Key pointsThe importance of the sufficiency of disclosure or enablement and written description for life sciences patenting is highlighted by recent case law decisions (i.e., Juno v. Kite, Amgen v. Sanofi). The claims need to be supported across the whole breadth by the examples provided.
Patenting diagnostics in the United States of America have been greatly impacted by the Mayo v. Prometheus decision of the Supreme Court. Nevertheless, different strategies to protect diagnostics within the country have been developed.
There is more than one IP strategy that can lead to success (e.g., acceleration or delaying of prosecution, broader vs. narrower initial claims, etc.), and each company or technology transfer office should consider their strategy in view of their unique circumstances.
3.1 Vaccines
The patenting of vaccines has been well discussed recently as a result of the COVID-19 pandemic. The use of previously patented technologies in the face of this challenge has allowed vaccine development and production to be much faster than might otherwise have been expected, although the implementation of a patent waiver on the COVID-19 vaccines was also proposed. , , The Moderna v. Pfizer patent race and dispute was also very highly publicized as a result of the pandemic. A very thorough analysis of the patent landscape on COVID-19 was published by WIPO in 2022. WIPO also published a more general vaccine patent landscape report in 2012 and a vaccine innovation and access report in 2017.
3.1.1 Patentable elements: case study
Vaccines are compositions designed to stimulate and prepare the immune system against certain infections or diseases. As well as active ingredients (antigens), vaccines have many other components such as adjuvants that help to boost the immune response, preservatives, stabilizers and also trace components from the manufacturing process. Vaccines can be classified either from the pathogens they target (viruses, bacteria, etc.), their ability to replicate in the host (live vs. dead active ingredient) or by the vaccine technology (DNA or RNA, virus-like particles, synthetic peptides, polysaccharide conjugates, whole inactivated or live attenuated).
The wide range of possible vaccine technologies coupled with the different types of claims and patenting strategies have led to a colossal number of possible patent-eligible elements and protection avenues. Examples of potential protection avenues for vaccines are presented by Sterne and Longsworth, who discuss different patent claims and their associated viral target. In this report, we focus on synthetic peptide vaccines as they have smaller and simpler structures compared with other technologies. Malonis et al. and Hamley review the development of peptide vaccines for various diseases from the influenza virus to different types of cancer.
As a case study, we consider BiondVax Pharmaceutical’s patents on the polypeptide vaccine for the influenza virus. The patent families that BiondVax have filed can be seen in the Global Dossier (an online service providing access to all related patent family data and communication with patent offices). BiondVax filed its first patent application as a priority application on August 2, 2007, with the application being continued as an international (PCT) application on August 3, 2008 (it is possible to file a PCT after the 12-month period has expired under PCT Rule 26 bis3 ) and then nationalized in many jurisdictions (Australia, China, Japan, the Republic of Korea, the United States of America and Europe, etc.). Their original filed claim was broad: “1. A synthetic or recombinant influenza multi-epitope polypeptide comprising multiple copies of a plurality of influenza virus peptide epitopes arranged in a configuration selected from an alternating sequential polymeric structure (X1X2X3…Xm)n and a block copolymer structure (X1)n(X2)n(X3)n…(Xm)n.” Subsequent claims mentioned the ranges for m and n, and further defined the peptide epitopes and number of amino acid residues.
The international search report (ISR) and the international preliminary report on patentability (IPRP) cited only two documents relevant to the novelty and inventive step requirements, and considered claims 9–17, 21 and 22 as being patent-eligible. Their claims are supported by a materials and methods section, followed by 12 examples. Examples 1–3 present three different multimeric polypeptide structures, with the DNA sequences encoding the peptide epitopes and the corresponding amino acid sequences being presented as figures. Examples 4–9 and 11 present mouse in vivo studies relating to immune response, efficacy and toxicology, and example 10 is a prophetic example relating to Phase I/IIa clinical trials. The last example reports the synthesis of the peptides.
The patent was granted in most of the chosen jurisdictions (between July 2013 and November 2019 ) after various amendments to the original claims that better describe the structure of the peptides – both in terms of the sequential polymeric structure but also in terms of their amino acid sequences – consistent with the presented examples and description of their invention. The company has further strengthened its patent portfolio with a further patent family in peptide vaccines for the influenza virus.
3.2 Diagnostics
Patenting diagnostic methods require different approaches in different jurisdictions around the world, and patent applications are usually adapted to each jurisdiction by patent attorneys practicing in the jurisdiction at the national phase entry stage. Careful consideration is required when drafting the application, as certain regions are very stringent about how the claims can be amended during prosecution in view of the detailed description. Obtaining a diagnostic granted patent at the USPTO is more complex than at the JPO or EPO. The International Association for the Protection of Intellectual Property (AIPPI) has recently published a report on the patentability of diagnostics methods internationally. The AIPPI report explores the current law and practice as well as proposals for improvements and harmonization of current law, and is based on a survey run by the association.
3.2.1 Japan
The JPO provides a handbook and guidelines document for life sciences inventions. Methods of treatment of the human body by surgery or therapy, and diagnostic methods practiced on the human body, are outside the scope of industrially applicable inventions because they are regarded as medical activity and are considered unpatent-eligible. In Japan, compositions, devices or kits for use in diagnosis that are practiced on the human body are considered industrially applicable and are therefore patent-eligible subject matter. Examples of patent-eligible subject matter as presented in the JPO guidelines include: methods for collecting information from a human body (e.g., X-ray, computed tomography scan, etc.), methods of operation of a medical device, medical devices, and a combination of physical and biochemical means (e.g., “A cancer treatment system comprising: a micro capsule X which contains an anti-cancer agent and releases the agent when disintegrated by a convergence supersonic wave, and an apparatus having means to obtain image data showing the position of the tumor, means to focus the convergence supersonic wave on the position of the tumor based on the image data, and means to irradiate the convergence supersonic wave onto the micro capsule X”).
3.2.2 United States of America
The diagnostics patent field in the United States of America was shaken in 2012 when the Supreme Court (Mayo Collaborative Servs. v. Prometheus Labs., Inc. - 566 U.S. 66, 132 S. Ct. 1289) decided that the diagnostic method claim of Prometheus was not patent-eligible subject matter, as the claim was considered as being a law of nature (specifically, the correlation between the metabolites in the blood and the thioguanine drug dosage) and that the steps in the claim were “routine, well-understood and conventional activity previously engaged in by scientists in the field.” Many articles have been written about this decision, but it is important to understand the resulting considerations for patenting diagnostics in this country. For the purposes of this document, we are only highlighting how this decision impacts current patent drafting. Most of the diagnostics methods are based on discovering a biological correlation rather than a new test method. In view of the Mayo v. Prometheus decision, a biological correlation is a law of nature, and it is not patent-eligible. Unfortunately, too often new diagnostics are designed on the understanding of a biological relationship (i.e., the correlation between a marker and a drug or disease state or metabolite) rather than on new test methods, which means that the relationship without anything further is a natural law and not patent-eligible. A few ways of addressing a rejection under Section §101 of Title 35 of the United States Code (U.S.C,) which governs patent-eligible subject matter under the U.S Patent Act, are: avoid basing the construction of the claim on the biological correlation; avoid using a general determining type step; outline anything unexpected or out of the ordinary; and try to distance the biological relationship from a law of nature.
Other strategies for patenting diagnostics include measuring new biomarker(s) without a diagnostic step; new ways of measuring new biomarker(s) (e.g., an improved method measuring or isolating a new biomarker from bodily fluid); or methods of treatment linked to the diagnostic test (e.g., a method of treating a certain disease with a drug, where one of the steps is the measurement of the biomarker). An example of a diagnostic claim that was found patent-eligible by the US Supreme Court is “A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of: determining whether the patient is a CYP2D6 poor metabolizer by: obtaining or having obtained a biological sample from the patient; and performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day, wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day” from the Vanda v. West-Ward case in 2018.
Ten years from the Mayo v. Prometheus decision, a bill titled the “Patent eligibility restoration act of 2025” was introduced by senator Thom Tillis. It aims to clarify the patent-eligibility matters of the different biotechnology debates from the past decade, especially for the diagnostics field. At the time of writing, the bill is many months/years? from a final vote in US Congress. The bill was introduced at the same time as a Nature Biotechnology article calling for a reform of the US patent system, with a focus on improving patients’ lives by attracting more investment in the space incentivized by the protection offered by patents. It has also been reported that the Supreme Court decision in 2012 led to a drop of USD 9.3 billion in the total investment for diagnostic technologies in the 4 years that followed.
3.2.3 Europe
Diagnostic methods can be patented in Europe as long as the method is not practiced on a human or animal body, established by determining whether there is an interaction with the human or animal body. If the method requires the presence of the live body, even without direct physical contact, then the practiced criterion is still fulfilled.
For diagnostic methods practiced on the human or animal body, there is a guideline to determine whether a claim is excluded from patentability in Europe. To be excluded from patentability, the claim must include all of the following steps:
examination: data collection
comparison: collected data vs. standard values
finding significant deviation during the comparison
decision: attribution of the deviation to a particular clinical picture.
Considering the above, methods practiced on the body that are just obtaining information (data) from a living human or animal body (e.g., X-ray investigations, magnetic resonance imaging studies, etc.) are not excluded from patentability. Diagnostic methods that are using isolated samples are considered patent-eligible because they do not fall under the exception to patentability of Article 53(c).
For exemplification purposes, the following claim is an exception under Article 53(c) because it includes all the four steps described above and is performed on a living subject: “A method of diagnosing Alzheimer’s disease in a living subject, which comprises: establishing a baseline pupil diameter for the pupil of the subject; using automated apparatus to repetitively and episodically image the subject’s pupil and measure pupil diameter, which measurements are made after the administration to the eye of the subject of a neural transmitter mediator in an amount insufficient to cause a significant pupil constriction or dilation if the subject is not afflicted with Alzheimer’s disease and during a time when said neural transmitter would have an observable effect on pupil diameter in a subject afflicted with Alzheimer’s disease; and processing said measurements in said automated apparatus to provide a comparison of pupil diameter changes after said administration against said baseline or against Alzheimer’s characteristic pupil diameter rates of change.”
As a second example, the following claim is patent-eligible as the collected data are not compared with standard values, and it does not find a significant deviation to attribute a particular clinical picture: “A method of detecting regional variations in oxygen uptake from the lungs of an air-breathing animal subject, said method comprising administering into the lungs of said subject a diagnostically effective amount of a gaseous hyperpolarized magnetic resonance imaging agent, detecting the magnetic resonance signal from said agent in said lungs, and characterized in that by determining the temporal variation in relaxation rate for said signal for at least one region of interest within said lungs, a qualitative or quantitative value or image indicative of the oxygen concentration in said at least one region of interest is generated from said variation, and if desired the time dependency of such concentration.”
Strategies for drafting diagnostic patents in Europe include drafting a method that has a step of measuring a certain marker in an isolated sample, e.g. “A method of diagnosing non-alcoholic steatohepatitis (NASH) and/or the hepatic fibrosis status of a subject, wherein the method comprises: (I) measuring, in a sample obtained from a subject, levels of at least three biomarkers being a pro-inflammatory cytokine, a chemokine and a glycosaminoglycan contributing to cell-adhesion and tissue modeling; (II) combining the levels of said at least three biomarkers measured in step (I) in a mathematical model; and (III) determining whether the subject is afflicted with NASH and/or determining its hepatic fibrosis status, said at least three biomarkers comprising IL-8, CXCL10 and Hyaluronic acid (HA)”), a method of predicting the response to a certain drug by measuring a specific marker from a sample (e.g., “A method of predicting responsiveness of an individual suspected of having, or having been diagnosed as having, a cancer to a DNA-damage therapeutic agent, the method comprising: a. measuring expression levels of one or more biomarkers in a test sample obtained from the individual, wherein one or more of the biomarkers are selected from the group consisting of CXCL10, MX1, IDO1, IFI44L, CD2, GBP5, ITGAL and APOL3; b. deriving a test score that captures the expression levels; c. providing a threshold score comprising information correlating the test score and responsiveness; d. and comparing the test score to the threshold score; wherein responsiveness is predicted when the test score exceeds the threshold score due to the cancer being associated with a DNA damage response deficiency (DDRD)”), and an improved method of measuring or isolating a specific marker from a sample, or a kit or device for the specific diagnostic (e.g., “Use of a kit in a method for diagnosing NASH and/or the hepatic fibrosis status of a subject of any one of claims 1-10, said kit comprising: (i) reagents for measuring, in a sample obtained from a subject, levels of at least three biomarkers being a pro-inflammatory cytokine, a chemokine and a glycosaminoglycan contributing to cell-adhesion and tissue modeling, said at least three biomarkers comprising IL-8, CXCL10 and HA; and (ii) instructions for (a) combining the biomarker levels in a mathematical model; (b) obtaining a score from the mathematical model; and (c) making the diagnosis; or (d) comparing the biomarker levels to threshold levels of said biomarkers; and (e) making the diagnosis of NASH on the basis of the comparison made in step (d)”). ,
3.2.4 Patentable elements: case study
Interest in the diagnostics field intensified as a result of the increased requirement for diagnostic kits during the COVID-19 pandemic. Rapid advancements in proteomics technologies, including the development of liquid biopsies, companion and at-home diagnostics, are some of the key trends that have the potential to make a high impact on healthcare. The vast potential for new technologies and the differences in assessing diagnostics patents between the different jurisdictions means that there is no fixed method for obtaining protection. Nevertheless, solid experimental data demonstrating the invention is key, and patent attorneys will always find new techniques for protecting your diagnostic (whether it is a piece of equipment, device or laboratory technique), such as switching the perspective to the particular chemical agent or entities that are used.
As a case study we can use a patent family from Mobidiag, a Finish diagnostics company. Mobidiag has filed more than 10 patent families in the diagnostics field since 2003. Their patent family on the “Methods for determining the presence of diarrhoea causing pathogens” was filed as a priority application in both Finland and the United States of America on June 27, 2012, followed by a PCT application 12 months later on June 27, 2013. The application was nationalized and granted in Australia, Canada, China, Denmark, Germany, Japan, Poland, Spain and the United States of America. The originally filed claim was ”1. Method for determining the presence of diarrhoea causing pathogens in a biological sample comprising the steps of: i) contacting the sample or nucleic acid isolated therefrom with primer pairs in a multiplex PCR assay comprising two or more separate PCR reactions, wherein the primers of said primer pairs amplify each of the ETEC amplicons as defined by SEQ ID NOS:61-63 at least partly; ii) performing a polymerase chain reaction with reaction mixes obtained from step i) so that the target sequences of diarrhoea causing pathogens are specifically amplified, if said sequences are present in the sample; and iii) detecting the presence of amplified target sequences in the reaction mix, wherein the presence of any of the target sequences is indicative of the presence of diarrhoea causing pathogens in the sample.”
The ISR and the IPRP cited two documents relevant for the novelty and inventive step requirements for claims 20 and 23–27, and a further two documents for claims 22–26. For claims 1–19, 21, 28 and 29, the documents cited were only to demonstrate the general state of the prior art , as these claims were considered patent-eligible. The IPRP also raised the issue of the application having 12 separate inventions as, in the examiner’s view, it lacked a single general inventive concept. The supporting experimental data for this patent family were not presented as different examples, but as an example in the style of a scientific paper with sections for materials and methods, results and discussion, presenting a clinical study of the invented method on human stool samples.
The first claims granted in Europe only had the small modification: “…SEQ ID NOS:61-63, wherein at least 20 nucleotides long sequence of each of the target amplicons are amplified; ii) performing a polymerase…”. In contrast, the first claims granted in Japan and in the United States of America were significantly modified from the original claim with specificity around each nucleic acid sequence from the claim. This is in accordance with the high divergency between jurisdictions when patenting diagnostics.
The innovation and strong IP position of Mobidiag were key factors in its acquisition in 2021 by Hologic for more than USD 700 million.
3.3 Therapeutics
The area of therapeutics is immense, and a lengthy report could be written on this topic alone. For this report, we focus solely on the major types of therapeutics (CGT, mAb and small-molecule therapeutics ) that cover most of the current global therapeutics market.
3.3.1 Biologics
CGTs
The CGT field can be split into many subfields; however, the most significant activity within this field is focused on chimeric antigen receptor (CAR) cell therapies, which form the major category of approved advanced therapeutics. As evidenced in the survey responses we received from patent attorneys and technology transfer professionals (cell and gene therapies are one of the key innovation trends in life sciences. Several patent landscapes have been published on CAR-T cell therapies: the EPO published an extensive report in 2019, and two reports on the evolution of patenting activity and a global systematic analysis were published in Nature Biotechnology in 2019 and 2020, respectively.
CAR cell therapies are personalized treatments for cancers; autologous treatments involve the harvesting of a sample of lymphocytes from a patient (T cells, natural killer [NK] cells, etc.) and reprogramming them to express the CARs on the surface of each cell. These cells are inserted back into the patient’s body and will attack the cancer cells. Compared with small-molecule drugs, which are just an active compound, it is more difficult to patent CAR cell therapies as they are specific to each patient. This is one justification for the push to develop allogeneic therapies (i.e., that do not have to be donor matched).
Most jurisdictions have limitations regarding the patentability of methods of medical treatment; are CAR cell therapies therefore patent-eligible? The answer depends on the way the therapies are characterized. If they are characterized as a method of treatment, then indeed it will be very hard to obtain protection.
The strategies for protecting CAR cell therapies focus on protecting the components of the CAR cell, the CAR cells themselves and the methods of producing the CAR cells. Composition of matter claims (the CAR cells themselves) are usually the preferred method of protection, because these would protect the cells irrespective of how they are made. The downside of composition of matter CAR cells claims is that it is much harder to prove infringement compared with small-molecule claims because of the patient dependency. Methods of manufacturing the CAR cells is another option of protection, but competitors only infringe if they use an identical method in the production of the CAR cell therapy.
At the JPO, CAR cell therapies are protected by product or composition of matter claims and methods of production. The JPO guidelines for life sciences emphasize the importance of clarity in the claims and the enablement requirement for inventions related to genetic engineering.
In the United States of America, in view of Juno Therapeutics v. Kite Pharma Inc. No. 20-1758 (Fed. Cir.2021), the most important element when patenting cell therapies is having a good written description and exemplification for the desired broadness of the claim. This is challenging as there are numerous possible variations, but the written description and provision of examples to fulfil the enablement requirement require careful consideration.
At the EPO, similarly to the JPO, methods of treatment of the human body are excluded from patentability under Article 53(c). Claims are therefore focused on the CAR cells themselves, the nucleic acids encoding the CAR construct, their components or their methods of manufacture.
mAbs
Therapeutic mAbs account for five of the top 10 drugs in terms of projected sales for 2025. The mAb field is relatively well established, meaning that obtaining patent protection for a broad claim has become increasingly difficult as there are already many prior art documents.
In the United States of America, the decision of the Federal Circuit in Amgen v. Sanofi No. 20-1074 (Fed. Cir. 2021) that invalidated Amgen’s patent demonstrated the importance of the enablement requirement for biologics (similarly to the cell therapy field). This decision also made it more difficult to use epitope claims for antibody protection in the future. The argument of the Federal Circuit was that the skilled person would have to screen millions of antibody candidates to determine which antibodies fell under the functional definition of the claim. On November 4, 2022 the Supreme court granted certiorari (an order by which a higher court reviews a case tried in a lower court) to Amgen’s petition, and its decision should make it clearer to patentees what is expected of them for the support required. On May 18, 2023, the Supreme Court unanimously affirmed that Amgen failed to provide enough detail to recreate the full scope of its claimed invention. A contrasting example of issues currently discussed in relation to the United States of America patent system concerns observations that large patent portfolios held by certain pharmaceutical companies may contribute to delays in the market entry of biosimilars (generics of biologic drugs) compared with other jurisdictions.
The same Amgen v. Sanofi dispute in Japan had a different initial outcome in 2019, with the IP High Court of Japan ruling in favor of Amgen and maintaining that the patent satisfies the enablement and support requirements. Nevertheless, the same IP High Court of Japan decided in favor of Regeneron (Sanofi’s co-development partner) in January 2023.
The EPO have published guidelines on the approaches used to assess antibody-specific patentability. Similarly to cell therapies patenting, for most antibody patents the claims should be quite focused and narrow. Broader claims could potentially be achieved when a new target for an antibody is identified, or when a target has been associated with a novel medical use. These guidelines discuss the different methods of defining the antibody (structure, nucleic acid sequence encoding the antibody, target antigen, production process, epitope, etc.). New antibodies that can bind to an established antigen need to be defined by their amino acid sequence. The EPO requires an antibody to be defined by the six CDRs of the variable domains of the light and heavy chains. As opposed to small-molecule therapeutics, the unique structure of an antibody to a known target is not considered an inventive step by the EPO. The EPO requires a new antibody to a known target to show “an unexpected effect” compared with already known antibodies to the same target. The EPO will often take the view that the generation of a new antibody against a known target falls under the category of routine experimentation, unless an unexpected property of the new antibody can be demonstrated in view of the closest prior art. The guidelines for examination need to be combined with the EPO Board of Appeal decisions when deciding the specific patent filing strategy.
3.3.2 Small molecules
Patenting small molecules is more straightforward than biologics, as the chemical structures can be described more precisely and are easier to produce. A detailed comparison of small molecules and biologics, and their influence on the cost and patient access, is presented in an article by Makurvet.
As for biologics, the balance between the broadness of the claims and the support provided in the written description is very important, especially for Markush-type claims that allow for a huge number of combinations (example of a Markush claim is presented in Section 2.3.1).
Pharmaceutical companies form patent thickets (overlapping clusters of patents) around their key APIs by first protecting the key class of molecules with Markush claims and then extending the protection by patenting crystal and salt forms of the API, co-crystals, formulations with the API, delivery systems, methods of manufacturing and use of their API. This strategy allows companies to obstruct competitors from designing around their patents, and to extend the duration of protection and delay entry to the market for generics. Another strategy employed by companies is to repurpose their inventions (APIs) for new therapeutics uses, especially cancer-related new uses.
3.3.3 Patentable elements: case study
As described in the Introduction, the field of therapeutics is immense; the immunotherapy field in particular is generating wonderful innovations that are already treating diseases previously thought of as incurable. As a case study, we describe a patent family from Noile-Immune Biotech, a Japanese company focused on cancer immunotherapy. One of their first patent families called “Proliferation-inducing and migration-enhancing (PRIME)” is focused on CAR-T cell technology, and improves local trafficking of CAR-T cells and other immune cells into solid tumors. Noile-Immune filed their priority application on October 9, 2014, and then continued with a PCT application on October 6, 2015. At the 30–31-month (March–April 2017) stage the application was nationalized in a wide range of jurisdictions, not only within the usual Japan, the United States of America and Europe, but also Israel, the Russian Federation, Asia and Latin America. Since nationalization, the patent was granted in all jurisdictions except for Thailand. The main claim filed at the PCT stage is: “A CAR expression vector comprising a nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding a T cell immune function-enhancing factor, wherein the nucleic acid encoding an immune function-enhancing factor is a nucleic acid encoding interleukin-7 and a nucleic acid encoding CCL19, a nucleic acid encoding a dominant negative mutant of SHP-1, or a nucleic acid encoding a dominant negative mutant of SHP-2.”
The ISR cited 10 documents relevant for inventive step; however, the IPRP mentioned that it considered claims 1 and 3–9 patent-eligible because none of the cited documents describe an expression vector that encodes the T-cell immune function promoters IL-7 and CCL19, especially one that exhibits a therapeutic effect against tumors. The Japanese patent was granted very soon (June 23, 2017) after the national phase with the first claim as filed. This granted Japanese patent was used as part of a strategy to accelerate the prosecution of the patent in other countries through the PPH (see Section 2.1.2), filed in both the United States of America and in Europe. The claims in Europe were accepted as filed under the PPH, but in the United States of America a few written arguments and an interview with the examiner were required for an allowance of the claims with a minor modification to the first claim: “1. A CAR expression vector comprising a nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding a T cell immune function-enhancing factor, wherein the nucleic acid encoding the T cell immune function-enhancing factor consists of a nucleic acid encoding interleukin-7 and a nucleic acid encoding CCL19.”
The supporting data for the patent was presented in 13 examples that included data for the preparation of the T cells expressing the IL-7 and CCL19, different in vitro experiments (CAR expression assay through flow cytometry, measurement of the secreted IL-7 and CCL19, cell numbers and survival rate of the CAR expressing T cells, T cell migration experiments, the proliferative potential of T cells, etc.) and different in vivo experiments (the therapeutic effect in mouse tumor models, in vivo survival of CAR expressing T cells, the effect of infiltrating into the tumor tissue, etc.). All the experiments described the different aspects of the invention, supporting the full scope of their claim.
Another observation about Noile-Immune’s patenting strategy is that, for the patent family described above, they still have live patent applications in Japan and the United States of America even though they already have granted patents in these jurisdictions. Maintaining live patent applications in the jurisdictions of your biggest markets is a risk mitigation strategy, as it potentially allows a company to obtain some protection in the case that one of the granted patents becomes invalidated for some reason.
