We are now in a time of uncertainty due to the current COVID-19 pandemic and we do not know how long this period will last. While most people are now working from home and it is easy to fall into a routine of just watching TV all day, now is the perfect time for a company to take this relative “down time” to review, build, and expand upon its IP assets.
Certainly not an exhaustive list, but below are three ways a company can use this time strategically to plan for the next phases of its development.
First, mine your notebooks for new IP ideas. I credit one of my clients with this idea. Review all the data and research generated over the past year or two that you previously did not have time to review. You never know what interesting information you missed the first time around because you were simply looking at the main findings. These jewels of information could provide valuable support for upcoming patent applications or could provide ideas for new patent applications and inventions all together. Take this period to really review your data and information and find new ideas or new uses for that information.
Second, review your landscape studies and strategically map your ideas. Landscape studies can be an important source of information for companies. These studies not only provide a glimpse of the “state of the art” of a particular technology space, but they also show you what opportunities exist for further development. As with the previous point, you may not have had time to thoroughly review your landscape studies initially, or you may not have even conducted one, but now is the ideal time to review those studies and get ideas of what you can work on next. Moreover, reviewing your landscape studies can provide additional insights into the new ideas you found from mining your notebooks. Either the landscape studies will reveal players who are already working on those ideas, or it will reveal open space for you to explore. Either way, reviewing your landscape studies can provide new ideas for further development.
Finally, explore potential partnerships. Based on the new information you found from either mining your notebooks or reviewing your landscape studies, you may have ideas for exploring potential collaborations with others in the industry. Another benefit from landscape studies is that they reveal who the main players are in a space, including companies and inventors. You could use this time to reach out to players in the space and explore ideas for development. For instance, if your company specializes in antibody discovery, but lacks expertise in developing vaccines, you may explore collaborations with a company that has that vaccine expertise. With many companies pausing clinical trials and halting projects, now is a good time to reach out to those companies and explore new ideas.
While it is easy to get distracted by the turmoil around us, I encourage companies, including startups and aspiring entrepreneurs, to take this time to review and reflect upon all the information that they have generated and brainstorm ideas that can either be used to support their existing IP, or ones that can turn into new IP.
Force majeure clauses are typically overlooked in agreements as merely “boilerplate” language, however, subtle differences in the language can have significant effects on the parties. With the potential business disruptions caused by the current COVID-19 outbreak, many impacted service providers and vendors are rightfully concerned about their exposure. What their rights and obligations will be will depend on the “force majeure” clauses that can be found in the back of their agreements.
In general, a “force majeure” event is an act beyond a party’s reasonable control. “Force majeure” means “superior force” in Latin. A force majeure clause, therefore, is a contractual provision that excuses a party’s obligation to perform under an agreement if the circumstances giving rise to the failure are beyond the party’s control. Below are several examples of a force majeure clauses and how they may be construed in an emergency situation such as this.
In the event either Party is delayed from performing any act required under this Agreement due to (i) flood, fire, earthquake or explosion; (ii) war, invasion, hostilities, terrorist threats or acts, riot or other civil unrest; (iii) government order or law; (iv) actions, embargoes or blockades in effect on or after the date of this Agreement; or (v) shortage of adequate power or transportation facilities, then performance of such act shall be extended for the reasonable period of such delay, and either Party shall be granted a reasonable period of time to perform after the cessation of the reason for the delay.
Under this this first example, only an occurrence that is specifically stated in the clause would constitute a force majeure event. Thus, the event in question would have to be one of (i) through (v) to trigger this clause. Since a “pandemic” or “epidemic” is not specifically stated, a failure or delay caused by the COVID-19 pandemic probably would not be covered in this situation.
In the event either Party is delayed from performing any act required under this Agreement due to, (i) acts of God; (ii) flood, fire, earthquake or explosion; (iii) war, invasion, hostilities, terrorist threats or acts, riot or other civil unrest; (iv) government order or law; (v) actions, embargoes or blockades in effect on or after the date of this Agreement; (vi) national or regional emergency; or (vii) shortage of adequate power or transportation facilities, then performance of such act shall be extended for the reasonable period of such delay, and either Party shall be granted a reasonable period of time to perform after the cessation of the reason for the delay.
Clause 2 is better than Clause 1 because, while it does not specifically mention “pandemics” or “epidemics,” it does mention “acts of God” and “national or regional emergency.” These two categories could give you some leeway when it comes to a health emergency such as COVID-19. Of course, it would be better to specifically name “pandemics” or “epidemics” or even “health emergencies” to eliminate confusion but having some additional categories which could encompass a pandemic could be helpful.
But what if you don’t list every possible situation that could lead to a force majeure? Clause 3 can help with that.
In the event either Party is delayed from performing any act required under this Agreement due to (i) acts of God; (ii) flood, fire, earthquake or explosion; (iii) war, invasion, hostilities, terrorist threats or acts, riot or other civil unrest; (iv) government order or law; (v) actions, embargoes or blockades in effect on or after the date of this Agreement; (vi) national or regional emergency; (vii) shortage of adequate power or transportation facilities, except to the extent such failure was caused by the party invoking this Section, or (viii) due to any cause beyond the reasonable control of a Party (collectively, a “Force Majeure Event”), then performance of such act shall be extended for the reasonable period of such delay, and either Party shall be granted a reasonable period of time to perform after the cessation of the reason for the delay. Regardless for the excuse of the Force Majeure Event, if such Party is not able to perform within ninety (90) days after such event, the other Party may terminate the Agreement.
Clause 3 contains the catch-all provision which allows the force majeure clause to be triggered for any cause “beyond the reasonable control of a Party.” Under such a definition, there is no need to name every single possible cause as the catch-all would cover causes that are “beyond the reasonable control of a Party.” Since pandemics and epidemics are “beyond the reasonable control of a Party,” disruptions caused by COVID-19 would likely be covered.
Clause 3 further adds two additional points worth noting. First, this clause requires that the force majeure event cannot have been caused by the party invoking this Section. This makes sense because it would not be fair for the non-performing party to benefit from its negligence or poor planning that resulted in the force majeure event. While this is unlikely in the context of COVID-19, it is good practice to include such limitations in force majeure provisions.
Second, Clause 3 allows the other party to terminate the agreement after ninety (90) days. This provides the other party the option to walk away from this Agreement and not be tied to a vendor who cannot provide services or supplies for an extended period of time. While a force majeure clause provides some flexibility to the non-performing party, it should also not force the other party to be stuck in a situation where it is not receiving the benefits of its contract.
As seen from the above examples, force majeure clauses should not be treated as merely “boilerplate” provisions as small differences can have significant repercussions on the rights and obligations of each party. Force majeure provisions should therefore be reviewed carefully, with particular attention given to the potential causes that could trigger them.
We previously addressed both freedom-to-operate and patentability analyses and what the benefits of each are. In this post, we will examine landscape analyses and the five pieces of information that can be learned from conducting one. At BPLG, we love landscape studies because of the valuable information they provide. We can use this information to not only guide our IP strategy, but also to help expand our product pipeline.
Provides a look at the market today
At its heart, a landscape analysis is essentially a look at the market to understand the existing technology and trends in a given technological area. Such an analysis involves looking at the past, present, and future trends in technology and learning important details about a given technology. Based on this information, companies, entrepreneurs, researchers, and scientists gain an understanding of the “state of the art” which ultimately helps them plan a research strategy to build, expand, improve, or modify that art.
Early insight into what the patenting activity of competitors
A landscape analysis can further provide early insight into what competitors have in the development pipeline and what products competitors are innovating. Examining patent filing trends together with market research is useful in determining the commercial phase (e.g., infancy, mature, or declining) of the technology and understanding the general trend of certain technology areas. Understanding this information can help companies better plan the development of their own products and allow them to identify which products should be developed and which should be abandoned.
Identify gaps for innovation
Similar to a patentability study, a landscape analysis can also help uncover further opportunities for development and ultimately patenting. If a landscape study reveals patent filings for an antibody in the field of inflammation, but not in the field of cardiovascular disease, for instance, this gap could encourage the development of products in the field of cardiovascular disease. The landscape study may further reveal other modifications that could be made to the product (e.g., changes in formulation, dosage amount, etc.) that could be pursued. Overall, understanding the patent filing trends is important in guiding a company to areas that worth pursuing commercially and those that should be avoided.
Explore opportunities for collaboration
Furthermore, a landscape study can help identify potential partners for collaborations. Since a patentability study identifies patents and patent applications directed to similar content, the assignees of those patents and applications can be found on those documents. This will allow a company to reach out to the assignees to discuss possible collaborations or identify opportunities for in- or out-licensing.
Identifies inventors to hire or collaborate with
Similar to the previous point, a landscape study can identify inventors who are developing new and exciting technology. Knowing what patent applications are being filed can help companies explore potential opportunities to either hire those inventors or collaborate with them on future projects.
When done correctly, a landscape study provides valuable information about the current market and its trends. Based on this information, a company can evaluate opportunities for developing new products, abandoning existing products, and exploring possible collaborations within the same space.
Imagine you conducted an FTO analysis and it turned out your invention was found to infringe a third-party patent. What can you do? This post will discuss three possible solutions that will help you practice your invention after it was found to infringe a third-party patent.
The purpose of an FTO analysis is to determine whether a product infringes another issued patent. This analysis is done by identifying patents and patent applications that, if later issued as patents, may be infringed when commercializing your product. This analysis is done by examining the claims of the issued third party patents and asking whether your product or service contains each and every element of that third-party patent claim. We discussed FTOs in detail here.
The first option when encountering a blocking third-party patent is to design around that third-party patent. This requires identifying an alternative way to develop the desired product without infringing the patent.
An example of designing around may be seen with a drug-eluting stent. A drug-eluting stent is a peripheral or coronary stent or scaffold, placed into peripheral or coronary arteries to release the drugs slowly into a patient's body. Assume that a company has developed a new drug and wants to use a stent to deliver the drug into the patients’ bodies. By developing a new drug, the company will likely satisfy the requirements of patentability; however, the issue resides with the stent. If a third-party owns the stent patent, the company will have to find an alternative design to the stent if it wants to continue using it.
If the original stent patent is broad enough, however, the company may not be able to design around the stent in a way that accomplishes its goals. If designing around becomes unfeasible, the next option may be a solution.
In situations where no design alternative is acceptable or possible, such as with the stent example above, a company may have no other option but to enter into a license agreement with the owner of the third-party patent.
A license is a contractual agreement in which the patent owner promises not to sue the licensee for patent infringement as long as the licensee abides by the terms of the agreement, which usually involves the payment of certain fees. Such an agreement allows the owner of a patent to retain ownership of the patented products or services while permitting the company (e.g., the licensee) to make, use, offer for sale, or sell the patented product or service. Once a license agreement is in place, the company can market the new product without infringing the third-party patent.
Challenge the Third-Party Patent
If the company cannot design around a third-party patent and cannot, or does not want to license the third party patent, then another option is to challenge the third party patent. If the company successfully challenges a patent and invalidates it, it clears the path to commercialization by removing that third-party patent as a hurdle.
Even if the patent challenge does not result in the invalidation of the third-party patent, it could allow the company to enter into a settlement agreement with the third-party patent holder, thereby allowing the company to commercialize its product. While the company may have to pay a licensing fee as part of the settlement, it would allow the company to practice its invention without having to worry about being sued for infringement by the third-party patent holder.
Inter partes review (IPR) proceedings have become a popular method by which someone can challenge an issued patent based on prior art (either Section 102 or Section 103) grounds. IPRs allow for a relatively quick and cost-effective means by which third party patents can be challenged. Moreover, they have yielded favorable results for the challenger, in part due to the lower burden of proof that a petitioner must satisfy. We previously discussed IPRs here and here.
Third-party patents can also be challenged in a traditional district court litigation. While longer and generally more costly than an IPR, district court litigation allows patents to be challenged on grounds in addition to those involving prior art. Challenges directed to inappropriate subject matter or written description, among others, can thus be raised in district court but not in an IPR.
If your product or service is found to infringe a third-party patent, not all hope is lost. There are still several options for practicing your invention.
We previously addressed what a freedom to operate analysis is and what information it provides. In this post, we will examine patentability analyses and the five pieces of information that can be gained from conducting one.
Uncovering hurdles to patentability
The first piece of information gained from a patentability study is simply uncovering prior art that may present hurdles to obtaining a patent. This is, after all, the purpose of a patentability analysis.
A patentability study is done by identifying prior art, both patent and non-patent, which may interfere with an invention satisfying the standards of patentability, novelty (Section 102) and non-obviousness (Section 103). To this end, a patentability study will uncover any printed publications—such as journal articles, scientific papers, textbooks, abstracts, conference presentations, and any other papers—that have been published and that may impact patentability. A good patentability study should not be limited only to patents and publications published only in the U.S. but should be global in scope. Both prior art hurdles, Section 102, and Section 103 are based on publications worldwide and in any language.
In the Section 102 case of In re Hall, an invalidating piece of prior art reference, a doctoral dissertation, was found in the basement of a library in Germany. The reference was neither available online nor written in English, but it was indexed according to the author's name and title in the library’s indexing system. As such, the court decided the reference could have been accessible by anyone visiting the library to look through the indexing system as early as 1977.
While such references may be difficult to find, a good patentability study should uncover these and other potentially problematic references. Once uncovered, those references can help a company better formulate a strategy for differentiating a product to satisfy patentability requirements.
Draft better patent applications
Knowing what prior references you may be faced with during patent prosecution can also help you better draft patent applications with adequate support to later overcome any such prior art rejections. If you know what possible rejections the USPTO can come up with based on the prior art, you can begin crafting your responses and making sure support for those responses is in the patent application when it is filed.
Identify possible blocking IP
A patentability study can also help uncover potential blocking third-party IP, the type that would come up in an FTO. Not only will a patentability study show you which patents have already been issued, but it will show which applications and claims are still pending. Knowing which applications are pending is important because pending applications could quickly turn into potentially problematic blocking patents if they are not monitored and carefully examined. Having this information can help you proactively mitigate a potential problem with blocking IP.
Identify opportunities for expanding development pipeline
A patentability study can also help uncover further opportunities for development and patenting. When dealing with a lot of prior, the patentability analysis is important in helping guide a company to patentable areas or to help avoid pursuing a product with too much prior art.
For instance, if a drug were previously patented for cancer indications, you will not likely be able to patent the drug composition (without modification of the composition) nor will you be able to patent the use of the drug for cancer treatment. You may, however, be able to patent the drug for other indications, such as treating cardiovascular disease or neuroinflammation. You may also be able to patent a different dosage form of the drug. Instead of having an immediate-release formulation, you may be able to patent a sustained or extended-release formulation.
In general, a patentability study will reveal options for patenting products as well as existing hurdles.
Explore opportunities for collaboration
Finally, a patentability study can help you identify potential partners for collaborations. Since a patentability study identifies patents and patent applications directed to similar content, the inventors and assignees of those patents and applications can be found on the documents. This will allow a company to reach out to the assignees to discuss possible collaborations and even to try to hire personnel with certain know-how and skill sets.
When complete, a patentability study provides valuable information about what is already in the public domain with respect to your product. Based on this information, a company can evaluate opportunities for patenting a new product, developing a pipeline of products, or exploring possible collaborations with other parties within the same space.
One of the most common questions we answer at BioPharma Law Group is when we need to do freedom to operate, landscape, and/or patentability analyses. There is a lot of confusion surrounding these three different types of analyses, namely what information they each provide and when is this information most helpful. In the next several posts, I will attempt to discuss the purpose of each type of analysis, what information it provides, and when this information is useful. I will start with the freedom to operate, or FTO.
The purpose of an FTO analysis is to determine whether a product infringes another issued patent or may be encompassed by a pending patent application. This analysis is done by identifying patents and patent applications that, if later issued as patents, may be infringed when commercializing your product.
Determining infringement will require examining the elements of each third-party patent claim and determining whether your product or service contains each and every element of that third-party patent claim. If this is the case, your invention infringes that patent. For instance, if your new product contains elements A, B, and C, but a third-party patent contains elements A and B, then your invention will likely infringe the third-party patent because each element of the third party patent (e.g., elements A and B) are found within your invention.
It is important to understand that a product may both be patentable and still infringe a third-party patent. This is because the standard for patentability is different from the standard for infringement. When determining patentability, the question is whether your product or service satisfies the requirements of patentability, including patentable subject matter, utility, novelty, non-obviousness, and written description/enablement. Generally speaking, this determination turns on whether your invention is novel and non-obvious over a third-party patent alone or in combination with other prior art. In the above example, your invention with elements A, B, and C may infringe a third-party patent because it contains elements A and B, but it could still be patentable because element C is not found in the third-party patent. We will discuss patentability in more detail in a separate post.
For products with multiple components, such as chimeric antigen receptor or CAR T cell therapies, an FTO should be conducted on each component. In other words, a separate FTO should be conducted for the antigen binder, the signaling domain, the binder, the linker, each co-stimmulatory domain, and so forth.
An FTO should further be conducted in each country where you intend on launching, manufacturing, or shipping your product. This is because patents are geographic in nature and the types of claims that are allowed can vary from country to country. Moreover, some types of patent claims are not allowed in certain countries. For instance, method of treatment claims are not allowed in many countries outside of the U.S. These differences can result in different FTO analyses.
When compared to patentability and landscape analyzes, an FTO is generally conducted later on in the process, when a company already has a product that it wants to commercialize. This is because the features of the proposed product need to be known in order to analyze each feature against the claims of a third-party patent. If your invention is not yet complete, it could be difficult to determine whether its features (which are not yet finalized) infringe a third-party patent.
If a product or service is found not to infringe the third-party patents, then the product or service can generally be considered safe for commercialization, assuming all other regulatory or other requirements are met. Of course, it should be understood that there is always a chance that a product manufacturer/seller could be sued for infringement down the road especially with the constantly changing patent landscape. However, having an FTO analysis can help minimize or proactively identity these threats.
If, on the other hand, product or service is found to infringe a third-party patent, then not all hope is lost. In such situations, certain options including designing around, licensing, or challenging the third-party patent could be considered. We will examine these in an upcoming post.
In the long run, an FTO opinion is important in helping a company or inventor identify possible hurdles to commercializing its product or services and to proactively develop a strategy for entering the market.
As you probably noticed, I haven't been as active on this site in the last few months. The reason for that is that I've been working on a new book which is available starting today through Amazon. The book is called, Billion Dollar Patents, and it is about how to create strong patent portfolios in today's uncertain patent climate. While the book is mainly tailored towards tech executives and entrepreneurs, the information in the book can be beneficial to anyone looking to understand more about patents and intellectual property rights in general. There are even some illustrations thrown in there for good measure!
Here is a summary:
In the past decade, the patent system has undergone many changes as a result of the courts issue far reaching decisions, the USPTO narrowing the scope of patentable subject matter, and Congress making it easier to challenge and invalidate patents. As a result of these changes, many companies have lost their patents. Those that have successfully withstood the challenges of today’s uncertain climate have seen their patents and, in turn, their products thrive. In Billion Dollar Patents, Joanna tells you exactly how they are doing it. How some drugs are earning billions of dollars in revenue with their patents, extending their market exclusivities, and keeping competitors off the market.
Billion Dollar Patents explains the current patent environment and covers the ins and outs of what it takes to build a strong patent portfolio that will generate revenue and keep competitors at bay. Far beyond the typical "how to build a strategic patent portfolio" lesson, Billion Dollar Patents explains how to create and manage intellectual property assets that will withstand changes, extend market life, and generate value. It contains many real-life examples and case studies of patents that have withstood the test of post-grant challenges and have helped extend the life of drug products on the market.
Whether you are launching a startup or managing a global company, patent law does not have to be intimidating. The practical knowledge in Billion Dollar Patents will help technology entrepreneurs and executives make smart decisions when protecting their company and its assets.
The ebook is available for an introductory price of $2.99 this week. The paperback version will be available next week.
Another year of the 43North start-up competition in Buffalo, NY has begun, and we thought it would be worth looking at 10 things that technology companies should remember about their IP when pitching to investors.
At BioPharma Law Group, we help our clients prepare and finetune their presentations to investors, and we also act as judges in start-up competitions. Based on these experiences, we created a list of things that will make your pitch more successful. Below are 10 things related to IP to keep in mind when pitching your technology.
First, know your patents. Make sure you are familiar with your patent portfolio and know exactly what patent applications are filed and where they stand in prosecution. This includes knowing if you own the patents outright or if you are licensing them. If you are licensing the IP from somewhere else, whether it be a university or other company, be prepared to discuss whether your license is exclusive or not. If the technology involves core IP, and your license is not exclusive, you may have to explain why this is not a competitive disadvantage to your company.
Second, know the scope of your patents. Are your patents directed to platform technology or do they only give you rights for a specific indication? Be prepared to talk about your claims and how they carve out your company’s footprint in the market.
Third, make sure your patents cover the product that you are trying to pitch. This may seem obvious but I have seen many instances where the pitched technology was not covered by the patent claims. If the claims do not cover the product, be prepared to discuss why and what you can do to improve them. Strategies to address this include filing continuation applications or follow on applications to yield the desired claim scope.
Fourth, know the proper IP terminology. Do not say that you have a patent when in fact you only have a patent application on file. Patent terminology can be difficult for the lay person. I may sometimes not appreciate how complex patent terminology is since I deal with it on a daily basis, but I cannot emphasize enough the importance of adequately and properly discussing your IP. Investors know IP terminology and using improper terminology will not only confuse the investors, but it could also reduce the value of your technology in their eyes. Saying that you have an international patent in many countries can mean a variety of things, or it can mean nothing at all. Work with your company’s IP counsel to make sure you understand what you need to focus on.
Fifth, know your competitor IP. This can be discovered in a landscape analysis. Unless you discovered a groundbreaking technology, chances are you have competitors. Be prepared to discuss your competitors, their IP, and what you are doing to stay ahead of them. This may include licensing certain competitor IP or designing around it. Landscape analyses do not have to be complicated or expensive but they will provide you with valuable information.
Sixth, know whether any third-party patents block your product’s path to market. This is important information to have because the existence of a blocking third party patent can present significant hurdles to ultimately being able to enter the market. These patents can be uncovered in a freedom-to-operate study. Just like with landscape analyses, freedom-to-operate studies can be obtained cost-effectively and can uncover crucial information.
Seventh, do not neglect other intellectual property rights, such as design patents, trademarks, and trade secrets. If you named either your company or your product but have not protected that name as a registered trademark, you may find yourself having to later change names if someone else has already claimed those names. Likewise, do not overlook the importance of trade secrets. Depending on the particular technology, keeping certain technology secret can often be as valuable, or even more valuable, than patenting it.
Eighth, make sure all the legal paperwork is signed. In particular, make sure all assignments are properly executed and recorded with the USPTO. This includes making sure that all inventors sign their assignment documents and any transfers from one party to another are also properly documented. Also make sure that employment agreements and consulting agreements include language that assigns any newly developed IP to the company. While a review of the paperwork may not happen during a pitch, uncovering any holes during diligence could raise questions surrounding ownership.
Ninth, know your company IP strategy. Investors do not expect you to have dozens of patent applications already filed but they do expect you to be able to tell them how you plan on building on the patents, patent applications, trade secrets, and other IP rights you already have. Be ready to discuss the need to license or acquire certain IP, if any, to bring your product to market. Be prepared to discuss how and when you plan on accomplishing that.
Finally, know the current patent and regulatory environment and how it may affect your IP. Depending on your specific technology, the current patent climate may have significant implications on your ability to get the claims you want. Think about Section 101 patentable subject matter issues. If you are developing biologics, the current climate favoring biosimilars and generic drugs may be problematic for you. If your technology falls within the types that may be affected by today’s uncertain patent and regulatory climate, be prepared to discuss how you plan on mitigating that uncertainty and what backup positions you may have.
Good luck to everyone participating in start-up competitions!
In January 2019, the Supreme Court denied certiorari in Amgen Inc., Amgen Manufacturing Ltd., and Amgen USA, Inc. v. Sanofi, Aventisub LLC, Regeneron Pharmaceuticals, Inc., and Sanofi-Avantis U.S., LLC, a case that asked the Court to review the law related to the written description requirement of 35 USC Section 112. We previously discussed the case here. This case arose when Amgen sued Sanofi and Regeneron, alleging that their monoclonal antibody product, Praluent® (alirocumab), infringed Amgen’s patents. In ruling on the case, the Federal Circuit (872 F.3d 1367, Fed. Cir. 2017, “Sanofi”) essentially overturned the “well characterized antigen” test, which allowed an antibody product to be described by the antigen that it binds, and held that in order to obtain broad patent coverage for a class of antibodies that bind to a particular antigen and perform a particular function, companies must disclose a sufficient number of representative antibodies across the claimed genus or establish a clear relationship between the function of the antibody and the genus of the antibody in their specification. In essence, the Federal Circuit’s decision in Sanofi raised the bar for protecting antibody inventions by requiring more data when disclosing and claiming antibodies. The Supreme Court’s refusal to review the Federal Circuit decision means that the standard for obtaining broad protections for therapeutic monoclonal antibodies will continue to be challenging.
In view of the Federal Circuit’s holding in Sanofi, the question becomes: how can a company build a patent portfolio that can withstand invalidation under Sanofi and withstand other challenges? The answer is: by building a multi-layered portfolio offering many different layers of protection.
A great example of a patent portfolio with many layers, creating a so-called “patent thicket,” is the patent portfolio protecting Humira®, also an antibody. Despite the challenges and invalidations of one of Humira’s core patents (the ‘135 patent) over the summer of 2017, no competitor can market a biosimilar of Humira in the US until at least 2023. This is because Humira® is protected by more than 110 patents, some of which extend its patent term all the way to 2034. Humira’s portfolio is so robust that several biosimilar manufactures have entered into settlement agreements with Abbvie that would delay the U.S. launch of a Humira®-based biosimilar product until 2023 rather than litigate the patents. While 2023 cuts Humira’s patent market exclusivity by more than a decade, Abbvie can still market Humira without competition more than five years beyond the expiration of the ‘135 patent, the patent that was invalidated by the PTAB.
The strength of Humira’s patent portfolio comes from several aspects. First, it is big. There are more than 110 patents protecting various aspects of the drug. Such a large portfolio is designed to continue standing even if a few patents may be invalidated.
Second, Humira’s portfolio is also very diverse. In a presentation in October 2015 entitled “Broad U.S. Humira Patent Estate”, Abbvie outlined its strategy: to cover every aspect of the drug. Abbvie listed 22 patents for various diseases or methods of treatment, 14 on the drug’s formulation, 24 on its manufacturing practices, and 15 “other” patents.
Third, Humira’s portfolio is staggered. By not filing all the patent applications at one time, Abbvie was able to extend Humira’s patent term to 2034, 16 years past the initial expiration of the primary patents in 2018.
Of course, it should be mentioned that a portfolio like Humira’s comes with a very steep price tag and not all companies are in the position to invest that much into patent protection. Nevertheless, creating layers within the portfolio as well as within each patent can greatly enhance the chances that at least some patents and claims will remain valid despite challenges and even changes to the laws.
For antibody patents, this can be done in several ways. First, each patent should claim the subject matter using several different formats yielding differences in scope so that even if some claims are invalidated in a post-grant challenge, other claims within the same patent still remain valid. Let us examine functional claims, for instance. Although functional claims directed solely to antigen binding are likely invalid under Sanofi, claiming by function should not entirely be ignored. Instead such claims can be strengthened by adding backup claims, including a set of narrower claims that include parts of the antibody sequence or other features of the antibody that have a greater chance of withstanding a challenge. Including one or two backup claim sets could thus increase the chances that the entire patent is not invalidated in a challenge. Further, functional elements could be combined with structural elements in the same claim, creating hybrid claims as well.
In addition to including multiple layers of claims within each patent application, the portfolio should also be chronologically staggered to include a range of different patent claims that act to extend the patent term. In the antibody space, there are several different types of claims available to developers of therapeutic antibodies. These include sequence claims, pharmaceutical composition claims, function claims, methods of treatment, and antibody-conjugate claims. To build a strong patent portfolio, each of these patent claims can be utilized at different points in the development process. For instance, the core patent could be a composition patent directed to the complimentarity determining region (CDR) sequences of the actual antibody. Later, claims directed to methods of treatment, compositions, and antibody-conjugates (if applicable) can be included. These later filed patents would serve to extend the patent life of the antibody beyond the expiration of the core composition patent.
Patenting antibodies has become more challenging in the wake of the Federal Circuit’s decision in Sanofi. When patenting antibodies, it is now more important to review each antibody on a case-by-case basis and decide which features to claim, and how best to claim them, based on the amount of data and investment available. By taking advantage of the different types of patents claims that are available for antibodies and by including backup claims in the form of layering, a company can increase the likelihood that at least some of the claims will remain patentable when the patent is subject to invalidation.
On Monday, February 11, 2019, the US Patent Trial and Appeals Board (PTAB) denied Dr. Reddy’s petition requesting institution of inter partes review (IPR) of Celgene’s myelodysplastic syndromes (MDS) patents (IPR2018-01504, IPR2018-01507, IPR2018-01509). This is the latest development in a dispute that has garnered much attention since Bristol Myers Squibb (BMS) announced last month that it planned to acquire Celgene in a deal valued at $74 billion. The question now is how does Dr. Reddy’s loss at the PTAB change Dr. Reddy’s overall strategy and outlook? The short answer is that while Dr. Reddy’s best-case scenario is likely off the table, little else has changed.
We previously wrote about the Celgene/Dr. Reddy’s dispute here. At the heart of the dispute is Celgene’s Revlimid®, a derivative of thalidomide (lenalidomide) used to multiple myeloma (MM), transfusion-dependent anemia due to myelodysplastic syndromes (MDS), and mantel cell lymphoma. Many patents protect Revlimid®, including a composition of matter patent covering lenalidomide (U.S. Patent No. 5,635,517) which expires in October 2019, method-of-use patents which expire by 2023, and two polymorph patents, including U.S. Patent Nos. 7,855,217 and 7,465,800, which do not expire until 2024 and 2027, respectively. Revlimid’s® long-term value thus stems from these two polymorph patents.
Dr. Reddy’s ability to get onto the market before 2023 depends on its ability to get around the patents, mainly the polymorph patents. To do this, Dr. Reddy’s is suing Celgene in district court litigation over the two polymorph patents and five patents directed at treating MM. With regards to the polymorph patents, Dr. Reddy’s will argue that is does not infringe those patents because its generic product is “amorphous” lenalidomide, whereas the patents are limited to “crystalline” lenalidomide. Dr. Reddy’s thus believes it can circumvent the polymorph patents.
The case is currently in the discovery phase with discovery ending this month or next, and then the case will presumably move on to trial later this year. We probably will not see a decision from the court before Q4 2019 or even Q1 2020. If there is an appeal, that will typically take a year, which means that a final decision could be expected in early 2021.
So now the question is how did the IPR factor into all this. Dr. Reddy’s chose to challenge three MDS patents through an IPR. This included U.S. Patent Nos. 9,056,120; 8,404,717; and 7,189,740. Dr. Reddy’s did not challenge the MM patents or the polymorph patents in this way possibly because: (a) IPRs are limited to Section 102 and Section 103 issues, whereas Dr. Reddy’s appears to be arguing that its product does not infringe, and (b) a win on invalidity in an IPR would open the door for other generics to launch their products, whereas a win on non-infringement in a district court litigation would keep other generics off the market. If Dr. Reddy’s had the IPRs instituted in February 2019, a final written decision would have been expected in February 2020, and an appeal of that decision would add another year to about February 2021. If Dr. Reddy’s managed to win the IPR and also win on the two polymorph patents, then it could enter the market with respect to MDS in early 2021. Even though MDS is a smaller indication than MM, Dr. Reddy’s product could still slowly eat into Celgene’s MM profits through off-label use.
Since the IPRs were not instituted, and the hurdle to appealing the denial is high especially in light of recent case law, Dr. Reddy’s has lost a valuable opportunity to enter the MDS market early. However, not all is lost. If Dr. Reddy’s prevails in showing non-infringement of the two polymorph patents by early 2021, then it just needs to wait until the method-of-use patents expire to enter. While Natco’s agreement allows it to enter the market with a limited supply in March 2022, Dr. Reddy’s will be able to enter with a full supply as soon as the patents expire. Revlimid®’s longevity assumes that no generic will fully enter before 2026 but Dr. Reddy’s will be able to do just that if it prevails at trial on the non-infringement issue.
The next major question is whether this IPR result, or lack thereof, will impact any settlement discussion between the parties. Settlements are almost always business decisions. To date, Celgene and Dr. Reddy’s have not been able to resolve their differences, likely due, in part, to Celgene’s prior settlement agreement with Natco, which limits what Celgene can offer Dr. Reddy’s. From Celgene’s perspective, they are likely to argue that because they “won” in the IPR setting where the bar is lower, they have a stronger hand. This, however, ignores the fact that different issues will be disputed in the litigation. Dr. Reddy’s will still argue that their generic does not infringe and that has not changed with the IPR result.
We will continue following this case and will keep you informed of any new developments.
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