Infringement of Patents

1. Infringement of Patents What Constitutes Infringement?

2. Scope of Rights of a Patentee • Although the scope and incidents of the rights granted to a patent holder are statutorily prescribed, the nature and character of such statutory provisions have necessarily been fleshed out by various judicial pronouncements. • From the statutory perspective, s. 42 of the Canadian Patent Act provides for the scope and incidents of patent ownership. • s. 42. Every patent granted under this Act…shall subject to this Act, grant to the patentee and the patentee’s legal representatives for the term of the patent, from the granting of the patent, the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used, subject to adjudication in respect thereof before any court of competent jurisdiction.

3. Infringing Acts • By the foregoing, it seems clear that a patent seeks to protect the subject-matter of the invention from unauthorised acts that interfere with the rights of the patent holder.Whirlpool v. Camco (1999), Apotex (2002) • In effect, any person who without the consent and permission of the patentee, makes, sells, uses, constructs or otherwise exercises proprietary control over the subject-matter of a valid patent has infringed the patent and is potentially liable to the patentee. • Infringement does not cover a product as such; it covers acts relating to a product such as making it, dealing with it, keeping it or by such other acts that interferes with the rights of the patent holder.

4. Nature of the Patent Rights • It should be noted that the issuance of a patent on an invention does not necessarily permit or authorize the patentee or the patentee’s legal representatives to make, use, or sell the invention. • There may be other statutory obligations to be met before inventions could be used, sold, or worked. • Therefore, the better description of the nature of the rights conferred by the grant is that the patentee has the right to EXCLUDE others from using, making, or selling the patented invention unless such persons have the authorization of the patentee.

5. Construction of Claims & Infringement of Patents • It must be understood here that the property rights forming the subject-matter of the patent are as delimited in that portion of the patent document generally known as the “claim/s”. The claim/s delimit(s) the scope and nature of the exclusive property rights granted to the patent holder . (Freeworld v. Electro Sante) • Therefore, in determining whether a claim has been infringed, it is to the claim(s) that counsel or the court must turn to. • Absent a determination of the scope of a patentee’s property rights, it is not possible to make a determination as to whether or not an act of infringement has occurred. This distinction is of radical importance because two or more inventions may cover a similar subject-matter and yet not infringe each other if the claims are worded differently or the words used capture the essence of different inventions.

6. Claims and Infringement • For example, if a person invents a pistol and another person invented a telescopic rifle, both products, though covering a similar subject-matter—guns—may differ in the property rights of each respective patentee. The latter would not infringe the former if the claim deals with the application of a telescope to a gun. • Thus, the words used in the claims and the approach adopted by court in the construction or interpretation of the words are crucial in determining whether or not an infringement has occurred.

7. Broad Claims & Infringing Acts • 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. • 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 • 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.

8. Construction of Claims • Given the central role of claims in the determination of infringement cases, the important question that falls for determination is: how do the courts interpret claims? • As earlier noted, finding infringement is both an issue of law and of fact. (Freeworld/2004). • This is so because the CONSTRUCTION of the claim is a QUESTION OF LAW. • On the other hand, whether the defendant’s actions fall within the scope of rights covered by the CLAIMS and conferred on the patentee is a QUESTION OF FACT.

9. Construction pf Claims • With respect to construction of claims, various courts in diverse jurisdictions have in the past century, grappled with the appropriate approach to the construction of claims and thus, the determination of infringement. • In the United States, for example, the “pith and marrow” approach held sway for decades (Graver Tank/1950). • The pith and marrow approach posits that an infringement occurs when a defendant unlawfully takes, makes, and uses the pith and marrow of an invention. • By this approach, courts in the United States purport to distinguish between the pith of an invention from the bells and whistles.

10. 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. Warner-Jenkinson v Hilton Davis/1997). • In making a factual determination on infringement, the test would have to determine whether the alleged infringer’s device interfered with the monopoly enjoyed by the original patented mechanical device. • Similarly, if the invention is a chemical compound, the issue would be whether the patented substance differs from similar compounds of the same class (Warner-Jenkinson/1997).

11. Warner-Jenkinson v. Hilton Davies • Hilton Davis and Warner-Jenkinson manufacture dyes, including 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. • 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."

12. 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. • 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. Warner-Jenkinson • 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. • 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.

14. 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. • “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..

15. Warner-Jenkinson • …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 theThe 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. 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.

16. 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. • 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.

17. 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 because it did not produce a sufficiently pure dye. • 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.

18. 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. • 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.

19. Triple Identity Test: FUNCTION- WAY-RESULT • 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. • The court held further that the question of infringement, whether literal or by equivalents, was a question of fact for the jury to determine. • Finally, the court held that prosecution history estoppel did not preclude application of the doctrine of equivalents in the case. • Warner-Jenkinson appealed the infringement and validity findings. At the US Supreme court, the SC affirmed the judgment of the lower court based upon the doctrine of equivalents.

20. Triple Identity Test • In practice, therefore, the US doctrine of equivalents boils down to what is generally referred to as the triple identity test, that is, whether the alleged infringing article performs the same function, in the same way, and produces the same result as the patented subject matter (Graver Tank/1950). • 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.

21. 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.“ • 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 • Such a limitation, the Court reasoned, might 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."

22. Triple Identity Test • The function-way-result test arose in an era characterized by relatively simple mechanical technology. • It offers little protection when the alleged infringement pertains to inventions of great sophistication and subtlety where the slightest difference or nuance could make radical differences between the allegedly infringing product and patented product. • Moreover, 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 inadequate in contemporary times.

23. Doctrine of Equivalent • 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. • 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."

24. McPhar Case • Although decisions in the court of one country are not binding on the courts of other countries, it is often the case that courts with similar legislative provisions often engage in some form of “dialogue” with one another. • It is therefore not surprising that the triple identify found its way into Canadian patent law in the 1960s and 1980s (McPhar/1960) but seems to have been eclipsed by what is referred to in Canada as the “purposive approach”. • 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.

25. 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.

26. Purposive Approach • The purposive approach seeks to understand what the purspose of the original invention is, having regard to the claims in the patent) (Whirlpool/2000). • Since the decision of the Supreme Court in Free World v. Electro Sante, it is settled law that courts in Canada construe the claims in a purposive manner to determine whether the defendant’s conduct infringed on the rights of the patent holder. • 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.

27. Purposive Approach • 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 • 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.

28. Literalism? • 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. • 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.

29. Predictability of Claims • “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 )

30. Summary • Infringement of patents is therefore at the core of patent law. • At the next lecture, we will examine acts that DO NOT constitute infringement even though such acts may interfere with the limited monopoly conferred on the patentee by the Patent Act. • In addition, we will resolve the problematic issue of whether intent is necessary to prove infringement.