Category: Life Sciences

1
Federal Circuit Further Clarifies Venue in Hatch-Waxman Cases
2
More than financial – blockchain’s potential in the healthcare and life sciences industries
3
Producers of generic medicines and biosimilars even more supported by EU
4
IP Exemptions to Competition Laws to be Removed: Restrictions in Licences to be Subject to Competition and Consumer Act 2010
5
Round 1 of Australia’s CRISPR patent dispute concludes
6
Federal Circuit holds that reissue application of hemodialysis shunt patent impermissibly recaptured surrendered subject matter
7
Getting closer to put the UPC into force
8
Methods of genetic testing still patentable (Meat & Livestock Australia v Cargill decision)
9
Protecting Plant Innovations in the U.S., Australia and New Zealand
10
Federal Circuit Instructs the PTAB on Written Description in University Interference Proceeding

Federal Circuit Further Clarifies Venue in Hatch-Waxman Cases

Last year, in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., the Federal Circuit confirmed that 28 U.S.C. § 1400(b) is the sole venue provision for domestic defendants in Hatch-Waxman actions.1 On Friday 5 November 2021, the Federal Circuit provided even greater clarity on venue rules in such cases, concluding that, for venue purposes, only submission of the ANDA qualifies as an act of infringement, not any action related to the submission.2

Read More

More than financial – blockchain’s potential in the healthcare and life sciences industries

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

Producers of generic medicines and biosimilars even more supported by EU

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

IP Exemptions to Competition Laws to be Removed: Restrictions in Licences to be Subject to Competition and Consumer Act 2010

The Australian Federal Parliament has been debating the Treasury Laws Amendment (2018 Measures No. 5) Bill 2018 (Bill), which seeks to repeal section 51(3) of the Competition and Consumer Act 2010 (CCA).
The Bill is expected to pass during this session of Parliament (by 6 December 2018). Section 51(3) of the CCA presently provides an exemption from most of the competition law prohibitions for certain types of transactions involving intellectual property (IP). The current exemption covers conditions in licences or assignments of IP rights in patents, registered designs, copyright, trade marks and circuit layouts.

Once passed, commercial transactions involving IP rights will be subject to the same competition laws as all other transactions involving other types of property and assets. The repeal will apply retrospectively but IP owners will have six months to review existing licences and agreements. It is important for brand owners to consider their key licensing arrangements and the possible competitive implications of those arrangements.

Read More

Federal Circuit holds that reissue application of hemodialysis shunt patent impermissibly recaptured surrendered subject matter

The Federal Circuit, in a nonprecedential decision, held that claims of a reissue application were properly rejected because they recaptured subject matter surrendered during the original prosecution of U.S. Patent No. 8,282,591 (“the ’591 patent”).[1]

The ’591 patent is directed to an arteriovenous shunt that connects a graft to an artery and passes returned blood through a “single lumen venous outflow catheter” into the right atrium of a patient’s heart.  This system reduces the risk of infection, clotting, and hyperplasia compared to systems that remove and return blood through a graft connected to a vein.[2]

Read More

Getting closer to put the UPC into force

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.

Read More

Methods of genetic testing still patentable (Meat & Livestock Australia v Cargill decision)

On Friday 9 February, the Federal Court handed down its highly anticipated decision in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51. The matter has attracted substantial media attention in Australia and generated debate about whether patents claiming methods which use genetic information should be allowed.

The principal claims of the application in suit involve method claims for identifying a trait of a bovine subject from a nucleic acid sample. In particular, the invention made use of single nucleotide polymorphisms (SNPs).

Read More

Protecting Plant Innovations in the U.S., Australia and New Zealand

The development of new plant varieties can be a costly and time-consuming process. To incentivise breeding endeavours, governments around the world have developed legal mechanisms which effectively provide breeders with a period of market exclusivity in which to commercialise their new variety. The mechanisms vary from country to country, and this article briefly reviews those available in the United States, Australia and New Zealand.

To read the full alert, click here.

By: Michael Christie and Margaux Nair

Federal Circuit Instructs the PTAB on Written Description in University Interference Proceeding

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.

By: Peter Giunta and Jenna Bruce

Copyright © 2022, K&L Gates LLP. All Rights Reserved.