Canadian Supreme Court Rejects Promise Doctrine as Test for Utility
In AstraZeneca Canada Inc v Apotex Inc the Supreme Court of Canada unanimously rejected the promise doctrine as a test for determining whether the utility requirement has been satisfied on the basis that it is incongruent with both the words and the scheme of the Patent Act.
Until 2002 utility was satisfied by a mere scintilla of utility. However, in 2002 Canadian Courts began using the promise doctrine to evaluate utility, invalidating patents that over-promised what the invention was and allegedly even reading promise of the invention into patent specifications even when none was intended.
In July 2014 the Federal Court invalidated AstraZeneca’s patent for a compound in a proton pump inhibitor drug it markets. The specification contains the following statement:
It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole (emphasis added).
The Federal Court held that the alleged promise of improved therapeutic profile such as a lower degree of interindividual variation was neither demonstrated nor soundly predicted. This was upheld by the Federal Court of Appeal.
The Supreme Court rejected the promise doctrine as a method for determining whether the utility requirement has been met. It held the promise doctrine to be incongruent with the principle that claim construction should precede all issues of validity, since the promise doctrine identifies potential promises by reading both the claims and the disclosures in the specification whether or not there is any ambiguity in the claims.
The Supreme Court also noted that where multiple promises can be read into a patent the promise doctrine will invalidate that patent if any one of those promises is not fulfilled. Further, the promise doctrine requires all promises to be demonstrated and soundly predicted at the date of filing. However, the Supreme Court held that such an approach is antagonistic to the bargain between inventors and the state, since it would discourage inventors from fully disclosing the benefits of the invention for fear of making an unintentional overstatement.
Rather, utility was held to be satisfied where the subject matter of the invention is capable of a scintilla of a relevant practical purpose and only that use of the subject matter needs to be demonstrated and soundly predicted at the filing date. If the proposed utility of the invention is unrelated to the subject matter or is purely speculative or merely a starting point for further research or if the invention is devoid of utility, then the utility requirement is not met. The Supreme Court held that AstraZeneca’s patent satisfied the proper standard for utility.
EPO Applies European Commission Criteria Excluding Claims to Plants and Animals Obtained by Essentially Biological Processes
With effect from 1st July 2017 the EPO has resumed examining patent applications containing claims to plants and animals obtained by essentially biological breeding processes.
Towards the end of 2016 it was notified that the EPO had stayed the examination of patent applications containing claims to plants and animals obtained by essentially biological breeding processes. This was done in response to a European Commission notice to the effect that the exclusion from patentability for essentially biological processes should also extend to products obtained by such processes.
Following a review the EPO Administrative Council has now stated that with effect from 1st July 2017 it will resume examining such applications and will apply the exclusion consistently with the policy expressed in the European Commission notice. The relevant regulations have also been amended to reflect this clarification.
IPONZ Joins Global Patent Prosecution Highway
On the 6th July 2017 IPONZ joined the Global Patent Prosecution Highway (GPPH) pilot program. The GPPH pilot program is already composed of the IPO’s of Australia, Austria, Canada, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Israel, Japan, Norway, Poland, Portugal, Russia, Singapore, South Korea, Spain, Sweden, United Kingdom, United States of America and the Nordic Patent Institute.
The GPPH pilot program uses the below set of qualifying requirements, under which patent applicants can request accelerated examination of a patent application in other GPPH IPO’s after at least one claim of a corresponding application has been accepted in an IPO of another GPPH IPO.
- The applications before the Office of Earlier Examination (OEE) and the Office of Later Examination (OLE) have the same earliest date (which may be the priority date or the filing date).
- Following substantive examination the OEE has found at least one claim to be allowable. The indication that a claim is allowable will be provided as an explicit statement in any substantive work product from the OEE. This includes claim(s) determined as novel, inventive and industrially applicable in PCT work products.
- All claims presented for examination under the GPPH pilot must sufficiently correspond to one or more of the claims found allowable by the OEE.
- The OLE has not begun substantive examination of the application. However, OLE’s may still choose to allow GPPH requests filed after examination of the OLE application has begun depending on the particular circumstances and needs of the OLE and its stakeholders.
- A request for substantive examination must have been filed at the OLE, either at the time of the GPPH request or previously.
Participating IPO’s may require that the OLE application is open to the public and require a fee for GPPH acceleration. Participating IPO’s acting as an OLE can also specify less, but not more, criteria in order for the GPPH to be used.
As the OLE IPONZ applies criteria (1), (2) and (3) and no additional fee is applied. It will consider a GPPH request as a request for substantive examination if that has not already been made, and allows the GPPH to be requested between filing and acceptance. Where New Zealand has been entered late via PCT National Phase restoration will have to be achieved before a GPPH request can be made. However, it can be made at the time of filing a late convention application, provided that the claim to the earliest convention priority or filing date is allowed.
IPONZ requires the following documentation with a request under the GPPH:
- A copy of the report or action issued by the OEE which expressly identifies the patentable claims.
- A copy of the claim set which includes the patentable claim(s) of the OEE application.
- A claims correspondence table which sets out the patentable claim(s) of the OEE application and identifies the corresponding claim(s) to be examined by IPONZ.
UK Supreme Court Favours Doctrine of Equivalents over Purposive Construction
In Actavis UK Ltd v Eli Lilly and Company the UK Supreme Court held that patent infringement can be established on a doctrine of equivalents basis, thereby giving UK patents a wider monopoly than they would have under a purposive construction.
Eli Lilly have a patent that claims the use of pemetrexed disodium in the manufacture of a medicament for use in combination with vitamin B12 (and, optionally, folic acid) for the treatment of cancer. Actavis sought to avoid the Eli Lilly’s patent by proposing to substitute the active ingredient pemetrexed disodium with either (a) pemetrexed diacid, (b) pemetrexed ditromethamine, or (c) pemetrexed dipotassium.
Under a purposive construction Eli Lilly’s patent claim would not capture Activis’s proposed substitution, even after taking into account variants found to be within the claims according to the Improver questions (Improver Corporation v Remington Consumer Products Ltd  FSR 181, at 189). Namely:
- Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no?
- Would this (ie that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes?
- Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.
Both the trial Judge and the Court of Appeal held there would be no direct infringement. While it was accepted that Activis’s variants are bioequivalent and so did not have any material effect on the way the invention worked, this would not have been obvious to a reader skilled in the art as they would be unable to predict that a variant will be sufficiently soluble to deliver an effective dose. Both lower Courts also found that the reader skilled in the art would understand the claim to be limited to the use of pemetrexed disodium, both on account of the use of that term in the specification and because it is a term that does not lend itself to a broad construction. Consequently the answered the Improver questions: No, No and Yes.
The Supreme Court also found that the meaning of pemetrexed disodium was clear and did not extend to pemetrexed diacid, pemetrexed ditromethamine or pemetrexed dipotassium. However, they then considered whether the Protocol on the Interpretation of Article 69 assisted Eli Lilly in extending the scope of their patent claims, given that the claims are to be interpreted in light of EPC 2000 Article 69.
The Supreme Court concluded that the Protocol allows departing from the language of the claim when considering the scope of protection in relation to variants or equivalents. Taking this into account the Supreme Court reformulated the Improver questions so as to take into account equivalents, and proposes use of the following questions to guide determination of whether there has been infringement:
(i) Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?
(ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
(iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?
Consequently, where there is no literal infringement, a patentee would have to establish that the answer to the first two questions was “yes” and that the answer to the third question was “no” in order to establish infringement. Applying this test the Supreme Court found Actavis to infringe.
A notable consequence of the new test is that experts would need to be briefed on the nature of the variant and provide evidence as to (a) whether the variant works in the same way as the invention to produce the same result; and (b) whether this would have been obvious to the skilled person had he been made aware of the variant at the priority date.
This differs from the previous approach which only required expert evidence as to how the claim would be understood by an expert, uninfluenced by claim construction issues in dispute before they formed their opinion.
It was also asserted that infringement can arise even when the variant was not known at the priority date of the patent, meaning that a claim to old technology can be infringed by new technology that is used for the same effect.
While the finding in relation to direct infringement meant there was no need to make a ruling on indirect infringement, the Supreme Court agreed with the Court of Appeals finding of indirect infringement. This finding was upheld as the dissolving of one of Actavis’s products in saline will result in solution containing pemetrexed disodium provided that the ratio of sodium ions to pemetrexed ions was at least 2:1.
United States of America
USPTO Issues Report Canvassing Issues and Perspectives on Patent Eligible Subject Matter
Following roundtable discussions with interested parties last year, the USPTO has now issued a Report on Views and Recommendations from the Public regarding Patent Eligible Subject Matter.
The Report starts with an overview of historical developments in patent subject matter eligibility in the United States and notes that the Supreme Court’s recent decisions of Bilski (2010), Mayo (2012), Myriad (2013) and Alice (2014) have had the effect of narrowing patent eligible subject matter. It then considers how the Federal Circuit Courts have applied those Supreme Court decisions, which have predominantly impacted on patents in the life sciences and computer-related technology fields.
The patent eligibility laws applicable in the patent offices of Europe, Japan, Korea and China are then briefly summarized. This is followed by a deeper exploration of how these are applied within the Offices and by the Courts of these jurisdictions in relation to the life sciences and computer-related technology fields.
The Report then summarizes the views and key arguments expressed by the public in the roundtable discussions and submissions, which ranged from agreement or acceptance to disagreement with the recent Supreme Court decisions.
Supporters asserted that the Mayo/Alice two-step test provides a beneficial way to challenge overly broad patents and helps to improve patent quality by indicating that claims be directed to a specific implementation of an inventive solution instead of a vaguely-claimed functional result. Supporters also argued that the new eligibility test gives them a useful tool to defend against abusive lawsuits by patent assertion entities and may even give the United States a competitive advantage internationally.
Detractors argued that the Court’s recent decisions are legally flawed and that the judicially-created exceptions to eligibility are too broad. Detractors also asserted that the two-step test is difficult to apply, leading to inconsistent decisions and unpredictability, and that it conflates § 101 analysis with other patentability requirements. Finally, critics argued that the Court’s jurisprudence stifles innovation, hurts businesses, and harms American competitiveness to the extent that the patent systems of other countries allow for a broader scope of patent protection.
Representatives of the computer-related technology field were spread across the spectrum of supporters and detractors, while life-sciences representatives were predominantly detractors who saw legislative change as the best way forward. Included in the appendices are the legislative changes proposed by several parties.