The following article was first published in issue 21 of BioScience Today.
As a result of the lockdown due to the global pandemic there is a greater need and renewed focus on using innovation to kick-start the economic recovery. The result is significant investment in R&D focussed on creating new products.
In the bio- or med- tech space there are many things to think about when creating a product, but overlooking your IP strategy could mean that not only could you not be making the most of the R&D investment, but you could also leave yourself wide open to expensive and time consuming legal issues. IP includes patents to protect the technology, trade marks to protect the brand, designs to protect the look of a product, and confidential information/trade secrets to protect know-how. In the biotech and pharma space IP protection which can provide a period of market exclusivity can be crucial to the future of the business due to the time and money required to develop, test and get to market.
While businesses without IP can thrive, having appropriate protection for key elements of a product can be crucial to success in some areas, particularly when it comes to gaining investment or funding in the early stages. Identifying what sort of business you want to build, and implementing an appropriate strategy, could be vital.
When creating an IP strategy there are some questions that should be asked:
1- What is your business plan?
IP rights are business assets and your IP strategy should support your business plan. What aspects of your business and products need protection? Do you intend to license any of your IP to generate a revenue, or for other reasons? Is the IP intended to secure an exclusive position for your product, and what happens if it cannot? Are there further products, improvements or brands to come?
2- What IP rights do you potentially already have?
If you have created a product or way of doing something, or developed a brand, you may already have more automatic IP rights than you know. Carrying out an IP audit can identify those rights you already have, such as trade secrets, copyright, unregistered designs and the like and ensure that they are appropriately captured. An audit can also identify inventions, brands or designs that can be protected if desired. Some form of regular audit should be included in an IP strategy to ensure that potentially valuable rights are not overlooked.
3- What do you want to be protected, and where?
Just because something can be protected, does not mean that it should be. The investment in securing IP can be substantial and, as most innovators have a limited budget, that investment needs to be justifiable financially and tactically. Considering the IP portfolio from the perspective of an external investor, what value is that right expected to bring to the business, and is that greater than the expected costs?
4- What are the potential IP risks?
Different IP protection strategies can bring with them different risks, and third parties may have rights that directly affect your ability to carry out your business plan. An IP strategy should consider third party activity and could include conducting focussed searches at appropriate times to try to identify problematic third party rights. Once identified, those rights can be analysed and a mitigation plan created to avoid them unduly restricting your activities. Regular, broader, IP searches can also provide valuable competitor intelligence by identifying areas in which competitors are active.
5- How will IP interactions with Third Parties proceed?
An IP strategy can include how you plan to defend yourself against third parties challenging your IP or using their rights against you and how you will challenge third parties. The strategy can also include how you will carry out, or prepare for, IP due diligence which might take place when monetising or otherwise exploiting IP assets.
Working with an IP attorney when developing your IP strategy can help to ensure that it is fit for purpose, supporting your business plan with the protection you require without unnecessary spend. While you may feel that developing your new product and commercialising it is critical, not protecting your IP could be the biggest mistake you make.