Calgon Carbon Corporation v. North Bay (City)

Calgon Carbon Corporation v. North Bay (City)
Court (s) Database
Federal Court Decisions
Date
2006-11-14
Neutral citation
2006 FC 1373
File numbers
T-1408-02
Notes
Digest
Decision Content
Date: 20061114
Docket: T-1408-02
Citation: 2006 FC 1373
Ottawa
,
Ontario
, November 14, 2006
PRESENT: The Honourable Mr. Justice Mosley
BETWEEN:
CALGON CARBON CORPORATION
Plaintiff
and
THE CORPORATION OF THE
CITY OF
NORTH
BAY
and
TROJAN TECHNOLOGIES INC.
Defendants
REASONS FOR JUDGMENT AND JUDGMENT
INTRODUCTION
[1] “We don't have to kill the little buggers, we only have to give them a vasectomy”. That is how Dr. Sam Stevens described the effects of irradiating Cryptosporidium parvum with low doses of ultraviolet light, in his testimony at the trial of this action for patent infringement. The plaintiff, Calgon Carbon Corporation ("Calgon") obtained Canadian Patent No. 2,331,525 (the '525 patent) for that method. That the method is useful is beyond question. But was it new? For the reasons that follow, I find that the patent was anticipated by the prior art and is invalid.
[2] The plaintiff alleges direct infringmentby the Corporation of the City of
North Bay ("
North Bay
"). Trojan Technologies Inc. ("Trojan") is alleged to have induced or procured
North Bay
’s infringement.
[3] The relief sought by the plaintiff includes a declaration of infringement, a permanent injunction and damages against Trojan and damages or an accounting of profits against
North Bay
. Calgon does not seek an injunction against
North Bay
. The defendants by counterclaim seek a declaration that the patent is invalid.
The Parties:
[4] Calgon is a
Delaware corporation based in
Pittsburgh ,
Pennsylvania
. It is primarily in the business of making and selling activated carbon products and systems for purifying water, air and food products. Calgon began to manufacture and sell its own line of ultraviolet (UV) water treatment systems under the Sentinel brand in the late 1990’s. Calgon owns the ‘525 patent and licenses water treatment facilities to use the ‘525 technology at a fee of 1.5 cents per thousand gallons of water treated.
[5]
North Bay is an
Ontario
municipal corporation. Among other things it owns water treatment facilities operated by the Ontario Clean Water Agency, and it provides drinking water for the residents and businesses of the city. The costs of water treatment and supply are borne by the ratepayers. The city’s primary source for drinking water is
Trout
Lake
, a large, deep and normally pristine lake adjacent to the municipality.
North Bay
contracted with Trojan in 2001 to supply a UV drinking water disinfection system for its water treatment plant.
[6] Trojan, based in
London ,
Ontario
is the wholly owned subsidiary of an American corporation. It has been in the business of designing, manufacturing and selling UV disinfection systems since the 1970’s. Initially, its drinking water systems were designed for residential applications. Trojan has more recently expanded however into municipal and industrial drinking water and waste water treatment. Trojan supplied the ultraviolet radiation system to
North Bay
that is alleged to infringe Calgon’s patent. In the course of completing that deal, Trojan agreed to indemnify
North Bay
against any claim of patent infringement arising from the use of the system.
The Patent
[7] The ‘525 patent application, entitled “Method for Preventing Replication In Cryptosporidium Parvum Using Ultra Violet Light” was filed on May 5, 1999 claiming priority from U.S. Application No. 09/078116 filed in the United States on May 13, 1998.The claim date for present purposes is, therefore, the date of the
U.S.
filing. The ‘525 application was laid open for public inspection on November 18, 1999 and the patent was issued February 19, 2002.
[8] There are just four claims found in the ‘525 patent:
1. A method for the prevention of Cryptosporidium oocysts comprising irradiating water with a continuous broad band of ultraviolet light in doses of from about 10 mJ/cm2 to about 175 mJ/cm2.
2. A method as set forth in claim 1 wherein said broad band is a frequency of 200 to 300 nm using a UV lamp.
3. A method as set forth in claim 1 or 2 wherein said dose is from about 20 mJ/cm2 to about 30 mJ/cm2.
4. A method as set forth in claim 1 wherein said broad band is a frequency of 200 to 300 nm using a medium pressure UV light.
PROCEDURAL HISTORY
[9] The statement of claim in this action was issued on August 29, 2002. Particulars were ordered and delivered in response to a motion to strike portions of the claim.
North Bay
then brought a motion seeking summary judgment on the ground that the ‘525 patent was anticipated.
North Bay
further argued that the ‘525 patent did not disclose an invention, but rather the mere discovery of an advantage of an old invention.
[10] In Calgon Carbon Corp. v. North Bay (City), 2005 FC 838, 41 C.P.R. (4th) 78,Justice James Hugessen allowed North Bay’s motion for summary judgment and dismissed the action as against that defendant. For the purposes of the motion,
North Bay
had abandoned its own expert evidence and relied upon that of the plaintiff’s expert, a Dr. Huffman. Dr. Huffman, whom Calgon did not call at trial, admitted on discovery that if the phrase "for the prevention of Cryptosporidium oocysts" was removed from claims 1-4, then the method could otherwise be described as well-known prior to the claim date. The prior art put into evidence by affidavit on the motion was that of the UV system installed at Fort Benton, Montana and point of entry systems installed at North Bay.
[11] On the strength of that evidence, Justice Hugessen held that the use of an old invention to prevent Cryptosporidium oocyst replication was a mere discovery and not a new invention even if the advantage was previously unknown.Accordingly, that use was not patentable subject matter.
[12] Calgon appealed the dismissal of its action. In a decision dated December 6, 2005, the Court of Appeal allowed the appeal and set aside the summary judgment decision: Calgon Carbon Corp. v. North Bay (City), 2005 FCA 410, 262 D.L.R. (4th) 476. Citing Shell Oil Co. v. Canada (Commissioner of Patents), [1982] 2 S.C.R. 536 (Shell Oil), and Hickton’s Patent Syndicate v. Patents and Machined Improvements Co. (1909), 26 R.P.C. 339, Justice Marshall Rothstein held for the Court that irradiating water for Cryptosporidium using low doses of UV light, while not a new method itself, constituted a newly discovered use for that method and was therefore a new and useful art. At paragraph 17 of the decision, Justice Rothstein stated:
…Here, what is useful is the method of using UV light at particular levels for preventing Crypto oocyst replication. What is new and was not previously known is that using UV light at particular levels adequately treats water to prevent Crypto infection. Because of this, a more costly means of producing that desired result can be avoided. That meets the definition of "invention". [Emphasis added]
[13] The Court of Appeal declined to deal with the issue of anticipation as it was not addressed in Justice Hugessen’s decision and was only “argued cursorily” by the parties. Leave to appeal to the Supreme Court of Canada from the Court of Appeal’s decision was dismissed without reasons: Calgon Carbon Corp. v.
North Bay
(City), [2006] S.C.C.A. No. 39.
[14] In the present case, the plaintiff asserts that the question of whether the subject matter of the ‘525 patent is patentable is now res judicata.
North Bay
and Trojan submit that the issues in the present trial case are not the same as those which were before the Court of Appeal. There is new fact evidence on the prior art, new expert testimony, and new constructions of the claims put forward by the experts. Thus I am free, the defendants submit, to arrive at a different conclusion from that of the Court of Appeal as to the validity of the ‘525 patent.
[15] The defendants urge me to revisit the issue of whether there is a mere discovery or a patentable new use of an old method based on the evidence at trial. This evidence establishes, the defendants submit, that the use was not new and that UV light in doses that fall within the claimed range of 10 to 175 mJ/cm² had been used to disinfect Cryptosporidium in drinking water prior to the patent application.
[16] I am clearly bound by the ratio of the Court of Appeal decision which I take to be the principle taught by Shell Oil applied to the limited evidence which the Court had before it. As the Court of Appeal expressly left open the question of anticipation, its decision does not preclude a finding that using UV light at the claimed levels was known to treat water to prevent Cryptosporidium prior to the date of the patent application. Moreover, the evidence to be addressed with respect to anticipation includes new evidence that was not before Justice Hugessen or in the record before the Court of Appeal.
[17] As the opening paragraph of these reasons indicates, I have concluded from the evidence that it was known prior to the date of the patent application that using UV light at particular levels adequately treats water to prevent Crypto infection, and that the invention was therefore not new.
[18] The following summary of the facts is drawn from the testimony and documentary evidence at trial.
FACTUAL B ACKGROUND
Cryptosporidium parvum
[19] There are several species of Cryptosporidium protozoa (i.e., single-celled) parasites. As parasites they can only reproduce within another organism (the “host”). Cryptosporidium parvum can cause a gastroenteritic disease, Cryptosporidiosis, when ingested by an animal or human host. Cryptosporidium parvum appears to be the predominant species responsible for Cryptosporidiosis in humans and animals and is known to spread through contaminated drinking water, contaminated foods and by close contact.
[20] In one stage of its life cycle, the oocyst or spore phase, the parasite is enclosed in a protective cyst-like membrane which may be thick or thin walled. Thick walled oocysts are highly resistant to environmental stresses and to common disinfectants such as chlorine.
[21] The oocysts are about 4-6 micrometers (4-6 µm or millionths of a meter) in diameter and will pass through many filtration systems. When ingested, stomach acids and enzymes cause the oocyst to open, a process called excystation, and to release up to four sporozoites. The sporozoites attach to intestinal cells and re-start the life cycle, replicating the protozoa within the host. Thin walled oocysts can remain within the intestinal tract and multiply, producing symptoms such as fever and diarrhoea.
[22] Both the disease and the parasite are commonly known as "Crypto" and that is the term that I will use unless it is necessary to distinguish between the two in a particular context.
[23] Thick walled Crypto oocysts are shed in the feces of infected hosts, where they can then be washed by rain, snow, or through sewage discharge into lakes, ponds, rivers and streams. The oocysts may therefore be present in water taken from above ground sources (“surface water”) or from shallow wells (“ground water under the influence of surface water”), where there are infected hosts in the watershed feeding that source. Typically Crypto is not found in deep wells due to natural filtration through the aquifer sediments.
[24] Crypto oocysts may appear only sporadically in a water source; typically after a heavy rain or following spring snow melt. It is difficult to determine whether a water source is contaminated as any given sample of water taken for analysis may contain no oocysts. Thus, in testing for the risk of the presence of Crypto, analysts rely on the presence of other contaminants such as E. coli bacteria which indicate the presence of fecal matter in the water.
[25] For healthy individuals, Cryptosporidiosis may be self-limiting within a few days. For others, particularly the very young or elderly or those with depressed immune systems such as persons with AIDS, the results can be severe including death. There is no specific treatment. Consequently it is a major public health concern.
[26] The first outbreak of Cryptosporidiosis linked to contaminated water was reported in a groundwater system in
Texas
in 1984. Two major outbreaks followed in Georgia,
U.S.A. and in
Swindon ,
U.K.
in the late 1980’s. What captured attention, however, was the outbreak in
Milwaukee ,
Wisconsin
in 1993 in which some 400,000 people reportedly became infected. That incident in particular appears to have focused interest on the use of alternative methods to prevent Crypto infection. In
Canada , an outbreak occurred in
Waterloo ,
Ontario in 1993 and in
Cranbrook
B.C. in 1996.
[27] Conventional water treatment uses several steps to produce potable or “finished water” including screening, coagulation, flocculation, and filtration. Under optimal conditions, coagulation and filtration can effectively remove Cryptosporidium oocysts. However, a substantial number of outbreaks of Cryptosporidiosis prior to 1998 were related to such water treatment systems. That was the case in
Waterloo ,
Ontario which operated a conventional system to treat water taken from the
Grand River , from groundwater wells, and from infiltration wells adjacent to the river.
[28] Following filtration, the practice in
North America at least, has been to add a chemical disinfectant, typically chlorine. North American regulations typically require that a constant amount of chlorine remain in the water pipes to the point of use. The presence of that residual chlorine in the water prevents bacterial infiltration and microbial growth in the pipes but is also the source of concerns about health effects and aesthetic objections. Chlorine produces Trihalomethanes which are known to be carcinogenic. In the concentrations used for water treatment, chlorine does not “kill” or inactivate Crypto.
[29] Chemical ozone is considered to be very effective against Crypto but it is costly and difficult to use. Ozone was employed by
Milwaukee
following the 1993 outbreak. Lesser amounts of ozone may be used for odour and taste control. Modern filtration systems employing fine membrane filters can also be effective at removing protozoa, including Crypto, if the pores in the membrane are small enough. Micro-filtration systems are also expensive to install and maintain.
[30] Pathogen removal is measured in logarithms or “logs”. One log reduction is equivalent to the removal of 90% of all pathogens present, two equals 99% removal, three 99.9% removal, four would be 99.99%, 5 is 99.999% and so on. This means of calculating efficiency of treatment depends on input. Removing 99.9% may still leave a considerable number of oocysts capable of replicating if a large number were initially present. Moreover, it is difficult to know whether the parasite is present or not. It is comparable to searching for a grain of sand in a swimming pool. One oocyst may be capable of infecting in a person with a weakened immune system. The adequacy of preventive measures may in some cases depend on a combination of barriers with different log reductions attributed to each, to ensure a sufficient reduction is reached.
Ultraviolet Irradiation
[31] The limitations inherent in conventional water treatment systems and the costs and other negative factors associated with ozone and membrane filtration led to increased interest in
North America in the use of ultraviolet light irradiation as a solution for Giardia and Crypto protozoa in the early to mid 1990’s.
[32] Ultraviolet light operates to disrupt replication in an organism by cross-linking its DNA or RNA double helix strands preventing their separation into two strands. This effect of UV light was known in the prior art, and the use of low levels of UV light as a disinfectant for bacteria and viruses in drinking water and waste water treatment was well established prior to the mid-1990’s.
[33] The standard units of measurement of UV energy are milliwatts per square centimetre (mW/sq cm). Doses are expressed in terms of intensity, time and area as milliwatt seconds per square centimetre or millijoules per square centimetre (mJ/cm²). A dose is the actual amount of energy delivered multiplied by the time taken to deliver it. The effect is the same whether the energy is transmitted intermittently or continuously.
[34] In a typical medium pressure UV lamp, mercury vapour is maintained at a pressure of about 1000 mm, a pressure at which it produces a continuous broadband of ultraviolet light at wavelengths below 254 nm. In a typical low pressure UV lamp, the mercury pressure is about 10 mm of mercury or less, a pressure at which it produces ultraviolet light primarily at a single wavelength of 254 nanometers (nm) with smaller emissions at other wavelengths within the UV spectrum. UV may also be delivered by pulsed light systems which deliver bursts of high intensity UV light intermittently.
[35] It was believed by many persons in the water treatment field in the early 1990s that a high dose of UV light, in the range of 3, 000 to 5, 000 mJ/cm², was necessary to “kill” or inactivate Crypto in the oocyst life-cycle stage.It was believed that it was difficult to penetrate the oocysts’ membranes with UV light. The in vitro methods used in laboratories for assessing and measuring the effectiveness of UV light were excystation and vital dye staining. These tests were considered as reliable surrogates for the more lengthy and expensive in vivo method, mouse infectivity - described in the evidence as the "gold standard" of microbiological assays. The U.S. Environmental Protection Agency required animal infectivity studies to demonstrate the efficacy of inactivation technologies.
[36] In assessing test results, it is important to remember that suspended solids in natural water can interfere with the absorption of UV light by organisms. Clarity is measured in nephelometric turbidity units (NTU). A turbidimeter estimates how light is scattered by suspended particulate material in the water.
[37] As of 1996-1997, there were several thousand known UV installations using doses in the range of 10 to 40 mJ/cm² to treat water. UV disinfection was more widely practised in Europe than in
North America . For example,
Germany
had developed a standard by 1997 and accredited eight manufacturers
[38] The North American market for municipal UV systems pre-1998 was small due to the reliance upon chlorine to disinfect for bacteria and viruses. Calgon’s research into the effectiveness of low doses of UV was a positive factor in the development of the municipal market. Prior to then, the bulk of Trojan’s market was in waste water treatment and UV applications for residences and cottages.
[39] As noted above,
Waterloo
suffered an outbreak of Cryptosporidiosis in 1993. Among other sources, the Regional Municipality of Waterloo takes water from infiltration wells adjacent to the
Grand River . Under current
Ontario
regulations, those wells are potentially considered sources of “groundwater under the direct influence of surface water” or GUDI wells. For wells in that category,
Waterloo
uses UV as the primary disinfectant supported by residual chlorine. It has about ten of these wells and uses UV equipment manufactured by Calgon, Trojan and Wedeco.
[40] UV systems for two
Waterloo
wells, one GUDI and one not, were commissioned and installed in October of 1996. At that time the provincial Ministry required extended contact time for the chlorine in the system and to provide that would have been extraordinarily costly. With the W-10 well, a GUDI well,
Waterloo
operates a Trojan 8000 UV reactor run in the 40- 60 mJ/cm² range. It was installed for bacteria and viruses. The Region has not tested for Crypto at that well as it would be difficult to establish whether it is present or not.
[41] Log “credits” are assigned by regulatory agencies for the use of various disinfection methods.
Waterloo
currently receives a credit of 2.5 log for natural filtration in wells under the direct influence of surface water (“GUDI wells) and just .5 log for UV treatment. The minimum standard it needs to meet is 2 log.
Waterloo also operates a Calgon Sentinel reactor at its
Mannheim treatment facility which takes water directly from the
Grand River . Given that the presence of Crypto in that river is well known, the targeted log reduction from the multiple barriers employed there is in the range of 5-7 logs. The plaintiff’s witness Dr. Stanley, of the
Edmonton
water utility corporation Epcor, testified that any log reduction would be valuable to a water producer.
The
North Bay
UV System
[42] In August of 2000,
Ontario introduced stricter water protection regulations following the contamination of the drinking water system in
Walkerton ,
Ontario
.
North Bay
’s water at that time received no treatment other than chlorine. Its source,
Trout
Lake
, was considered to be pristine apart from spring and fall inversion which produced increased turbidity (particulates) and colliform levels.In the aftermath of Walkerton, the Ontario Ministry of the Environment (MOE) advised the city that its treatment process must be capable of handling a higher risk of microbiological contamination including 99% (2 log) removal of Giardia. Crypto was not referenced at that time, but it was expected by the city to be included in the near future. There is no evidence that Crypto was in the lake or that it was expected to be present.The city had never had a Crypto outbreak and they had not tested for its presence.
[43]
North Bay retained the services of an environmental consultant to conduct a risk assessment of its
Trout
Lake
water supply. That assessment indicated that Giardia was likely present in the lake from time to time and that there was “some chance” Crypto may also be present.
[44] Further to the regulatory requirements, an engineering firm CH2M Hill Canada (CH2M) was hired to assess the available options. Four were considered: a new membrane filtration facility; adding an ozone contact tank; adding a chlorine contact tank; and ultraviolet irradiation. Membrane filtration was the preferred option but, at that time, it was very expensive. Additional chlorine would have had no effect on Crypto. Ozone was costly and complex to install and dangerous to operate. The UV option did not then have MOE approval.However, Trojan was prepared to install a pilot system to verify the log reduction at its own cost and CH2M recommended the city pursue that opportunity which it did. The testing was conducted over three months and was evaluated as successful.
[45]
North Bay
officials sought to avoid having to adopt membrane filtration because of the major capital expenditures involved and because the lake source was normally pristine and within provincial turbidity guidelines. However, in April 2001 the lake experienced a significant “turbidity event” or inversion which led to a boil water advisory by the Medical Officer of Health. The conclusion reached by city officials as a result of that event was that they would have to seek funding for construction of a new filtration system. They have since done that and a new system is scheduled to come on line in 2008. They were advised that UV disinfection would not be effective at high turbidity levels. In the interim, city officials were under pressure to install additional protection and, on the advice of their consultants, considered UV disinfection to be the best temporary solution.
[46] CH2M had a working relationship with Trojan. Trojan provided CH2M with research, test equipment and lab facilities. CH2M evaluated competing systems on the market for the city including Calgon’s but recommended Trojan’s system as best overall. It was open to the City to accept the recommendation to adopt UV irradiation through another company’s products but clearly Trojan had the advantage of an established presence in the field and its relationship with CH2M. Calgon was a late arrival. It entered the market in 1996 and made its first sale of the Sentinel system in 1999. Trojan had made UV disinfection systems for waste water treatment and point of entry or point of use drinking water systems for over a decade.
[47] The City Engineer, John Simmonds, recommended to Council that it accept CH2M’s recommendation. Given the time pressures, there was no bidding process. City Council passed resolutions on July 9, 2001 to install UV equipment purchased from Trojan. In a document dated July 13, 2001 Trojan undertook to indemnify
North Bay
against any damages or costs incurred as a result of any legal action arising from a patent infringement claim. It appears that this was requested by CH2M on the city’s behalf but there is no evidence that it was made known to the city before the purchase decision was made. In September 2001 Calgon had written to inform the city that the proposed UV treatment process was covered by its patent and that it was prepared to license use of the technology by the city.Mr. Simmonds testimony that he learned of the indemnity in October, 2001 following receipt of the Calgon letter is supported by a memorandum dated at that time.
[48] Notwithstanding notice of the ‘525 patent, North Bay chose to proceed with the implementation of the Trojan system without seeking a license from Calgon or paying the fee. On the assumption that the city treats roughly 20 million gallons a day, the cost would be about $100,000 annually. In Mr. Simmonds words, they considered the patent “bonkers” and without validity.
[49] In June 2002 the
North Bay
municipal plant began to process drinking water with UV irradiation. The Trojan Swift system employed by
North Bay
uses medium pressure lamps in continuous operation at a wavelength of 200-300 nm producing doses in the range of 40-50 mJ/cm².The city has now undertaken construction of an entirely new water treatment facility which will employ micro-filtration (2-3 microns), chlorination and UV irradiation in a multi-barrier system with built in redundancies.
Background to the Patent Application
[50] Dr. Stevens testified that he had been working with ultraviolet light in various applications for about 30 years. At a previous employer, Solarchem, acquired by Calgon in 1996, he had considered the use of UV to inactivate Crypto in 1993-94 but lacked the resources to develop the concept. Stevens stated that he and his colleagues were perplexed by the literature which indicated that very high doses were required in the range of many thousands of mJ/cm2 as the dosages required to inactivate bacteria and viruses were a thousand times lower. He said they could not understand why Crypto, another living thing with DNA, would behave differently. I take that to be an indication of what others with similar expertise would have thought at the same time.
[51] Prior to acquiring Solarchem, Calgon had undertaken a literature review of UV applications for preventing Crypto infection.This review was conducted by a Dr. Bertrand Dussert, one of the three named inventors of the ‘525 patent. Dr. Stevens and Dr. James Bolton of the
University of
Western Ontario
are the other two named inventors. Calgon then sponsored research by a Dr. Gerba of the
University of
Arizona
to attempt to “bracket” the range of UV doses required to inactivate Crypto. They were not satisfied with Dr. Gerba’s progress and in June of 1997, assembled a number of people active in the water treatment field to discuss research that was underway at that time. Included was Dr. Jennifer Clancy of a
Vermont
based firm, Clancy Environmental Consultants (CEC).Dr. Dussert had attended a presentation by Dr. Clancy earlier in 1997 that discussed the use of UV technologies for the inactivation of Crypto.
[52] Following the June meeting, Calgon sought to engage Clancy to train Gerba’s staff to carry out the research they wanted done. Clancy declined but offered to develop her own protocol if they wanted the work done by her firm. Stevens sent Clancy a request to budget a particular scope of work (Ex. D-51). That document appears to be the research protocol for which they had engaged Gerba as it refers to the use of
Tucson and
Phoenix
tap water. Clancy preferred to develop her own proposal which she sent Calgon in July, 1997.
[53] The object of the Gerba research, as disclosed by Ex.D-51, was to determine the dose necessary to inactivate Crypto up to 2 logs using both low and medium pressure lamps, to be measured by in vitro excystation tests for viability. Some animal infectivity assays were to be conducted with high pressure lamps at doses expected to kill 99% and 99.9% of the oocysts (my emphasis). It does not appear, therefore, that Stevens and others at Calgon were at that time pursuing the idea that irradiation at low doses would render oocysts incapable of replication. They were interested in finding out what range of dose would “kill the little buggers”.
[54] Dr. Clancy is a highly respected microbiologist with long experience in the drinking water field. She had managed water quality for a large municipal utility before opening her own firm and had been working on Crypto in water since the late 1980’s. She also has a Masters degree in Environmental Law.
[55] Clancy and her team had done research in 1995 and 1996 for a
U.K. firm on Crypto inactivation with a UV device which the firm wished to market in the
U.S.
The research involved tests at flow rates of 100-400 gpm and verification of inactivation by excystation and mouse infectivity studies to meet EPA standards. This was described at trial as a “trap and zap” system as filters were employed to capture the oocysts whereupon they would be subjected to a dose of UV. The results of that study were published in the November 1997 proceedings of the Water Quality Technology Conference.
[56] Clancy had also been conducting research under the auspices of the American Water Works Association Research Foundation (AWWARF) on methods for detecting Crypto in water and at the effectiveness of various disinfectants.That had led to a project, AWWARF 282, which involved research using a pulsed UV system supplied by INNOVOTECH, a company owned by Dr. Bob LaFrenz and also with a low pressure UV system. A subsequent project, AWWARF 395, which began in 1997 was co-funded by the United Kingdom Drinking Water Inspectorate and led by Dr, Clancy. The goal of AWWARF 395 was to compare animal infectivity with in vitro surrogate tests for Crypto inactivation. This project also involved the use of a pulsed UV system supplied by Dr. LaFrenz. Dr. Clancy gave a presentation on this research at the June 1997 meeting with Calgon.
[57] The proposal Dr. Clancy submitted in July 1997 led to an agreement with Calgon in September 1997 to test the inactivation of Crypto oocysts with UV light over a broad range of doses from 100 to 10,000 mJ/cm². Under that agreement, CEC was to conduct in vitro excystation and vital dyes assays.Mouse infectivity studies were to be used to verify the results of the in vitro surrogates to satisfy EPA requirements. That part of that work was to be done by Dr. Marilyn Marshall of the
University of
Arizona
who was also involved with the AWWARF research. Dr. Marshall was also under contract to Calgon.
[58] Clancy and her team knew from their 1995-96 project that doses in the range of 4000 to 8000 mJs/cm² would inactivate Crypto oocysts to a greater than 4 log level but they did not know what the lower limits were. The object of the study plan developed for Calgon was to prepare a response curve showing the lowest doses required to be effective for 1 to 3 log reduction. The results were to be determined by in vitro assays and some would be verified by mouse infectivity studies.
[59] As part of AWWARF 395, in September 1997 doses of 14, 40, 80 and 120 mJ/cm² were administered to viable oocysts with Dr. LaFrenz’ pulsed UV system and the results were subjected to in vitro assays by CEC and to mouse infectivity tests by Dr. Marshall. As recorded in a fax from Dr. LaFrenz dated November 5, 1997 (Ex.D-55), none of the mice given the doses of UV irradiation at 14 and 40 mJ/cm² were infected while the control group given untreated oocysts were infected as expected. In my opinion, this was the source of the discovery that low levels of UV radiation could prevent Crypto replication and infection.
[60] Dr. LaFrenz disclosed these results in a paper (Ex. D-56) presented at the Water Quality Technology Conference ("WQTC") held from November 9-12,1997 along with similar results he had obtained in parallel research funded by the Electric Power Research Institute (EPRI) which dealt with the irradiation of flowing water. While the LaFrenz work was conducted with pulsed UV, the evidence is that a dose of UV light is the same whether the energy is delivered in pulses or continuously over time. Dosage is a factor of intensity and time. Dr. Stevens agreed with this on cross examination.
[61] Upon learning of these mouse infectivity results from Dr. Marshall, Dr. Clancy concluded that the in vitro surrogates and mouse infectivity were measuring different things: the in vitro surrogates were measuring cell activity, not infection, and could not therefore correlate with mouse infectivity.
[62] Dr. Clancy disclosed the AWWARF 395 results to Drs. Bolton, Stevens and Dussert by letter dated December 10, 1997 (Ex. D-1). The purpose of the letter was to report on the in vitro studies conducted for Calgon but Dr. Clancy went on to advise them of her conclusions about the lack of correlation between the in vitro surrogates and mouse infectivity drawn from the AWWARF 395 results. She described how at UV doses of 14 and 40 mJ/cm² the in vitro surrogates demonstrated only a 50% reduction in viability while the mouse data showed no infection.At that stage, the Calgon mouse infectivity data was not yet in. This was AWWARF data. In an accompanying draft report (Ex.D-58), Dr. Clancy indicated that the difference between the in vitro and the in vivo results was not a new phenomenon as it occurs in bacteria. The organism appears alive when looked at in the surrogate tests but is not infective because it cannot divide.
[63] A reasonable inference is that it was this correspondence that taught Drs. Stevens,
Bolton and Dussert that “you don’t have to kill the little buggers”, you just have to render them non-infectious by altering their DNA. Apart from Dr. Stevens’ testimony, there is no evidence that they had the idea that this could be done previously.
[64] As of December 10, 1997 CEC’s Tom Hargy had performed UV exposures of Crypto oocysts for Calgon but the results of the mouse studies had not yet been obtained. This work was done in a petri dish using low and medium pressure lamps and a collimated beam apparatus supplied by the company. Hargy was trained by Dr. Jim Bolton in the use of the apparatus. Filters were used to diminish the radiance of the medium pressure lamp as the light would otherwise have been too intense. The low pressure doses administered ranged from 125 to 750 mJ/cm² and the medium from 150 to 1000 mJ/cm².
Bolton subsequently recalculated the doses downward. The in vitro assay results from those doses were not consistent with the AWWARF 395 mouse infectivity results.
[65] Dr. Marshall provided the mouse study data from the Calgon exposures to Dr. Clancy's team in a report dated January 26, 1998 (Ex. D-59).The samples sent to
Marshall
had been exposed to UV irradiation at doses of 300, 600 and 1000 mJ/cm².At those doses, no infection occurred in the treated mice but neither was there much infection in the control sample.The tests had to be repeated with a different oocyst isolate to achieve more consistent results. Marshall reported again on March 10, 1998 that the results from bench doses of 100, 200, 300 and 600 mJ/cm² were that no mice were infected, except for one anomaly in the 300 exposure group, while the expected proportion in the control group were infected. This translates into at least a 4 log reduction given the number of oocysts injected per mouse. If more had been used, the log reduction would have been higher.
[66] To satisfy the verification requirements of the US Environmental Protection Agency which would determine whether Calgon received any log credits for its UV equipment, Calgon undertook a pilot challenge study at the
Mannheim water treatment plant in
Waterloo ,
Ontario
in February-March of 1998. This was done by injecting oocysts into water which flowed from the plant through a Calgon Rayox UV reactor. Filters collected the post-treatment oocysts which were then assayed either in vitro or in vivo. CEC’s Hargy also did the oocyst exposures for this pilot.
[67] In an e-mail dated March 9, 1998 from Dr. Bolton to a number of people including Mr. Hargy,
Bolton discusses the data from the field tests. He stated:
We now have preliminary data on the lab mouse infectivity experiments. Amazingly, even at the lowest UV dose applied (100 mWs/cm2) no mice got sick!!! This means that the doses we had planned for the field trip were too high…
[68] Mr. Hargy’s evidence, supported by the documentary evidence, was that the field trials were conducted with doses of 100 to 300 mJ/cm².
Bolton recalculated the lowest dose amounts down to approximately 19 mJ/cm². That resulted in a EPA verification statement that 3.9 logs of Crypto inactivation can be obtained with 20 mJ/cm. Hargy’s uncontradicted evidence is that the lowest dose that can be directly attributed to the bench tests at the CEC lab or to the pilot tests at Waterloo was 50 mJ/cm². It is this data that was submitted as part of the patent specification in support of the claims.
[69] It appears that
Bolton recalculated the dosages administered in the bench and pilot tests several times before the patent claim date for two reasons. First, he had miscalculated correction factors for the filters employed in the bench tests. Secondly, the effect of light absorption in the water used in the pilot tests had not been taken into account. The mathematical model employed by Dr. Bolton to arrive at the claimed doses was not put into evidence by the plaintiff. Defendant’s expert, Dr. Linden testified that a skilled person would not be able to determine how the dose was calculated from the specification. It also appears that there was no verification of the actual doses administered at the
Mannheim
plant.
[70] I find from the evidence that exposures confirming the efficacy of a dose as low as 10 mJ/cm², as claimed in the patent, were not performed until after the May 13, 1998 claim date. I arrive at this conclusion from the testimony of Dr. Clancy and Mr. Hargy and the supporting pre-May 13, 1998 documentation. A report by Dr. Bolton dated April 6, 1999 and marked for identification as Ex. D-65 was not properly identified by a witness at trial and was, therefore, inadmissible.
[71] In my view, the tests conducted for Calgon merely confirmed what had already been discovered through the AWWARF and EPRI research with LaFrenz’ pulsed UV system. Low UV doses inactivated Crypto and that could only be verified with mouse infectivity studies as the in vitro surrogates did not correlate.
[72] Bolton and Stevens sought to have Clancy and her associate, Dr. Bukhari, listed as inventors on Calgon’s patent application submitted in May, 1998 in the
U.S.
.They declined. Dr. Clancy gave two reasons in her testimony. She did not want to be seen as aligned with one of the several firms employing UV technology and secondly, she did not believe that the research had disclosed a patentable invention. She conveyed only the first reason to Calgon at the time and cooperated to some extent in the preparation of the patent application.
[73] Dr. Clancy candidly acknowledged that she was extremely upset when she learned that Calgon was asking for a licensing fee for usin