Building a Robust Patent Portfolio to Navigate the Biotech Landscape
Biotechnology companies operate in a complex landscape where innovation intersects with legal frameworks. A robust patent strategy is indispensable for safeguarding intellectual property, securing market share, and attracting potential partners. This article delves into some key considerations for building an effective biotech patent portfolio.
A robust patent portfolio may safeguard a company's valuable IP assets from unauthorized use or exploitation by competitors. The exclusive rights granted by patents may, allow a company to capture market share and maintain a competitive advantage.
Patents are key business tools, which can be used by companies in different ways depending on the stage of their growth. For example, patents can be monetized through licensing agreements, enabling biotech companies to generate additional revenue streams by granting others the right to use their patented technology. A strong patent portfolio may enhance the credibility and attractiveness of biotech companies to potential investors or collaborators. For example, potential partners may scrutinize the strength of such patent rights ahead of any deal, so patent portfolios need to hold up to such due diligence.
Patents may also be used defensively, for example, to deter competitors from suing for patent infringement or to countersue in case of litigation. A robust patent portfolio can serve as a deterrent against potential legal threats and strengthen the company's negotiating position in legal disputes. Patents can be filed in multiple jurisdictions, allowing biotech companies to protect their inventions in key markets worldwide. A global patent portfolio provides territorial exclusivity and facilitates market expansion into new regions or countries.
In the context of drug development, a company may consider initial patent filing(s) directed to the structure and/or function of any new small molecule or biologic. Later patent filing(s) may then cover any further innovative developments such as improved manufacturing processes, new therapeutic indications, dosing regimen, combination therapies, and/or routes of administration. This may help prolong the life of patent protection covering on-label indications of the drug and reduce the impact of the so-called “patent cliff”, where there may potentially be a sharp decline in revenues upon patent expiry of one or more leading drug products.
By strategically managing their patent assets, biotech companies can strengthen their competitive position and maximize the value of their innovations in the marketplace.
1. Timing matters
The most appropriate time to file a biotech patent application may depend on the stage of development of the project and/or company, the competitive landscape and/or the availability of data. For example, it has become increasingly difficult in recent years, in at least Europe, to achieve grant of speculative patent claims in the field of biotechnology (e.g., relating to “armchair” inventions which are not supported by any experimental data). With respect to second-medical use claims in Europe (e.g., directed to a new medical use of a known drug), the proof of a claimed therapeutic effect may need to be provided in the application as filed if otherwise it would not be credible to the skilled person that the therapeutic effect is achieved. In this situation, any lack of experimental data may not be remedied by post-published evidence (see recent Decision of the EPO’s Enlarged Board of Appeal, G2/21). Ideally, a patent application relating to a second medical use may therefore contain as much data as possible supporting the technical effect of the invention.
Such a requirement for adequate data needs to be balanced against pragmatic considerations such as the need to otherwise publish or publicize the invention or to first secure patent rights to help attract investment to secure funds which may be needed to complete such experiments. In this regard, it is important for biotech companies to consider filing any patent application before any public disclosure of the invention. In territories such as Europe, public disclosure, such as presentations at conferences or publication in scientific journals, can jeopardize the novelty of the invention.
Once a novel invention is identified and its potential commercial value recognized, companies may consider filing a patent application. Early filing ensures that the company secures priority rights and may prevent competitors from obtaining patents for similar inventions, helping to establish a stronger market position. However, early filing needs to be balanced against having sufficient data to support the patent claims. Filing prematurely without adequate experimental data or proof of concept may result in weak patents that are vulnerable to challenges. Biotech companies therefore often face a dilemma between filing early to secure a priority date and waiting to gather sufficient data to support the patent claims. It's therefore essential to strike the right balance between filing early to prevent disclosure and waiting to accumulate robust data for stronger patent protection. Ultimately, this may need to be decided on a case-by-case basis.
For example, if the invention involves a new pharmaceutical or medical use, data demonstrating efficacy may enhance the patent application's credibility and likelihood of being granted. In some situations such as for second-medical use claims, preliminary data or proof-of-concept studies may suffice, where a potential functional relationship between the drug and another new disease has been identified through initial experiments but any extensive clinical testing not yet conducted. Ultimately, the goal may be to provide at least some credible evidence that the treatment works. For any later patent applications, such as dosing regimen or new routes of administration, clinical trial results may be valuable. In such situations, patent filings should be considered ahead of publication of trial results on clinical trial databases or in subsequent journal articles.
2. Assessing the relevance of prior art
Identifying a novel invention may involve a thorough search for prior art prior to drafting any patent claims. Prior art refers to any publicly available information relevant to the invention, including existing patents, scientific publications, and other technical literature. By searching for prior art before drafting of any patent application, any existing disclosures that may affect its patentability may be identified. This may help tailor the patent claims to differentiate the invention from existing technologies whilst still seeking to maximise the scope of potential protection. In addition, potential patent office objections may be anticipated and addressed proactively during the drafting process increasing the likelihood of patent grant and withstanding potential challenges.
Typically, a patent office search may also be requested following filing of any initial priority application. For example, UK search reports are thorough (whilst relatively cheap) any may also help uncover any additional prior art during the priority year. An advantage of such a search is that any unexpected further prior art may potentially be addressed by making substantive amendments to the patent specification. After the initial 12-month period, the potential for making any substantive amendments to the patent specification is substantially reduced.
3. Expanding horizons?
The Patent Cooperation Treaty (PCT) route may offer numerous benefits for biotech companies seeking to protect their inventions on a global scale. It provides a centralized filing process (via the World Intellectual Property Organization) reducing administrative burdens associated with filing separate applications in multiple jurisdictions. It also provides an extended deadline (typically 30 months from the priority date) to decide in which specific countries or regions to pursue patent protection. This extended timeframe allows companies to defer the significant costs associated with filing national or regional patent applications until they have a clearer understanding of the commercial viability of their invention and which countries they may wish to proceed. In addition, PCT applications undergo an international search accompanied by a written opinion on patentability which may help companies make informed decisions about pursuing patent protection in specific jurisdictions. This may also prove valuable during any due diligence by potential investors or collaborators.
4. Strategic crossroads
From the 30-month stage of the Patent Cooperation Treaty (PCT) process, biotech companies may decide in which specific countries or regions they wish to pursue patent protection by entering the national phase. In doing so, companies should consider the commercial implications of their patent strategy, including market potential, regulatory requirements, competitive landscape, and budget constraints. Aligning the patent strategy with the company's overall business objectives and commercialization plans is essential for maximizing the value of the company's patent portfolio.
During the national stage, biotech companies may need to develop strategies for responding to any objections raised by patent examiners on a country-by-country basis. This may involve amending patent claims, providing additional evidence or arguments, and negotiating with various patent offices to secure favourable patent protection.
Going forwards, companies may also wish to monitor the patent landscape and competitive activities in their field to stay informed about emerging technologies, potential infringements, and litigation risks. Monitoring competitors' patent filings and enforcement actions can inform strategic decisions and help protect the company's market position.
In conclusion, a well-crafted patent strategy is indispensable for navigating the intricate biotech landscape, safeguarding innovation, and driving commercial success. By strategically aligning patent filings, leveraging international frameworks, and vigilantly managing patent portfolios, biotech companies can thrive in an ever-evolving industry.
Contact Secerna today to discuss your IP strategy and ensure you are positioned for success in this competitive market.
