Infringement of Patents

1. Infringement of Patents • S. 42 provides that the patentee or the legal representative of the patentee has an exclusive right to “make”, “construct”, “use” or “sell” the invention during the life term of the patent. • A patent is infringed when the incidents of ownership of patent rights are performed by persons other than the patentee without necessary consent, permission or authorizations.

2. Claims and Infringement • As already noted, the claim(s) of the patent define(s) the legal scope of property rights vested on the patentee by law. It is therefore to the claim(s) that counsel or the court must turn to determine whether or not a patent has been infringed.

3. Broad Claims • Given that claims determine whether or not a patent has been infringed, broad claims have a greater tendency to be infringed that claims crafted in narrow bounds. For example, a patent with a claim of a broad scope on the basis of limited exemplification or on sound prediction is more likely to be infringed than one that is limited to actual exemplification.

4. Examples of Broad Claims • The Harvard mouse patent (USP 4 736 866) exemplified for mice, but CLAIMED for all non-human mammals. • Generation of antisense RNA in situ to switch off genes (EP 140, 308 B1) example of one gene in one micro-organism-claims to all genes in all organisms

5. Claims and Infringement • As the examples above show, the question of whether a particular patent has been infringed or not is one that must first be answered in direct reference to the scope of the claims. Consequently, the issue of infringement of patents almost always turns on HOW THE COURTS CONSTRUE CLAIMS.

6. Construction of Claims • Whether an infringement has occurred is a question of mixed law and fact. This is so because the CONSTRUCTION of the claim itself is a QUESTION OF LAW while the related issue of whether the defendant’s actions fall within the protected scope covered by the CLAIMS is a QUESTION OF FACT.

7. Construction of Claims • Various schools of thought have predominated at various times on HOW or the appropriate methodology in the construction of claims. In the US, for example, taking the “pith and marrow” of the invention leaving aside “useless embodiments” constitutes infringement of the utility patent. This approach has given rise to the “doctrine of equivalents.”

8. Doctrine of Equivalents • In applying the doctrine of equivalents, the court determines what constitutes the essential components of a device. If the invention is a mechanical device, for example, the test is one of mechanical equivalence. The test looks for the equivalent of what was allegedly taken by the infringer.

9. Warner-Jenkinson • Hilton Davis and Warner-Jenkinson manufacture dyes, including FD&C (food, drug, and cosmetic) Red Dye #40 and Yellow Dye #6. The process of making these dyes yields impurities as byproducts. Manufacturers must remove these impurities from the dyes to meet stringent governmental requirements for food and drug purity.

10. Warner-Jenkinson • Historically, Hilton Davis and Warner-Jenkinson used an expensive and wasteful process known as "salting out" to purify the dyes. The '746 patent, assigned to Hilton Davis, discloses an improved purification process that replaces salting out with "ultrafiltration."

11. Warner-Jenkinson • Ultrafiltration uses osmosis to separate components of a solution by drawing some of the components, but not others, through a membrane. Thus, the '746 process filters impure dye solution through a membrane at certain pressures, pHs, and pore diameters. Impurities, but not dye molecules, pass through the membrane, leaving a high purity dye product.

12. Warner-Jenkinson • Hilton Davis began its search for an alternative to the salting out process in 1982. The co-inventors of the '746 process, Drs. Cook and Rebhahn, led this project for Hilton Davis. The inventors decided to investigate a membrane separation process.

13. Dr. Cook then hired Osmonics, Inc., a filtration equipment manufacturer, to test the process on a Hilton Davis Red Dye #40 solution which had been disclosed to Osmonics under a secrecy agreement. The first test, in August 1982, did not succeed. Dr. Cook then instructed Osmonics to perform a second Red Dye #40 test with specified changes in the test membrane and filtration procedures.

14. Warner-Jenkinson • This second test, in October 1982, succeeded. Osmonics successfully purified Hilton Davis Yellow Dye #6 under Dr. Cook's instructions in January 1983.The inventors filed their initial patent application based on the October 1982 and January 1983 test results.

15. Warner-Jenkinson • After further in-house testing by Dr. Cook, the inventors filed a continuation-in-part application claiming a broader range of membrane pore sizes. The '746 patent issued in 1985. • The '746 patent claims a process for purifying commercial dyes including Red Dye #40 and Yellow Dye #6.

16. The Claim in “Jepson” Form • “In a process for the purification of a dye selected from [a group including Red Dye #40 and Yellow Dye #6] . . . the improvement which comprises: subjecting an aqueous solution . . . to ultrafiltration through a membrane having a nominal pore diameter of 5-15 Angstroms under a hydrostatic pressure of approximately 200 to 400 p.s.i.g., at a pH from approximately 6.0 to 9.0, to..

17. The Claim in “Jepson” Form • …thereby cause separation of said impurities from said dye, said impurities of a molecular size smaller than the nominal pore diameter passing [through] said membrane and said dye remaining in the concentrate, and when substantially all said impurities have been removed from said concentrate . . . recovering said dye, in approximately 90% purity from said concentrate by evaporation of said concentrate to dryness.

18. Distinction from Booth’s Patent • The inventors added the phrase "at a pH from approximately 6.0 to 9.0" during prosecution to distinguish U.S. Patent 4,189,380 to Booth al. (the Booth patent). The Booth patent discloses an ultrafiltration process that, among other differences from the '746 process, operates at a pH above 9 and preferably between 11 and 13.

19. Does Size Matter? • Warner-Jenkinson developed its accused ultrafiltration process for Red Dye #40 and Yellow Dye #6 in 1986. Like the '746 process, Warner-Jenkinson's accused process included ultrafiltration through a membrane. At trial, Hilton Davis showed that Warner-Jenkinson's process operated at pressures somewhere in a range of 200 to nearly 500 p.s.i.g. and a pH of 5.

20. Warner-Jenkinson • While Hilton Davis did not present actual pore size measurements for Warner-Jenkinson's membrane, several experts testified that a membrane collecting Red Dye #40 and Yellow Dye #6 would have a nominal pore diameter of 5 to 15 Angstroms.In 1982, Warner-Jenkinson had tested a membrane separation process on a dye solution that had already been salted out.

21. Warner-Jenkinson • Warner-Jenkinson, like Hilton Davis, hired Osmonics under a secrecy agreement to perform its test. Osmonics performed the Warner-Jenkinson test in August 1982, one week before it performed the first Hilton Davis test. The Warner-Jenkinson test was not successful, however, because it did not produce a sufficiently pure dye.

22. Warner-Jenkinson • After the unsuccessful test, Warner-Jenkinson ceased work on filtration of Red Dye #40 and Yellow Dye #6 until 1986.Warner-Jenkinson did not learn of the '746 patent until October 1986, after it had begun commercial use of its ultrafiltration process to purify Red Dye #40.

23. Warner-Jenkinson • Hilton Davis learned of Warner-Jenkinson's process in 1989 and sued Warner-Jenkinson for infringement of U.S. Patent No. 4,560,746 (the '746 patent). The jury found that the '746 patent was not invalid and that Warner-Jenkinson infringed under the doctrine of equivalents. The jury found that Warner-Jenkinson did not willfully infringe, however, and awarded only 20% of Hilton Davis' request in damages.

24. Function-Way-Result • The trial court entered judgment on the jury verdict. The district court then denied Warner-Jenkinson's post-trial motions, and entered a permanent injunction prohibiting Warner-Jenkinson from practicing ultrafiltration except at pressures above 500 p.s.i.g. and pHs above 9.01.

25. Warner-Jenkinson • On appeal, the court affirmed, holding that the application of the doctrine of equivalents rested on the substantiality of the differences between the claimed and accused products or processes, assessed according to an objective standard. The court held that the district court's function-way-result instruction correctly guided the jury to consider the relevant evidence.

26. Warner-Jenkinson • The court held further that substantial evidence supported the jury finding of infringement and that the question of infringement, whether literal or by equivalents, was a question of fact for the jury if properly demanded. The court held that prosecution history estoppel did not preclude application of the doctrine of equivalents in the case.

27. At the U.S. Supreme Court • Warner-Jenkinson appealed the infringement and validity findings. At the US Supreme court, the court affirmed the judgment, holding that defendant infringed based upon doctrine of equivalents.

28. The Triple Identity Test • In essence, the doctrine of equivalents requires proof of the fact that the alleged infringing invention offers substantially same: • Function; • Way; and • Result as the patented invention. • The organizing idea is the protection of the alleged ‘substance’ of the invention by rejecting “colorable” difference and slight improvements as patentable subjects.

29. Triple Identity Test • First formulated by Justice Bushrod Washington, the triple identity test postulates that "where the [claimed and accused] machines are substantially the same, and operate in the same manner, to produce the same result, they must be in principle the same."

30. Rationes in Warner-Jenkinson • In explaining the bases for the doctrine, the United States Supreme Court observed that limiting enforcement of exclusive patent rights to literal infringement "would place the inventor at the mercy of verbalism and would be subordinating substance to form." See Graver Tank Case, 339 U.S. 605

31. Rationes of Warner-Jenkinson • Such a limitation, the Court reasoned, might even encourage infringers "to make unimportant and insubstantial changes and substitutions in the patent which, though adding nothing, would be enough . . . [to evade] the reach of law." Based on these predicates, the SC concluded, the doctrine applies if, and only if, the differences between the claimed and accused products or processes are insubstantial

32. Substantial and Insubstantial • The U.S. Supreme Court in Graver Tank thus made insubstantial differences the necessary predicate for infringement under the doctrine of equivalents.

33. Limitations of Triple Identity Test • The function-way-result test arose in an era characterized by relatively simple mechanical technology. As technology becomes more sophisticated, and the innovative process more complex, the function-way-result test may not invariably suffice to show the substantiality of the differences. Put simply, the triple identity test seems archaic in contemporary times.

34. Equivalent vs. Purposive • Under the doctrine of equivalents, a defendant is liable for infringement even where the alleged infringing device or product does not appropriate the express description of the invention as articulated in the disclosure and claimed. The substance of the claim would be infringed where the offending article is the equivalent of the original.

35. Refinement of Triple Test • The current state of the law on the doctrine of equivalents is that quite apart from function, way, and result, an important factor to be considered "is whether persons reasonably skilled in the art would have known of the interchangeability of an ingredient not contained in the patent with one that was."

36. Mcphar and Equivalence • In the McPhar case (1960), 35 CPR 105, the plaintiff obtained a patent for an apparatus for detecting subterranean ore bodies. A crucial unit of the device was a suspended transmitting coil. The defendant achieved the same result by supporting the transmitting coil on a mast erected on a tripod. In determining whether the defendant infringed the plaintiff’s patent, the court reasoned that plaintiff took the ‘substance’ of dft’s invention.

37. Purposive Approach • In Whirpool v. Canco, [2000] 2 SCR 1067, the Canadian Supreme Court revisited the issue of whether a claim must be construed literally or purposively. In the opinion of the courts, the key to purposive construction is identification by the court of the PARTICULAR WORDS or PHRASES in the claim that describe what the inventor considered to be ESSENTIAL ELEMENTS of the invention.

38. Purposive Approach • By such an approach, the inventor is not necessarily tied to the letters of the claims but to the INTENDED MEANINGS” of the words and phrases used in the claims. The purposive approach is not a new method of analysis and construction of claims. See Binnie, J at para 6, page 473 of Reading Materials.

39. Double-edged Sword? • Although interpretation of patent laws is distinctive, s.12 of the Interpretation Act justifies the purposive approach to the interpretation of claims. It must be emphasized that although the purposive approach is apparently slanted in favour of the patentee, it can in fact “cut either way.” Binnie, J. in Whirlpool v. Canco

40. Purposive Approach • The point which Justice Binnie was making in Whirpool v. Canco is that a purposive construction is capable of expanding or limiting a literal text. A purposive construction is not necessarily a broader construction than a purely literal one. A purposive approach looks at the CONTEXT of the claims. See para 1, p. 477 handbook.

41. Literal Construction? • Canadian law eschews a literal construction of claims. The construction of claims is not a meticulous “verbal analysis in which lawyers are too often tempted by their training to indulge.” The purposive approach construes claims in a mindset that seeks to understand the essence of the invention. However, unlike the US, Canada does not allow extrinsic evidence to determine the intent of the patentee in his/her dealings with the PO.

42. Predictability of Claims • It is of the utmost importance that a patent claim be clear and precise. A a private property, the claims of a patented invention must be delineated with exactitude and precision so that both the patentee and the public are put on adequate notice on the limits of the property rights vested in the patentee. See para. 4, page 483 of Handbook.

43. Freeworld v. Electro Sante • “Predictability is achieved by tying the patentee to its claims; fairness is achieved by interpreting those claims in an informed and purposive way”. Binnie, J. in Freeworld v. Electro Sante. • Note the question of “prosecution history estoppel” in Canadian law and compare with Warner Jenkinson, in US law. (Binnie J, in Freeworld v. Electro Sante, at para 1 p. 2

44. Interpreting Claims • In sum, our courts look at the rest of the specification, including the drawing, to understand the nature of the invention and by so doing, relate the claims to the disclosure to properly construe the ambits of the claims. It is after the court has delimited the scope of the claim that the factual question of infringement would then be determined.

45. Innocent Infringement? • Patent law does not countenance intent in ascertaining determining infringement. However, the emergence of genetic patents challenges the implicit assumptions of patent law on the factual characteristics of actions which infringe patented inventions. For example, the dispersal of patented genes by forces of nature does not quite fit with the imagery of an infringer as a methodical thief of intellectual property.

46. Schmeiser’s case • The suit alleged that Schmeiser planted glyphosate-resistant canola for harvest, without a license from Monsanto. This is the first suit anywhere in the world on the question of (innocent?) infringement of a genetic patent. The central question for determination is whether a person can be said to have infringed the patented invention without as much as intentionally planting the patented crop in question?

47. Whodunit? • Schmeiser’s farm was not licensed to plant the patented canola seeds but such plants were found to be growing on his farm. Evidence from a witness, Dr. Downey clearly demonstrated that “the canola plants growing there (on Schmeiser’s farm) were not the result of pollen movement into those fields…[but] from commercial Roundup Ready canola seed” [pg. 11-14 of law report] Query: Whodunit?

48. Genetic Promiscuity and Infringement • An astonishing legal proposition made by Mackay J., is that a person may be liable for infringing a genetic patent EVEN IN CASES where genetic pollution or promiscuity was in fact an act of forces or factors beyond the control of the alleged infringer. Given the novelty of the issue, this is a problematic proposition of law. In tort law, the owner of a straying bull may be liable for the damages arising from the activities of HIS/HER bull.

49. Antiquated Law? • Surely, a farmer does not become the owner of patent rights to a genetically altered gene merely because the wind blew some genes to his/her farm. But this does not answer the question of potential liability of the owner of the altered gene for damages caused by such straying altered gene.

50. Rethinking the law? • The law on infringement does not look upon intent. Where the essence of the invention is taken, intention is immaterial. But given the peculiar nature of genetic patents, is it not time to rethink this position of the law? The point is that the rules disregarding intent on infringement were designed at an age when most patents went to machines and other highly controllable inventions. It seems that some genetic patents don’t fit in that paradigm.