Patent claim resulted from "skilled work", not "creative work", and is found to be obvious
The Federal Court has dismissed an application for prohibition for obviousness. The invention was described as "to take the 'naturally occurring' protein reported by Dr. Karl Welte at Sloan-Kettering Institute and to create, by recombinant means, a protein having some or all of the amino acid sequence and some or all of the biological properties of that protein so as to have available, in sufficient quantities, a recombinant protein which showed promise for further research."
Apotex alleged the patent was invalid for novelty, obviousness and inutility at the hearing.
The Court was satisfied on the evidence that the product of Claim 43 was not anticipated because it is not identical to the "natural" product of Welte because of the inclusion of the "Met" at the beginning of the amino acid sequence, and because the amino acid sequence of claim 43 following the "Met" is quite possibly but not certainly the sequence of the natural product.
In finding the invention obvious, the Court held that the difference between the inventive concept of Claim 43 and what Welte disclosed is that Claim 43 identifies the amino sequence of a polypeptide beginning with a Met that has some or all of the sequences of Welte's factor and some or all of its biological properties. This was found to require "skilled work" and not the "creative work" necessary to deserve patent protection. While the Court noted that perhaps Amgen would be entitled to a patent claiming an inventive process or processes, the end product, which is simply the protein made by whatever process, was not itself inventive.
For utility, the Court found the promise of the patent was to create a manufactured protein having some or all of the amino acid structure, and some or all of the biological properties of the natural protein. Claim 43 was found to do this and it was demonstrated at the time the patent was filed. The Court further held that whether or not the inventor had a sound basis for predicting that the manufactured protein would be useful in certain therapy is relevant only with respect to claim 33, and not claim 43. Claim 43 is directed only to the recombinant protein and not to its uses. Therefore, claim 43 had utility.
Costs were not awarded to any party. The Court stated that Apotex pursued many issues as to invalidity and non-infringement in its NOA, and all were dropped but the three mentioned above. Furthermore, Amgen was found to have initially asserted many claims, before reducing it to only one claim. The Court found this constant change meant the parties did not make matters clear and efficient for each other or the Court.
Court orders the production of transcripts from prior unrelated cases because they are relevant to issues in the current action
Teva has appealed a Prothonotary's order to provide documents refused to be produced at examination for discovery of the Teva representative. The motion was originally allowed in respect of the production of certain documents consisting of confidential transcripts of trial testimony in two prior actions and the Confidential Reasons for Judgment in one of those prior actions. The Court agreed the order on the motion was overbroad, but otherwise dismissed Teva's appeal.
The area of contention in this matter concerns information about Teva's "trade-spend" in two other actions. Trade spend was previously described as being the rebates paid by pharmaceutical companies under different descriptions to pharmaceutical purchasers to encourage them to buy their product and to reward them when they do. Teva has indicated that no written trade-spend policies existed in 2006 and 2007, and Lilly sought the transcripts because they argued that the testimony speaks to the prevailing rate of trade-spend during a period generally the same as the present matter.
On appeal the Court held that the prior confidentiality order contained a clause providing a waiver for use or disclosure of a party's own confidential information. Therefore, the Court interpreted Rules 151 and 152 in a fashion that recognized the Prothonotary's authority to order a party to exercise its discretion to waive the confidentiality order to produce relevant documents in the interests of procedural fairness.
However, the Court modified the order to only require Teva to produce relevant portions of the materials, rather than the entire transcript. The Court ordered the parties to work out some form of process whereby the materials in question are disclosed on a "counsel's eyes only basis" to Lilly's counsel with the view to reaching some consensus on the relevant portions of the Confidential Documents that should be disclosed.
The question of registration of five trademarks is sent back to the Federal Court for redetermination by a different Federal Court Judge
The Court of Appeal has not agreed with either party on the appeal of a decision of the Federal Court (2014 FC 549) that was previously summarized the week of June 16, 2014, dealing with the registration of five trademarks, one of which was a word mark ASIA MILES.
The Federal Court decision was set aside for two reasons. First, the Court of Appeal found that the Federal Court erred in law in its treatment of the new evidence tendered pursuant to section 56 of the Trademarks Act. The Federal Court had declined to review the fresh evidence, and the Court of Appeal held that the parties are entitled to have the Federal Court consider, in light of the fresh evidence, whether it should decide the case by way of a fresh hearing on the extended record or, alternately, by way of a review of the Board's decision on the record as it was before the Board.
Second, while purporting to apply the reasonableness standard to the Board's decision, the Federal Court applied the correctness standard instead. The Federal Court had re-weighed the evidence itself and found that there was support for the view it takes of the matter, but a decision is not unreasonable because the evidence would support another conclusion. The question is whether the decision-maker's conclusion falls within the range of acceptable and defensible outcomes, having regard to the facts and the law. The Court of Appeal was not given any reason to believe that the Board's decision was unreasonable, given the record which it had before it, thus the cross appeal was allowed.
The matter has been returned to the Federal Court for redetermination of all issues raised by the appeal by a different Federal Court Judge.
Federal Court of Appeal provides guidance on how to bring the materials that were before the administrative decision-maker before the reviewing court
The Court of Appeal has addressed the issue of how to properly put materials before the Court on judicial review.
By way of history, Access Copyright made a Rule 317 request for the material that was before the Copyright Board and in its possession. The Copyright Board informed the parties that it did not have in its possession any relevant material not already in the possession of the applicant. Thus, Access Copyright added the material into the applicant's record. However, the Court of Appeal held that material should have been supplied under affidavit.
The Court of appeal held that materials produced by the administrative decision-maker in response to a Rule 317 request can simply be placed in the applicant's record or the respondent's record. No affidavit is necessary. The same is true for the portions of any transcript of oral evidence before a tribunal.
But if the materials are not transmitted to the parties under Rule 317, then the Court of Appeal held that the materials must be provided by way of affidavit pursuant to Rules 306-310. This way, the parties may be able to exercise their right to cross-examine.
The Court of Appeal ordered the parties to remedy the application record by properly filing the evidence and subsequent materials.
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