Posts in Government

One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, published by the National Institute of Standards & Technology (NIST) and the Department of Commerce last month, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.

The first software patent was granted in 1968. It’s now been three decades since the “Year of the Algorithm” in 1994, when cases such as In re Allapat, In re Lowry, and In re Beauregard initiated a wave of software patents. Well over half of U.S. patents granted annually are at least “software-related,” and even a cursory search of U.S. patents reveals software patents in fields ranging from encryption to speech recognition to network security. Why, then, do so many people continue to think that software cannot be patented at all? What explains the stark contrast between the long-standing legal reality and the beliefs of otherwise well-informed engineers, high-tech business people, and even some lawyers?

On April 1, 2024, a new fee system will enter into force at the European Patent Office (EPO). Apart from moderate fee increases (more than 7% below the real inflation rate) and the abolishment of several rarely used fees, the new fee system introduces a new fee reduction scheme for so-called micro-entities.

An en banc panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) today heard arguments from LKQ Corporation, the U.S. government and GM Global Technology Operations in a case that could change the test for assessing design patent obviousness. The judges seemed interested in tweaking the existing “Rosen-Durling” test but struggled with getting the parties to clearly articulate a replacement approach that wouldn’t be potentially just as bad. The so-called Rosen-Durling test for design patent obviousness requires that, first, under In re Rosen (C.C.P.A., 1982), courts identify a prior art reference “the design characteristics of which are basically the same as the claimed design.” Next, under Durling v. Spectrum Furniture Co., 101 F.3d 100, 103 (Fed. Cir., 1996)), if such a reference is identified, the court must consider whether it can be modified based on other references to come up with “the same overall visual appearance as the claimed design.”

February 6 is the final day of the 60-day public comment period set by the National Institute of Standards and Technology’s (NIST) request for information on its draft interagency framework for exercising march-in rights under the Bayh-Dole Act of 1980. While lauded by drug pricing advocates, almost every other sector of the American economy has come out in opposition to the draft framework. Senator Thom Tillis (R-NC), the U.S. Chamber of Commerce and the Bayh-Dole Coalition have all publicly opposed NIST’s efforts to exercise legal authority for relicensing patent rights based on product pricing considerations.

Today, the U.S. Department of Health and Human Services (HHS) made its initial offers to pharmaceutical companies pursuant to the Biden Administration’s Inflation Reduction Act of 2022 (IRA), which allows the U.S. Government to “negotiate” Medicare drug prices under a set framework based upon the amount of time a drug has spent on the market. Opponents of the program, including the U.S. Chamber of Commerce, which is suing the government over the plan, argue it cannot be characterized as a voluntary negotiation since the affected companies would be subject to onerous excise taxes for refusing to participate and because it would have devastating consequences for patients if companies were to actually pull the affected drugs. The amounts of today’s initial offers were not revealed.

It was an average week for patent filings at the Patent Trial and Appeal Board (PTAB) and a slightly above-average week in district courts, with 62 district court complaints filed and 21 new PTAB petitions—one petition for Post Grant Review (PGR), and 20 for Inter Partes Review (IPR). The PTAB instituted 13 cases; iInstitution was denied in 12 cases and 15 cases settled. In district courts, 62 new cases were filed and 12 cases were terminated.

In a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. According to the brief, when Moderna was seeking approval for its COVID-19 vaccines, the company “candidly represented to the FDA that prior studies for related vaccines…supported an expectation of safety and efficacy. But now, faced with invalidating vaccine prior art…Moderna wrongly casts the same vaccine prior art as irrelevant.” The brief referred to this as a “litigation-driven one-eighty.”

Speakers at IPWatchdog’s PTAB Masters 2024 program this week predicted there will be little movement on the U.S. Patent and Trademark Office’s (USPTO) Advance Notice of Proposed Rulemaking anytime soon, but some pinned their hopes for change at the Patent Trial and Appeal Board (PTAB) to the pending Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. Both panelists who typically represent petitioners and those who represent patent owners at the PTAB also agreed there are a number of ways the perception of the Board could be improved. These could include changes like allowing oral argument more often, allowing experts to testify in person, and a more meaningful rehearing procedure, for example.

Last week, biopharmaceutical company Liquidia Technologies filed a petition for writ of certiorari with the U.S. Supreme Court to appeal a Federal Circuit ruling that affirmed induced infringement findings against Liquidia following the patent at issue being invalidated at the Patent Trial and Appeal Board (PTAB). In the petition, Liquidia argues that two previous Supreme Court rulings lead to a result contrary to the Federal Circuit’s determination that the invalidation of patent claims at the PTAB do not have preclusive effect on infringement litigation pending an appeal of the PTAB’s decision.

It was little more than a month ago when the Biden Administration unleashed its draft guidelines for applying the march-in provisions of the Bayh-Dole Act. For more than 43 years, the law was implemented as written. Every Administration—including the Biden Administration—rejected repeated attempts to misuse the law so the government could license copiers when critics felt that a product based on a federally-funded invention was too expensive. This was mainly sought under the guise of lowering drug prices. Even though the Administration issued a stinging denial of the most recent attempt last March, in December it reversed course.

Both the Biden and Trump Administrations have made it abundantly clear that economic and technology security is now national security. In the latest National Security Strategy, the Biden Administration stated, “Technology is central to today’s geopolitical competition and to the future of our national security, economy, and democracy. U.S. and allied leadership in technology and innovation has long underpinned our economic prosperity and military strength. In the next decade, critical and emerging technologies are poised to retool economies, transform militaries, and reshape the world.”

An examiner interview is the best tool available to progress patent prosecution. Examiner interviews provide an avenue to quickly clear up misunderstandings, explore options, and reach resolutions. By the time I left law firm life to work in-house, I was interviewing nearly every Office Action. Over the years, I refined a style that was very effective, so much so that a partner once asked me how I was getting such good results, but at the time, I could not articulate what exactly I was doing or why it worked. In retrospect, I was successful because I argued less and negotiated more.

Filings began picking up again this week after a slow start in the new year in both the Patent Trial and Appeal Board (PTAB) and district courts. The PTAB had a busy week with 31 new filings—one Post Grant Review (PGR) and the rest Inter Partes Reviews (IPRs). Nearly half of all new PTAB filings came from just two entities: Apple and Neurent Medical…. The PTAB was also busy issuing 27 institution decisions (21 instituted and 6 not instituted).

Today, a letter signed by a coalition of top academics opposing the Biden Administration’s efforts to exercise march-in rights under the Bayh-Dole Act of 1980 was sent to the White House. Signed by academics in fields including law, economic policy and sciences, the letter warns the Biden Administration that its efforts to drive down drug pricing by seizing patent rights will “undermine fundamental principles that have made the American IP system the golden standard for supporting domestic innovation.” A growing topic during recent Congressional debates, march-in rights under Bayh-Dole took on a new focus in early December when the National Institutes of Standards and Technology (NIST) and the U.S. Department of Commerce released a draft framework of factors that federal agencies should consider for the exercise of authority codified at 35 U.S.C. § 203 that would compel patent owners holding rights to federally-funded inventions to license those rights to “responsible applicants.”