Canada-Europe open new Patent Prosecution Highway pilot program

Justine Johnston -

The Canadian Intellectual Property Office (CIPO) has entered into a new Patent Prosecution Highway (PPH) pilot agreement with the European Patent Office (EPO). The PPH has a three year mandate; it began on January 6, 2015, and will operate until January 5, 2018. CIPO has previously entered into PPH agreements with other patent offices around the world and is a part of the Global Patent Prosecution Highway.

The PPH allows applicants with patent claims in one jurisdiction to accelerate processing in the other jurisdiction for no additional fee. PPH requests at the CIPO can be filed based on EPO national work products and EPO Patent Cooperation Treaty work products. PPH requests at EPO can be filed based on a CIPO application that was filed or entered the national phase at CIPO on or after January 6, 2015. Since applicants must file corresponding patent claims, the PPH accelerated processing is only suitable for applicants seeking similar patent protection in both jurisdictions.

The PPH allows the expedited office to work more efficiently by reviewing other office’s analysis before completing its own review and assessment of patentability. CIPO notes that the PPH reduces workload and improves patent quality.

Under the accelerated processing, CIPO intends to provide a first office action (either allowance or first substantive report) within three months (90 days) of receiving a PPH request. This is faster than a traditional application where a first examiner’s report is received 18 to 24 months after a request for an examiner’s report. CIPO has also noted that approximately 40% of PPH applications are approved without an office action, whereas only 4.4% of non-PPH national applications are approved without an office action. As such, the PPH program will save both time and effort for CIPO and the applicants.

Please see Stikeman Elliott’s Canadian Technology and IP Law blog posts on other PPH agreements here and here.

Court of Appeal clarifies - for utility the promise of the patent must be "clear and unambiguous"

Ryan Sheahan -

On July 24, 2013, the Federal Court of Appeal (FCA) issued its decision in Apotex Inc. v. Sanofi-Aventis, overturning a Federal Court decision invalidating Canadian Patent No. 1,336,777 (’777 Patent) - a patent owned by Sanofi claiming the active ingredient of the drug Plavix (clopidogrel bisulfate). This decision is the latest step in a lengthy history of proceedings between the parties, including an appeal to the Supreme Court of Canada (SCC), which held that the ’777 patent was valid. As that SCC decision was in the context of the Patented Medicines Notice of Compliance (PM(NOC)) proceeding, the finding was not (strictly speaking) binding on the Federal Court. It was still surprising that the Federal Court subsequently decided to invalidate the patent. The FCA decision points out the errors of the Federal Court and clarifies the law on the promise of the patent.

In order for an invention to be patentable in Canada it must be new, inventive and have utility. (This is true under both the pre-October 1, 1989 Patent Act (the Old Act, which the ’777 Patent was subject to) and the post-October 1, 1989 Patent Act.) Generally speaking, the threshold for meeting the utility requirement is quite low; absent a promise in the patent, a “mere scintilla” of utility will suffice. On the other hand, when a patent sets out an “explicit” promise, the utility of the invention will be assessed against such a promise. If the invention does not meet the stated promise – the patent will fall for lack of utility.

The FCA reiterated that not every patent contains an explicit promise of utility and that there is no legal obligation to disclose the utility of the invention in the patent. Selection patents are an exception to this disclosure requirement. The utility requirement of a selection patent is met by the selected compounds having an unexpected advantage over the other compounds in the genus and by disclosing such unexpected advantages in the patent. The ’777 Patent is considered to be a selection patent because it claims a subset of compounds that fall within the scope of the teachings and claims of an earlier genus patent. 

The trial judge concluded that the ’777 Patent contained an “explicit promise” regarding the use of the compounds in humans (i.e., that the compounds will be useful in humans). The trial judge came to this conclusion by drawing inferences from various statements in the patent, for example, the references to the “medicine of the invention” and that the “medicine of the invention can be usefully administered in the treatment and prevention of platelet disorders…”.

The FCA held that the trial judge erred in law by reading this promise into the patent. The FCA stressed that courts should not strive to find ways to defeat otherwise valid patents. In other words, the courts should avoid reading a promise into a patent where one does not explicitly exist.

In reaching its decision, the FCA emphasized the distinction between the potential use of an invention and an explicit promise of a specific result, noting that inferences, goals, hopes and potential applications are not promises. The FCA concluded that the trial judge “erred in law in reading into the ’777 Patent a promise for use in humans on the basis of inferences, in the absence of language at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of the genus patent” (emphasis added). The “clear and unambiguous” statements referred to by the FCA include statements such as “[i]n an unexpected manner only the [selected] enantiomer exhibits a platelet aggregation inhibiting activity, the [unselected] enantiomer being inactive. However, the inactive [unselected] enantiomer is the less well tolerated of the two enantiomers.”

In other words, the FCA concluded that the patent did not promise that the compounds would be useful in humans. According to the FCA, all the patent promised was that the selected compounds had greater platelet aggregation inhibiting activity and were less toxic than the unselected compounds. The patent had data to support such a promise. Therefore, the patent was not invalid for lack of utility.

Justice Gauthier, in his concurring decision, also noted that Canadian applications filed on the basis of European applications will often contain statements regarding the invention’s industrial application because European patent law requires the invention be capable of industrial application. Justice Gauthier cautions that “one must be careful not to treat each reference to a practical purpose as a promise of a specific result…”.

Though it is still possible for Apotex to seek leave from the SCC to appeal this decision, it is unlikely that such leave will be granted. The SCC has already issued a decision regarding the validity of this particular patent, albeit in the context of a PM(NOC) proceeding, and this particular utility issue was not raised. The SCC may be reluctant to have another hearing to again decide the validity of this patent.

On a strict reading of the FCA’s decision, absent an explicit promise, i.e., a clear and unambiguous statement, it will be very difficult to find that a patent promises any particular utility. Absent an “explicit promise”, all the patentee must show is that the invention has the merest scintilla of utility.

White House pushes for innovation in U.S. patent system

On June 4, 2013, the President of the United States announced seven legislative recommendations to Congress and five executive actions designed to protect innovators from frivolous litigation and to better the quality of patents issued by the United States Patent and Trademarks Office. (The informal Executive Actions differ from Executive Orders in that they are not legally binding and are seen more as a way to signal a policy shift.)

The Executive Actions announced by the White House are as follows:

  1. Identifying the “Real-Party-In-Interest”: the USPTO will begin a rulemaking process to require regular updates to ownership information, specifically designating the parent entity in control of the patent. This is expected to assist defendants in identifying the full extent of the patent portfolio held by a plaintiff, as such information is quite helpful in negotiating settlements.
     
  2. Additional USPTO training on Functional Claims: the USPTO will provide targeted training to examiners and develop strategies to address overly broad claims, especially in the context of software patents.
     
  3. Empowering “Downstream Users”: the USPTO will develop new education and outreach materials to aid those end-users using patented technology who face demands from a possible patent troll for simply using a product as intended. 
     
  4. Expanded Outreach and Study: the White House has acknowledged that engagement with stakeholders (including patent holders, research institutions, consumer advocates, public interest groups and the general public) is very important in ensuring that necessary reforms are identified to ensure that the U.S. patent system is efficient and reliable. The USPTO Edison Scholars Program, which permits academic experts to conduct research on the issues involved in abusive patent litigation, will be expanded.
     
  5. Exclusion Orders: the U.S. Intellectual Property Enforcement Coordinator will launch a review of existing procedures that U.S. Customs and Border Protection and the U.S. International Trade Commission use to evaluate the scope of exclusion orders (orders which prevent the importing of products that infringe patent claims) and work to ensure that the process for enforcement of those orders is transparent, efficient, and effective.

The Legislative Recommendations ask Congress to pursue the following measures (some of which echo the priorities set out above) to protect innovators from frivolous litigation. 

  1.  Require patentees and applicants to disclose the “Real-Party-In-Interest” by requiring the filing of updated ownership information with the USPTO or district court when sending demand letters, among other acts. 
     
  2. Permit more discretion in awarding “costs” to prevailing parties in patent cases. 
     
  3. Expand the USPTO’s “covered business method patent” transitional program to more types of computer-enabled patents, and permit a wider range of challengers to petition for review of issued patents. The program provides faster and cheaper review of covered patents as an alternative to litigation. 
     
  4. Protect consumers by providing them with better legal protection against liability if they are using a patented product “off-the-shelf” and solely for its intended use, and allowing a stay of judicial proceedings against consumers if there is a lawsuit against the vendor, retailer, or manufacturer of a product.
     
  5. Change the standard applied by the International Trade Commission for obtaining injunctive relief in order to enhance consistency in the standards applied by the ITC and district courts. 
     
  6. Initiating steps to incentivize public filing of demand letters so that the public may search them.
     
  7. Ensure the International Trade Commission has the flexibility required to hire judges with a background in administrative law

Federal Court examines "good faith" in patent prosecution

In Lundbeck Canada Inc.  v. Ratiopharm Inc., 2009 FC 1102 (F.C. Nov. 23, 2009), the Federal Court provided guidance on the requirement to deal in good faith with the Patent Office during patent prosecution. Since 1996, s. 73(1)(c) of the Patent Act has required that applicants reply in “good faith” to any request by a patent examiner. However, until now the scope of that requirement had been somewhat uncertain.

Justice Mactavish took this opportunity to clarify that an applicant must not provide information that could mislead the Patent Office. The case involved a patent for a combination of drugs used in treating dementia. To meet the requirement of non-obviousness, it was necessary to show that this combination of drugs led to a result that was new and unexpected in light of the state of knowledge of researchers at the time. Lundbeck, in support of the patent, indicated to the patent agent that prior articles taught that this combination was ineffective. However, Lundbeck did not point out that one significant study (of which they were aware) stated that only certain subsets of the combinations in question were ineffective, but that others could be. Mactavish J. held that the omission of this information was misleading and thus a breach of the duty of good faith. In addition, Mactavish J. equated this obligation to the Patent Office with obligations to the court in an ex parte proceeding.

CIPO announces three new Patent Prosecution Highway programs

The Canadian Intellectual Property Office (CIPO) has entered into agreements with the Japan Patent Office(JPO), the Danish Patent and Trademark Office(DKPTO) and the Korean Intellectual Property Office (KIPO) to launch two-year pilot Patent Prosecution Highway (PPH) programs, each commencing October 1, 2009.

These pilot programs can be compared to the PPH pilot program between CIPO and the United States Patent and Trademark Office initiated on January 28, 2008 and extended for a period of two years ending on January 28, 2011.

The PPH program provides for significantly accelerated examination of patent applications by CIPO if examination work has already been conducted at the other intellectual property office. Under the PPH, if claims of an application have been found to be acceptable by the other intellectual property office, an accelerated examination can be requested at CIPO (assuming that the Canadian examination has not yet commenced). Each Canadian patent application will be examined in accordance with the Canadian Patent Act and Rules and CIPO's Patent Office Practice.

During the pilot program, CIPO will process requests for accelerated prosecution under the PPH program free of charge. CIPO will consider what, if any, fees should apply for this service if it later becomes permanent. Regular fees for requesting examination will continue to apply during the PPH pilot.

PPH programs can not only accelerate examination, but can also lead to lower prosecution costs for applicants, because patent claims already allowed by one patent office can be reused in a corresponding application in a participating PPH country. Patent applicants who have an application allowed in one country should consider whether any PPH programs are available to facilitate allowance of corresponding applications in other countries.

The procedures and requirements for filing a request to CIPO for participation in the PPH program are available from the CIPO PPH website.

Canada-U.S. Patent Prosecution Highway pilot program extended

The Canadian Intellectual Property Office (CIPO) and the United States Patent and Trademark Office (USPTO) have extended the pilot Patent Prosecution Highway (PPH) program for another two years until January 28, 2011. The PPH program, begun on January 28, 2008, provides for significantly accelerated examination of patent applications by CIPO if examination work has already been conducted at the USPTO.

Under the PPH, if claims of an application have been found to be acceptable by the USPTO, an accelerated examination can be requested at CIPO (assuming that the Canadian examination has not yet commenced). Each Canadian patent application will be examined in accordance with the Canadian Patent Act and Rules and CIPO's Patent Office Practice. There is also a reciprocal PPH program run by the USPTO, which provides accelerated examination for U.S. patent applications where the corresponding Canadian application has been allowed by CIPO before examination has commenced at the USPTO.

The experience gained by CIPO during the initial year of the PPH program has led to changes being implemented. Most notably, Patent Cooperation Treaty (PCT) filings where the PCT application does not contain any priority claim are now eligible to participate in the PPH pilot program.

During the pilot, CIPO will process requests for accelerated prosecution under the PPH program free of charge. CIPO will consider what, if any, fees should apply for this service if it later becomes permanent. Regular fees for requesting examination will continue to apply during the PPH pilot.

The CIPO-USPTO PPH programs are part of a growing international movement to leverage the patent search-and-examination resources of national patent offices around the world. In addition to Canada and the United States, other countries participating in PPH programs with one or more other national patent offices include the European Union, Germany, Denmark, the United Kingdom, Japan, Korea, and Australia.

PPH programs can not only accelerate examination, but can also lead to lower prosecution costs for applicants, because patent claims already allowed by one patent office can be reused in a corresponding application in a participating PPH country. Patent applicants who have an application allowed in one country should consider whether any PPH programs are available to facilitate allowance of corresponding applications in other countries.