Novartis is currently involved in a multi-district patent litigation campaign to block generic entrants for Entresto®, which is Novartis’ blockbuster heart medication. In the fall of 2022, Novartis went to trial on the validity of one of the asserted patents, U.S. Patent No. 8,101,659(“the ‘659 patent”). On July 7, 2023, the district court invalidated the patent for lack of written description despite rejecting an enablement defense based upon the same evidence. The district court’s decision highlights a clear tension between claim construction and enablement that, if left to stand, could permit pharmaceutical companies to block lower-cost generic medications with patents they did not actually invent. Read the full post at IPWatchddog.
Read MoreI 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.
Read MoreThe long-running patent dispute between Amgen ($AMGN) and Regeneron($REGN) and Sanofi over their competing PCSK9-inhibitors (Repatha® and Praluent®) has reached another milestone. The case also represents another milestone in the changing landscape for patents covering biologic drugs. The Amgen decision is at least the second district court decision this year that has invalidated biologic antibody patents under the doctrine of enablement. The earlier decision related to MorphoSys patents asserted against Janssen related to Darzalex®. The takeaway is clear: as biologic drugs take up a larger share of the pharmaceutical medications in the U.S., courts are making it harder for drug companies to use overly-broad patents to corner the market on a particular inhibitor.
Read MoreTheranos’ 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.
Read MoreSee our post in IPWatchdog. “The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.”
Read MoreMorphosys’ ($MOR) patent trial against Janssen ($JNJ) and Genmab was headed for trial in February. In advance of that trial, however, the parties traded numerous summary judgment motions. On January 26, Genmab announced that the District Court granted its motion to invalidate the asserted patents. What happens next?
Read MoreEarlier this week, we blogged about the series of pending summary judgment motions in MorphoSys’ ($MOR) lawsuit accusing Janssen’s ($JNJ) Darzalex® of infringing its patents. The Court heard oral argument on December 3. The transcript of that hearing is not currently publicly available. The Court, however, did issue oral rulings at the end of the hearing that hit the docket on December 4. What do the rulings mean?
Read MoreAmgen’s ($AMGN) patent fight against Regeneron ($REGN) and Sanofi has been quiet for much of this year. But it is likely to heat up again shortly. What is coming up?
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