Apotex Inc v Sanofi-Synthelabo Canada Inc

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Apotex Inc v Sanofi-Synthelabo Canada Inc
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Supreme Court of Canada
Hearing: April 16, 2008
Judgment: November 6, 2008
Full case nameSanofi‑Synthelabo Canada Inc., Sanofi‑Synthelabo and Minister of Health
Citations 2008 SCC 61, [2008] 3 S.C.R. 265
Docket No. 31881
Prior historyJudgment against Apotex in the Federal Court of Appeal.
RulingAppeal dismissed
Holding
Selection patents are not invalid under the Patent Act .
Court membership
Chief Justice: Beverley McLachlin
Puisne Justices: Michel Bastarache, Ian Binnie, Louis LeBel, Marie Deschamps, Morris Fish, Rosalie Abella, Louise Charron, Marshall Rothstein
Reasons given
Unanimous reasons byRothstein J.
McLachlin C.J. took no part in the consideration or decision of the case.

Apotex Inc v Sanofi-Synthelabo Canada Inc, [2008] 3 S.C.R. 265, is a leading Supreme Court of Canada decision on the novelty and non-obviousness requirements for a patent in Canada. The Court rejected a challenge by the generic drug manufacturer Apotex to declare Synthelabo Canada's patent for Plavix, an anti-coagulant drug, invalid. At issue was whether selection patents are invalid in principle, and if they are not, whether the subject selection patent was invalid on the grounds of anticipation, obviousness or double patenting.

Contents

Reasons of the Court

Selection Patents

A selection patent by definition is a patent for a selection of compounds from a larger class of compounds described in a prior patent. The prior patent, often referred to as the originating patent or genus patent, is usually based on the discovery of a new reaction or class of compounds.

As with all patents, selection patents must be novel and non-obvious. The selected compounds cannot have been made before, otherwise the selection patent is not novel. But if the selected compound is novel and possesses a special property of an unexpected character, the invention is not obvious.

Justice Rothstein, for the Court, accepted that selection patents do not in their nature differ from other patents and are acceptable in principle.

Novelty

Apotex claimed that the patent did not satisfy the novelty requirement. The Supreme Court of Canada employed a two-part test for anticipation. In order for there to be a finding of anticipation, the prior art must satisfy both of the following branches:

  1. prior disclosure; and
  2. enablement.

The disclosure branch requires that a single prior art reference must have been available to the public and must disclose the subject matter of the claimed invention.

Once the disclosure requirement has been made out, the enablement branch must be satisfied. A disclosure is enabling if the skilled person of the art is able to work the invention. While routine trials are acceptable for this branch, no inventive steps are permitted.

The Supreme Court stated four non-exhaustive factors to be considered in determining whether there has been enablement:

  1. Enablement is to be assessed having regard to the prior patent as a whole including the specification and the claims. There is no reason to limit what the skilled person may consider in the prior patent in order to discover how to perform or make the invention of the subsequent patent. The entire prior patent constitutes prior art.
  2. The skilled person may use his or her common general knowledge to supplement information contained in the prior patent. Common general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time.
  3. The prior patent must provide enough information to allow the subsequently claimed invention to be performed without undue burden. When considering whether there is undue burden, the nature of the invention must be taken into account. For example, if the invention takes place in a field of technology in which trials and experiments are generally carried out, the threshold for undue burden will tend to be higher than in circumstances in which less effort is normal. If inventive steps are required, the prior art will not be considered as enabling. However, routine trials are acceptable and would not be considered undue burden. But experiments or trials and errors are not to be prolonged even in fields of technology in which trials and experiments are generally carried out. No time limits on exercises of energy can be laid down; however, prolonged or arduous trial and error would not be considered routine.
  4. Obvious errors or omissions in the prior patent will not prevent enablement if reasonable skill and knowledge in the art could readily correct the error or find what was omitted.

In this case, the Supreme Court concluded that the prior genus patent did not disclose the special advantages of the selection patent. Therefore, the enablement step did not need to be undertaken and the selection patent was novel.

Non-obviousness

In determining whether the subject patent was obvious, Justice Rothstein, for the Court, endorsed the four step approach from Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1] as restated in Pozzoli SPA v. BDMO SA: [2]

  1. Identify the notional "person skilled in the art" and identify the relevant common general knowledge of that person;
  2. Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
  3. Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;
  4. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?

In fields where advances are typically obtained by experimentation, an "obvious to try" test may be taken into consideration in the fourth step of the obviousness inquiry. The Supreme Court stated that if an "obvious to try" test is warranted, the following non-exclusive factors may be relevant:

  1. Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art?
  2. What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine?
  3. Is there a motive provided in the prior art to find the solution the patent addresses?

The subject case turned on the "obvious to try" test. The Supreme Court found that the advantage of the selection patent was not quickly or easily predictable, and therefore the person skilled in the art would not have found it self-evident to try to find the claimed invention.

Double patenting

Apotex claimed that selection patents allow a patent holder to "evergreen" an invention. The Supreme Court rejected this argument for two reasons. First, a selection patent may be obtained by someone other than the inventor of the genus patent. Second, selection patents encourage improvement by selection.

The Supreme Court concluded that there was no "same invention double patenting" because the claims of the genus patent and the subject selection patent are not identical or coterminous. Furthermore, there was no "obviousness double patenting" because the claims in the selection patent reflected a patentably distinct compound from the compounds in the genus patent. In view of the above, there was no double patenting.

See also

Related Research Articles

Prior art is a concept in patent law used to determine the patentability of an invention, in particular whether an invention meets the novelty and the inventive step or non-obviousness criteria for patentability. In most systems of patent law, prior art is generally defined as anything that is made available, or disclosed, to the public that might be relevant to a patent's claim before the effective filing date of a patent application for an invention. However, notable differences exist in how prior art is specifically defined under different national, regional, and international patent systems.

A person having ordinary skill in the art, a person of (ordinary) skill in the art, a person skilled in the art, a skilled addressee or simply a skilled person is a legal fiction found in many patent laws throughout the world. This hypothetical person is considered to have the normal skills and knowledge in a particular technical field, without being a genius. The person mainly serves as a reference for determining, or at least evaluating, whether an invention is non-obvious or not, or involves an inventive step or not. If it would have been obvious for this fictional person to come up with the invention while starting from the prior art, then the particular invention is considered not patentable.

Novelty is a requirement for a patent claim to be patentable. An invention is not new and therefore not patentable if it was known to the public before the filing date of the patent application, or before its date of priority if the applicant claims priority of an earlier patent application. The purpose of the novelty requirement is to prevent prior art from being patented again.

The doctrine of equivalents is a legal rule in many of the world's patent systems that allows a court to hold a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed invention. U.S. Judge Learned Hand has described its purpose as being "to temper unsparing logic and prevent an infringer from stealing the benefit of the invention".

The inventive step and non-obviousness reflect a general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive—i.e., non-obvious—in order to be patented. In other words, "[the] nonobviousness principle asks whether the invention is an adequate distance beyond or above the state of the art".

Sufficiency of disclosure or enablement is a patent law requirement that a patent application disclose a claimed invention in sufficient detail so that the person skilled in the art could carry out that claimed invention. The requirement is fundamental to patent law: a monopoly is granted for a given period of time in exchange for a disclosure to the public how to make or practice the invention.

Japanese patent law is based on the first-to-file principle and is mainly given force by the Patent Act of Japan. Article 2 defines an invention as "the highly advanced creation of technical ideas utilizing the law of nature".

<i>Apotex Inc v Wellcome Foundation Ltd</i> Supreme Court of Canada case

Apotex Inc v Wellcome Foundation Ltd, [2002] 4 S.C.R. 153, is a leading Supreme Court of Canada decision on the utility requirement for a patent in Canada. The Court rejected a challenge by the generic drug manufacturers Novopharm and Apotex to declare Glaxo Wellcome's patent for AZT, an AIDS-fighting drug, invalid.

This is a list of legal terms relating to patents. A patent is not a right to practice or use the invention, but a territorial right to exclude others from commercially exploiting the invention, granted to an inventor or his successor in rights in exchange to a public disclosure of the invention.

<span class="mw-page-title-main">Canadian patent law</span>

Canadian patent law is the legal system regulating the granting of patents for inventions within Canada, and the enforcement of these rights in Canada.

Hotchkiss v. Greenwood, 52 U.S. 248 (1851), was a United States Supreme Court decision credited with introducing into United States patent law the concept of non-obviousness as a patentability requirement, as well as stating the applicable legal standard for determining its presence or absence in a claimed invention.

Article 83 of the European Patent Convention (EPC) relates to the disclosure of the invention under the European Patent Convention. This legal provision prescribes that a European patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

Under the European Patent Convention (EPC), European patents shall be granted for inventions which inter alia involve an inventive step. The central legal provision explaining what this means, i.e. the central legal provision relating to the inventive step under the EPC, is Article 56 EPC. That is, an invention, having regard to the state of the art, must not be obvious to a person skilled in the art. The Boards of Appeal of the European Patent Office (EPO) have developed an approach, called the "problem-and-solution approach", to assess whether an invention involves an inventive step.

Sufficiency of disclosure in Canadian patent law

In Canada, every patent application must include the “specification”. The patent specification has three parts: the disclosure, the claims, and the abstract. The contents of the specification are crucial in patent litigation.

<span class="mw-page-title-main">Novelty and non-obviousness in Canadian patent law</span>

For a patent to be valid in Canada, the invention claimed therein needs to be new and inventive. In patent law, these requirements are known as novelty and non-obviousness. A patent cannot in theory be granted for an invention without meeting these basic requirements or at least, if a patent which does not meet these requirements is granted, it cannot later be maintained. These requirements are borne out of a combination of statute and case law.

<span class="mw-page-title-main">Defences and remedies in Canadian patent law</span>

A patent holder in Canada has the exclusive right, privilege and liberty to making, constructing, using and selling the invention for the term of the patent, from the time the patent is granted. Any person who does any of these acts in relation to an invention without permission of the patent owner is liable for patent infringement.

<span class="mw-page-title-main">Utility in Canadian patent law</span>

In Canadian patent law, inventions must be useful, in addition to novel and non-obvious, in order to be patented.

<i>Shell Oil Co v Canada (Commissioner of Patents)</i> Supreme Court of Canada case

Shell Oil Co v Canada , [1982] 2 S.C.R. 536, is a landmark decision by the Supreme Court of Canada in the area of Canadian patent law. Prior to this decision, there was no general principle of patent law, and no direct authority, for the proposition that a new use of an old compound can be claimed as a patentable invention. Furthermore, the decision is a leading case on the test for patentable "art".

<i>Teva Canada Ltd v Pfizer Canada Inc</i> Supreme Court of Canada case

Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 is a leading Supreme Court of Canada decision on the disclosure requirements for a patent in Canada.

"Non-obviousness" is the term used in US patent law to describe one of the requirements that an invention must meet to qualify for patentability, codified in 35 U.S.C. §103. One of the main requirements of patentability in the U.S. is that the invention being patented is not obvious, meaning that a "person having ordinary skill in the art" (PHOSITA) would not know how to solve the problem at which the invention is directed by using exactly the same mechanism. Since the PHOSITA standard turned to be too ambiguous in practice, the U.S. Supreme Court provided later two more useful approaches which currently control the practical analysis of non-obviousness by patent examiners and courts: Graham et al. v. John Deere Co. of Kansas City et al., 383 U.S. 1 (1966) gives guidelines of what is "non-obvious", and KSR v. Teleflex (2006) gives guidelines of what is "obvious".

References

  1. ↑ Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] RPC 59 (CA).
  2. ↑ Pozzoli SPA v. BDMO SA, [2007] F.S.R. 37 (p. 872), [2007] EWCA Civ 588.

Trial

Patents

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