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Federal Circuit Case Law |
Takeda Chemical Industries, Ltd. et al. v. Alphapharm Pty. Ltd
et al.
Decided June 28, 2007
It is still important to identify "a reason that would have prompted a person of ordinary skill in the relevant field to combine" prior art in an obviousness determination.
Takeda sued Alphapharm at the U.S. District Court for the Southern District of New York after Alphapharm filed an abbreviated new drug application at the FDA for the pharmaceutical pioglitazone. Judge Denise Cote found the patent not-invalid on obvious grounds because: 1) Alphapharm failed to prove motivation in the prior art for combination of a known compound; 2) the prior art taught away from the invention; and 3) the invention showed unexpected results of non-toxicity. Alphapharm appealed to the Federal Circuit.
Although the district court decided this obviousness case before the Supreme Court’s KSR decision, the Federal Circuit confirmed that as long as the teaching/suggestion/motivation test ‘is not applied as a ‘rigid and mandatory formula,’ that test can provide ‘helpful insight’ to an obviousness inquiry." Further "it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound." Judge Dyk separately concurred to point out that unexpected results did not cover two of the narrower claims, which should be held invalid.
This case reassures that teaching away, unexpected results, and the need to show a reason to make a combination of prior art, continue to dominate obviousness determinations. The recent KSR case did not suddenly weaken existing patent claims via a drastic change in obviousness law.
KSR International Co. v. Teleflex Inc. et al
Decided April 30, 2007
The U.S. Supreme Court
"The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results."
The Supreme Court declared in this decision that a claim can be proved obvious without a showing of motivation or suggestion to combine claim elements. A challenger now can more easily rely on other art and other problems/solutions of others to prove obviousness. Furthermore, obviousness can be proven if a combination was "obvious to try" and if the results were expected.
Teleflex obtained patent claims to an adjustable pedal system for cars using
a "fixed pivot" for a sensor. Teleflex sued KSR for infringement but KSR won
summary judgment of invalidity because adding a sensor to a fixed pivot point
was obvious in view of similar solutions in other art. The Federal Circuit
reversed, however, because the district court failed to point to specific
motivation for combining the claim elements. KSR appealed to the Supreme Court.
The Supreme Court reversed and remanded because "the Federal Circuit addressed
the obviousness question in a narrow, rigid manner that is inconsistent with
103…" While agreeing with use of the motivation - suggestion test as one way to
prove obviousness, the Supreme Court explained that an obviousness challenge is
not limited to "the problem the patentee was trying to solve" or to "only those
prior art elements designed to solve the same problem."
A theme in the obviousness calculus is whether the claimed combination yielded predicable results. The Federal Circuit also relied on this theme in the recent Pfizer v. Apotex case
pdf and was not far away from the Supreme Court’s view. Practitioners should carefully look for and document unexpected results as well as teaching away by others when obtaining and defending broad claims.
Leapfrog Enterprises, Inc. v. Fisher-Price, Inc. et al.
Decided May 9, 2007
An "adaptation of an old idea or invention…using newer technology that is
commonly available and understood in the art" is obvious.
Leapfrog sued Fisher at the U.S. District Court for the District of Delaware for
allegedly infringing claims to a child’s toy that uses electronic sensing to
detect a child’s response to letters and pictures. Judge Gregory Sleet found
invalidity on obviousness grounds and Leapfrog hopped to the Federal Circuit.
This is the first obviousness case from the Federal Circuit following the Supreme Court’s KSB decision. The Federal Circuit confirmed obviousness because patentee Leapfrog failed to present evidence that inclusion of a new element to an old combination for its invention "was uniquely challenging or difficult for one of ordinary skill in the art." The Federal Circuit also mentioned that the patentee failed to "present any evidence that the inclusion…represented an unobvious step over the prior art" and thus seemed to be looking for an "inventive step" argument such as what we use in European practice.
Practitioners should gather and assert evidence that an inventive combination provides unexpected results, using devices and methods in unorthodox ways. Obviousness fights will require more fact-based trench fighting over unexpected results, unexpected devices and methods to solve problems, and unexpected functioning of those devices and methods.
Pfizer, Inc. v. Apotex, Inc.
Decided March 22, 2007
pdf
Judge Michel with Judges Mayer and Linn
“[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.”
Pfizer patented the active ingredient in Norvasc™ and sued Apotex at the U.S. District Court for the Northern District of Illinois after Apotex filed an Abbreviated New Drug Application for a generic version of the drug. Judge James Rosenbaum found no invalidity and enjoined Apotex from making or selling the product. Apotex appealed to the Federal Circuit.
The Federal Circuit found the claims, which recite a novel salt of a known drug, obviousness and reversed. Motivation was found from routine “optimization of a range or other variable within the claims.” The court noted that 53 different recommended salts had been tested to find the one inventive salt, and skilled artisans already knew to carry out this routine optimization of a known, desirable variable.
The Federal Circuit reviewed the motivations and “research” plan logic of “scientists” in deciding obviousness of so-called “research.” Much of what is called “science” is routine optimization or “engineering.”
Eli Lilly et al. v. Zenith Goldline Pharmaceuticals, Inc. et al.
Decided December 26, 2006 pdf
Judge Rader with Judges Schall and Gajarsa
* “[M]ere identification in the prior art of each component of a composition does not show that the combination as a whole …. is obvious.”
Eli sued Zenith at the U.S. District Court for the Southern District of Indiana
for allegedly infringing a patent to a pharmaceutical, after Zenith filed an
Abbreviated New Drug Application at the FDA for a generic version of the claimed
compound. Judge Richard Young found the patent valid and not infringed, and Eli
appealed to the Federal Circuit.
The Federal Circuit affirmed after reviewing invalidity arguments and finding that a small (one atom) difference in the compound that led to improved safety was not obvious. Statements by others led away from making the compound with one atom different, prompting the court to explain that “one would have to depart from the teaching of the (prior art) article and recombine the components …with hindsight.”
The patentee’s success in withstanding invalidity attacks was based partly on a showing of unexpected results linked to small differences from the prior art.
Alza Corporation v. Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc.
Decided September 6, 2006
Judge Gajarsa with Judges Clevenger and Prost
“A suggestion to combine (prior art references) need not be found in the prior art” but “may be implicit from the prior art as a whole.”
Alza sued Mylan at the U.S. District Court for the Northern District of West
Viginia for allegedly infringing claims to “a sustained-release oxybutynin
formulation” that is absorbed slowly by virtue of its chemical ability to pass
through the colon wall. Judge Irene Keeley found the claims invalid on
obviousness grounds. Alza appealed to the Federal Circuit.
The Federal Circuit affirmed, because a skilled artisan (someone with an “advanced degree”) “would have had a reasonable expectation that oxybutynin would be colonically absorbed” and thus be motivated to make the extended release formulation. A prior art teaching that “lipophilic drugs are absorbed along the length of the GI tract” was combined with the fact that oxybutynin is a lipophilic drug, without further specific evidence of motivation..
The Federal Circuit now, often stresses that “implicit” motivation can be found in background art for obviousness challenges. The best defense to this loose motivation requirement is to show unexpected results or evidence of teaching away in the prior art.
Ormco
Corporation et al. v. Align Technology, Inc.
Decided August 30, 2006
Judge Dyk with Judges Schall and Gajarsa
“[T]eaching, motivation, or suggestion [to combine references] may be implicit from the prior art as a whole, rather than expressly stated in the references…”
Align sued Ormco at the U.S. District Court for the Central District of California for allegedly infringing claims to an orthodontic system of multiple brace parts assembled in “a package” with “instructions” for use. Judge Gary Taylor granted Align summary judgment of no-invalidity and granted a permanent injunction. Align appealed to the Federal Circuit.
The Federal Circuit held all of the infringed claims obvious and reversed the summary judgment. The Federal Circuit was not impressed by the technical feat of combining 3 braces with one instruction in a single package, and referred to inherency of motivation (i.e. motivation was “implicit”) for reversing the unobviousness determination.
The Federal Circuit recognizes implicit motivation to combine references for obviousness, particularly for simple mechanical inventions.
In Re Scott E.
Johnston
Decided January 30, 2006
pdf copy
Judge Newman with Judges Michel and Bryson
* “[S]uggestion or motivation to combine references does not have to be
stated expressly; rather it may be shown by reference to the prior art itself,
to the nature of the problem solved by the claimed invention, or to the
knowledge of one of ordinary skill in the art.”
The PTO refused Johnston’s claims to pipes having diameters over 15 feet, in view of extensive prior art dating back to 1956. Johnston appealed his loss to the Federal Circuit.
The Federal Circuit reviewed the PTO’s anticipation and obviousness rejections and affirmed. The most contested claim recited a pipe that had been “reshaped into an arch shape” with “a beginning diameter above 144 inches.” The examiner had asserted an obviousness rejection against this claim over two references but did not show explicit motivation from the literature for their combination. Nevertheless, the Federal Circuit agreed that the combination was obvious because “both references deal with the same field of technology, and both show (the same principal claim element of) spirally formed pipe of large diameter.”
The PTO does not allow claims that merely recite unique combinations of extremely well known parameters and may not have to provide statements from the prior art to establish motivation in these instances. Such applicants should consider protecting the fruits of their believed inventive genius by trademark or design patent registration.
Dystar Textilfarben GMBH et al. v. C.H. Patrick Co. et al.
Decided October 3, 2006 pdf
Judge Michel with Judges Rader and Schall
“[E]vidence of a motivation to combine (for obviousness) may be found…in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved.”
DyStar sued Patrick at the U.S. District Court for the District of South Carolina for alleged infringement of claims to a textile dying process that uses a “hydrogenated” dye. A jury determined that the “level of ordinary skill in the art” of the invention was “a dyer with no knowledge of chemistry” and who thus had no motivation to combine chemical art. The jury found infringement and magistrate judge William Catoe, Jr. denied a motion from Patrick for judgment as a matter of law (“JMOL”) of obviousness. Patrick appealed to the Federal Circuit.
The Federal Circuit reversed the lower court because the jury had used an overly unsophisticated definition of a skilled artisan.
This decision reviews the problem of how to determine motivation to combine prior art for obviousness while noting that the Supreme Court is reviewing an important case (KSR Int’l Co. v. Teleflex Inc.) on this topic. The Federal Circuit emphasized that motivation can be found “from common knowledge and common sense of the person of ordinary skill in the art without any specific hint or suggestion in a particular reference.” The Federal Circuit summarized that “implicit motivation” for obviousness requires: determining the level of a skilled artisan in the field of an invention, determining the common knowledge of that person, and finally, considering the nature of the problem to be solved. Further, a finding of implicit motivation may require an explanation of “why ‘common sense’ of an ordinary artisan seeking to solve the problem at hand would have led him to combine the references.” Evidence of “why” may be a resulting “product or process that is more desirable” such as a cheaper or more convenient product.
Hopefully, the Supreme Court will give us all a bright line test for determining motivation that is at least as specific as the vague steps enunciated in this opinion from the Federal Circuit.
Princeton Biochemicals, Inc. v. Beckman Coulter, Inc.
Decided June 9, 2005
pdf copy
Judge Rader with Judges Schall and Gajarsa
*
Motivation to combine claim elements for obviousness can arise from a skilled
artisan's general knowledge of how closely related prior art solves similar
problems.
Princeton sued Beckman for allegedly infringing patent claims to a coiled capillary electrophoresis apparatus at the U.S. District Court for the District of New Jersey. A jury found infringement and no invalidity but Judge Mary Cooper deemed the verdict unsupported by substantial evidence and granted judgment as a matter of law in favor of Beckman. Princeton appealed to the Federal Circuit.
The Federal Circuit affirmed the invalidity holding after reviewing evidence of motivation to combine a coiled (versus straight) tube to a capillary tube apparatus from the prior art. An implicit suggestion to combine was found in the knowledge of the skilled artisan and "the nature of the problem (which) called for exactly the solutions in the prior art." Still further, the court pointed out (as expressed by the PTO during examination) the cited prior art that contained all claim elements in combination "are closely related techniques." That is, motivation to combine existed because all elements were found in close prior art that solved the same problem, and it was established (using expert testimony in this case) that "one of ordinary skill in the art would look to these related fields."
The plaintiff in this case may have lacked sufficient expert testimony. The jury decision was overturned because "there was not substantial evidence to support the jury verdict (of no motivation to combine)." Furthermore, the Federal Circuit decision emphasized that the plaintiff "offered no evidence to rebut" statements from the defendant that a suggestion to combine items of prior art merely came from knowledge of a skilled artisan. If rebuttable evidence had been presented, perhaps the jury verdict would have stood scrutiny.
In Re. Alberto Lee Bigio
Decided August 24, 2004 pdf copy
Judge Rader with Judges Newman and Schall, Newman dissenting
* Analogous prior art for obviousness may be selected via similarity of structure
The PTO rejected Bigio's application for patent claims to a hair brush having "hair brush" bristles in an hourglass shape. The PTO interpreted "hair brush" to include "brushes that may be used on other parts of animal bodies." The PTO thus determined that toothbrush prior art is analogous for obviousness determinations and the Board of Patent Appeals and Interferences upheld an obviousness rejection from a combination of toothbrush references. Bigio appealed to the Federal Circuit.
The Federal Circuit affirmed, citing two alternate tests for determining the scope of analogous prior art. One test is "whether the art is from the same field of endeavor, regardless of the problem addressed," which can include art that has "essentially the same function and structure," and the other is "whether the reference still is reasonably pertinent to the particular problem" addressed. The court agreed with the PTO that the toothbrush art fell within the claim scope via the first test because the "claimed invention relates to the 'field of hand-held brushes,'" which includes toothbrushes having similar structure and function. Judge Newman dissented with a structural observation that "teeth are not bodily hair."
Obviousness often is asserted by a combination of references from an "analogous art." A patent applicant sometimes can control the scope of the analogous art by defining the claims carefully in consideration of the art and should add narrow, dependent claims to avoid foreseeable analogous art.
Iron Grip Barbell Company, Inc., and York Barbell Company,
Inc. v. USA Sports, Inc.Decided December 14, 2004
pdf
copy
Judge Dyk with Judges Newman and Archer
* "[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness."
Iron sued USA at the U.S. District Court for the Central District of California, for allegedly infringing claims to a weight training plate having 3 handle openings. Judge Gary Taylor found the claims invalid on obviousness grounds in view of prior art devices with 1, 2 and 4 handle openings. Iron appealed to the Federal Circuit.
The Federal Circuit affirmed because "[w]here the prior art discloses a range encompassing a somewhat narrower claimed range, the narrower range may be obvious" and the prior art for this technology had exploited 1, 2 and 4 openings. Iron was unable to rebut the presumption of obviousness with a showing "that the particular range is critical, generally by showing that the claimed range achieves unexpected results."
The district court did not comment favorably on the deep
insight or flash of genius required to substitute 3 holes in a device, where 1,
2, and 4 holes had been used previously, but remarked that "[t]he obvious
test…calls upon the court to just simply exercise common sense."
In Re: Daniel S. Fulton and James Huang
Decided December 2, 2004
pdf copy
Judge Michel with Judges Rader and Gajarsa
* "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior."
The PTO refused to allow a patent for Fulton's idea of a shoe sole having hexagonal studs facing the "fore-aft axis," because of obviousness over patents that show triangular, square and rectangular protrusions. Fulton unsuccessfully argued that the prior art followed "a path that is in a divergent direction," which showed that his technology was inferior, and appealed to the Federal Circuit.
The Federal Circuit affirmed, noting that teaching away requires that a cited art "criticize, discredit, or otherwise discourage the solution claimed." Furthermore, motivation to make the combination "does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art" but can be "somewhat inferior to some other product for the same use."
Shoe tread is an old and crowded art. The applicant in this case argued that his novel tread was unobvious because so many similar designs were preferred, but these same facts were used to show motivation to combine instead.
Knoll Pharmaceutical Company, Inc. et al. v. Teva
Pharmaceuticals USA, Inc.
Decided May 19, 2004
pdf copy
Judge Newman with Judges Archer and Prost
* Evidence of unexpected results for an unobviousness determination can be generated and relied on after grant of a patent.
Knoll sued Teva at the U.S. District Court for the Northern District of Illinois for alleged patent infringement under 35 USC 271(e)(2) after Teva filed a New Drug Application at the Food and Drug Administration for a drug combination. Judge John Darrah granted Teva summary judgment of invalidity on obviousness grounds, despite Teva's strong showing of unexpected synergistic results from the combination. Knoll appealed to the Federal Circuit.
A Federal Circuit panel reversed because although prior art suggested combining an opioid with an analgesic, Knoll's patent specification refers to unexpected results of combining the specific pharmaceuticals hydrocodone and ibuprofen. Knoll also relied on unexpected results found by testing after obtaining the patent. The Federal Circuit explained that "[e]vidence obtained after the patent grant is not excluded from consideration, for understanding of the full range of an invention is not always achieved at the time of filing the patent application."
It is helpful to assert at least some unexpected results in a patent specification. Stronger, more persuasive evidence of unexpected results may be generated later, such as during litigation.
Richard Ruiz and Foundation Anchoring Systems, Inc. v. A.B.
Chance Company
Decided January 29, 2004
pdf copy
Judge Rader with Judges Newman and Michel
* Implicit motivation to combine prior art may arise from the nature of the problem to be solved, particularly for "simpler mechanical technologies."
Ruiz and Chance contested various aspects of Chance's patent to screw anchoring systems for shoring up buildings, at the U.S. District Court for the Eastern District of Missouri. In a previous appeal, the Federal Circuit affirmed infringement but remanded for a decision on invalidity. Judge Catherine Perry subsequently found Chance's patent claims obvious over two earlier patents. Motivation to combine the prior patents was found from the nature of the problem, wherein both "reach the same result as the method covered by the patents in issue." Chance appealed to the Federal Circuit.
The Federal Circuit affirmed, in a decision that reviewed the role of "implied" motivation, which "is particularly relevant with simpler mechanical technologies." The court explained that 'the nature of a problem to be solved (leads) inventors to look to references relating to possible solutions to that problem" (citing Pro-Mold, Fed. Cir. 1996).
Obviousness contests often are complicated by motivation issues wherein one side attempts to prove obviousness by a showing of motivation to combine two or more references. This case indicates that mechanical patent claims in particular are more susceptible to "implied motivation" arguments based on the nature of the problem to be solved. In addressing obviousness, one should first determine whether the technology is a "simpler mechanical" invention, which may have a lower threshold for implied motivation.
In Re Sang-Su Lee
Decided January 18, 2002
pdf copy
Judge Newman with Judges Clevenger and Dyk
* The PTO cannot rely on common knowledge for motivation to combine references for an obviousness rejection but must present a specific hint or suggestion from a particular document
An examiner rejected Lee's patent claims to a method for displaying video functions on obviousness grounds in view of two references. The examiner combined the references with a conclusory statement that the references should be combined. The examiner refused Lee's request to provide a specific teaching, suggestion or motivation from the prior art to select and combine the references. Lee unsuccessfully appealed the obviousness rejection to the Board of Patent Appeals and Interferences (the "Board"). The Board repeated the examiner's conclusory arguments that the claimed "demonstration mode (of the invention) is just a programmable feature which can be used in many different devices …. by adding the proper programming." The Board further declared that "a specific hint or suggestion" of motivation from a reference was not required for an obviousness rejection. Lee appealed to the CAFC.
The CAFC vacated the obviousness finding because the PTO failed to include "evidence relevant to the finding of whether there is a teaching, motivation, or suggestion to select and combine the references relied on as evidence of obviousness." The CAFC pointed out that "a showing of a suggestion, teaching, or motivation to combine the prior art references is an essential component of an obviousness holding." Thus, [t]he examiner's conclusory statements ….do not adequately address the issue of motivation to combine" and the "factual question of motivation …..could not be resolved on subjective belief and unknown authority."
This case affirms that an examiner must provide more than a conclusory statement of unspecialized knowledge for motivation to combine when asserting obviousness. A patent practitioner should cite this case to the PTO when arguing a lack of motivation to combine references for obviousness.