeywell and held that the post-negotiation figures could be used.

    [T]he court is presented with two cases, both of which are binding, that dictate opposite results. . . . HSC suggests that the court should resolve the conflict by following the more recent case,

    Integra. The court disagrees. The recent vintage of a case has no bearing on how well it was reasoned. In this case, the court is persuaded that the result dictated by Fromson is the most sensible. First, it promotes flexibility in damage calculations by not erecting an unnecessarily rigid barrier to relevant post-negotiation information. Second, it discourages infringement by placing the risk of success on the infringer. Third, it protects the quid pro quo underlying patent law by preventing a premature valuation of the patent. Finally, it permits a damage award more in keeping with the plain language of § 284 by adequately compensating the plaintiff for the “the use made of the invention” by the defendant. This list is probably not exhaustive, but is, in the court’s view, sufficient to demonstrate that Fromson should control in this case.

    HSC’s motion to preclude post-negotiation sales figures denied.

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