While securing effective intellectual property (IP) rights for any business can have challenges, inconsistencies around the globe in what is considered ‘patentable subject matter’ in the biotech sector marks it out as a particularly complicated industry from an IP perspective.
This is compounded by the significance of getting IP protection right for biotech businesses. The core value of any biotech company, aside from its key people, is often in an innovative piece of science and the intellectual property – usually patents – protecting it. It is likely that, at the early stages, much of a small biotech business’s value will come from its patent portfolio – meaning filing the right and most robust patent applications is vital to the long-term success of the company and, in the shorter term, having assets to showcase to potential investors.
However, patent law has evolved in such a way that certain types of subject matter are not considered ‘inventions’, or are specifically excluded from being awarded patent protection. The field of biotechnology, in particular, has a number of such obstacles littering the way for a biotech company which vary from jurisdiction to jurisdiction, meaning that something which may be patentable in the US may be more difficult to get patented in Europe and vice versa. Clearly if useful patent protection is to be obtained in a biotech company’s target markets, the patenting strategy must include ways to manoeuvre around those obstacles. Even when looking at already granted patents, for example when considering acquiring a new opportunity and associated patent portfolio, there can be cause for concern about the patentability (also called patent eligibility) of the subject matter involved if leading case law on that subject has changed over time.
One example of these obstacles is the question of whether you can get patent protection for new methods of treatment for diseases – this is important because a key goal of the biotech and healthcare sector is the development of new treatments for disease.
US and Australian patent practice allow claims directed to a method of treating a disease by administering a specific new drug to treat that disease. However, for public policy reasons, a number of jurisdictions do not allow patents for methods of treatment as it is believed that doctors should not be hindered by patents when looking after their patients. Such jurisdictions include the important markets of Europe, Japan, China, Korea and India. Fortunately, in most jurisdictions with such exclusions, it is possible to obtain patent protection for the new chemical compound, or for a new pharmaceutical composition containing that chemical compound. Also, other approaches are often allowed to secure the required patent protection. In Europe, for example, it is possible to obtain patent protection in the guise of a ‘purpose-limited product claim’ for the first medical use of a new compound and for subsequent uses of that compound in new and inventive treatments. The key is to have language for these different claim formats built into the patent specifications from the outset. This requires an understanding ahead of time of the issues that might be faced and ways to keep options open.
Another example of such obstacles is the question of whether you can get patent protection for methods of diagnosing disease and for personalised medicine. Again, this is important, as other key goals of the biotech and healthcare sector are early stage disease detection, the accurate differentiation between conditions with similar symptoms but different underlying causes, and personalising medicine to ensure a patient gets the correct treatment.
Following a US Supreme Court ruling in 2012, it became more difficult to obtain patent protection for diagnostic methods in the US. The Court presided over a patent case involving a method, which included giving a drug to a patient, measuring the metabolites of that drug and comparing it to known effective threshold amounts, prior to determining whether to increase or decrease the dosage of the drug for that patient (Mayo v Prometheus). The Court determined this method was not patent eligible subject matter because the relationship between the naturally produced metabolites and therapeutic efficacy and toxicity was considered to be a natural phenomenon; other steps of the method did not constitute a patentable invention. The situation then became more challenging in 2015 when the US Court of Appeals considered another diagnostic method based on the finding that cell-free foetal DNA could be detected in maternal plasma or serum (Ariosa v Sequenom). The method required amplifying a paternally inherited nucleic acid from the maternal plasma or serum sample and then detecting the paternally inherited nucleic acid of foetal origin. The court determined that the presence of the cell-free foetal DNA in maternal plasma or serum is a natural phenomenon and that the remaining steps of amplifying and detecting DNA were standard at the time of the invention.
The United States Patent and Trademark Office (USPTO) has issued guidelines intended to clarify what is patentable, offering examples of strategies that could be employed to get patent protection in this area. However, there have subsequently been several cases suggesting that the Patent Trial and Appeal Board, part of the USPTO, is not following those guidelines. Some commentators have even suggested these cases also bring some of the doubts towards methods of treatment. It appears that the situation is still evolving and that for the time being getting patent protection for diagnostic methods and certain personalised medicines in the US may be difficult or at least require additional considerations.
In Europe, diagnostic methods practiced on the human or animal body are explicitly excluded from patent protection. Nevertheless, there are ways to secure valuable patent protection associated with diagnosis and correlations between a biomarker and a disease. Methods that give interesting results, but don’t allow a final diagnosis on which action can be taken, are not excluded as diagnostic methods. Also, methods involving steps of a technical nature that are performed in vitro on biological samples previously taken from the body do not fall under this exclusion. Again, language for these claim formats should be built into the patent specification from the outset. If this is correctly done, since the case law in Europe is fairly settled on this subject matter, biotech businesses can currently have more certainty about likely patent grants on an invention relating to diagnosis in Europe than in the US.
Therefore, from the outset your patent strategy should incorporate approaches to deal with the various obstacles to patentability affecting biotech and healthcare innovation. Additionally, when reviewing granted patent rights, whether for possible acquisitions or investment, there may now be reasons for doubting the validity of those existing rights and so giving good reason to take extra steps to secure the IP position. Having robust IP protection is critical for a new healthcare product, as it is one of the key foundations on which a biotech company is built.