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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Cannon Rubber v. The First Years (Fed. Cir. 2005, NONPRECEDENTIAL).
In a claim construction dispute over the term “in,” the CAFC used its trashcan analogy:
As an initial matter, we note that the term “in” is a simple, non-technical term, and that under its ordinary meaning, a “diaphragm disposed in the body” includes diaphragms contained entirely and partially in the body. For example, a trash bag is “in” a trashcan even though a portion of it is hanging outside of the trashcan.
NOTE: It is good that this decision is nonprecedential because it does not follow Phillips v. AWH. Rather, the case merely cites Phillips for the proposition that the construction may depart from the plain meaning of a claim term “when the patentee has acted as a lexicographer or when the patentee has clearly limited the scope of the invention through a disclaimer in the specification or prosecution history.” . . .
Research-In-Motion v. NTP (Supreme Court). [Updated 12/19/05]
The BlackBerry patent battle continues. In a well written petition, RIM has requested that the Supreme Court hear its appeal from the Federal Circuit’s decision that that was decided in NTP’s favor in August, 2005.
The appeal involves the question of territoriality of the patent laws. Specifically, RIM poses the following question to the Court:
Under § 271(a) of the Patent Act, “use” infringement is expressly limited to use of a patented invention “within the United States.” The question presented is: Whether an Internet-based global telecommunications system, such as the BlackBerry wireless email system, is used “within the United States,” where components crucial to the system’s operation are located outside the United States.
RIM, a Canadian company, maintains its routers in Canada and has argued that because a portion of its allegedly infringing system was outside of the US that it could not infringe a US patent. NTP argued the other side — that the mere fact that some servers were located abroad (while many others were within the US) cannot let RIM escape judgment. For its part, the Court of Appeals for the Federal Circuit split-the-baby and differentiated between system claims and method claims.
In the past two years, the Court has turned down at least two cases involving extraterritorial application of the patent laws.* Perhaps setting the stage for certiorari here. (odds are still low).
More Info:
Patent Reform Scholarship:
Patentable Subject Matter:
by Richard Carden
Following on the heels of its decision to extend the transition period for least-developed countries (“LDC’s”) to implement intellectual property laws consistent with the TRIPS (Trade Related Aspects of Intellectual Property) agreement, the WTO General Council has agreed to permanently implement a 2003 waiver of Article 31(f) of the TRIPS agreement. This decision expands access to generic pharamaceuticals by eliminating the restriction contained in Article 31(f) that use of compulsory licenses on pharmaceutical patents must be “predominantly for the supply of the domestic market of the Member authorizing such use.” The revision still requires ratification by WTO Member States, however, upon ratification, the revision will essentially allow any WTO member state to grant compulsory licenses on pharmaceutical patents in order to produce pharmaceuticals for other nations, specifically for export to LDC’s.
The decision results in the addition of Article 31bis to the TRIPS agreement. Article 31bis provides a compulsory licensing scheme where a Member country notifies the WTO if its intention to avail itself of the provisions of Articles 31 and 31bis (both exporting and importing Members must provide notification). The revision further includes an Annex to the TRIPS agreement which (1) defines many of the terms used in Article 31bis, (2) provides specifics regarding the content of the notifications, and (3) provides a method for assessing manufacturing capacity in an LDC. While Article 31bis and the Annex purport to require the importing Member to provide safeguards against re-exportation and to provide access for patent holders to legal process, the provisions are sufficiently vague that they will be difficult to police in any significant way. Further ambiguity results from the failure of the WTO to explicitly define the conditions under which compulsory licenses are appropriate. Instead, the WTO relies on “good faith” implementation by Member states.
A number of WTO members had indicated after the 2001 Doha Ministerial Conference (which resulted in the Doha Declaration, paragraph 6 of which provided for a parallel compulsory licensing scheme covering both exporting and importing Member States) and the subsequent August 2003 waiver of Article 31(f) that they would not take advantage of these provisions as importers under any circumstances. Several other members indicated that they would only avail themselves of the compulsory licensing scheme to import in “emergencies or extremely urgent situations.”
The General Council decision comes shortly after the WTO TRIPS Council decided to extend the time LDC’s have to implement IP laws in accordance with WTO standards from 2006 to 2013. LDC’s presently also have until 2016 to implement patent protection for pharmaceuticals.
Richard Carden is an intellectual property litigator at MBHB with litigation experience in cases involving diverse technologies, including medical devices, diagnostic equipment, pharmaceuticals, injection-molding systems, and automotive refrigerants. His background includes a BSE in chemical engineering from Tulane University, an MS in chemical engineering from the University of Pennsylvania, and JD from Washington University in St. Louis.
Of course, Patent reform will continue in 2006. In a recent four-page magazine style article, Professors Lemley (Stanford), Lichtman (Chicago), and Sampat (Columbia) present their proposal for patent reform. The professors argue that we should not waste money worrying about the patent office doing poor examinations on unimportant patents. Rather, they argue, we should focus on the inventions that are economically important. Their proposals allow market participants to identify the important issues:
Read the proposal here: What To Do About Bad Patents?
eBay v. MercExchange
The upcoming MercExchange case is important, but it will not lead directory to a compulsory patent licenses on any large scale. In this case, patentee MercExchange won its infringement suit against eBay, but was denied a permanent injunction. The district court gave four reasons for denying the injunction.
Reviewing them in turn, the Federal Circuit panel dismissed each of these reasons — finding each unpersuasive. Ultimately, finding that the defendant had shown “no reason to depart from the general rule that courts will issue permanent injunctions against patent infringement absent exceptional circumstances.”
Now, this case has arrived at the Supreme Court to question this “general rule.” In the backdrop, the statute in question — 35 U.S.C § 283 — is written with the standard equitable language seemingly implying that injunctions are discretionary:
The several courts having jurisdiction of cases under this title may grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent, on such terms as the court deems reasonable.
It is unclear at this point what a damages calculation would be in a case where a permanent injunction is denied — probably most importantly is whether a patentee will be allowed treble damages for the ongoing infringement.
For years, injunctions have been a mainstay in US patent laws. That notion will be questioned in the upcoming Supreme Court case of eBay v. MercExchange. As it turns out, other countries require compulsory patent licenses much more freely than does the US.
Robin Le Goff of Laurent & Charras in France provides the following summary:
———
In accordance with the Paris Convention (see below), the French Patent Law (Code de la Propriété Intellectuelle) provides five reasons for compulsory licensing:
1- Non working of invention during four years from filing,
2- Cross-licensing to and from a third party who patents an improvement depending from the initial invention,
3- Public health,
4- Insufficient production to meet market requirements,
5- National defense needs.
The German Patent Law provides the same schemes as the French one: see Sections 13, 24 and 81 here.
As noted above, the Paris Convention allows for compulsory licenses:
(2) Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work.
(4) A compulsory license may not be applied for on the ground of failure to work or insufficient working before the expiration of a period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last; it shall be refused if the patentee justifies his inaction by legitimate reasons. Such a compulsory license shall be non–exclusive and shall not be transferable, even in the form of the grant of a sub–license, except with that part of the enterprise or goodwill which exploits such license.
The USPTO is seeking applicants for the job of Deputy Patent Commissioner for Patent Examination Policy. Stephen Kunin, who is now in private practice, held the job for about ten years. Currently, Joe Rolla holds the position but is reportedly retiring. This is an extremely important role for the ongoing health of the US patent system.
IPO has posted the job announcement here: LINK.
The Patent Reform Act of 2005 will not be enacted this year. There is still a possibility of a back-door push to include some provisions in an omnibus appropriations bill, but at this point it is unclear what those provisions would be and whether they would be successful.
The failure of reforms this year has several sources:
One of the proposed measures would have eliminated the best mode requirement. Dale Carlson of Wiggin & Dana has written a short article explaining his reasons for keeping best mode. [Article].
Molecular Diagnostics Lab v Hoffman La Roche (D.D.C. 2005)
By S. Richard Carden
MDL, a purchaser of Thermus aquaticus DNA polymerase or “Taq” (a component used in performing polymerase chain reaction), brought suit against Roche, Applera and others for violations of the Sherman Act, allegedly arising from Roche’s enforcement of U.S. Patent No. 4,889,818 (“the ‘818 patent”) knowing that it had been procured through inequitable conduct. The ‘818 patent claims a thermostable DNA polymerase isolated from the Thermus aquaticus bacteria. Defendants moved to dismiss the complaint on several bases including (1) lack of standing, (2) tolling of the statute of limitations, (3) failure to sufficiently allege a conspiracy, and (4) failure to comply with the pleading requirements of Rule 9. The D.C. District Court denied Defendants’ motion in its entirety, with a minor exception that precluded MDL from seeking damages for the period prior to the four year statute of limitations period prior to its filing of the suit.
by Richard Carden