I have blogged about the Amgen v. Sanofi case several times, and the case has been summarized in my prior posts andelsewhere.  The case pitted two competing PCSK9-inhibitors against one another, and after several years, resulted in cancelling broad patents covering the new class of antibodies.  Whenever there is any case that cancels patents within the pharmaceutical or biotech space, the common knee-jerk retort from some commentators is that the decision will suppress innovation, chill R&D and discourage any investment in life-saving medicine.  In this case, the opposite is true.

In February 2023, United States Senator Elizabeth Warren penned a letter to Kathi Vidal, Director of the USPTO, asking what the Patent Office can do to blunt Merck’s use of patents to stall entry of lower-cost alternatives for Keytruda.  Unfortunately for consumers, the answer may be, not that much.

Senator Warran recently asked what the Patent Office can do about patent thickets. Yet, the courts are in the unique position of having to contend with scores of patents asserted within a single suit.  When a brand pharmaceutical company shows up with 20, 60 or 100 patents in a single suit, those challenges can be exacerbated by orders of magnitude. So, how have courts face this challenge?  Regeneron’s pending patent suit against Mylan over its prospective biosimilar for Eyelea® is an interesting example.

On April 28, Google published a policy statement on the need for specific patent reforms. The statement was published by Google’s General Counsel, Halimah DeLaine Prado, and titled, Reforming the patent system to support American innovation. The statement is a notable read given that it issued from one of the largest Big Tech companies. The statement identifies four concrete areas where patent reform is purportedly required. Behind its prescriptions lingers its agenda—namely, that patents should have no value at all.

On June 4, the Federal Circuit issued a precedential decision holding that § 285 under the Patent Statute is inapplicable for awarding attorneys’ fees to the prevailing party in a proceeding for inter partes review. The case is Amneal Pharmaceuticals, LLC v. Almirall, LLC, Case No. 2020-1106 (Fed. Cir. Jun. 4, 2020). While the Court’s decision dispenses rather cleanly with the possibility of collecting fees for prevailing in an IPR, the Court nonetheless left open the door to collecting fees if the IPR is intimately tied to a pending parallel district court case. How much does that matter?

The PTAB’s decision in Apple, Inc. v. Fintiv, Inc., Case No. IPR2020-00019 (Paper No. 11) has been designated precedential as of May 5, 2020. The decision outlines the factors that the PTAB will consider when determining whether petitions should be denied under § 314(a) based upon a parallel district court litigation in which the same invalidity arguments have been raised. The case implicates the balance between patent owners and patent challengers, and who carries the heavier load.

Theranos’ patents may have assured investors that the company was a good bet, but that does not mean those patents were a failure of the patent system.  Rather, the patents illustrate a deficiency of IP literacy.  Investors—and recent commentators still—have taken the patents to mean something they are not.  Indeed, the patents—and the file histories behind them—have been public for years. Those patents and file histories revealed many red flags that were apparently ignored. 

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Viewed through that lens, the Respondents argue there is nothing unconstitutional about IPRs.  Congress was expressly given the power to grant patents within the Constitution.  Congress has delegated that power to a federal agency, namely, the USPTO.  Any “right” to a patent therefore derives directly from a Federal Government action, and by that token, it is a public right.  In other words, patents do not embody a natural right of the inventor to exclude others from using his or her invention.  Rather, a patent only exists because Congress has expressly provided for it.