The use of prosecution history in post-grant patent proceedings. The Groups are invited to answer the following questions under their national laws.

Transcription

1 Question Q229 National Group: Canada Title: The use of prosecution history in post-grant patent proceedings Contributors: ZISCHKA, Matthew SOFIA, Michel HAMILTON, J. Sheldon HARRIS, John ROWAND, Fraser CAWTHORN, Christian CHARI, Santosh SHIPLEY, Kevin COTTRILL, Val BARBIERI, S. Fred WHITE, Bradley Reporter within Working Committee: ZISCHKA, Matthew (Ex-officio) BARBIERI, S. Fred Date: May 17, 2012 Questions The Groups are invited to answer the following questions under their national laws. 1) What types of post-grant proceedings are available in your jurisdiction? Are post-grant proceedings available both at a patent office and at a court? The following post-grant proceedings are available in Canada: (i) Infringement action: a plaintiff may bring a claim for patent infringement by commencing an action in either the Federal Court or a provincial superior court. A defendant to a patent infringement claim may defend on the basis that the patent is invalid. Thus, in an infringement action, a Court may consider both issues of infringement and invalidity. When proceeding in the Federal Court, the defendant may also make a counterclaim for a declaration of invalidity (Patent Act, s. 60(1)). While a finding of invalidity in favour of a defendant is an in personam finding, a declaration of invalidity by the Federal Court operates in rem, and may be registered against the patent. 1

2 (ii) Declaration of non-infringement/invalidity: an interested person may preemptively commence an action in the Federal Court for a declaration of noninfringement (Patent Act, s. 60(2)), and/or a declaration of invalidity (Patent Act, s. 60(1)). (iii) Proceedings under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations): as a pre-requisite to obtaining regulatory marketing approval for a patented medicine, a generic pharmaceutical producer may allege invalidity and/or non-infringement of certain patents listed by an innovator pharmaceutical producer against the medicine. A subsequent court proceeding brought by the innovator considers whether the allegations of invalidity and/or non-infringement are justified (PM(NOC) Regulations, s. 6). The result of such a proceeding is not determinative of the invalidity of the patents or infringement, and is not binding on the parties private rights of action under the Patent Act, as set out above in items (i) and (ii). As a result, notwithstanding any findings made during PM(NOC) proceedings, parties may assert infringement and/or invalidity in other Court proceedings. (iv) Re-examination: any person, including the patentee, may request reexamination by the Patent Office of any claim of an issued patent (Patent Act, ss ). A request for re-examination may be filed at any time during the term of the patent. To initiate re-examination, a requesting party must submit a request for re-examination, the prescribed fee, prior art (consisting of patents, applications for patents open to public inspection, and printed publications), and an explanation of the pertinence of the prior art and the manner of applying it to the claim for which re-examination is sought. If the request is not made by the patentee, the Patent Office will send a copy to the patentee. A re-examination board established by the Patent Office renders a preliminary decision as to whether the request raises a substantial new question of patentability. If the re-examination board determines that the request does not raise a substantial new question of patentability, the decision of the board is final and not subject to appeal or to review by any court. If the board decides that the request for re-examination does raise a substantial new question of patentability, it notifies the patentee, who then has an opportunity to reply. Although a third party can initiate the re-examination process, once the board determines that a substantial new question is raised, the third party may not participate in the reexamination process (Novozymes v. Genencor International Inc., 2007 FCA 129). During re-examination, the scope of the board s examination is limited to the prior art submitted by the requesting party. The patentee may propose amendments to the claims, including new claims, but the scope of the claim(s) may not be broadened. Furthermore, the re-examination board will not make any changes to the description portion of the patent. The re-examination proceeding must be completed within one year. The re-examination board may issue a certificate canceling a claim determined to be unpatentable, confirming a claim determined to be patentable, or incorporating any proposed amended or new claim determined to be patentable. A decision of a re-examination board may be appealed to the Federal Court by the patentee. (v) Reissue: a patentee may correct a defective patent before the Patent Office (Patent Act, s. 47) by requesting reissue of the patent with correcting amendments. Reissue is available only if an application for reissue is made within 2

3 four years from the date of grant of the patent, and only if the patent is deemed defective or inoperative by reason of insufficient description and specification, or by reason of the patentee s claiming more or less than he had a right to claim as new. To be entitled to reissue, it must be shown that the error which the patentee seeks to correct by reissue arose from inadvertence, accident or mistake. Furthermore, the claims of the reissue application must be directed to the same invention that the patentee attempted to describe and claim in the original application. Upon issue of a new patent, the original patent is surrendered. In addition to the above post-grant proceedings, the following post-grant mechanisms for amending claims are also available in Canada. These post-grant mechanisms are not post-grant proceedings as defined for Q229 as they generally do not require determinations of claim scope. (i) Correction of clerical errors: a patentee or applicant may correct clerical errors in any "instrument of record" in the Patent Office (Patent Act, s. 8) by submitting a request for correction to the Patent Office. A granted patent is an "instrument of record". A clerical error is one that arises in the mechanical process of writing or transcribing (Bayer Aktiengesellschaft v. Canada (Commissioner of Patents) (1980), 53 C.P.R. (2d) 70 (F.C.T.D.) at 73). The significance or importance of the error in the document is not relevant to the determination of whether it is a clerical error. If the Patent Office determines that a clerical error was made, the Patent Office exercises discretion as to whether to correct the clerical error. The Patent Office corrects the clerical error by issuing a Certificate of Correction. (ii) Disclaimers: a patentee may file a disclaimer to amend to narrow the claims of an issued patent, whenever by any mistake, accident or inadvertence, and without any wilful intent to defraud or mislead the public the patentee has made claims that are too broad (Patent Act, s. 48). The patentee thereby disclaims a portion of the monopoly defined by issued claims. Disclaimers are recorded by the Patent Office without examination, and a patentee is not required to explain the mistake, accident or inadvertence justifying a disclaimer. 2) In your country or region, may the prosecution history be taken into account for purposes of interpreting claim scope during post-grant proceedings? In Canada, prosecution history is generally inadmissible in post-grant proceedings for the purpose of construing claims (Free World Trust v. Électro Santé Inc., 2000 SCC 66 at pars ). However, the Patent Office and Courts may use prosecution history in post-grant proceedings for the following limited purposes other than construing the claims. (i) Establish admissions: Courts may allow statements made in the prosecution history to be admitted for the purpose of establishing an admission (Merck Frosst Canada Inc. v. Canada (Minister of Health), 2000 CanLII (FC), aff d 2001 FCA 192). 3

4 (ii) Determine the prior art that was before the Examiner: Canadian case law suggests that the prior art before the Examiner may be relevant at trial. Accordingly, in some instances Courts have held that the prosecution history is relevant to determine what prior art was before the Examiner (Samsonite Corp. v. Holiday Luggage Inc. (1988), 20 C.P.R. (3d) 291 (F.C.)). However, the prosecution history is inadmissible to clarify the meaning of the prior art. Where the prior art that was before the Examiner is known, the prosecution history is irrelevant. (Novartis AG v. Apotex Inc., 2001 FCT 1129, appeal dismissed for mootness, 2002 FCA 440). (iii) Improper prosecution conduct: prosecution history may be admissible in Court proceedings to establish grounds of attack that squarely raise the issue of conduct before the Examiner. (iv) Application for reissue: prosecution history may be admissible in a reissue proceeding before the Patent Office to assess whether the requirements for a reissue application are satisfied. As discussed above, a patentee may correct a defective patent by requesting reissue of the patentthe patentee must establish the amendments sought in a reissue application correct an error in prosecution that arose from inadvertence, accident or mistake (Patent Act, s. 47(1)). Therefore, the alleged error must not have been deliberately caused by the patentee during prosecution through amendments to the claims. For example, the patentee may not reassert claims that were cancelled or withdrawn in the prosecution history, e.g., to overcome prior art. In particular, the patentee may not insert claims broader in scope than claims cancelled or narrowed by the applicant in response to previous rejections by the Examiner. Although amendments to the claims made during prosecution are the most relevant considerations, amendments to the description, e.g., deleting subject matter that is now being claimed in the reissue, may also be relevant. Both amendments made to address prior art and amendments made to address disclosure requirements, e.g., sufficiency or enablement will limit the scope of possible claims that may be pursed in the reissue application. Furthermore, arguments both express and implied made by the patentee during prosecution will also be relevant to assessing whether the error in the resulting patent was inadvertent. The claims of the reissue application must be directed to the same invention that the patentee attempted to describe and claim in the original application (Patent Act, s. 47(1)). Accordingly, the Patent Office assesses the scope of the issued claims and what the patentee intended to protect in the prosecution. The Patent Office then assesses whether the reissue claims are directed to the same invention. In making these assessments, the Patent Office may have regard to statements regarding the nature of the invention or what was intended to be protected by the claims. To counter the Patent Office s reliance on such statements, the patentee may argue that the agent of record erroneously misunderstood the nature of the invention or the patentee s intentions and that the statements previously submitted were based on this erroneous understanding. Nonetheless, statements on the record may become relevant to assessing the intention of the patentee for the purpose of determining whether the requirements for a proper reissue application have been met. (v) Improper reissue: prosecution history may also be admissible in Court proceedings to assess whether a patent was properly reissued by the Patent Office, i.e., whether the requirements for a reissue were satisfied (Burton Parsons Chemicals Inc. v. Hewlett-Packard (Canada) Ltd., [1976] 1 S.C.R. 555). 4

5 (vi) Improper disclaimer: prosecution history may be admissible in Court proceedings to assess the validity of a disclaimer, e.g., whether the requirements for a disclaimer were satisfied. As indicated above, disclaimers are recorded by the Patent Office without examination. However, the validity of a disclaimer may be tested by a Court during subsequent litigation. Furthermore, the Federal Court has held that as a disclaimer is an admission [by the patentee] that the subject matter of the disclaimer is not the proper subject matter of a patent but is open and free to the public generally, invalidity of a disclaimer invalidates the claims which the patentee sought to amend by the disclaimer (Hershkovitz v. Tyco Safety Products Canada Ltd., 2009 FC 256, hereinafter Tyco, at pars. 79, 95-96). Thus, while a Court will normally disregard evidence relating to claim amendments made during prosecution, when a claim amendment by disclaimer has been filed and the validity of that disclaimer is challenged during litigation, the Court will consider both the form and substance of the disclaimer to assess its validity. In particular, the Federal Court has established the following requirements for a valid disclaimer: o the patentee claimed too broadly as a result of a legitimate mistake, accident, or inadvertence (Sanofi-Aventis Canada Inc. v. Hospira Healthcare Corporation, 2009 FC 1077, hereinafter Hospira at pars. 141, 153; Tyco at pars. 74, 91-92); o the patentee filed a disclaimer promptly and diligently upon becoming aware of the mistake, accident, or inadvertence (Tyco at par. 78); o the patentee filed the disclaimer in the prescribed form and manner (Tyco at pars. 75, 80); and o the patentee did not amend claims to introduce inventive features (Tyco at pars. 76, 81-83). When determining the validity of a disclaimer, a Court may, in some circumstances, be willing to look to the prosecution history, particularly when the existence of a legitimate mistake, accident, or inadvertence is at issue. For example, in Tyco the Federal Court stated that a mistake, accident, or inadvertence may be established on the basis that prior art was discovered after issuance of the patent (Tyco at par. 74). Therefore, it appears that to determine whether prior art was discovered after issuance, a Court may need to consider evidence identifying the prior art available to the Examiner during prosecution. In Hospira, the patentee tried to establish a mistake, accident, or inadvertence on the basis that during prosecution the Examiner failed to cite one of the patentee s other patents against the patent at issue, thereby leaving it open to a double patenting attack. While this argument was rejected by the Court, the Court was required to consider the objections made by the Examiner during prosecution (Hospira at par. 144). (vii) Improper correction of a clerical error: prosecution history may be admissible in Court proceedings to assess the validity of a Certificate of Correction correcting a clerical error. A decision by the Patent Office to grant or reject a request to correct a clerical error in a patent is subject to judicial review by a Court. The Court will determine whether the decision of the Patent Office was reasonable, e.g., whether or not the Patent Office s determination of whether or not an error was a clerical error was reasonable (Laboratoires Servier v. Apotex Inc., 2008 FC 825 at pars ). If the answer to question 2 is yes, please answer the following questions: N/A 5

6 a) Please explain the types of prosecution history that may be considered. For example: i. Does applicable prosecution history include amendments, arguments, or both? ii. Could applicable prosecution history include a limiting interpretation that is implied through the applicant s arguments, or would it include only explicit definitional statements? iii. Does applicable prosecution history include only amendments to the claims, or does it also include amendments to any aspect of the disclosure? iv. Does it matter if the amendments and/or arguments are made to overcome prior art versus being made to address sufficiency or some other formal requirement? v. Does it matter if the prosecution history has the effect of broadening the interpretation of the claim, versus narrowing it? b) Does the applicability of prosecution history depend on when the prosecution history occurred? For example, does it matter if a particular statement by an applicant was made during initial examination as opposed to during a later invalidity proceeding? c) Does the applicability of prosecution history depend on the type of post grant proceeding, or on the authority before which the proceeding is held? For example, would prosecution history be more applicable in an infringement action at court than in a post-grant patent office invalidity proceeding? d) Is the applicability of prosecution history limited to infringement proceedings where equivalents are an issue? e) Could prosecution history from a corresponding foreign application be considered in a post-grant proceeding in your jurisdiction? If so, under what circumstances? f) Is the use of prosecution history authorized by statute or by case law in your jurisdiction? g) Explain the policy reasons for considering prosecution history during the claim interpretation process. If the answer to question 2 is no, please answer the following questions: h) Is the disallowance of use of prosecution history mandated by statute or by case law in your jurisdiction? The prohibition against the use of prosecution history for claim construction arises from case law. i) Explain the policy reasons for not considering prosecution history during the claim interpretation process. The Supreme Court of Canada has provided the following policy rationale for excluding the use of prosecution history (referred to as the file wrapper by the 6

7 Court) for claim construction, namely that the test for the inventor s intention is objective, extrinsic evidence would undermine the public notice function of the claims and would increase uncertainty in litigation, and the focus of purposive construction should be on the language of the claims (Free World Trust v. Électro Santé Inc., 2000 SCC 66 at par. 66): [T]hose references to the inventor's intention refer to an objective manifestation of that intent in the patent claims, as interpreted by the person skilled in the art, and do not contemplate extrinsic evidence such as statements or admissions made in the course of patent prosecution. To allow such extrinsic evidence for the purpose of defining the monopoly would undermine the public notice function of the claims, and increase uncertainty as well as fuelling the already overheated engines of patent litigation. The current emphasis on purposive construction, which keeps the focus on the language of the claims, seems also to be inconsistent with opening the pandora's box of file wrapper estoppel. If significant representations are made to the Patent Office touching the scope of the claims, the Patent Office should insist where necessary on an amendment to the claims to reflect the representation. 3) Assuming that at least some countries will consider foreign prosecution history as part of claim interpretation in their jurisdictions, does this have implications for how you would handle prosecution of a patent application in your country? Is this problematic? The possibility that the prosecution history of a Canadian patent may be considered in connection with claim interpretation in another country (i.e., interpretation of claims in a patent based on a corresponding application) may impact the prosecution of a particular patent application in Canada. Where the patent application was drafted by the Canadian patent agent, the Canadian patent agent is in the best position to determine an optimum course of action, in view of the status of prosecution of corresponding applications in other countries. In this case, the Canadian patent agent generally takes care to prosecute the Canadian case in a way that is consistent with the prosecution of the corresponding applications. Where the examination of the corresponding applications is concurrent with the examination of the Canadian application, the Canadian patent agent keeps the foreign associates generally informed of the status of the Canadian patent application. In many cases, prosecution of the corresponding applications is completed before examination of the Canadian application has started, simplifying the Canadian patent agent's task. Where the patent application originated elsewhere, the Canadian patent agent typically relies on the information from an instructing foreign associate to provide instructions that are generally consistent with the prosecution histories of the corresponding applications. In each case, attempting to take the prosecution histories of corresponding (non- Canadian) patent applications into account in the prosecution of the Canadian patent application can be problematic, due to differences in the applicable laws. 4) In your country or region, may a patent be invalidated in post-grant proceedings on the basis of the same prior art which was taken into account by the examiner of the patent office during prosecution of the patent? If so, may the patent be invalidated on the basis of the same prior art and the same argument used by the examiner or may the same prior art only be used if it is shown that there is a new question based on some other teaching or aspect of that prior art? 7

8 Patent validity is assessed de novo by Canadian Courts, and the person challenging the patent is in no way limited by the prior art or arguments taken into account by the Examiner. As discussed above, in re-examination proceedings before the Patent Office, the reexamination board will only consider prior art which raise a substantial new question of patentability, as submitted by the requesting party. However, there is no express requirement that this prior art be different from that considered by the Examiner during prosecution of the patent. Proposals for harmonization The Groups are invited to put forward proposals for the adoption of harmonized rules in relation to the use of prosecution history in post-grant proceedings. More specifically, the Groups are invited to answer the following questions without regard to their national laws: 1) Is harmonization of the applicability of prosecution history in post-grant proceedings desirable? Yes. 2) Is it possible to find a standard for the use of prosecution history that would be universally acceptable? Possibly. 3) Please propose a standard you would consider to be broadly acceptable for a) the types of prosecution history that should be considered, if any; and b) the type of proceeding and circumstances in which it should be considered. Harmonizing the effect of prosecution history in post-grant proceedings across all jurisdictions may be impractical, and may offer limited benefit without more generally harmonizing laws governing claim interpretation/construction and validity. However, it may be possible and desirable to harmonize the inbound effect of foreign prosecution history in domestic post-grant proceedings. Preferably, a standard that prohibits consideration of foreign prosecution history in any post-grant proceeding should be adopted in all jurisdictions. From the perspective of an applicant/agent within a particular jurisdiction, this standard would eliminate uncertainty in assessing extra-territorial effect of steps taken in domestic prosecution namely, there would be no extra-territorial effect. This standard would allow applicants/agents to prosecute applications with greater candour, and without being burdened by consideration of foreign law in multiple jurisdictions having a variety of post-grant proceedings, and a variety of laws governing such proceedings. This standard would also eliminate the risk of deleterious effect of imperfect translation of any prosecution history in post-grant proceedings. In alternative, a standard that uniformly permits consideration of foreign prosecution history for limited purposes in all jurisdictions, such as establishing admissions, or impeaching credibility on the basis of prior inconsistent statements would also be desirable. Under this standard, statements made in foreign prosecution would not give rise to legal estoppels or questions of conduct, but may undermine positions on claim scope taken by the patentee in post-grant proceedings. This standard would promote consistency between statements of fact made during prosecution and in post-grant 8

9 proceedings, without burdening applicants/agents with consideration of foreign law during prosecution. In the further alternative, a standard that uniformly permits consideration of foreign prosecution history for any purpose in all jurisdictions, though less desirable, would still promote clarity and predictability in extraterritorial effect of domestic prosecution namely, there may be extraterritorial effect in all foreign jurisdictions. 9