The Designs Amendment (Advisory Council on Intellectual Property Response) Bill 2020 (Bill), with important changes to designs law, is currently before Senate for consideration. It includes a much-anticipated change to implement a grace period that will allow designers to publish their designs before applying for design protection.Read More
One thing is clear about artificial intelligence (AI) and intellectual property (IP) at the moment: there are more questions than answers. Who should be author? Who is responsible for a work’s liability? What about moral rights? Is a computer programme capable of making an ‘inventive step’ or forming an ‘intellectual creation’ normally reserved for humans? And for those Matrix fans – should we let machines make decisions for us, lest we become seen as the planet’s true virus?
In September 2019, the World Intellectual Property Organisation (WIPO) launched a much-needed conversation on IP and AI, and consulted with member state representatives on the potential impact of AI on IP. Over the course of the consultation, WIPO received more than 250 responses from a wide range of global stakeholders.Read More
After the CJEU’s ruling earlier this year (as discussed here), the Sky v Skykick case has now returned to the English High Court and Lord Justice Arnold on 29 April 2020 issued a final judgment in the case (see full text of the judgment here).
Although Sky’s trade marks were found to be partially invalid on the ground that they were applied for in bad faith, Sky was still ultimately successful in establishing infringement.Read More
Blockchain technology is considered by many to be one of the most important technologies developed in recent years. It is often misunderstood and its potential has yet to be fully realised and harnessed. Blockchain has been the subject of a large amount of negative press due to volatile price fluctuations of its biggest user, the cryptocurrency, and this has generated a public mistrust.
However, blockchain could hold the answer to two of technology’s greatest challenges: data reliability and security. These two things are particularly important in the healthcare and life sciences sector where veracity of data is a life or death question and the safety of our most intimate data is paramount.Read More
Effective 1 July 2019, the EU adopted a regulation by introducing a supplementary protection certificate (SPC) manufacturing and stockpiling waiver. This waiver also applies for biosimilar versions of SPC-protected medicine during the term of the SPC.Read More
April 26, 2018 is a remarkable date: first it’s World IP Day celebrating IP around the world. Second, and this is unique, the British IP Minister Sam Gyimah MP announced that the UK ratified the Unified Patent Court Agreement (UPC Agreement). By doing so the UK agreed to be bound to both the UPC agreement and the UPC’s Protocol on Privileges and Immunities (PPI). The UPC will be a court common to the contracting member states within the EU having exclusive competence in respect of European Patents and European Patents with unitary effect.
The emergence of “plausibility” as a test for inventive step, sufficiency and industrial applicability represents a significant legal development in Europe in recent years. Now the concept of plausibility has reached Australian shores, with the Australian Patent Office applying it in a test for sufficiency.
On June 27, 2017, the U.S. Federal Circuit vacated and remanded the Patent Trial and Appeal Board’s (Board) decisions in three interference proceedings between the Board of Trustees of Leland Stanford Junior University (Stanford) and the Chinese University of Hong Kong (CUHK) (Case No. 2015-2011).
Competing inventors at Stanford and CUHK developed methods for diagnosing aneuploidies—conditions characterized by an abnormal number of chromosomes (e.g., Down’s Syndrome and Turner’s Syndrome)—using maternal blood samples. Maternal blood contains very small amounts of fetal DNA, and maternal blood sampling is far less invasive than previous methods of sampling fetal DNA. Competing inventors developed techniques for detecting the fetal DNA in maternal blood.
A Stanford application was filed in 2007 with claims to analyzing certain “target sequences” of fetal DNA. A CUHK application, published in 2009, described a “random sequencing” method. This method uses a massively parallel sequencing (MPS) technique that does not require use of “target sequences.” After the CUHK application published, Stanford cancelled its original claims and replaced them with claims to sampling “randomly selected” DNA fragments using MPS. The 2007 Stanford application had disclosed that “the Illumina [DNA] sequencing platform” could be used to perform MPS.
Both Stanford and CUHK requested interferences before the Board to determine who invented the random sequencing method. CUHK claimed that, in 2011, Stanford saw CUHK’s claims to random MPS, and changed its application to claim that technique. CUHK moved to have Stanford’s claims held unpatentable for lack of written description support for random MPS. The Board found that Stanford’s specification disclosed “targeted” rather than “random” MPS, and would not have indicated to one of ordinary skill in the art that the inventor was in possession of the claimed random MPS method. It held Stanford’s claims unpatentable for lack of written description.
The Federal Circuit, inter alia, vacated the Board’s decision, stating that the Board erred in analyzing written description, and remanded the case. The Circuit first found the Board erred by relying on CUHK’s expert testimony and several publications discussing a DNA sequencing platform that differed from the Illumina platform. The Circuit further stated that the Board erred because “the Board’s task was to determine whether the [Stanford specification’s] written description discloses random MPS,” “not whether the description does not preclude targeted MPS.” Finally, the Circuit stated that the Board failed to compare specific sentences and phrases referencing the sequencing process of the Stanford specification to the Stanford claims, e.g., the specification phrase “using the attachment of randomly fragmented genomic DNA.”
On remand, the Circuit instructed the Board to examine whether a person of ordinary skill in the art would have understood that the Stanford specification disclosed random MPS sequencing, as opposed to whether the specification did not preclude targeted MPS sequencing. Specifically, it instructed the Board to determine whether a person of ordinary skill would have known, as of the Stanford priority date, that the reference to Illumina products meant random MPS sequencing as recited in the claims, by examining pre-filing date factual record evidence.
The U.S. Courts have repeatedly invalidated patents under 35 U.S.C. § 101 as lacking patentable subject matter in areas such as business methods and computer-based inventions. However, decisions addressing inventions in the life sciences are substantially less frequent. In Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017), the Federal Circuit provided some additional guidance for patent eligibility of life sciences inventions.
Three of the patents at issue were directed to methods of detecting myeloperoxidase (MPO) (diagnostic patents), and the fourth patent was directed to methods of treating patients with heart disease based on the MPO detection methods of the other patents. The district court granted the defendant’s motion to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim because the diagnostic patents lacked patentable subject matter, and the Federal Circuit affirmed that decision.
According to the Federal Circuit, the diagnostic patents were directed to a law of nature: the correlation between MPO level and heart disease. Interestingly, the opinion notes that the correlation was known in the art prior to filing the patents, however, there was no way to directly detect the MPO or correlate the levels to a risk of heart disease. The Court found that the claims did not teach a new test or laboratory technique, nor did they alter the MPO levels. Rather, the levels existed in nature without human action. Thus, the Court concluded that the claims did “not result in an inventive concept that transforms the natural phenomena of MPO being associated with cardiovascular risk into a patentable invention.”
The Court left open the question of whether the method of treatment patent contained patent-eligible subject matter because the Court held that the pleadings for that patent were deficient (this patent was only alleged to be infringed through inducement or contributorily infringed).
Unlike other decisions on patentable subject matter in the life sciences area, the holding did not turn on whether the claims broadly preempted application of a law of nature. The Patent Owner argued that the claims should be patent eligible because they were narrow and did not preempt all uses of the alleged law of nature, but the Court stated that the preemption argument was fully addressed and made moot by its determination that the claims only disclosed patent-ineligible subject matter.
In view of this decision, care should be taken when drafting claims directed to diagnostic methods to be sure to clearly claim more than the diagnostic correlation.