by Kathleen Lynch | May 18, 2026 | Entrepreneur, Infringement, Innovation, Intellectual Property, Invention, Inventor, IP, Litigation, Patent, Patent Prosecution, Protection, Small Business, Start Up, Start Up Considerations, Uncategorized
This week, Actelion Pharmaceuticals (“Actelion”) failed in its effort to hold Mylan Pharmaceuticals (“Mylan”) liable for infringing its patents on a highly successful hypertension drug, Veletri®. The Federal Circuit’s decision serves as a stark reminder to businesses everywhere: in the world of intellectual property, omitting a single technical detail can cost you a monopoly.
The Dispute: A Battle Over a Generic Alternative
Actelion holds patent protection for Veletri, a life-saving drug used to treat pulmonary arterial hypertension. Seeking to enter the market with a lower-cost generic version, Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA, asserting that its generic product did not infringe Actelion’s intellectual property. Actelion promptly sued Mylan in federal court, asserting infringement of two patents covering the formulation process.
The entire case ultimately hinged on a single chemical metric: pH measurement.
The Flaw: The Missing Temperature Parameter
Actelion’s patent claims focused heavily on a specific requirement: the drug must be formulated from a bulk solution having a “pH of 13 or higher.” The issue at trial was how that pH should be measured. In chemistry, a solution’s pH fluctuates based on environment—specifically, temperature. However, Actelion’s patent specification failed to provide any explicit instructions on the temperature conditions required for taking the measurement.
Because the patent was silent, the court turned to standard industry practices. Generally, unless a scientist indicates otherwise, pH is measured at standard room temperature. When Mylan’s product is measured at room temperature, its pH is well below 13, meaning it does not literally infringe the patent.
Actelion attempted to argue that because Mylan refrigerates the solution during actual manufacturing, the pH should be measured at that colder operating temperature—where the chemical properties shift and the pH does indeed rise above 13. The district court rejected this argument, holding that because Actelion failed to specify any special conditions in its paperwork, standard room temperature must apply.
The Federal Circuit Weighs In
The Federal Circuit Court of Appeals upheld the district court’s finding of non-infringement. In its opinion, the court stated:
“The district court here properly relied on just that sort of extrinsic evidence to find that those skilled in making pharmaceutical compositions, when referring to pH, mean a measurement at standard temperature unless they indicate otherwise, and we discern no clear error in how the district court evaluated the record.”
The Takeaway
Details are everything. Had Actelion explicitly stated in its patent specification that the pH threshold was meant to be measured at the cold manufacturing temperature, Mylan’s product would have clearly infringed. Instead, because Actelion left out that vital context, Mylan was able to successfully design around the patent and keep its generic product on the path to market.
Capitalizing on innovative developments is critical to your organization’s growth, but protecting those developments requires meticulous execution. Having the right legal partner to help you navigate and stress-test your intellectual property strategy is essential to staying ahead of the game.
The Law Office of Kathleen Lynch PLLC is designed to help businesses secure their innovations and avoid costly drafting traps. Your first consultation is free. Contact us today at kl****@*****aw.com to protect what you build.
by Kathleen Lynch | Mar 26, 2026 | Patent, Patent Prosecution
A client of mine read this post and found me. He recently contacted me about a different matter, and it reminded me of this post, so I thought I would share it again.
We hear a lot these days about cost cutting and austerity. I also hear a bit of grousing from time to time from people who use IP legal services about costs. I believe inventors and companies can find reasonably priced intellectual property law services when the potential client does her homework.
First, check out smaller cities, towns and suburbs. Larger cities have higher overhead costs. Firms pay more for rent, salaries etc. Smaller cities and towns have many talented patent firms, attorneys and agents equally qualified to do the work at more reasonable rates.
If you are focusing on patent preparation and prosecution, you don’t need to stay in your own backyard. With all of the wonderful modern tools of connectedness, your patent agent or attorney can be as close or as far away as you want them to be. Documents are easily exchanged via the internet, and telephone and video conferences can connect folks who are time zones apart. Where there is a significant distance, time zones may become an issue, but you will find that most patent attorneys and agents are willing to provide the necessary flexibility to make the relationship work, including trips to your offices at a discount or gratis in exchange for keeping your business.
Background matters. Take a look and ask questions about what kind of work your patent attorney does. What was his or her major in college? Did they work as a scientist or engineer before they practiced patent law? If so, what did they do? What is the focus of their present practice? If you are looking for someone to prepare and file a patent application, you don’t want to work with someone whose experience is limited to patent litigation. Just like you wouldn’t allow your internist to perform heart surgery, you don’t want someone with a chemistry background preparing patent applications for you if you are in the high tech industry. Find someone who has the technical background suited to your project, as well as the experience needed to meet your needs. In looking for possible patent attorneys or agents, check out the US Patent and Trademark website which enables you to search either for a particular person or those registered to practice before the US Patent Office in a particular location. Once you have that, check out their credentials and ask questions before you make your decision.
Selecting the right patent attorney is important to ensure your patent strategy is managed by someone with the appropriate experience and background. The Law Office of Kathleen Lynch PLLC has over 35 years of experience in the preparation and prosecution of patent applications and is designed to help businesses such as yours keep ahead of the game. The first consultation is free. Email us at kl****@*****aw.com.
by Kathleen Lynch | Jul 22, 2014 | Examiner, Patent, Prosecution
The US Patent Office is expanding its Patent Examiner Technical Training Program. The Patent Office is seeking voluntary assistance from technologists, scientists, engineers, and other experts from industry and academia to participate as guest lecturers and provide technical training and expertise to patent examiners regarding the state of the art.
Guest lecturers must have relevant, historic and current technical knowledge, including industry practices/standards in technological areas of interest. Guest lecturers must also have relevant technical knowledge, as well as familiarity with prior art and industry practices/standards in areas of technologies where such lectures would be beneficial.
So if you or someone you know has expertise or knowledge in a cutting edge area of technology, here’s a chance to help an examiner out.
Having the right person to help you identify and protect your intellectual assets is critical. The Law Office of Kathleen Lynch is designed to help businesses such as yours keep ahead of the game. The first telephone consultation is free. Email us at kl****@*****aw.com.
by Kathleen Lynch | Aug 30, 2013 | Entrepreneur
Recently, I was discussing with one of my clients what strategy to implement in moving forward with a provisional patent application filed less than a year ago. Our discussions highlighted the pros and cons of filing domestically or internationally, especially for an individual entrepreneur or small business. Here are some thoughts.
First, a note about the provisional patent system. For most parties involved, the provisional patent system is a good one. Especially in view of the new America Invents Act, where priority is given to the first inventor to file, the provisional system provides an effective and relatively inexpensive way to preserve priority while fine tuning your invention. In addition, once the provisional application is filed, you have up to a year to file a US utility application or seek protection on an international scale. In either case, the time provides an opportunity for increasing marketing efforts as well as further development of the invention.
For an individual entrepreneur or small business, there are obvious advantages to filing exclusively in the US. First, the cost benefit of filing in the US is noticeably less (for a small entity it is about $800 vs. $3500 internationally). In addition, the US markets are perhaps more developed and known at the time of initial development. However, an international application, even with its increased cost, will provide a platform from which multinational patent protection may be obtained. This may be a very attractive feature for a prospective investor or buyer. The option to seek patent protection in much of the world may outweigh the more costly upfront fees. In addition, once the international application is filed, the decision regarding national phase filing will not expire for roughly 18 months. In this rather substantial window of time, a marketing plan may be developed in which a third party may wish to assume the costs of the national phase filing or buy the innovation outright. At any rate, I believe an international patent filing strategy is certainly something to consider when weighing your patent filing options.
by Kathleen Lynch | Jul 8, 2013 | Patent
Usually the Patent Office website provides a gateway to other information, such as a patent or trademark search information, related forms, general information, etc. However, on the home page, there are news items and information worth checking out. One of those is the IP Awareness Assessment Tool. This tool provides basic information for inventors and small businesses to help identify IP needs. In particular, the tool is a series of questions posed to help you understand what IP you may have and/or what IP you may want to protect. For example, you may think that you may need a copyright registration to protect your marketing material, but in fact, it might be more appropriately addressed and protected by trademark or service mark registration.
Having checked out the pre-assessment tool myself, I think it is a helpful starting point to those who are individual entrepreneurs, or small businesses who have not yet sought any IP advice. However, I would not rely on the tool alone and would seek advise from an attorney experienced in IP issues.
