Nearly seven years after the landmark Supreme Court decision in Alice Corp. v. CLS Bank Int’l, subject matter eligibility for patent claims under 35 U.S.C § 101 remains a moving target. In Alice, the Court found claims for a computerized escrow arrangement ineligible for patenting because they were directed to the abstract idea of “intermediated settlement” and did not recite an inventive concept that could impart eligibility under Section 101. While the Alice case focused on a software invention, a few recent lower court decisions suggest that, in certain circumstances, medical device patents may not be immune from similar patent eligibility challenges.

Late last year, in a case captioned DUSA Pharmaceuticals, Inc. v. Biofrontera Inc., a federal court in Massachusetts faced the question of whether patent claims directed to an improved light source for photodynamic therapy were ineligible for patenting. The representative claims at issue recited:

  • “An illuminator for diagnosing or treating a patient” including “a plurality of light sources…configured and controlled to provide a uniform output of light to the patient…such that uniform output of light is provided when measured at distances of 2 [inches] and 4 [inches];” and
  • “A method of photodynamically diagnosing or treating a patient” by “illuminating the patient with an illuminator whose measured output over an active emitting area is at least 60% of the measured maximum over all operation distances.”

Defendant Biofrontera argued the claims lack an inventive concept and therefore not eligible under Section 101 because they (i) are directed to light itself which is an unpatentable natural phenomenon and (ii) contain only generic components to produce the claimed uniform output of light.

The district court disagreed. In finding the claims patent eligible, the court stated that “[a]lthough the claims relate to light, they are not directed to light as a natural phenomenon … [t]he uniformity of light output is a requirement of and inseparable from the claimed illuminator.” Further, Biofrontera failed to provide evidence that the light produced by the illuminator—specifically, light whose measured irradiance over the active emitting area is at least 60% of the measured maximum from 2 inches to 4 inches—occurred in nature or could be produced by conventional illuminators.

While the DUSA Pharmaceuticals decision may give holders of medical device patents some comfort with respect to patent eligibility, a recent decision from the Federal Circuit raises fresh questions about the patent eligibility of device claims. In Yu vs. Apple, Inc., the court addressed claims directed to an improved digital camera that includes a plurality of image sensors and corresponding lenses. Each image sensor produces a separate digital image with a different intensity value, which the camera then merges to produce an enhanced digital image.

Defendants Apple and Samsung filed a Rule 12(b)(6) motion to dismiss, arguing that the patent claims were ineligible as being directed to the abstract idea of “taking two pictures and using those pictures to enhance each other in some way.” The lower court granted the motion, concluding that photographers have been using this technique for over a century, and the patentee had not shown any of the claimed elements were not well-known and conventional.

In a 2-1 decision, the Federal Circuit affirmed the lower court’s ruling. Despite the explanation of specific camera configurations and embodiments set forth in the patent specification, the majority found that the claims lacked elements that sufficiently covered this detail. As a result, because the image processing technique encompassed in the claims had been performed for over a century and the claims recited only conventional camera components (e.g., image sensors, lenses, memory, A-D converter, image processor) to carry out the image processing, the majority reasoned that the claims were ineligible for patenting as directed to an abstract idea.

Takeaways

These two decisions highlight the continued unpredictability of Section 101 jurisprudence and re-emphasize the importance of having both a detailed specification that fully describes the technical improvements realized by the invention, and claims of reasonable breadth that clearly incorporate the aforementioned improvements. With its Yu decision, the Federal Circuit has issued a caution to those seeking patents on medical device technology that inclusion of device structure and components in a claim set does not automatically exempt the patent from scrutiny under Alice. Instead, claims should be carefully drafted to account for the specific advancement over the prior art and contain limitations that go beyond generic, well-known process steps and hardware.

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad range. Others have estimated the average cost at approximately $2.5 to $3 billion, with costs increasing annually at a post-inflation rate of approximately 8.5%.

Continue Reading “Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement complaint filed by Allele Biotechnology and Pharmaceuticals, Inc. (“Allele”) in the Southern District of California. The patent at the center of the case is U.S. Pat. No. 10,221,221 (“the ’221 Patent”) which covers Allele’s mNeonGreen, a monomeric yellow-green fluorescent protein notable for its intense brightness. On May 4, 2021, the court denied the motion to dismiss, leaning heavily of the Federal Circuit’s 2008 decision Proveris Science Corp. v. Innovasystems, Inc. As this case continues to develop it could help shed light on an unsettled issue – are “research tools” categorically excluded from the 35 U.S.C. § 271(e)(1) Safe Harbor?

Continue Reading A Guiding Light for the Research Safe Harbor and “Research Tools”?

As we mentioned in the early days of the pandemic, COVID-19 has been accompanied by a rise in cyberattacks worldwide. At the same time, the global response to the pandemic has accelerated interest in the collection, analysis, and sharing of data – specifically, patient data – to address urgent issues, such as population management in hospitals, diagnoses and detection of medical conditions, and vaccine development, all through the use of artificial intelligence (AI) and machine learning. Typically, AIML churns through huge amounts of real world data to deliver useful results. This collection and use of that data, however, gives rise to legal and practical challenges. Numerous and increasingly strict regulations protect the personal information needed to feed AI solutions. The response has been to anonymize patient health data in time consuming and expensive processes (HIPAA alone requires the removal of 18 types of identifying information). But anonymization is not foolproof and, after stripping data of personally identifiable information, the remaining data may be of limited utility. This is where synthetic data comes in.

Continue Reading Synthetic Data Gets Real

On May 5, 2021, the Biden Administration announced its support for waiving intellectual property protections for COVID-19 vaccines.  Understandably, the news made headlines and stirred passionate reactions from the medical community and IP holders alike. But actually bringing about that waiver will be a complicated process, and one that depends on many countries and parties besides the United States.

Continue Reading IP Waiver for COVID-19 Vaccines: What the United States’ Support Means in Practice

In an opinion issued on March 3, 2021, the Supreme Court of Delaware, one of the top commercial courts in the country, overturned a jury verdict that Glaxo Group Limited and Human Genome Sciences, Inc. (collectively, “GSK”) breached the implied covenant of good faith and fair dealing when GSK disclaimed all the claims of a lupus treatment patent it had licensed from Biogen thereby extinguishing its obligation to pay ongoing royalties on sales of its lupus treatment drug. The court’s reasoning and the outcome raise important considerations for life sciences practitioners in the transactional, litigation, and patent disciplines.

Continue Reading Delaware High Court Allows Licensee To Stop Royalty Payments By Disclaiming Patent Claims

The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act of 2021. Formerly S.164, it was introduced in the Senate in February 2021 and sped through the House to enactment on April 23, less than three months later.

Continue Reading “Advancing Education on Biosimilars”: Game Changer or More of the Same?

In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed

The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result, pharmaceutical companies need to consider freedom to operate issues long before they receive FDA approval or market their new product. These considerations might lead a company to take a license, seek to invalidate a competitor’s patent, or some combination of the two. The Patent Trial and Appeal Board (“PTAB”) is a popular venue for challenging patent validity and in 2020, Bio/Pharma and Chemical Patents accounted for 12% of petitions filed at the PTAB.

Continue Reading When Is Less Really More for a Patent Licensee?

Reference product sponsors often obtain patents claiming methods of using a known drug to treat a condition or disease. Because generic and biosimilar developers typically do not treat patients, and thus do not directly infringe the claims, plaintiffs must sue under a theory of induced infringement—i.e., that the generic or biosimilar developer recommended, encouraged, or promoted a patented use for the drug. Demonstrating induced infringement most often involves the label of the defendant’s product, but increasingly may involve non-label evidence such as the defendant’s press releases, brochures, product catalogs, advertisements, and statements to the FDA, doctors, and investors. This non-label evidence is likely to be especially significant in the biologic context.

Continue Reading Induced Infringement of Method of Treatment Claims: Looking to the Label and Beyond

The Ensuring Innovation Act recently became law after passing in the Senate with unanimous, bipartisan support. According to one Senator, the intent of the legislation was to “close loopholes to prevent awarding market exclusivity to products that do not present true innovation and unduly delay cheaper generic from entering the market.” Is this much ado about nothing, or much to be concerned about?

Continue Reading The Impact of the Ensuring Innovation Act on NCE Exclusivity