Back to the Basics: Patents (Part 2)

Back to the Basics: Patents (Part 2)

This is the second in our series of posts breaking down the fundamentals of patents. In [Part 1], we discussed the scope of a patent and the process of obtaining one. Today, we’re focusing on the payoff: the benefits of a patent and how you can enforce your rights.

Now that you have a patent, what can it actually do for you?

Ultimately, a patent is only as valuable as your ability to enforce it. As a patent owner, you hold the exclusive right to prevent others from making, using, selling, or offering to sell your invention. But how do we determine if someone is actually stepping on your toes? It all comes down to the claims.

Defining the “Metes and Bounds”

A patented invention is strictly defined by its claims. Located at the very end of the patent document, these numbered paragraphs map out the legal “metes and bounds” of your intellectual property. Think of them as the invisible fence around your innovation.

When a dispute arises or a patent is asserted against an alleged infringer, the process follows two main steps:

  1. Interpretation: The court interprets the claims to determine the exact scope of the invention.
  2. Application: That scope is compared directly to the competitor’s product or activity to see if it falls within your protected territory.

The Power of Enforcement

Patent infringement is a serious matter handled exclusively via federal civil actions. If a competitor crosses the line, the law provides robust remedies to make things right.

As a patent owner, you can pursue:

  • Monetary Damages: Recovery of actual damages (like lost profits or reasonable royalties).
  • Treble Damages: If the infringement is proven to be willful or intentional, the court can award up to three timesthe actual damages.
  • Injunctions: Court orders to immediately halt existing and future infringing activity.
  • Fees: In exceptional cases, the recovery of court costs and attorneys’ fees.

Protect Your Innovation

Capitalizing on your innovative developments is critical to your organization’s growth, but you shouldn’t navigate the complex world of intellectual property alone. Having the right legal partner to guide your decisions is vital.

The Law Office of Kathleen Lynch PLLC is designed to help businesses like yours stay ahead of the game and safeguard what they build.

Ready to protect your competitive edge? Your first consultation is completely free.

Details, Details, Details: Why Precise Patent Drafting Matters

Details, Details, Details: Why Precise Patent Drafting Matters

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.

U.S. Patent Office Waives Fee For AI Search Automated Pilot Program

U.S. Patent Office Waives Fee For AI Search Automated Pilot Program

A patentability search and assessment is always recommended when evaluating whether your invention would be entitled to meaningful patent protection. The search also helps to inform the inventor and patent attorney where there may be areas of more narrow protection and draft accordingly.

The United States Patent Office recently launched the AI Search Automated Pilot Program. The program is designed to evaluate the examination process by including an automated pre-examination search, and whether the inclusion will improve quality and efficiency of examinations.

The program (ASAP!) will conduct an automated search for original, noncontinuing, nonprovisional applications. The automated search results will be sent to the applicant and will provide an earlier communication regarding potential prior art issues. Under the pilot program, applicants will not be required to respond to the search results.

However, the search results may provide an opportunity to the applicant to file a preliminary amendment in an effort to place the application in a stronger position for allowance. Alternatively, the applicant may wish to file an express abandonment and obtain a fee refund in view of search results that indicate a lack of patentability.

Recently, the U.S. Patent Office has announced that it is waiving the fee requirement for any petition to participate under 37 C.F.R. 1.182 filed after March 23, 2026. This should enable self filing entrepreneurs and inventors to take advantage of this new program for free!

Capitalizing on innovative developments is critical to any organization.  Having the right person to help you make those decisions is important.  The Law Office of Kathleen Lynch PLLC is designed to help businesses such as yours keep ahead of the game.   The first consultation is free.  Email us at kl****@*****aw.com.

Photo by Szorstki on FreeImages

Looking for Patent Counsel? Do your homework.

Looking for Patent Counsel? Do your homework.

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.

Wright Brothers’ Patent File Went Missing for 36 Years

Wright Brothers’ Patent File Went Missing for 36 Years

One of the most famous patents had part of its record lost for 36 years.  Part of the patent file on the Wright Brothers’ first flying machine disappeared in 1980 when it was returned to the National Archives by the Smithsonian Museum where it had been on loan for an exhibit.  It was not until 2000 that archivists discovered it missing.  In March of this year the record was discovered in a cave outside of Kansas City where government records are stored. 

Government officials speculate that the record was likely misfiled in 1980 and made it difficult to find.  The papers, along with the rest of the patent file, will now be part of an exhibit at the National Archives starting May 20th. 

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.

Apple Patent that Censors Bad Language in Music and Books

Apple Patent that Censors Bad Language in Music and Books

Apple recently was granted a patent that detects and deletes swear words from song lyrics on audio tracks.  The system first finds the explicit language in a track and then removes it.  In addition, the system can replace the profane language with milder lyrics or background music.  The system also works with audio books. 

Apple has not indicated that it plans on bringing the technology to Apple Music in the near future. As the mother of twin teenagers, I can only hope!

Capitalizing on innovative developments is critical to any organization.  Having the right person to help you make those decisions 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.