On November 5, 2024, Donald J. Trump won the presidential election in a convincing fashion. One of his allies Robert F. Kennedy, Jr. will play a prominent role in his Administration. Mr. Kennedy has pledged to Make America Healthy Again. Movement in this direction may have profound impacts to pharmaceuticals, vaccines, and food which can … Continue reading →
On June 10, 2024, the New Jersey District Court ordered Teva to remove (or delist) five patents from the Orange Book in a case involving Pro-Air HFA®(albuterol). Of course, the decision analyzed exactly what patents belong in the Orange Book. The Orange Book – A Quick Primer Decades ago, FDA established a book where NDA … Continue reading →
Counting is one of the first things you learn as a child, sort of like this bunny counting carrots in his cart. While counting may seem relatively easy, sometimes it’s not so simple when interpreting patent claims. “pH of 13 or higher” To improve the product’s stability, the developers of Veletri®(epoprostenol) focused on its pH … Continue reading →
A curious PIV case surfaced at the end of October involving Lonsurf®(trifluridine and tipiracil) Tablets and its 9,943,537 patent. It reminds us of some similar behavior of Bristol-Myers from 20+ years ago which brought an aggressive response from the US Federal Trade Commission. On October 20, 2023, Taiho filed a PIV case against ANDA filer … Continue reading →
We can’t let January go by without some personal fanfare. ParagraphFour.com has reached the 20 year mark! “Just put up a website.” The ParagraphFour.com journey started in the summer of 2003 when I had the idea to start researching PIV cases. At the time, legal cases were all over the place and hard to access. … Continue reading →
This year’s Annual Review made me reflect on the Paragraph IV Market over the past years. We have reached a new plateau which indicates that the terrain is a bit rocky at this point for anyone participating. Consistently Fewer ANDA Filings The high-point of the PIV Market was 2015 which saw a record number of … Continue reading →
On November 7, 2023, the Federal Trade Commission issued a Press Release targeting more than 100 patents currently listed in the Orange Book. The Press Release elevates its position that certain device-related patents are not appropriate for listing and demands their removal. 10 Companies Notified, Sort-of Over the past couple of months, FTC has notified … Continue reading →
Like a salmon at the end of a buffet, decades-long PIV litigation over Latisse®(bimatoprost) Topical Solution came to a hard ending. PIV Litigation since 2010 Back in 2010, several generic companies showed an interest in the eyelash growth product Latisse®(bimatoprost). Allergan subsequently filed nearly 20 PIV cases against five ANDA filers. The Court of Appeals … Continue reading →
On July 14, 2023, Gilead filed two PIV cases in Delaware which were similar, yet curiously different. They both involve its $2B product Genvoya®(elvitegravir, cobicistat, emtricitabine, tenofovir) Tablets and one ANDA filed (ANDA 218575). The First Complaint Gilead filed its first Complaint against two defendants Apotex and MSN Laboratories over the 10,039,718 patent (# 1:2023cv00774). … Continue reading →
Earlier this month, Vanda submitted a Citizen Petition asking FDA to revoke the approval of Teva’s ANDA product for Hetlioz®(tasimelteon) Capsules, the sleep disorder drug. Vanda also asks FDA to remove the Teva product from the market. This Petition comes after Vanda lost its PIV case in December which case is pending appeal. (Citizen Petition: … Continue reading →
