Public Use in Clinical Trials Outside Standard Grace Period Found Not to Anticipate
In Bayer Inc v Cobalt Pharmaceuticals Company the Federal Court held that Bayer’s patent for a contraceptive pharmaceutical composition was valid even though use was made of the invention in phase III clinical trials more than one-year before the filing date.
In the phase III clinical trials participants were provided with tablets that they were asked either to ingest or return. No other restrictions were placed on the participants’ disclosure of information concerning the tablets. Evidence established that hundreds of tablets were recorded as either lost or not returned.
While the Court accepted it was possible that a tablet had made its way to a person skilled in the art, the Court considered that such access was insufficient to reverse engineer the invention. In particular, understanding the dissolution profile of the tablet and the location of exposure of the pharmaceutically active ingredient would have required access to many tablets and so could not have been discovered without inventive insight.
The Court also held that the clinical trials fell within the experimental use exception. In particular it was reasonable and necessary that the experiments were conducted in public. While the clinical trials to confirm their safety and efficacy were held for the purpose of gaining regulatory approval the Court held that the trials were still inherently experimental, even though the risks at this advanced stage were minimal.
- patent protection will no longer be available for inventions relating to a new use of a known or existing product;
- computer software per se is excluded from patentability;
- petty patents can be issued for new processes or development of an existing process;
- a signed Statement of Ownership of an invention must be submitted by the applicant with the patent application;
- accumulated annuities from the filing year to the year of grant as well as the subsequent annuity must be paid within 6 months of the grant date;
- subsequent annuities must be paid in advance - one month before every anniversary of the filing date, whereas previously it was every anniversary of the grant date;
- subject to a late fee the deadline for annuity payment can be extended by 12 months;
- post-grant opposition is allowed for in addition to pre-grant opposition.
Second Reading of Patents (Trans-Tasman Patent Attorneys and Other Matters) Bill
The Patents (Trans-Tasman Patent Attorneys and Other Matters) Bill was given its second reading on 13th October 2016 and the Government agreed with the Commerce Committee’s recommendation not to continue with the trans-Tasman single application and single examination processes. However, the single trans-Tasman patent attorney regime remains on track and is expected to commence by 24th February 2017 at the latest.
The Bill also remedies a drafting error in the Patents Act 2013, which currently allows applications to be opposed with a unity of invention objection despite such a ground being ruled out as a ground of revocation. The correction will be deemed to have come into force when the Patents Act 2013 commenced on 13th September 2014.
Conditional Amendments Not Allowed in Pleadings
In Resmed Limited v Fisher & Paykel Healthcare Limited an Assistant Commissioner confirmed that conditional amendments cannot form part of pleadings or have any other type of formal status.
In its counterstatement to Fisher & Paykel’s opposition to it patent application Resmed proposed conditional amendments to the claims. IPONZ (and Fisher & Paykel) objected on the basis that proposed amendments can only be made unconditionally which resulted in Resmed requesting a hearing.
Resmed argued that it should be allowed to make conditional amendments on the basis that Fisher & Paykel’s pleadings were not sufficiently clear and that if it made unconditional amendments it may not be allowed to withdraw or change them. In so doing Resmed acknowledged that whether it would be allowed the conditional amendments would be at the discretion of the Commissioner, but submitted that the early signalling of the amendments should weigh in their favour.
The Assistant Commissioner noted Court of Appeal precedent which held that maintaining two versions of a patent is inconsistent with the need for competitors to know the scope of the monopoly into which they cannot trespass. The Assistant Commissioner held that conditional amendments cannot be justified on the basis of inadequate pleadings and that they only add to any complexity and ambiguity. Allowing conditional amendments would transfer risk from the applicant to the opponent and would transform litigation into an uncertain movable feast. The Assistant Commissioner held that any risk with amendments rightly belongs with the applicant. Amendments can be proposed after an adverse finding, but the risk that discretion will not be exercised in favour of allowing them is for the applicant to bear. It was noted, though, that outside of formal pleadings conditional amendments can still be made between the parties on a “without prejudice” basis.
Extension to Supplementary International Search Deadline
The deadline for requesting a supplementary international search has been extended from 19 months to 22 months from the priority date. Supplementary international searches are particularly useful where the technology in question has a strong developmental presence in non-English speaking countries. Currently supplementary international searches are available from ISA’s in the following jurisdictions or organisations: Austria, EPO, Finland, Russian Federation, Sweden, Singapore, Ukraine, Nordic Patent Institute, Visegrad Patent Institute.
Implications of Brexit on UK IP Examined
CIPA has published an exhaustive guide to the impact of Brexit on all intellectual property rights. The 12-page paper details a strong preference for the UK to remain part of the Unified Patent Court system after Brexit, along with the likely impact on the full range of IP rights, systems and transactions. The paper examines the effect that the UK leaving the EU will have on:
- EPC, PCT and UK patents
- Community trade marks, registered designs and community plant variety rights
- Trade secrets and data safety
- Supplementary Protection Certificates
- Regulatory data protection
- Orphan drug exclusivity
- The Nagoya Protocol
- IP disputes
- The Unitary Patent and the Unified Patent Court
- IP transactions
- Parallel imports and exhaustion of rights
- IP tax relief
The guide followed CIPA obtaining an opinion on whether the United Kingdom could continue participation in the Unified Patent Court and Unitary Patent following Brexit. The conclusion of that opinion is that:
- The UK may only continue to participate in the Unitary Patent by entering into a new international agreement with the participating EU Member States
- It is legally possible for the UK to continue to participate in the UPC after ‘Brexit’ and to host the Life Sciences/Chemistry section of the court, but changes would have to be made to the UPC Agreement.
- The UK’s continued participation would require it to submit to EU law regarding proceedings before the Court. It would also need to sign up to an appropriate jurisdiction and enforcement regime.
- It would only be possible to obtain a pre-emptive opinion from the Court of Justice of the EU on the legality of the UPC Agreement if the Union became a party to the Agreement
- If the UK ratified the Agreement without amendment, and subsequently left the EU, the UK division would have to close
United States of America
CAFC Holds Itself Unable to Review PTAB's No Assignor Estoppel Ruling
In Husky Injection Molding Sys Ltd v Athena Automation Ltd the Court of Appeal for the Federal Circuit (CAFC) held that it did not have jurisdiction to review a determination by the Patent Trial and Appeal Board (PTAB) that assignor estoppel has no effect in inter partes review.
The equitable doctrine of assignor estoppel is based on the principle of fair dealing and prevents the party who assigns a patent from later challenging the validity of the assigned patent. Before forming Athena the owner and CEO of Husky was a co-inventor of the patent in question. After assigning the patent to Husky in 2007 he then sold the company and subsequently formed Athena. In 2012 Athena filed for inter partes review of the patent on the ground of anticipation. The PTAB held that the equitable doctrine of assignor estoppel does not provide an exception to the otherwise broad statutory mandate that a person who is not the owner of a patent may file with the Office a petition to institute an inter partes review of the patent.
Inter partes review became possible in 2011 as part of the America Invents Act and replaced chapter 31 of the US Patent Laws. Section 314(d) provides that the determination by the Director whether to institute inter partes review under this section shall be final and nonappealable.
The CAFC followed the Supreme Court’s recent decision in Cuozzo Speed Technologies LLC v Lee in deciding whether the Director’s determination is appealable. In Cuozzo the Supreme Court held that to be appealable the challenge would have to implicate constitutional questions, or depend on other less closely related statutes, or present other questions of interpretation that reach, in terms of scope and impact, well beyond section 314. The CAFC readily held that no constitutional questions were involved and that on account of assignor estoppel being an equitable doctrine the challenge does not depend on less closely related statutes. The CAFC held that assignor estoppel does not present questions of interpretation that reach well beyond section 314. It noted that section 314 pertains to arguments concerning patentability and the necessary strength of those arguments before the Director is authorized to initiate review. It found that assignor estoppel is pertinent to those enquiries and so does not present questions of interpretation reaching well beyond the section.
The CAFC then went on to consider whether the question of assignor estoppel is beyond the PTAB’s authority in relation to invalidation actions. The CAFC concluded that it is not, contrasting it with the statutory limits that are placed on the PTAB’s authority in relation to covered business method review. Consequently, the CAFC held that it did not have jurisdiction to review the PTAB’s determination.
2. Trade Marks
Fresh Cause of Action Allowed in Appeal
In Monster Energy Company v Ox Group Global Pty Ltd the High Court Judge allowed Monster Energy to add a further ground of objection to its appeal of an Assistant Commissioner’s decision that dismissed Monster Energy’s opposition to Ox Group’s trade mark application.
Monster Energy had opposed Ox Group’s application for a device mark consisting of a particular arrangement of OX UNLEASH THE POWER on the basis of their registration for UNLEASH THE BEAST! The Assistant Commissioner held that the differences between the respective marks meant that confusion or deception was unlikely to arise.
However, subsequent to the Assistant Commissioner’s decision, Monster Energy received evidence indicating that Ox Group had no intention to use the mark applied for, preferring instead to use the stylised phrase UNLEASH THE POWER. They then sought to add ‘no intention to use the mark’ as a ground of opposition. Ox Group argued that they were only temporarily ceasing use of the mark applied for.
The Judge allowed the fresh cause of action on the basis that the evidence which supports it is new and that its inclusion will not result in a substantially new case, while also noting that the parties and the Judge will have the opportunity to thoroughly consider all of the issues at the substantive hearing. The Judge thereby endorsed the principle that the parties should have every opportunity to ensure that the real controversy should be heard so as to secure the just determination of the proceedings. While Monster Energy could have made an independent application to the Assistant Commissioner to hear the new ground of objection, the Judge considered that the High Court was in as good a position as the tribunal to reach a conclusion on the issue of intended use by Ox Group. While Monster Energy would have a considerable onus in demonstrating that Ox Group did not intend to use the trade mark applied for, the Judge considered that the wider interests of justice outweighed any prejudice caused to Ox Group by the admission of the fresh ground.
Copyright Tribunal to be Allowed to Charge Interest
On the 17th October 2016 the Copyright Amendment Act 2016 received royal assent and will enter into force on 1st January 2018. From that date the Copyright Tribunal will have the power to award interest on the whole or part of the money owing from a Copyright Tribunal order under Part 8 as compensation for delay in payment of the money. Any such awarding of interest must be calculated in accordance with Schedule 2 of the Interest on Money Claims Act 2016.