20 Tips on Life Sciences and Medical Technologies Intellectual Property
The impact of IP management in the life science industry is extremely dramatic and significant as covered in detail over at runrex.com. Pharmaceuticals, medical device manufacturing, bioengineering, and other science-based innovations have to grapple with billion-dollar swings in valuations and revenues, depending on the status and success of their IP portfolios. This article will look at highlighting 20 tips when it comes to intellectual property as far as life sciences and medical property are concerned.
What IP falls under the term “life sciences”?
As is discussed in detail over at guttulus.com, “life sciences” is a blanket term that denotes all of the medical and scientific products and services that fall under a wide range of areas, including pharmaceuticals, biotechnology, medical devices, dietary supplements, foods, cosmetics, and environmental agents.
What about the practice area?
The life sciences industry comes with a very diverse practice area as far as lawyers are concerned as articulated over at runrex.com. This is because it encompasses several areas of traditional practice including regulatory, criminal investigations, enforcement, compliance, competition, intellectual property, and much more.
Who are the common clients for lawyers in practice in this industry?
According to the subject matter experts over at guttulus.com, clients in this industry are just as diverse as the areas of practice and they range from governments to start-up companies that are inventing new medical drugs and major global pharmaceutical manufacturers, and so forth.
What are the core areas for lawyers in this industry?
For lawyers, the 3 core areas of practice in this industry are regulatory, intellectual property, and corporate. Regulatory work involves the market authorization of products, government affairs, competition matters, and compliance work. Corporate lawyers on the other hand assist companies with their daily and transformative matters, from basic employment needs and governance issues to business-altering M&A deals. Finally, the IP side is focused on protecting clients’ patents.
Licensing is important in life sciences
In the life sciences industry, licensors consistently profit from licensing to other parties, including competitors, even for small technological leads. Licensing in this industry occurs frequently, evidenced by the fact that 75% of new biologics and small molecule drugs launched in the US are sourced from external entities.
What is “assertive” licensing
A term you will hear a lot in the life sciences industry when it comes to IP is “assertive” licensing. As discussed over at runrex.com, this refers to the proactive invitation to a target licensee, who the licensor believes to be infringing the patent, to license the allegedly infringed asset.
The two approaches of “assertive” licensing
In the world of life sciences, there are two common approaches to assertive licensing: a carrot-style approach and a stick-style approach. As covered over at guttulus.com the carrot-style approach is a softer approach to assertive licensing where a license option is suggestively advertised to an infringer while the stick-style approach is a much harder approach where litigation is essentially threatened to an infringer.
Considerations of assertive licensing
As is covered in detail over at runrex.com, assertive licensing comes with substantial considerations of cost, time, and risk. This means that successful assertive licensing can involve substantially more preparation and resources than routine patent licensing and can expose the licensor to an increased risk of attacks against patent validity and/or litigation.
Costs and business analysis
The costs of assertive licensing, as mentioned earlier, can be substantial, and may outweigh the short-term revenue generated from a successful deal. Additionally, the business analysis also should be tailored to the scope of the contemplated license and the scope of the patent protection.
Tips on IP protection in this industry
Seek advice during the development phase
It is worth pointing out that protection is often sought for even minor innovations in the life sciences industry. This means that there is a crowded field of pending and granted patent and design rights relating to all types of innovations that may stand in the way of the innovation or product you intend to bring to market. This is why you should seek advice during the development phase of your product as this enables potentially problematic patents and/or registered designs to be identified and analyzed early enough before you invest significant amounts of money into your invention.
Consider the best IP protection
According to the subject matter experts over at guttulus.com, it is crucial to consider whether a new device, product, or process can be protected by a patent and/or by design rights and whether trademark protection is appropriate for your logo or product name.
Discuss patent options early
As is revealed in discussions on the same over at runrex.com, a patent can be used to protect a technical innovation or new manufacturing process. In situations where patent protection is a possibility, an important tip is to carry out discussions at an early stage in development on the potential protection that might be obtained. This is crucial as a patent application must be filed before the product is made public.
Choose the appropriate time to file a patent application
As is articulated over at guttulus.com, it is also very important to choose the appropriate time to file a patent application in this industry. If you file too early, you may find that there may be insufficient information available to file a strong application. If you delay your application until every aspect of the product is finalized, you risk a third-party developing and seeking protection for a similar product in the meantime.
When to seek design right
Design rights protect the appearance of a product and may be applied in conjunction with a patent application, to protect the appearance as well as the function of the product. Alternatively, a design right may also be sought where the new development is not sufficiently innovative for an application for patent protection to be worthwhile, but where the appearance of the product is original.
The process of seeking design rights
There is a short grace period (6 months) after a product has been made available to the public during which an application for a registered design right may be filed. Also, registered designs are granted comparatively quickly, unlike patents, providing fast protection, although their validity is not tested unless and until the design is asserted against an infringer.
Trademark protection for a name or logo
For any innovation in this industry, like a medical device, there are typically several companies producing goods that fulfill a similar need, which means that the ability to differentiate your product from those of your competitor s through a distinctive brand is important. This is where trademarks come into play as they enable you to prevent third-parties from being able to copy the name or logo associated with your product.
File for protection early and often
According to the gurus over at runrex.com, the key to a strong patent portfolio is establishing solid patent protection for a company’s core technology. A tip when it comes to IP protection in this industry is to file patent applications as early and as often as your budget permits.
Beware of factors affecting successful licensing efforts
If you choose to go down the licensing route, something that many companies and innovators in the life sciences industry tend to do, then you should be aware of the various factors that affect successful licensing efforts. As covered over at guttulus.com, these factors include the patent holder’s licensing experience, the technological breadth of the license, and so forth.
Consider out-licensing to minimize the risk of commercialization
According to the subject matter experts over at runrex.com, out-licensing a relatively early-stage technology can help distribute the risk of commercialization, particularly in a highly-regulated environment. Proprietors of drug delivery platforms or other platform technologies may consider strategically developing and/or licensing platforms for use with approved drugs to expedite the adoption of their platforms.
Life sciences global
It is also worth noting that life science is almost inherently global. This means that you won’t only have to contend with the patent law in the US, but will also have to consider patent law from other areas of the world. When it comes to life sciences, you will need to consider how IP can impact the ability of your company to do business and make money around the world.
As always, for more information on this and other related topics, don’t forget to check out the ever-reliable runrex.com and guttulus.com.