The Patent Lawyer Magazine – FILING LIFE SCIENCES PATENTS ; May/June 2022
Daniel Tjoernelund and Sharon Meyer of Azami Global evaluate the filing process for life sciences patents with advice for protecting inventions on a global scale.
Despite the uncertain environment that characterized much of the last few years as the world grappled with a global pandemic, patent applications continue to be on the rise with steady year-over-year growth.
These increases can be found across the spectrum and have been reflected in the life-sciences field as well. Life science patents are a critical part of the global patenting ecosystem and represent 27.8% of all the patents filed from 2014-2019.
In addition, during the same period of time, life science patents grew at an average of 5.1%. Life science patents encompass subject matter including drugs, biological research assay tools, medical devices, agricultural products, biofuels, food, cosmetics and more.
While the explosion of technology-driven life science innovation is exciting, it has simultaneously yielded challenges for owners and practitioners. For life science inventions,
global patent eligibility laws are among the most confusing and challenging to follow.
As an example, when trying to protect an invention globally, abstract ideas, laws of nature, and natural phenomena may be rendered ineligible in some countries but not others.
No “one size fits all” approach to SME
As a general rule, there is no “one size fits all” approach to subject matter eligibility (SME). It
varies between jurisdictions, with different laws for filing and enforcing patents in addition to determining eligibility. SME in the life sciences is particularly complex in that so many different aspects must be considered including, but not limited to, the product itself, the manufacturing process, the method of use for the product, whether the patent demonstrates a new use of the product, the treatment method, the diagnosis method, whether it is a naturally occurring substance, a modified form of existing compounds
or recombinant cells. All of these aspects and the laws relating to them are developing and
changing in jurisdictions across the globe making it increasingly difficult to keep up.
In India, for example, according to Durgesh Mukharya of K&S, “claims on new uses, medical
treatment, and naturally occurring substances are non-negotiable when it comes to subject
matter eligibility. For diagnostic methods, in vitro limitations have become handy, and some
examiners find those acceptable. For all other kinds of claims, technical advancement by way of comparative data against the closest prior arts/known substances is key to overcoming inventive step and subject matter eligibility objections.” In Australia, according to Dr. Toby Thompson of Griffith Hack, the “diagnostic methods that involve the practical application of natural phenomena are usually allowable. The situation may be different in some other countries, and so during the patent drafting process, it is important to build in flexibility, allowing tailoring of claims later on during prosecution locally and overseas to meet those different requirements.” In Canada, second use applications are particularly problematic and in China, exceptions to SME include patents for methods for the diagnosis or treatment of diseases, and animal or plant varieties. In Europe, the EPC excludes from patentability several exceptions in the field of medicine, including “methods for treatment of the human or animal body by surgery or therapy” and “diagnostic methods practiced on the human or animal body.”
The list goes on and on in each country, demonstrating these varying rules and making it
clear that a key question before drafting any application is where protection will be sought. Based on the answer, the approach can be adjusted accordingly.
SME Complexities in Life Sciences Technologies
Complexities are evident in many subcategories of life science technologies. For example, in the sub-category of diagnostics, methods that involve only data acquisition and do not lead to a particular clinical diagnosis can be eligible for patent, such as a method of determining
ear temperature or a method of using magnetic resonance imaging techniques on an artery. This is the case in the United States. In Europe, other diagnostic-related inventions
that are eligible for patent include methods in which steps of a “technical nature” that lead to a diagnosis are carried out without any interaction with the human body. For example, a method for diagnosing predisposition for breast cancer, by looking for a mutation in a specific gene in a tissue sample taken from a subject, was patenteligible because the steps were carried out in vitro and not directly on the subject.
Other complexities are evident in naturally occurring products existing in their natural form.
Most countries claim that such products would not qualify as patent-eligible subject matter.
However, some jurisdictions make allowances for patenting naturally occurring products if
they have been isolated from their natural environment. For example, in Japan and Korea,
if naturally occurring substances are artificially isolated from their environment, they can be
Tips for overcoming SME rejections
In the life sciences field, most SME rejections can be overcome by incorporating some key adjustments at the drafting stage. Aspiring patent owners and patent practitioners should ask themselves the following questions:
- What are the jurisdictions where I will seek protection?
- What local nuances or SME rules am I likely to face?
o Is the innovation a natural occurring substance?
o Is there a technical nature?
o Is the innovation a therapeutic, surgical, or diagnostic method?
o Is this a second use patent?
- What changes should I make to my application to address the likely challenges in some jurisdictions and ensure better coverage?
Need for a global network of experts
Over the last decade, innovation processes have become less focused on individual firms
and more dependent on interactions among global networks. Shifts in the legal and regulatory framework of patents have resulted in wider spheres of patentable subject matter. Companies bringing their healthcare and life science innovations to the far reaches of the world need trustworthy partners who can assist them in navigating the nuances and demands of the local patent process.
Azami Global is the world’s largest global IP services network, providing law firms and
corporations with tech-enabled, high-quality, streamlined services supported by an
international network of IP professionals.
“Since its inception, Azami Global has carefully vetted, recruited, and tested highly specialized life science patent attorneys. Over the years, we have invested in this niche market and formed a “dream team” that handles some of the most interesting, complex, and enriching subject matter and inventions. Through our network, this global team of distinguished life science experts work together seamlessly to enable their clients to expand and protect their international presence” – Lauren Pick, Co-CEO Azami Global.