How Long Do Medical Device Patents Last?
The first question to ask is how long do medical device patents last? This article will discuss the length of the patents, including the 20-year patent, the 14-year design patent, and the three-year new use rule. We’ll also look at how extensions can work to extend the life of the medical device patent. This article was originally published in July, but has since been revised to reflect current regulations.
A medical device patent protects the inventor of an invention from others’ use or sale. Patents are important in protecting the inventor of a medical device, as well as smaller manufacturers from larger competitors. A medical device patent generally lasts 20 years, but it can be longer if a product changes over time or undergoes significant development. This article will review the various types of medical device patents and discuss the benefits of filing for one.
A medical device patent is protected for 20 years after the date of invention. However, the exclusivity period is generally only around 180 days, so the product can be sold before it expires. This is known as the ANDA period. A medical device patent protects the underlying inventive concept as well as the method, manufacturing process, and use of a medical device. These patents last 20 years and are the most commonly granted by the U.S. government.
Patents protect physical devices used by physicians. They can include surgical tools, surgical suite equipment, and sterilization hoods. In addition, medical patents cover patient monitoring devices, drug delivery systems, food delivery systems, and tube feeding. These patents are useful for the innovator because they help them to improve their designs. They are an essential part of medical innovation. There are countless ways to improve a medical device, and patents can protect you.
If you’re a medical device company, patent your invention. In most cases, you won’t need to pay for the patent yourself. The patent lasts for twenty years, but you’ll need to pay periodic fees to ensure that your invention is protected. If you need more information, you should sign up for DrugPatentWatch. Among other useful resources, it has original articles written by experts and patent attorneys.
Understanding how pharmaceutical and medical device patents work will help you understand how to leverage and extend patent protection for your products. It’ll also help you navigate the patent process when negotiating with payers. Understanding patents will help you better appreciate the benefits of new product launches, formulary positioning, and patient care. And you’ll be better prepared when your product goes off-patent. You’ll also be able to protect your innovation from competitors, including generics.
14 years for design
Prior to May 13, 2015, the term of design patents was seventeen years, renewable if a new patent was filed within ten years of the date of issuance. However, patents filed before this date will still have a fourteen-year term. In addition, patents claiming the entire design will reduce emphasized differences and broaden the scope of protection. This is a welcome development for medical device companies.
The Federal Circuit has confirmed that a medical device maker can be sued for infringing a design patent if it sells a component that contains the patented design. With ABPA’s recent decision, pursuing design patents may be easier than ever before. After all, many of the components of a medical device are replaceable, and design patents protect against potential knockoffs. So, if you are in the medical device business, designing a patent for a component that is replaceable is an essential element of protecting your market share.
A design patent is issued when you create a new, original, ornamental design for a product. It is easier to obtain than a utility patent. The only difference is that a design patent has no maintenance fees after it’s granted. The process of obtaining a design patent is also easier and quicker than a utility patent. A design patent may even supplement a utility patent. The term of a design patent is fourteen years, but it may be extended in the near future.
Design patents protect the appearance of a medical device. While utility patents protect the functionality of a medical device, design patents are more about aesthetics. For example, a new imaging device might have various user interfaces or exterior configurations. Those are all examples of designs that are protected under a design patent. So, when developing a medical device, remember that it’s vital to consider all aspects of the invention.
Three-year new use rule
The Three-year New Use Rule for Medical Device Patents was enacted in December 2011 as a way to encourage innovation in the medical device industry. In the past, the FDA had favored the “first to market” (FTO) route when considering medical device patents. However, the three-year rule now allows the FDA to use data that a company submitted in its PMA in its subsequent applications. This is similar to the exclusivity granted to drugs or biological products.
Despite the three-year new use rule, the FDA had never used the four-of-a-kind rule. Many viewed it as an unworkable solution, and it was virtually forgotten when reauthorizing the Medical Device Amendments in the summer of 1990. In the meantime, a draft version of Senate Bill 3006 proposed a ten-year exclusivity period and was endorsed by the FDA. However, during markup in September 1990, the four-of-a-kind approach was substituted for the four-year approach.
In addition to the Three-year New Use Rule, pharmaceutical companies can also apply for a seven-year extension for their medical device patents when they reformulated the original drug. Often, this involves simple changes in the dosage of a drug, such as a drug that should be taken three times daily instead of three. The new patent enables the company to continue manufacturing the product and re-form it.
The FDA allows a company to submit a 510(k) to receive FDA approval for a medical device. However, the MA process can have significant interplay with the FDA’s regulatory review process. The next article in this series will discuss the implications of a 510(k) submission on medical device patent rights. If approved, this submission can result in a patent infringement lawsuit.
The three-year New Use Rule for Medical Device Patents is a crucial change that will benefit patients and innovators alike. If a company can successfully extend a patent once, it may limit competition in the field. In some cases, however, it can extend the term once. If this occurs, the company may be faced with several patent applications involving the same product. The new rule is designed to ensure that companies receive the maximum number of patents that they need to protect their innovation.
Extensions of medical device patents
Patents for new medical devices require review by the FDA, which takes considerable time. An extension of the patent term allows the device maker to regain the time lost in the review process. This is one of the key benefits of patent extensions, which are governed by 35 U.S.C. SS 156. Applicants should draft their claims accordingly, anticipating FDA review. This decision does not affect the validity of the medical device patents, but it is an interesting analysis of how patent term extensions should work.
There are several criteria that must be met for the extension to be granted. If the delay was caused by the development process, it was not within the patent’s term, and the device had been in use for several years, the developer may request an extension of the patent term under the Hatch-Waxman Act. Generally, the extension can last up to five years. Extensions can be granted to only certain medical devices if they are eligible.
Medical devices include physical devices used by physicians, including implants and surgical tools. They also include medical suite equipment, such as sterilization hoods, patient lifts, and medical monitors. Drug and food delivery systems include IV bags, tubing, and patient feeding devices. Aside from patenting medical devices, extensions also protect them from imitation and counterfeiting. The legal framework around these extensions has changed dramatically over the years. Medical device patents provide minimal protection to the companies who created them.
Generally, medical devices are manufactured by a variety of companies. These companies have a unique advantage. They can supply the volume national distributors need. In addition, these companies tend to be multiproduct concerns, and a distributor’s reputation for one product line influences their decision to carry another. Additionally, the establishment of a national distribution network is an entry barrier to smaller medical device companies. This may result in a competitive environment where only large firms can survive.
Similarly, SPCs can be granted to devices that use drugs. For a SPC to be valid, a device must be “a medicine on its own” and achieve a therapeutic effect by pharmacological, immunological, or metabolic means. These devices fall under the EU’s Medicines Directive, which regulates medical devices. The term “medical product” also refers to medical devices that are implanted. This includes heart valves, pacemakers, and breast implants.