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 | May 12, 2026 | Copying, Copyright, Entrepreneur, Entrepreneurship, Infringement, Innovation, Intellectual Property, IP, Licensing, Small Business, Start Up
The legal battle over Generative AI reached a fever pitch this past week as five of the world’s largest publishing houses—Elsevier, Cengage, Hachette, Macmillan, and McGraw Hill—joined forces with celebrated author Scott Turow to file a massive copyright infringement action in New York.
The case, Elsevier Inc. et al. v. Meta Platforms, Inc. and Mark Zuckerberg (S.D.N.Y. 2026), marks a significant escalation in the industry’s defense of intellectual property. The plaintiffs allege that Meta, under the personal direction of Mark Zuckerberg, infringed upon millions of copyrighted works to build its “Llama” AI models.
A Three-Phase Infringement Strategy
The complaint meticulously outlines a “three-phase” process of alleged infringement:
- Torrenting from “Shadow Libraries”: The plaintiffs allege Meta willfully downloaded millions of books and journals from notorious pirate sites, including LibGen, Sci-Hub, and Anna’s Archive.
- Unauthorized Training and Reproduction: The suit claims Meta made millions of unauthorized digital copies during the preprocessing and training phases of its Llama Large Language Models (LLMs).
- The “Infinite Substitution Machine”: Perhaps most critically, the plaintiffs argue the end product is designed to directly compete with their original works, creating an “infinite substitution machine” that generates content intended to replace the need for the original copyrighted materials.
Beyond Copyright: The DMCA and Personal Liability
The lawsuit further alleges violations of the Digital Millennium Copyright Act (DMCA). Specifically, the plaintiffs claim Meta systematically stripped away Copyright Management Information (CMI)—such as ISBNs, DOIs, and digital watermarks—to obfuscate the illicit sources of its training data.
Most notably, the case names Mark Zuckerberg personally as a defendant. The complaint characterizes Zuckerberg as the “guiding force” behind a “move fast and break things” strategy that prioritized data acquisition at any cost. This bold move raises significant questions regarding corporate veil-piercing and the extent to which a high-level executive can be held personally liable for a corporation’s infringing activities.
Protecting Your Intellectual Capital
Capitalizing on innovation while navigating the complexities of intellectual property law is critical to the survival of any modern organization. Having a strategic partner to guide these decisions is no longer optional—it is a necessity.
The Law Office of Kathleen Lynch PLLC is dedicated to helping businesses like yours stay ahead of the curve and protect what they build.
Start the conversation today. Your first consultation is free. Email us: kl****@*****aw.com
by Kathleen Lynch | Apr 19, 2016 | IP Management, Start Up Considerations
I wrote earlier this year in my blog about a pending trade secret bill approved by the judiciary committee in the senate. Recently the senate passed the Defend Trade Secrets Act. The act essentially provides for a federal cause of action for trade secret cases. The bill is now in the house and is expected to pass. President Obama has shown his support for the bill.
While the federal law is pending, state trade secret laws are the only remedy currently available. Recently Epic Systems brought a trade secret case against Tate Group, an Indian company, for theft of trade secrets, computer fraud, breach of contract and unfair competition in the western district of Wisconsin (case 14-cv-748-wmc). The jury awarded Epic $240 million in compensatory damages and $700 million in punitive damages. The jury found Tata guilty of downloading documents from hospital software and providing those documents to one of its subsidiaries, Med Mantra. If Epic ends up collecting the award, it will be more than double Epic’s expected annual profits this year.
What’s the take away here? If you are the owner of trade secrets-protect them. Ensure that you have implemented systems and educated your people on best practices to keep your trade secrets confidential. If someone takes your trade secrets without authorization, go after them. Hopefully you will be able to do that in federal court in the near future. If you are working with companies that have trade secrets, make sure you abide by the terms of the confidentiality agreement and treat the trade secret information in the same manner as you would treat your own proprietary information.
Protecting your innovative developments is critical to any organization. Having the right person to help you make that decision is important. The Law Office of Kathleen Lynch PLLC 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 | Apr 1, 2016 | Patent Prosecution
Writing a patent application is always a challenge. In each case, it is a balance. On one side, you are trying to ensure that you have provided an accurate and complete description of the invention. On the other you worry about what the patent examiner might turn up in prior art that you didn’t think about when drafting the application. Sometimes what is included may come back to limit the scope of your invention.
This is exactly what happened to UltimatePointer LLC when they sued Ninentendo for patent infringement (UltimatePointer, LLC v. Nintendo Co., Ltd., No. 15-1297 (Fed. Cir. Mar. 1, 2016). The Federal Circuit, the appellate court for patent cases, affirmed a district court finding of noninfringement by Nintendo. The district court found the term “handheld device” to require a “direct pointing device”. The Federal Circuit found that UltimatePointer had made “repeated derogatory statements” relating to indirect pointing devices in the patent specification. The court stated that the “criticized technologies were not intended to be within the scope of the claims.” The court determined that Nintendo’s pointing involves the hand held remote relative to the sensor bar and not the television screen image. As a result, the court found the Wii system was considered an “indirect” pointing device and did not infringe.
What’s the take away here? Be careful what you write in your specification, especially in the area of describing other prior art. You never know what prior art you may encounter down the road and you need to keep as many options open as possible.
Protecting your innovative developments is critical to any organization. Having the right person to help you make that decision is important. The Law Office of Kathleen Lynch PLLC 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 | Feb 23, 2016 | IP Management, Patent Prosecution
In Transweb LLC v. 3M Innovative Properties Company & 3M Company, the Federal Circuit Court of Appeals affirmed the district court’s finding that 3M was liable for antitrust violations in that 3M was found to have obtained its patent through inequitable conduct and subsequently sought to enforce the patent. As a result of 3Ms behavior in both acquiring and enforcing the patent, the appellate court awarded treble attorneys’ fees which came to about $26 million.
The patents at issue focus on filter material used in respirators for construction workers etc. Transweb had developed a new filter material similar to the 3M subject patents. The Federal Circuit found the 3M patents were invalid based on evidence indicating that Transweb’s president distributed samples of their new filter material at a trade show more than a year before 3M filed patent applications covering their new filter material. The finding of inequitable conduct was confirmed because the evidence indicated 3M knew of Transweb’s prior distribution, and did not properly disclose it to the US Patent and Trademark Office as required.
The court then found that 3M’s enforcement of their patent against Transweb constituted an antitrust violation as an abuse of the legal process and awarded Transweb’s attorneys’ fees for defending against 3M’s lawsuit. In justifying the award, the court stated that the attorneys fees were appropriate because they flowed directly from “3M’s unlawful act [of] bringing suit based on a patent known to be fraudulently obtained.” In awarding treble attorneys’ fees, the court indicated that the enhanced award was justified because the suit brought by 3M forced Transweb to either cease competition in the market or expend money to defend itself.
What’s the take away here? When preparing and prosecuting a patent application, ensure that your organization meets all requirements with regarding to disclosure to the US Patent Office. This requires diligence and educating all involved in the process. Sometimes that can include sales, marketing, and business development personnel as well as R&D and manufacturing.
Protecting your innovative developments is critical to any organization. Having the right person to help you make that decision is important. The Law Office of Kathleen Lynch PLLC 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.
