A Review of Developments in Patentability

Introduction………………………………………………………………… 1

I. United States…………………………………………………………… 2

B. Anticipation……………………………………………………… 3

II. Canada………………………………………………………………… 5

III. European Union……………………………………………………… 10

Litigation of patentability in the field of biotechnology since the turn of the millennium has in large part simply reviewed established principles. The bulk of patent litigation occurred in the United States; the majority of these cases followed established principles, and few discussed new dimensions to the law. Some groundbreaking cases were heard in Canada, though these developments followed previously established American rationale. In Europe, the question of patentability was less often asked, although some differences from the American and Canadian models were apparent. Cases dealing with fields other than biotechnology are also reviewed where developments were made or principles reviewed that have implications in biotechnology.

In the United States, the question of patent validity was most often asked in response to a claim of infringement, and most often hinged on the question of obviousness. The New L & N Sales and Marketing v. Big M[1] provided a recent, thorough review of the possible grounds for a claim of invalidity: claim construction, functionality, anticipation, and obviousness.[2] The question of functionality was the only one of these four not discussed sufficiently in the case law to warrant comment.

Winner International Royalty v. Wang[3] identifies four factual inquiries (scope and content of the prior art; level of ordinary skill in the art; differences between the prior art and the claimed invention; extent of any objective indicia of non-obviousness)[4] into the question of obviousness (cited in New L & M as the “Graham factors”)[5] in the context of multiple prior art references, where there must be some “teaching, suggestion, or reason” to combine the references.[6] Neato v. Rocky Mountain Traders[7] expands further the second factor to determine obviousness (level of ordinary skill in the art) into five sub-factors,[8] eventually reducing the qualification (for the purpose of this case involving a machine that applies labels) to “one skilled in making and designing basic mechanical devices.”[9] In reversing a finding of non-obviousness in a case of an internet-based purchasing system, the same question was considered when the Court of Appeals in Amazon.com v. Barnesandnoble.com[10] found that the District Court erred in considering the personal view of a witness; “the relevant inquiry is what a hypothetical ordinarily skilled artisan would have gleaned from the cited references at the time.”[11]

In a case more closely aligned to biotechnology, the court in 1995 in Novo Nordisk v. Genentech[12] weighed secondary considerations to support its finding of the non-obviousness of a human growth hormone product. The court collected four factors from precedent: the commercial success of the products; a long felt need in the art satisfied by the invention; failure of others to make the invention; and copying the invention by others in the field.[13] More recently, and also in the field of biotechnology (considering the manufacture of a recombinant DNA product [EPOGEN] similar to erythropoietin [EPO]), the court in Amgen v. Hoechst Marion Roussel[14] listed eight secondary considerations, although it was careful to state that “[a]lthough secondary considerations must be weighed, they do not control the determination of obviousness”:[15] copying; long-felt, but unresolved need; the failure of others; commercial success; unexpected results created by the claimed inventions; unexpected properties of the claimed inventions; licenses revealing industry respect for the invention; and skepticism of skilled artisans before the invention.[16]

In addition to reviewing obviousness, the court in Honeywell v. Hamilton Sundstrand[17] also considered anticipation, stating that “invalidity by anticipation requires that the four corners of a single, prior art document describe every element of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could practice the invention without undue experimentation.”[18] Likewise, the court in Amgen considered anticipation in a similar manner, adding “[t]he identical invention must be shown in a single prior art reference in as complete detail as contained in the patent.”[19] Thus, the test for anticipation presents a high threshold against which no claim for invalidity was successful in the new millennium.

The third ground of invalidity, according to New L & M, is claim construction. The court in Glaxo Wellcome v. Genentech[20] outlined the principles of claim construction, stating “[c]laims are construed from the vantage point of a person of ordinary skill in the art”[21] and “[i]n construing a claim, a court first looks to the intrinsic evidence of record, namely, the claims, the specification, and the prosecution history.”[22] The court further stated that in construing claims, the court starts with the words themselves and gives them “their ordinary and customary meaning unless a patentee clearly sets forth a different definition”.[23] In another case in the field of biotechnology, the court in Affymex v. Hyseq[24] reviewed claim construction in a similar manner.[25] However, the court narrowed the latitude allowed in its own and Glaxo’s review by saying “[a]lthough the Court acknowledges that it must attempt to interpret claims in a manner which will sustain their validity, courts do not have authority to redraft claims for this purpose.”[26] [emphasis in original] Thus the courts in Affymex and Glaxo acknowledged a wide latitude of claim interpretation to sustain validity, extending to but not including redrafting. The court in Affymex also considered the defendant’s argument that precedent in biotechnology supported an enablement requirement in claim construction, and concluded “none of these cases dictate that the enablement analysis must be incorporated into claim construction.”[27]

One interesting development in the American arena concerns prosecution history estoppel. In a rare development, the Court of Appeals in Festo v. Shoketsu Kinzoku Kogyo Kabushiki[28] reversed an affirmed finding of infringement as the patents that were found to be equivalent under the doctrine of equivalents were amended during prosecution of the patents, thus giving rise to prosecution history estoppel, under which the patents could not be infringed by equivalents.[29] This finding, and the court’s discussion of the issue, represents consideration of prosecution history estoppel de novo.[30] The court had no little trouble in coming to its holding: eight of the twelve judges formed the majority, and almost every one gave a separate judgement concurring and dissenting in part with various aspects of the issue. Although the court in Festo had trouble deciding prosecution history estoppel, its holding has been applied with relative ease. The court in Honeywell v. Honeywell[31] distilled the holding in Festo to arrive at a test[32] with which it determined that prosecution history estoppel was not applicable in the case at bar.[33] Likewise, in both Amgen[34] and Graco Children’s Products v. Regalo International[35], the issue of prosecution history estoppel was raised and quickly dismissed as inapplicable. Whether because the Festo decision is controversial, courts are reluctant to apply its principles, or cases which match the criteria are rare, Festo has yet to be argued successfully.

In Canada, the question of claim validity was also discussed within the context of patent infringement in cases since the turn of the millennium. The most substantial area of development was with respect to claim construction. In addition, two cases broke ground with respect to biotechnology in discussing what kind of matter can be patented.

The Supreme Court of Canada in Free World Trust v. Electro Sante[36] began the discussion of purposive construction in the context of a two-step approach to (literal and substantive) infringement.[37] The Supreme Court of Canada in the two cases Whirlpool v. Camco[38] and Whirlpool v. Maytag,[39] heard together, took the opportunity to examine at length the question of validity with respect to both claim construction and double patenting. The court in Camco reviewed at length and adopted the “purposive construction” approach advocated in the House of Lords case Catnick Components v. Hill & Smith.[40] Claims construction was seen to be antecedent to both validity and infringement issues,[41] where the key to purposive construction was “the identification by the court, with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the “essential” elements of his invention”;[42] a dictionary approach to claim construction was dismissed.[43] Interestingly, this shows a divergence between Canada and the United States in the consideration of claim construction: where in the United States, according to New L & M, claim construction is one component of a validity analysis, by Camco in Canada considerations of claim construction come before the validity analysis and apply equally to infringement.

Prior to the Camco decision, the Federal Court in Novartis AG v. Apotex[44] described purposive construction in these terms: “one is asking what did the inventor intend to claim as disclosed in the text of the patent – what is the purpose of the written text.”[45] Interestingly, the court also distinguished purposive construction of a patent from the purpose of a given chemical reaction (in a case relating to the manufacture of a pharmaceutical drug): “In asking what is the purpose of a given chemical step, process or reaction, the answer may indeed be that it is to make the same molecule as that to which the patent relates… but this does not mean that the given step, process or reaction falls within the text of the patent, purposively construed.”[46] Thus the court seems to take a more narrow approach to claim construction than the wide latitude found in the United States. Furthermore, the Federal Court of Appeal commented in Kirin-Amgen v. Hoffman-La Roche[47] that “construction of a patent turns heavily on the evidence accepted at trial of a person skilled in the art,”[48] further limiting the ability of judges to interpret claims.

The court in Camco also discussed patent validity with respect to double patenting. The court identifies two types: “same invention” double patenting and “obviousness” double patenting. The former has a strict test where the two claims need to be shown “identical or coterminous”.[49] This parallels closely the American test for anticipation found in Sunstrand and Amgen. The latter has a “more flexible and less literal test that prohibits the issuance of a second patent with claims that are not ‘patentably distinct’ from those of the earlier patent,”[50] which speaks to the issue of novelty[51] (or, in the United States, anticipation) and is predicated largely on the testimony of experts who are “ordinary workers”.[52] “Obviousness” double patenting thus combines components of obviousness and novelty analyses to form a type of hybrid invalidity claim.

Apotex v. Wellcome Foundation[53] sets out the test for obviousness as a “difficult onus to discharge”:[54] “whether the notional technician, devoid of inventiveness, but skilled in the art would, in light of the state of the art and of common general knowledge at the date of the invention, have come directly and without difficulty to the solution taught by the invention.”[55]

The test for anticipation (or novelty) was reproduced in the Supreme Court of Canada case Electro Sante from Beloit Canada v. Valmet OY[56]:

One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention.[57]

and likewise described it as a “difficult test to meet”.[58] The Canadian test, then, like its American counterpart, also presents a high threshold. The court, however, found that as long as a “claimed invention effected an ingenious combination rather than a mere aggregation of previously known components” and “the ingenious combination was neither taught nor anticipated [by prior publications]”[59] a patent could be held valid as novel. The court in Apotex also held that “the discovery of a new use of an old compound”[60] (in this case the new use in treating HIV of the already known compound AZT) is patentable.

The concept of utility was simplified in Federal Court case Goldfarb v. W.L. Gore & Associates[61] to a test that “reflects the notion that what is patented will work”.[62] However, in the Court of Appeal case Apotex, the court refined that test by holding, “so long as an inventor can demonstrate utility or a sound prediction at the time a patent is attacked, the patent will not fail for lack of utility,”[63] and, “where an invention constitutes a speculation as of the priority date claimed in the patent, the patent will not be invalid if it turns out that the speculation is valid at the time the patent is attacked.”[64] From Apotex, then, it seems clear that utility need not be certain at the time of patent prosecution, but must be demonstrated upon an attack on validity: “The time at which usefulness is to be established is when required by the Commissioner of Patents or in court proceedings when the validity of the patent is challenged on that ground.”[65]

The Federal Court of Appeal case President and Fellows of Harvard College v. Canada[66] recently addressed the question of the patentability of genetically altered non-human mammals for use in carcinogenicity studies.[67] The case represents one of the first higher court considerations of the patentability of higher life forms.[68] In reversing the Federal Court decision, a majority of two to one held that the Federal Court was right to uphold a patent in the “preparation of the genetically engineered plasmid”[69] but was wrong to uphold the Commissioner’s decision to exclude “the development of a genetically engineered mouse in the uterus of the host mouse” from patentability.[70] Instead, Justice Rothstein for the majority of the Court of Appeal determined that the ocnomouse was “both unobvious and a new and useful ‘composition of matter’”[71] even though the Federal Court had disagreed with the matter as being an invention.[72] Both courts agreed that the mouse was non-obvious, new, and useful, but disagreed on whether or not it was an invention; the Appeal court, using the provisions of the Patent Act[73] and U.S. Supreme Court precedent,[74] determined that the mouse was a “composition of matter” within the meaning of “invention” from the Act,[75] keeping in mind the object and purpose of the Patent Act.[76] In doing so, the higher court determined that a higher life form is eligible for patent application as long as it involves the application of inventive ingenuity,[77] dismissing the lower court’s concerns over issues of control, the distinction between human intervention and the laws of nature, reproducibility, and the distinction between higher and lower life forms.[78]

Concerns regarding public policy in the patenting of higher life forms were also largely dismissed in light of American precedent[79] and deference to Parliament.[80] Interestingly, though, the court seems to waive this deferential attitude in its final comments on implications for human beings. The court summarily dismisses the possibility of patenting human beings, citing property concepts and Charter rights,[81] but leaves the determination of the patentability of human genes to courts or Parliament.[82] While the Federal Court reserves the opportunity to review the patentability of human genetic products, it effectively precludes the court from excluding higher life forms from patentability, which was arguably what the lower court was attempting to include for public policy reasons. One might view this progression as a narrowing of the scope of patentability review, as courts take a progressively “hands-off” approach to reviewing patentability of materials of public and ethical concern. This progression may result in a similar hands-off approach with respect to human genetic material, contrary to the parting thoughts of the court.

Justice Isaac, dissenting, preferred to defer to the Commissioner of Patents’ decision, finding that it was reasonable and cautious,[83] but also warned that “the serious moral and ethical implications of this subject-matter” were best dealt with by Parliament.[84] Perhaps because of the dissent in this case, the Supreme Court of Canada is currently deciding whether to hear an appeal.

Further to this development, the Federal Court in Monsanto Canada v. Schmeiser[85] answered the defendant’s claim that the gene and its insertion into Roundup-Ready canola plants were not patentable by relying on the Harvard decision.[86] The defendant is currently considering appealing the court’s decision.[87]

While little developments were made in the European Union regarding the patentability of biotechnological material since the turn of the millennium, the issue is still alive. The President of the EPO recently responded to attacks on the office’s practices in patenting life, assuring his audience that while the Directive “does not in principle exclude living matter from patentability,” his office was conducting itself with sensitivity to ethical considerations. The President used statistics showing a low opposition rate for European patents (6%) and a very small proportion of revocation (0.1%) to support his claim.[88]

In the much litigated case Kirin-Amgen v. Roche and TKT[89] in the European Union and elsewhere[90] relating to the protein erythropoietin (EPO), the court examined several issues relating to patent validity: sufficiency, breadth, and validity with respect to discovery vs. invention, novelty, and added matter. With respect to mere discovery, Justice Neuberger cites Gale’s Patent Application:[91] “It is trite law that you cannot patent a discovery, but if on the basis of that discovery you can tell people how it can be usefully employed, then a patentable invention may result… [A] discovery as such is not patentable as an invention… But when applied to a product or process which… is capable of industrial application, the matter stands differently.”[92] This standard of useful employment and industrial application has potential influence on the debate of the patentability of living material, which is argued to be outside the realm of invention.[93]

The accepted approach to a determination of obviousness was reviewed in the English case of Coflexip v. Stolt Comex Seaway:[94] identify the inventive concept, assume the mantle of the normally skilled but unimaginative addressee, identify what differences exist between the matter cited and the alleged invention, and finally determine whether those differences constitute steps that would have been obvious to the skilled man.[95] This test differs from the American test found in Winner, but mirrors many of its components. The court further rejected a “common general knowledge” assessment as the correct test for obviousness.[96]

In a rare finding of invalidity for obviousness, the court in Asahi Medical v. Macopharma[97] also reviewed the issue of obviousness. The focal point in this case of a method and unit for separating blood into components was the issue of identifying the inventive concept.[98] In dismissing the claim as “nothing more than a workshop variation”[99] on prior art, Justice Laddie refused to consider “whether anyone in practice would have thought of implementing it at all.”[100] While American courts consider secondary considerations to obviousness that take into consideration factors such as this,[101] Asahi seems to stand for the principle that these secondary considerations will not be taken into account in an assessment of obviousness.

[1] 2001 WL 111613 (E.D.Pa.) [hereinafter New L & M].

[2] Ibid at 4-7.

[3] (2000) 202 F. 3d 1340 [hereinafter Winner].

[4] Ibid. at 1348.

[5] Supra note 1 at 7.

[6] Supra note 3 at 1348, citing Gambro Lundia AB v. Baxter Healthcare Corp. (1997), 110 F.3d 1573 (Fed. Cir.) at 1579.

[7] 2001 WL 358857 (D.Conn.)

[8] Ibid. at 6.

[9] Ibid.

[10] 239 F.3d 1343.

[11] Ibid. at 1364.

[12] 1995 WL 512171 (S.D.N.Y.) [hereinafter Novo].

[13] Ibid. at para. 91.

[14] (2001) 126 F. Supp. 2d 69 [hereinafter Amgen].

[15] Ibid. at 113.

[16] Ibid.

[17] 2001 WL 66348 (D.Del.) [hereinafter Sunstrand].

[18] Ibid. at 2.

[19] Supra note 14 at 105.

[20] 2001 WL 409705 F. Supp. 2d [hereinafter Glaxo].

[21] Ibid. at 12.

[22] Ibid.

[23] Ibid.

[24] (2001) 132 F. Supp. 2d 1212 [hereinafter Affymex].

[25] Ibid. at 1218.

[26] Ibid. at 1219.

[27] Ibid.

[28] (2000) 234 F. 3d 558 [hereinafter Festo]

[29] Ibid. at 564.

[30] Ibid. at 571: “Because the Supreme Court has not fully addressed the range of equivalents that is available once prosecution history estoppel applies, we must independently decide the issue.”

[31] 2001 WL 66348 (D.Del.)

[32] Ibid. at 5: The court must determine: whether the elements at issue were amended during prosecution, where if they were not, amendment-based estoppel will not apply; statements made during prosecution may give rise to amendment-based estoppel; whether the amendment narrowed the literal scope of the claim, where if it did prosecution history estoppel will apply, unless the amendment was made for a purpose unrelated to patentability.

[33] Ibid. at 6.

[34] Supra note 14 at 134.

[35] 2001 U.S. Dist. LEXIS 4737 at 9-14.

[36] [2000] 2 S.C.R. 1024 [hereinafter Electro Sante].

[37] Ibid. at 1051.

[38] [2000] 2 S.C.R. 1067 [hereinafter Camco].

[39] [2000] 2 S.C.R. 1116.

[40] [1982] R.P.C. 183 (H.L).

[41] Supra note 38 at 1089.

[42] Ibid. at 1091.

[43] Ibid. at 1097-1104.

[44] [2000] F.C.J. No. 563 (T.D.).

[45] Ibid. at para. 46.

[46] Ibid. at para. 43.

[47] [2000] F.C.J. No. 2137 (C.A.).

[48] Ibid. at para. 16

[49] Supra note 37 at 1105.

[50] Ibid.

[51] Ibid. at 1106.

[52] Ibid. at 1108.

[53] [2001] 1 F.C. 495 (C.A.) [hereinafter Apotex].

[54] Ibid. at para. 60.

[55] Ibid.

[56] (1986), 8 C.P.R. (3d) 289 (F.C.A.) at 297.

[57] Supra note 36 at 1041.

[58] Ibid.

[59] Ibid. at 1041-1042.

[60] Supra note 52 at para. 65.

[61] [2001] F.C.J. No. 208 (T.D.).

[62] Ibid. at para. 110.

[63] Supra note 53 at 519.

[64] Ibid. at 518.

[65] Ibid. at 519.

[66] [2000] 4 F.C. 528 [hereinafter Harvard].

[67] Ibid. at 560.

[68] See Pioneer Hi-Bred Ltd. v. Canada, [1987] 3 F.C. 8 (T.D.); affd by [1989] 1 S.C.R. 1623.

[69] Supra note 66 at 563, citing Decision of Commissioner of Patents, dated August 4, 1995.

[70] Ibid.

[71] Ibid. at 572.

[72] Ibid. at 564, citing [1998] 3 F.C. 510 (T.D.) at para. 12.

[73] R.S.C., 1985, c. P-4, s. 2 "invention" (as am. by S.C. 1993, c. 2, s. 2).

[74] Diamond v. Chakrabarty (1980), 447 U.S. 303 (S.C.) [hereinafter Chakrabarty].

[75] Supra note 66 at 572.

[76] Ibid. at 567. Also at 572-3: “The language of patent law is broad and general and is to be given wide scope because inventions are, necessarily unanticipated and unforeseeable.”

[77] Ibid. at 577: “What is sought to be patented is a mouse with a genetic structure different from what it would have been without human intervention at the genetic level.”

[78] Ibid. at 585-92, concerns summarized at 565-6.

[79] Ibid. at 579-85, relying on Chakrabarty, supra note 74.

[80] Ibid. at 602-3: “It is Parliament and not the Court that defines the limits of patentability.”

[81] Ibid. at 605-6.

[82] Ibid. at 606: “As scientific research advances, [the patentability of human genes or products or processes at the genetic level] will require determination by the courts or by Parliament.”

[83] Ibid. at 551-2.

[84] Ibid. at 560.

[85] [2001] F.C.J. No. 436 (T.D.).

[86] Ibid. at paras. 86-90; at para. 88: “It is essentially matters similar to those recognized by the patent granted originally to the applicant for the patent of the mouse that are the subjects of the claims patented in this case.”

[87] S. McCarthy, “Canola farmer given appeal money” The Globe and Mail (26 May 2001), online: The Globe and Mail < http://archives.theglobeandmail.com/> (date accessed: 30 May 2001).

[88] I. Krober, “Comments on genetic engineering” (Annual Press Conference, E.P.O., Munich, 27 June 200), online: European Patent Office <http://www.european-patent-office.org/news/headlns/2000_06_27_e.htm> (date accessed: 30 May 2001).

[89] 2001 WL 332103 (Ch.D. Pat. Ct.).

[90] Ibid. at para. 7.

[91] [1991] R.P.C. 305 [hereinafter Gale’s].

[92] Supra note 89 at paras. 534-5, citing Gale’s at lines 553-66 and 31-6.

[93] See Harvard, supra note 66.

[94] 2000 WL 1027097 (C.A.), [2001] 1 All E.R. 952.

[95] Ibid. at para 32, citing Windsurfing International v. Tabur Marine, [1985] R.P.C. 59 at 73.

[96] Ibid. at para. 63.

[97] 2000 WL 1841586 (Ch.D. Pat. Ct.), (2001) 24(3) I.P.D. 24,016.

[98] Ibid. at para. 28.

[99] Ibid. at para. 45.

[100] Ibid. at para. 46.

[101] See discussion on secondary considerations in Novo and Amgen.