1. AIPLA Mid-Winter Institute. Feel free to introduce yourself during next month’s meeting in La Quinta. I will be presenting the best of CAFC 2005 at the patent litigation committee meeting on Thursday afternoon.
2. SmithKline v. Apotex: The Supreme Court has asked the Solicitor General for views on whether to hear this case involving the question of inherent anticipation, whether the inherency must have been recognized by a PHOSITA, and when that recognition must have taken place. Link, Link.
Several years ago, in Dutch Industries Ltd. v.
In response to this onerous decision, the Canadian Patent Act was recently revised to create a time-limited window to make catch-up fee payments in those Canadian patents and patent applications that irrevocably lapsed as a result of the Dutch Industries Ltd. decision. New section 78.6 of the Canadian Patent Act will come into force on
Practice Suggestion
A small entity in
NOTE: This post comes from the files of Blair Hughes. Blair is a partner at MBHB LLP and has extensive experience in protecting patent rights, in both the U.S. and abroad.
Link:
Phillips v. AWH (on petition for certiorari)
AWH has petitioned the Supreme Court to with the broad question of whether patent claim construction should be reviewed de novo on appeal.
Question Presented: Whether the Federal Circuit is correct in holding that all aspects of a district court’s patent claim construction may be reviewed de novo on appeal.
AWH’s petition picks up where Judge Mayer and Newman’s dissent left off in the en banc Phillips decision. In their dissent, the judges focused their attention on the “futility [and] absurdity” of the de novo rule.
Now more than ever I am convinced of the futility, indeed the absurdity, of this court’s persistence in adhering to the falsehood that claim construction is a matter of law devoid of any factual component. Because any attempt to fashion a coherent standard under this regime is pointless, as illustrated by our many failed attempts to do so, I dissent.
Indeed, many believe that the high reversal rate of claim construction is primarily due to the de novo standard. To that effect, AWH’s petition does not mince words:
Left to its own devices, the Federal Circuit will continue to improperly devote the chief measure of its energy to rejudging the facts of patent claim constructions, rather than to fulfilling its purpose of bringing uniformity to patent law.
Now Phillips has posted his opposition. Phillips argues that claim construction should be considered a matter of law and should continue to receive de novo review.
The construction of written instruments is one of those things that judges often do and are likely to do better than jurors unburdened by training in exegesis. Similarly, the Federal Circuit is uniquely equipped to make such determinations on appeal.
The main thrust of the Phillips argument, however, is that the case is not ripe for review because the CAFC did not rule on the issue of de novo review.
Notes:
The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management
By: Martin Voet
$24.95 from Amazon
.
Book Review: I read the Generic Challenge in one evening. It is easy to read, anecdotal and short (100 pages). My favorite portions of the book were Chapter 2 (pharmaceutical patenting strategy) and Chapter 7 (drug life-cycle management). It is hard to believe that so much information and seasoned advice is packed into this little book.
Generic Challenge is not written as a reference for experts. Rather, the book is written as an introduction for readers who are new to the field and interested in the topic. Because patents are now so fundamental to the business of pharmaceuticals and biotechnology, I would recommend this book to virtually everyone working in those industries regardless of whether you will deal directly with patents.
Perricone v. Medicis Pharmaceutical (Fed. Cir. 2005)
This case involved two patents (the ‘693 and the ‘063) on treating skin damage or disorders–particularly sunburn–by the application of ascorbyl fatty acid ester (vitamin C in a fat soluble form). On summary judgment, the district court determined that the asserted claims of both patents were invalid due to anticipation and double-patenting. On appeal, the CAFC affirmed the district court’s decisions in all respects but one: according to the majority, the district court erred when it determined that four claims to methods of treating “skin sunburn” by the application of ascorbyl fatty acid ester were anticipated by a prior art patent (“Pereira”) disclosing ascorbyl fatty acid ester as “suitable for topical application to the skin or hair.” Judge Rader wrote the opinion for the court, which Judge Linn joined, while Judge Bryson dissented.
Claim 1 of the ‘693 patent is representative of the “skin sunburn” claims at issue:
A method for treating skin sunburn comprising topically applying to the skin sunburn a fatty acid ester of ascorbic acid effective to solubilize in the lipid-rich layers of the skin an amount effective to scavenge therefrom free radicals present as a result of transfer of energy to the skin from the ultraviolet radiation which produced said sunburn.
Pereira disclosed cosmetic compositions for topical application, including the recited ascorbic acid composition, and identified the compositions as “suitable for topical application to the skin or hair.” The district court determined that Pereira anticipated Perricone because “Pereira will inherently function in [the claimed beneficial manner] when topically applied to the skin.”
According to Judge Rader, however, “The issue is not, as the dissent and the district court imply, whether Pereira’s lotion if applied to skin sunburn would inherently treat that damage, but whether Pereira discloses the application of its composition to skin sunburn. It does not.” Judge Rader continued: “Claim 1 of the ‘693 patent recites a new use of the composition disclosed by Pereira, i.e., the treatment of skin sunburn. The district court’s inherent anticipation analysis for this claim contains a flaw. The disclosed use of Pereira’s lotion, i.e., topical application, does not suggest application of Pereira’s lotion to skin sunburn. In other words, the district court’s inherency analysis goes astray because it assumes what Pereira neither disclosed nor rendered inherent.”
Judge Rader’s majority opinion distinguished claim 8 of the ‘693 patent, directed to a method for “preventing sunburn damage,” from claim 1, finding it anticipated by Pereira. According to Judge Rader, claim 8 “merely requires application of the composition to exposed skin surfaces. Because all skin surfaces are susceptible to sunburn damage, and because one can only realistically apply a composition to a skin surface when that surface is exposed, Pereira’s ‘topical application’ encompasses the application step of claim 8.”
Judge Bryson dissented, writing, “In my view, the differences between the claims that the court invalidates and those that it holds not to be invalid do not justify a difference in outcome.” Judge Bryson explained: “The majority seems to attach significance to the notion that topical application of Pereira’s emulsion always prevents sunburn, because all skin is subject to sunburn, but that it does not always treat sunburn, because not all skin is sunburned and in need of treatment. That distinction, however, does not stand up: the fact that the sunburn treatment function is pertinent to only a subset of users of the Pereira method (i.e., those already suffering from sunburn) does not mean that Pereira does not anticipate the treatment claims.”
The key point, according to Judge Bryson, was that the mechanism underlying both the prevention and treatment of sunburn by ascorbyl fatty acid ester is the same. According to Judge Bryson, “topical application of the Pereira composition to normal skin inherently produces the same chemical processes that underlie the sunburn prevention claims, including scavenging free-oxygen-containing radicals and neutralizing other reactive oxidants. Topical application of the Pereira composition to sunburned skin inherently produces the same processes, which also underlie the sunburn treatment claims.” Accordingly, in Judge Bryson’s view, “[t]o hold that the treatment claims of the sunburn patent are not anticipated by Pereira is to permit an inventor to secure patent rights to an existing invention merely upon identifying an inherent benefit of the prior art that had not previously been specifically identified, but that falls within a broader class of benefits already identified in the prior art.”
NOTE: This case review was written by a patent attorney (not me) who wishes to remain anonymous.
Links:
Read the Opinion
Patent Baristas Review Case
Patent Hawk Reviews Case
Heinze Reviews Case
LizardTech v. Earth Resource Mapping (Fed. Cir. 2005) (on request for rehearing).
Plaintiff LizardTech lost its case at the Federal Circuit because its written description was lacking.
The asserted patent was related to the use of discrete wavelet transform (DWT) to compress digital images. The specification provides an example method for creating a seamless DWT. One of the claims included a claim to seamless DWT without including all of the limitations of the example method.
In its original decision, the CAFC stated the rule that a claim will not be invalidated under Section 112 for only disclosing a single embodiment. However, the court went on to determine that the claim in question was improperly directed at “all seamless DWT’s” — a coverage not adequately supported by a single embodiment.
The CAFC has refused LizardTech’s request for rehearing, but has issued concurring and dissenting opinions.
Lourie, Michel, Newman: Disclosure containing only one embodiment will result in limiting the scope of the claims to cover only that embodiment.
[Claims] must be interepreted, in light of the written description, but not beyond it, because otherwise they would be interpreted to cover inventions or aspects of an invention that have not been disclosed. Claims are not necessarily limited to preferred embodiments, but, if there are no other embodiments, and no other disclosure, then they may be so limited. One does not receive entitlement to a period of exclusivity for what one has not disclosed to the public.
Rader, Gajarsa:
“This court’s written description jurisprudence has become opaque to the point of obscuring other areas of this court’s law.”
FieldTurf v. Sprinturf (Fed. Cir. 2005) (Newman, Schall and Dyke)
Offer to Sell: In a competitive bidding process, SportField (Sprinturf) submitted a bid to supply a school district with artificial turf that would allegedly infringe FieldTurf’s patents. Although the written bid specified an infringing product, SportField argued that it actually intended to supply its standard product that did not infringe (contrary to the written offer).
On appeal, the CAFC affirmed the lower court’s finding that the bid was not an infringing “offer to sell.” In its decision, the appellate panel cited three reasons for ignoring the explicit language of the bid:
Standard Setting: The appellate panel revered the lower court’s finding that FieldTurf had improperly interfered with SportField’s business. This decision may be read to support businesses that push their patented products as “industry standards.”
Efforts of commercial entities to achieve specifications that favor their product are not illegal, absent fraud or deception.
Links:
LabCorp v. Metabolite (on writ of certiorari).
This case involves a patented method of correlating a body protein level with a vitamin B deficiency. (U.S. Patent No. 4,940658). The claim in question (Claim 13) includes two steps: (1) assaying a body fluid for an elevated level of total homocysteine and (2) correlating an elevated level of total homocysteine with a folate deficiency. (paraphrased).
The patent holder won at trial and at the CAFC. The defendant, Metabolite, then brought its case to the Supreme Court arguing that the patent is invalid because it “claim[s] a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.”
Interestingly, the question presented is not firmly grounded in any particular rule of patent law. Rather, it implicitly raises issues of indefiniteness, enablement, written description, and patentable subject matter. (to name a few). However, the Supreme Court has given some indication that it is most interested in this case because of the issue it raises regarding the patenting of natural phenomena under Diehr.
LabCorp has filed its brief on the merits as have a number of third parties:
Petitioner’s Brief PDF (211 KB)
In Part I, Petitioner LabCorp’s stance is essentially that the law is correct, but that it has been misapplied in this case.
Claim 13 violates this Court’s longstanding rule barring patents on “laws of nature, natural phenomena, and abstract ideas.”
According to LabCorp, the claim involves “no actual invention beyond the scientific discovery it recites.” The claimed correlation is a scientific principle or law of nature, and its discovery alone cannot be patentable. The “trivial pre-solution” activity of assaying “cannot transform claim 13 into a patentable invention.” Here, Petitioner never strays far from the precedential pillars of Diehr, Chakrabarty, Funk Bros., and Flook.
In Part II, LabCorp goes on to argue that the claim is neither definite, enabled, nor adequately described. The Brief appears to ask the court to invalidate any claim that includes a “correlating” step unless the process of how to calculate a correlation is spelled out in the specification.
The Federal Circuit relied on the accepted dictionary definition of “correlate” as meaning “to establish a mutual or reciprocal relationship between.” But nothing recited in the claim or disclosed in the specification tells a practitioner how to actively “establish” a “relationship” between a particular test result and a vitamin deficiency. At most, the Patent discloses that such a scientific relationship
exists.
More is required for a valid claim. . . .
In the remaining sections of the Brief, Petitioner argues that, on policy grounds, a very broad claim hinders scientific and technological progress and that the lower court judgment should be reversed.
Solicitor General’s Amicus Brief for the U.S. Government PDF (165 KB)
The Solicitor General with assistance from the PTO’s counsel has filed its brief that falls closely in line with its prior unsuccessful brief in opposition to the petition for certiorari.
In line with Petitioner, the Government agreed that the patent “appears to [impermissibly] claim all substantial practical applications of the natural relationship.” However, the Brief specifically states that this case should not be decided on an issue of whether a law of nature has been improperly claimed because the lower court record has not been developed on this issue. Directly addressing Petitioner’s part II, the Government argues that the specification does satisfy the requirements of 35 USC 112 “by describing, enabling, and claiming the method.”
Intellectual Property Owner’s Association (IPO) Brief PDF (97 KB)
IPO realized that the question presented for review in this case does not directly challenge the current standards for patentable subject matter. However, the Supreme Court has indicated an interest in considering whether the patent-in-suit claimed patentable subject matter.
IPO believes that the current standards for patentable subject matter, as set forth by the Court in
Diehr, correctly delineate between those innovations that should be eligible for patent protection and those that should not. Accordingly, IPO believes that this case should not serve as a vehicle for overturning or altering those standards. Rather, this case should reinforce the standards of Diehr and thus, support the expectation that innovations in yet unknown areas of technology will be eligible for patent protection.
Specifically, IPO argues that a broad scope of subject matter eligibility properly places research and development decision-making into the hands of individuals and private entities rather than in the judiciary. This “free market” approach “beset allocates research and development resources without judicial entanglement.” The requirements of novelty, nonobviousness, and description protect against over-reaching patents and warrant against further restricting patentability based on subject matter.
* NOTE: I was a coauthor of the IPO brief along with Paul Berghoff and Joshua Rich from MBHB as counsel for IPO. The IPO Board of Directors approved the Brief.
Affymetrix Brief PDF (104 KB)
Affymetrix is a supplier of commercial DNA microarrays and “has an interest in ensuring that patents not issue on basic laws of nature so as to impede scientific progress in analyzing DNA and gene expression.” Affymetrix argues that the fact that “elevated levels of an amino acid in the blood correlated to a vitamin deficiency” is a natural phenomenon that leaves claim 13 unpatentable under current precedent.
Interestingly, Affymetrix argues that ambiguity of whether a claim impermissibly covers a natural phenomena should be resolved in favor of invalidity to avoid serious constitutional questions. (citing Feist).
Public Patent Foundation PDF (375 KB)
PubPat argues that the CAFC has gone astray by over-reaching the permissible bounds of patentable subject matter. (Citing Alappat and State Street). Rather, PubPat would have the Court return directly to Flook.
Reviews Coming:
Download Bear Stearns & Lehman Brothers Amicus Brief.PDF (3617 KB)
Download American Heart Association.PDF (3800 KB)
Download AmerClin.pdf (3007.8K)
Patently-O Blog: Terms of Use
Updated December 1, 2016
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