Posts Tagged: "FDA"

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the world. Meanwhile, the Chinese national government extended the period of exclusivity on pharmaceutical patents from 20 years up to 25 years. While China makes moves to embrace further innovation in the pharmaceutical sector by extending exclusivity for drug developers, the United States has evidenced an incredible amount of skepticism regarding the activities of pharmaceutical patent owners trying to protect their property.

Altaire filed two complaints against Paragon: (1) alleging a breach of the non-disclosure clause of the Agreement, and (2) seeking declaratory judgment that the ‘623 patent was invalid. Paragon, in turn, alleged a material breach of the same clause and sought the termination of the Agreement. Altaire also sought post-grant review of the ‘623 patent, arguing that the patent was obvious over two production lots of its products. After the PTAB issued a final written decision determining that Altaire failed to prove that the asserted claims were obvious, Altaire appealed. The Federal Circuit reversed-in-part, vacated-in-part, and remanded for further proceedings. Circuit Judge Schall disagreed.

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (FDA) seeking to bring generic versions of brand-name pharmaceuticals to the U.S. market. This total number of ANDA cases was below recent highs set in 2014 (437 cases) and 2015 (475 cases) but it was also a significant increase over the 324 ANDA cases filed in 2016. Going back to 2009, 2017 saw the third-highest number of ANDA cases in a single year. The fact that ANDA litigation is rising is pretty consistent with the number of ANDA applications being received by the FDA. In 2017, the FDA approved a record number of ANDAs with 763 such approvals that year; the agency attributed this uptick to an increased number of agency hires.

The preservation of food and beverage products for safe consumption despite extended shelf lives at grocery stores is a major global industry. Both consumers and companies have soon to be Hall of Fame member Mary Engle Pennington to thank… This May, Pennington will be honored along with the rest of the 2018 class of inductees into the National Inventors Hall of Fame for her technological contributions to food storage and safety. With the anniversary of Pennington’s egg preservation patent upon us, we return again to our Evolution of Technology series to take a long view at the history of food storage and the contributions of this year’s Hall of Fame inductee, a pioneering scientist and the first female lab chief at the U.S. Food and Drug Administration.

Competitors like Mylan and Teva, rather than inventing better treatments or cures for dry eyes chose the shortcut. They attacked Allergan’s patent in the PTAB. Allergan responded by assigning their patent to the Saint Regis Mohawk Tribe who in turn invoked sovereign immunity at the PTAB, and demanded their rights in a real court with a real judge and jury. Mylan, Teva, the PTAB, Congress, and class action lawyers have formed a mob to gang up on Allergan for defending their intellectual property rights. They filed hundreds of suits accusing Allergan and the Tribe of fraud, conspiracy, and sham transactions stemming from an “invalid” patent. The attackers are mistakenly focusing on the patent as the problem. The problem is not the patent, but rather all of the incentives that reward copying instead of innovating.

Nothing in my own experience leads me to believe that the PTO applies a lower anticipation or obviousness standard to pharmaceuticals, and I expect this would be news to my colleagues in the industry too. I do, however, often get questions from policymakers, journalists, and others who have been misinformed and led to believe that pharmaceutical companies are re-patenting old drugs to keep prices high, and that our industry is spending “too much” effort on trivial modifications to old medicines rather than creating new ones. Be assured – there is no such thing as “re-patenting,” and our industry is spending plenty on true innovation – but Dr. Michelsohn is certainly raising a fashionable complaint. Public debate by and large seems to have accepted that any given smartphone model is covered by hundreds of patents, but when a complex pharmaceutical product is covered by more than one patent there’s immediate scrutiny and concern.

The Federal Circuit reiterated that the on-sale bar does not exempt commercial agreements between a patentee and its supplier or distributor. It is the commercial character of the transaction that is more relevant than the parties involved when assessing whether there was a commercial offer for sale.

May a court rely on post-priority-date evidence offered to show that a patent lacks written description support even though written description is judged based on the state of the art as of the priority date?  Yes, at least when the evidence relates to whether or not a claimed genus discloses a representative number of species.  Amgen v. Sanofi No. 2017-1480 slip op. Fed. Cir. Oct. 5, 2017 (“Amgen”).   Such evidence, the Federal Circuit observed, is likely to postdate the priority date, because were it to predate, it might be anticipatory.  To consider such evidence is therefore a matter of “common-sense,” the Court added.

The issues I will be watching in 2018 other than Oil States are as follows: (1) What does the new Director of the USPTO do with respect to reforming the PTAB? (2) Will the USPTO adopt a code of judicial ethics for PTAB judges? (3) Will the U.S. drop out of the top 10 countries for patent protection in the annual U.S. Chamber IP Index? (4) How will the Federal Circuit resolve Eleventh Amendment sovereign immunity and the assertion of sovereign immunity by Indian Tribes? (5) Will the Federal Circuit continue its unprecedented disposition of cases without an opinion by relying on Rule 36 summary affirmance? (6) Will Conservative groups become even more vocal advocates of a strong patent system?

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned on a finding that the jury was improperly instructed on the criteria for invalidating a patent directed to an antibody for lack of written description.  Thus, will the precedent recently established in Amgen’s PCSK9 case doom the validity of its patents covering Enbrel®?  There are likely two ways that the decision in Amgen v. Sanofi made a validity challenge to Enbrel®’s patents easier.

Novartis has agreed to acquire French radiopharmaceutical firm Advanced Accelerator Applications (AAA) in a deal which values AAA at $3.9 billion USD. The deal, funded through short- and long-term debt, adds the radioligand therapy (RDL) known as Lutathera to the Novartis pipeline. This drug, approved for use in the European Union and currently undergoing trials for approval by the U.S. Food and Drug Administration (FDA), is used in the treatment of patients suffering from neuroendocrine tumors.

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm AbbVie (NYSE:ABBV) against Thousand Oaks, CA-based drugmaker Amgen (NASDAQ:AMGN). According to reports, the settlement follows an agreement between the two companies to delay a generic version of the anti-inflammatory drug Humira from the U.S. market until 2023… Of AbbVie’s total $6.94 billion in net revenues from U.S. and international sales during the quarter, Humira contributed $4.71 billion in revenues.

A memorandum signed by Judge Sleet shows that Mallinckrodt’s patents were invalidated under the Section 101 patentability standard set by the U.S. Supreme Court in 2012’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., a standard affirmed by SCOTUS’ 2014 decision in Alice Corporation v. CLS Bank International. Applying the two-step test for Section 101 patentability, the Delaware court found that the Mallinckrodt patents covered natural phenomenon which did not include an inventive step. The court found that patent claim limitations directed at echocardiography or severe adverse reactions did not satisfy the inventive concept step. “It does not matter what the severe adverse reaction is,” Judge Sleet’s memo reads. “Any reaction to treatment with iNO will be a natural phenomenon, dictated by the patient’s physiological response to the drug.”

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from their efforts. However, in the pharmaceutical industry, the practical duration of protection is often substantially shorter since obtaining a patent is just one piece—albeit a critical one–of bringing a drug to market.

IP-skeptics charge that these inventions are little more than a way for pharmaceutical companies to cynically prolong patent life and maximize profits, without providing any meaningful innovation. This rather simplistic view misunderstands how the patent system works, and the role of patents in incentivizing drug discovery and development. In reality, many of today’s most significant medicines owe their existence to the ability of medical innovators to secure patents for novel new forms and new uses of existing treatments.