Establishment of Callaghan Innovation
On 1st February 2013 Callaghan Innovation was established as a stand-alone Crown Entity through the merger of innovation roles across a number of government sectors. Callaghan Innovation aims to help businesses be more innovative and derive greater returns on that innovation. It will also continue to operate its extensive science, engineering and technology laboratories and specialist equipment that were transferred to it from the likes of Industrial Research Limited.
By investing in and supporting events, forums, networks and related publications, as well as education based internships and scholarships it seeks to nurture an appetite for and appreciation of innovation. Another initiative to strengthen innovation capability is the exchange of staff with businesses.
Callaghan Innovation’s services and funding options are available to businesses regardless of their size, provided they have the aspiration and ability to be globally competitive through R & D. As a sign of its innovation its 0800 number (0800 4CALLAGHAN – 0800 422552) connects directly with a human. Along with the expertise of its staff, Callaghan Innovation will also utilize its laboratories and specialist equipment to assist businesses in developing sophisticated products.
Practice Note on Medical Use Claims
The Canadian Intellectual Property Office (CIPO) has issued a practice note for patent examiners regarding the examination of medical use claims. The practice note is particularly relevant to claims that recite dosage regimens or dosage ranges. While noting that medical use claims (as opposed to medical method claims) are generally permitted, it states that inventions preventing physicians from exercising their skill and judgment in using a known compound for an established purpose effectively cover a method of medical treatment.
This is further clarified by distinguishing between essential elements in a claim that instruct a medical professional ‘how’ to treat a patient (not allowable) as opposed to those directed to ‘what’ is used to treat a patient (allowable). Examples indicating limitations on a physician’s skill or judgment are identified as details of a dosing schedule, a range of potential dosages and narrowing treatment to a patient sub-population or administration site.
Insufficiency Not to be Disregarded
In The IAMS Company v Nestec S.A. it was held that there is insufficiency of disclosure if the skilled person, taking into account the entire teaching of the patent, is not able to rework an invention which is defined in the claims in a completely clear and comprehensible manner, unless they disregard a meaningful feature thereof.
Predictions and Insufficiency Considered
In Regeneron Pharmaceuticals Inc v Genentech Inc the Court of Appeal clarified when patent claims containing predictions (i.e. unsupported by experimental work) satisfy the sufficiency requirements of the Patents Act.
The patent in question discloses and claims the use of human vascular endothelial growth factor (hVEGF) antagonists for the treatment of non-cancerous (non-neoplastic) diseases which are characterised by excessive blood vessel growth (neovascularisation or angiogenesis).
Regeneron argued that, despite being framed as a medical use patent, the claims are entirely speculative and cover a wide range of non-neoplastic diseases and disorders without the experimental work needed to support them. More specifically, some non-neoplastic neovascular diseases cannot be treated with VEGF antagonists; some VEGF antagonists are not therapeutically active; and the patent imposes on the skilled person an undue burden to establish which antagonists are effective for which disease states. Regeneron further argued that either its VEGF product does not fall within the claims on their proper interpretation or, if it does, the claims cover products that they do not enable and are insufficient for this reason too.
After reviewing precedent the Court of Appeal found that when considering the sufficiency of a patent an assertion that the invention would work across the scope of the claim had to be plausible or credible. If it was possible to make such a prediction, then it could not be said that the claim was insufficient simply because the patentee had not demonstrated that the invention worked in every case. However, if it was not possible to make such a prediction, or if it was shown that the prediction was wrong, and the invention did not work with substantially all the products or methods falling within the scope of the claim, then the scope of the monopoly would exceed the technical contribution made by the patentee to the art and the claim would be insufficient. In applying this to the case at hand the Court of Appeal held that Regeneron’s insufficiency attack failed, along with the other pleaded grounds of revocation.
Clearing the Path before Launching
In the Court of Appeal decision Novartis AG v Hospira UK Ltd Novartis was successful in obtaining an interim injunction against Hospira even though the relevant Novartis patents had been declared invalid. Novartis obtained two patents covering the use of zoledronic acid for the treatment of osteoporosis. It also had a patent to the compound, which expired on 15th May 2013.
The two use patents were revoked by the High Court in February 2013 on account of not being entitled to the claimed priority date and also for some of the claims being found to be insufficient. Although Novartis subsequently lodged an appeal to the revocation, Hospira informed Novartis that it intended to launch a generic version of zoledronic when the compound patent expired.
The Court of Appeal held that the burden is on generic manufacturers to ‘clear the path’ fully before launch. Since the generic knows more about its plans than the innovator, the generic ought to arrange things to have the merits tried before it launches. Appeals are normal in the pharmaceutical industry, and litigation is not concluded until all appeal options have lapsed or been disposed of. Consequently, Novartis obtained the interim injunction, given that its revocation appeal had a real chance of success and the unquantifiable damage to Novartis outweighed any to Hospira.
United States of America
Isolated DNA not Patent Eligible
In Association for Molecular Pathology v Myriad Genetics Inc the Supreme Court overturned in-part the Court of Appeals finding that both isolated DNA and complementary DNA (cDNA) are patent eligible.
Scientists can synthetically create strands of nucleotides known as complementary DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns. It is also known that mutations of BRCA1 and BRCA2 genes can dramatically increase the risk of breast and ovarian cancer. If valid, Myriad’s patents would give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA.
The Court of Appeals for the Federal Circuit (CAFC) initially reversed, but on remand in light of the Supreme Court’s Mayo Collaborative Services v Prometheus Laboratories decision on patentability, the CAFC found both isolated DNA and cDNA patent eligible.
The Supreme Court reversed this finding in respect of isolated DNA, holding that isolated DNA is still a product of nature and not patent eligible merely because it has been isolated. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the patentability inquiry.
Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, the claims focus on the genetic information encoded in the BRCA1 and BRCA2 genes.
However, the Supreme Court held that cDNA is patent eligible because it is not naturally occurring - it is not a product of nature. Something new is created when the introns are removed, leaving only exons – even if the order of the exons is dictated by nature. The Supreme Court also clarified that this case does not involve a consideration of the patentability of method claims, new applications of knowledge about the BRCA1 and BRCA2 genes, or DNA in which the order of the naturally occurring nucleotides has been altered.
The USPTO has subsequently issued a provisional memorandum to patent examiners asking them to reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter.
Fair Go for Fair Use Copyright Amendment Proposed
The Copyright Legislation Amendment (Fair Go for Fair Use) Bill 2013 was recently introduced to the Senate. The Bill has several aims, including:
• Removing geo-codes that are used to enforce different prices and conditions on consumers, thereby allowing Australians to purchase legitimate content from overseas.
• Removing digital locks or technical protection measures that restrict accessibility for the visually impaired and disabled.
• Providing legal protection from being sued to universities, libraries, schools, cultural institutions and content service providers and ISPs for infringing activities carried out by those using their facilities.
• Creates a flexible open-ended fair use exception for purposes such as criticism, comment, news reporting, teaching, scholarship or research. It also clarifies that fair use can occur even when the copied material has not been published.
The Bill is asserted as an attempt to restore Australians enjoyment of Article 19 of the Universal Declaration of Human Rights relating to the right to freedom of opinion and expression without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.