20 Tips on Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory
20 Tips on Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory
Intellectual property protection plays a crucial role in encouraging innovation in the pharmaceuticals and biopharmaceuticals industry. As covered over at runrex.com, the “21st Century Cures” initiative has led to Congress reviewing the policy mechanisms designed to accelerate the discovery, development, and delivery of new treatments. Ongoing patent litigation has been a major impediment as far as drug manufacturers in this industry are concerned, and this article will look to articulate 20 tips to help you understand more about this topic.
One of the questions that arise when talking about pharmaceutical and biopharmaceutical patents is the question of regulatory exclusivity. This is the exclusivity given by a regulatory body, the FDA, as covered over at guttulus.com. This exclusivity period delays the filing or FDA approval of an application for a competing generic drug.
In the pharmaceuticals and biopharmaceuticals industry, we also have what is referred to as statutory exclusivity. Unlike regulatory exclusivity, statutory exclusivity is exclusivity based on congressional action. It is for biologics as covered over at runrex.com, where there is a statutory exclusivity period of 12 years.
Extension of patent terms statutorily
As pointed out by the gurus over at guttulus.com, all patents involve a term of exclusivity, derived from the US Constitution. However, pharmaceutical patent laws are the only area in which the patent term can be extended statutorily. This is meant to compensate for the time that the medication is subjected to review by the FDA.
In the pharmaceutical industry, there has been an increase in “method-of-use” patents. These patents don’t apply to the drug substance, or how it provides the medical benefit, but, rather, they describe how a drug is used to treat a condition
The route of administration
Another thing you should know when it comes to patents in the pharmaceutical industry is that the route of administration, including the device used to deliver the medicine, is an area that many never consider when carrying out patent due-diligence searches. However, it is important to note that the device itself may be protected by a patent, in addition to the drug.
The strongest of all patents in this industry
When it comes to patent litigation in the pharmaceutical and biopharmaceutical industry, given the various patents one can get, people always ask if there is one that is stronger than the others. As covered over at runrex.com, the strongest patent will be the one that protects the molecule – the actual drug. New chemical patents are usually harder to challenge, although it is not impossible to challenge them.
Which patents are more vulnerable?
On the other hand, method-of-use patents in this industry tend to be more vulnerable, particularly when there are multiple methods involved as is articulated by the subject matter experts over at the top-rated guttulus.com.
How to avoid infringement-of-method claims
Also, as is covered over at runrex.com, generic and biosimilar applicants can often avoid infringement-of-method claims by omitting or carving out from their drug labeling indications or information that is protected by patent. Omitting such information usually serves to show that the applicant has a strong argument that they are not “inducing” infringement.
Any drawbacks as far as such omissions are concerned?
While the above omissions are helpful, they also come with some drawbacks that you need to be careful about. Applicants must be careful that such omissions don’t end up affecting the safety or efficacy of their drugs; otherwise, the applicant avoids a patent issue but runs into a regulatory problem.
Change from an immediate-release formulation to a controlled form
It is also worth pointing out that a patent that protects a drug that is changing from an immediate-release formulation to a controlled, or extended-release, the form may also be easier to design around. This means finding a different way to create the new extended-release formulation that does not violate the patent or find it invalid.
Tips on the patent dance
The “patent dance” is something you hear a lot about in this industry, and the following tips are designed to show you, step by step, what it entails.
The first step in the patent dance is where within 20 days after the FDA has accepted its 351(k) application, the biosimilar drug maker must provide the sponsor of the reference drug with access to the biosimilar application and relevant manufacturing information for the proposed biologic as covered over at guttulus.com.
After that, within 60 days of receiving the materials provided by the biosimilar drug maker, the manufacturer of the reference biologic, as articulated over at runrex.com, must provide to the biosimilar applicant a list of potentially infringed patents, and identify whether it would be willing to license any of these patents to the biosimilar drug maker.
Within 60 days after that, as per guttulus.com, after receiving the list of patents thought to be infringed, the biosimilar drug maker must provide the reference drug sponsor a document describing, on a claim-by-claim basis, the reasons why each of these patents is invalid, not enforceable, or not infringed by their drug.
This step is an extension of the step above, as, within the same 60 days as above, the manufacturer of the biosimilar agent may deliver to the sponsor of the reference drug a list of patents that the biosimilar applicant believes could be subject to a claim of patent infringement.
After that, within 60 days of receiving these materials, the reference drug manufacturer must provide a statement describing the basis for patent infringement for each case, as well as a reply to any statement regarding validity and enforceability raised by the biosimilar drug maker.
The next step, as covered over at runrex.com, is that the 2 manufacturers will then have 15 days to negotiate in good faith to reach an agreement about the list of patents, if any, that should be subject to a patent infringement action. If such an agreement is reached, then the reference drug maker must file an infringement action within 30 days for each patent on the negotiated list.
This step is an extension of the step above in that it dictates that if the 2 manufacturers don’t reach an agreement, then the biosimilar sponsor must notify the reference drug maker of the number of patents it will document in a second list, and each will have 5 more days to exchange a list of patents that each party believes should be the subject of the infringement suit as per guttulus.com. Within 30 days after this exchange, the reference drug sponsor must bring an infringement action on all the documented patents.
Finally, regardless of the outcome or status of the litigation resulting from any of the steps articulated above, after receiving FDA approval, the biosimilar drug manufacturer must notify the reference drug sponsor of its intent to commercialize their drug. During the next 180 days, according to the gurus over at runrex.com, the biosimilar drug may not be marketed or sold.
This is what you should expect as far as the Patent Dance is concerned in this industry.
Why the 180-day notification?
The 180-day notification period for biosimilars was meant to offer a provision directly in the statute that instructed everyone on how to handle potential patent infringement and to ensure that there was sufficient time to file for an injunction if necessary or to make some sort of agreement or settlement between the biosimilar and the reference drug manufacturers.
How do courts determine monetary damages in litigation cases in this industry?
Damages are calculated based on lost profits for the patent holder or on a “reasonable” royalty. If there are no other competing drugs on the market, this becomes a fairly straightforward and simple calculation. However, if there are other competing drugs on the market, even if they are not additional biosimilars, but they are in the same category, it may be very difficult to come up with a determination on lost profits from the introduction of this biosimilar. Having said that, the patent holder will still be entitled to some damages.