Intellectual property law is a complex, often bewildering tangle that I make no claim to be deeply conversant with. However, it has always struck me as odd to consider the notion that ideas can be owned. While I understand the purpose of allowing innovators to profit from their work, I also see knowledge, particularly knowledge about the physical world to which we all have access, as something impossible, or at least inappropriate, to try and restrict in the pursuit of market advantage. In any case, whatever one thinks about the underlying philosophical and moral issues, the processes of claiming and enforcing ownership of an idea often make interesting narratives.
A recent example is a lawsuit filed by veterinary Hemopet, a blood blank and diagnostic testing company founded by Dr. Jean Dodds, and the pet diet manufacturer Nestle-Purina. Dr. Dodds is herself a complex character. She has done great and important work in promoting transfusion medicine and is well-regarded as an advocate and researcher, though without a traditional academic background or affiliation. She is undoubtedly a pioneer in veterinary medicine.
However, like many pioneers she holds a number of views which are not compatible with a conventional medical or scientific understanding, and her accomplishments do not automatically make these views legitimate. She goes beyond the available evidence in claiming that vaccines are an established and important cause of disease (so-called vaccinosis). Her theories about thyroid disease are not generally accepted by endocrinologists, though they are widely promoted by practitioners of alternative veterinary medicine. In fact, Dr. Dodds’ ideas are quite popular with this community, and in addition to being on the board of the American Holistic Veterinary Medical Foundation, she has been awarded the honor of Holistic Veterinarian of the Year.
This current lawsuit stems from a couple of other projects of Dr. Dodds which are not part of mainstream science-based medicine. She has developed a method which she claims can identify dietary sensitivities in animals through testing saliva (a claim most immunologists and dermatologists do not accept), and she has patented an idea for implementing a nutrigenomics program for identifying and modifying disease risk in animals.
Nutrigenomics is an interesting idea. The theory is that the expression and function of genes interacts with specific nutrients in a way that can be identified and manipulated through gene sequencing, dietary modification, and other diagnostic, preventative, and therapeutic practices. If that sounds vague, it is. The idea is far from being established even in general principle, much less in actual clinical practice, and there is little evidence to suggest any specific diagnostic or therapeutic approach that can be owned and marketed exists. The term nutrigenomics, and the small amount of laboratory research suggesting that it might one day be a real approach to health, have been used to market specific products well before this is justified by appropriate scientific evidence. And not only has Dr. Dodds joined in this practice, she is apparently willing to sue to assert her ownership of the general idea in animals.
The initial details of the lawsuit, and the patents Hemopet alleges have been infringed, are contained in this complaint:
There is a great deal of repetitive verbiage describing the patents held, but the general sense is that Hemopet has patented the idea of using a comprehensive computer database containing information about individual animals and groups of animals, as well as the results of both legitimate and questionable or misapplied laboratory tests, to identify health risks and appropriate nutrition for companion animals. The description seems to envision a database and consulting system made available, for a fee, via the Internet. Here are a few selections from the patents:
…it is necessary in animal health diagnosis and care that appropriate predictive testing for diseases and disorders of animals be achieved in order to reduce morbidity and mortality, and improve the quality of life and lifespan. Currently this is not done in relation to the health assessment data of an animal together with the genetic data related to that same animal. Current tests do not provide as much data as possible to attain correct diagnosis and disorder predictions with the net result of an improvement in the quality of life and increased longevity.
The disclosure is directed to a method, apparatus and system of obtaining, analyzing and reporting laboratory test data in relation to the health assessment data of an animal together with the genetic data related to that same animal.
The disclosure also provides a bioinformatics system for inputting, controlling, analyzing and outputting of a broad range of criteria related to the health, genetic background and longevity of animals. This includes a system concerning phenotype data and genetic data relating to animals. Further, there is provided a system for screening of genetic data and genomic mapping, and integrating the phenotype health assessment data and genetic identifier and assessment data in a computerized data processing resource (“CDPR”).
The present disclosure offers a unique solution to above-described problems by providing an apparatus, method and system, in relation to animals, for performing data analyses of biological specimens from specific subject animals or animal groups in relation to specific subject animal or animal groups of genetic data. The apparatus, method and system comprises a controller for obtaining, inputting, and analyzing biological, physiological, and pathological test data together with genomic mapping and genetic screening data into the CDPR.
The biological, physiological, and pathological data of the subject animal or animal group and the genetic data of the subject animal or animal group are communicated to a remote user as raw data or as related, analyzed biological, physiological, and pathological data and genetic data. The remote user can also appropriately access the CDPR to input data to, or obtain data from, the CDPR.
The disclosure also includes the step of reporting the determination of the health care, well-being, nutrition or other therapeutic requirements and suggestions or health on a communications network including the Internet. Preferably, there is a payment procedure for the report which is achieved through the Internet.
A further aspect of the disclosure is the accessibility of the health assessment database and/or genetic database or other databases of the CDPR by the remote user selected on the basis of password, security control, and financial payment such that the data can be transmitted into and from the CDPR by a computer network. Use of selected passwords, encryption systems, and payment systems are employed to facilitate and restrict the flow of data in and/or out of the databases.
A diagnosis of the health of an animal is obtained through a combination of computerized data analysis, and human interpretation. Data relates to the physical characteristics of the animal, and includes data obtained from a physical inspection of the animal. A blood or other fluid sample is used to obtain a computer generated laboratory analysis. This is reported through an internet network to specialist for analysis by a specialist clinical pathologist. The clinical pathologist has the data relating to the physical characteristics, and thereby makes a diagnosis of the animal’s overall health status.
So what appears to have been patented here is the idea of collecting a wide range of pieces of information about an animal in a computer, passing it around to people, and using it to “reduce morbidity and mortality, and improve the quality of life and lifespan” in companion animals. It’s hard to see how this could be a patentable idea, or even truly original apart from the unsubstantiated general claims about the links between gene sequences and health, but again I’m not expert in patent law. And despite a list of scientific papers included with the patent application (but not used as specific citations to support particular claims), it’s not clear that there is an actual preventative or therapeutic healthcare intervention here.
So how has Nestle-Purina allegedly violated the ownership of this very general idea? That’s not entirely clear from the complaint either. The allegation is that,
Purina has infringed and continues to infringe the ’343 patent by its manufacture, use, sale, importation, and/or offer for sale of its products and services developed using molecular nutrition or ‘-omics platforms,’ including Purina’s Veterinary Diet JM and OM products.
Again, it appears that the basis of the complaint is that Hemopet owns the idea of nutrigenomics and that Nestle-Purina has stolen this idea by utilizing this method which, from a scientific point of view, doesn’t really exist yet. Nestle-Purina does claim on its website to use nutrigenomics in developing its diets:
Nestlé Purina scientists use molecular and functional genetics to help them understand the “why” behind dog health. Our goal is to impact the processes through nutrition.
Nestlé Purina scientists use molecular nutrition to identify gene-expression changes related to specific health conditions and examine how nutrition can help manage canine health. Whether scientists are studying the nutritional management of obesity, joint conditions, or food allergies, molecular nutrition helps them to fully understand the biological context of certain changes and how they can be used in order to benefit dogs.
How exactly the company does this given the embryonic, even blastocystic, state of current knowledge about genes and nutrients, isn’t explained.
So we have a theoretical approach to health and nutrition which has not yet been validated scientifically. Hemopet claims to own it. And Nestle-Purina claims to use it in developing its pet foods. You might think Dr. Dodds would approve of this, given her apparent lack of confidence in the healthfulness and safety of current commercial foods and her belief that nutrigenomics is the right way to approach nutrition, but apparently not. In any case, it’s a bit baffling how these two organization can compete for ownership of an idea which doesn’t really exist in a tangible form yet.
I’ve written before about the fact that the legal system has very different priorities than the systems of science. Malpractice lawsuits involving alternative medicine, for example, rarely hinge on whether the practice being challenged is scientifically legitimate or can be shown to be safe or effective. The lawyers and judges involved seem more interested in the balance of state power and individual liberty than whether the therapy at issue is legitimate or pseudoscientific nonsense. And individuals often and easily get away with egregiously ridiculous medical practices entirely incompatible with science despite laws that sound like they should protect the public from such people. And securing a patent has more to do with proving an idea is original that proving it is true or actually works, as evinced by the weird and clearly implausible things that can be patented.
So I suppose it shouldn’t be a surprise that Hemopet can claim to essentially own the concept of nutrigenomics and choose to sue Nestle-Purina for claiming to use it. It does seem, however, like putting the cart before the horse, since who gets to profit from a new approach to health and nutrition should at least have something to do with whether the approach actually works and who has done the work to demonstrate this. But maybe that’s why I’m a scientist and not a lawyer.
A reader was kind enough to point out that Hemopet is also suing Hill’s Pet Food for apparently the same violation of its ownership of the idea of nutrigenomics. Here’s the complaint:
Hill’s does also claim to use nutrigenomics, though again it isn’t clear what exactly that means.