Greenblum & Bernstein, P.L.C.
Recent News in Intellectual Property
In This Issue:
· GDUFA Regulatory Priorities for 2016
· Allergan will not appeal Second Circuit Ruling Blocking it from Discontinuing Alzheimer’s Drug in Favor of Newer Version
· CRISPR Named Breakthrough of the Year
Walter Schlapkohl, Ph.D., Esq.
The purpose of the Generic Drug User Fee Act (GDUFA) program is to help FDA ensure U.S. generic drugs comply with quality standards and to increase the likelihood that Americans have access to low cost, high quality generic drugs. Industry must pay user fees to supplement the costs of reviewing applications for generic drugs and for inspecting facilities.
As part of GDUFA, FDA has also committed to preparing a yearly list of regulatory science priorities for generic drugs. The priorities are based on input from stakeholders.
For fiscal year 2016, the regulatory science priorities are:
· Post-market evaluation of generic drugs;
· Equivalence of complex products;
· Equivalence of locally-acting products;
· Therapeutic equivalence evaluation and standards; and
· Computational and analytical tools.
Interestingly, FDA noted that it is spending an increasing amount of time reviewing and developing policy for complex drug products, such as drug-device combinations, transdermal systems, implants, nanomaterials, and products that contain “complex mixtures and peptides.” FDA also noted that future generic drugs will need to demonstrate equivalence to increasingly complex reference drugs. Thus, FDA has included in its 2016 regulatory science priorities research into making generic versions available in all product categories, including complex drugs with “unique characteristics,” specifically “transdermal irritation studies” and “human factors studies that will aid in evaluation of product substitutability and robustness for drug-device combinations.”
On November 25, 2015, Allergan PLC (formerly Actavis PLC) announced that it would not appeal a ruling that enjoined it from pulling its product, Namenda IR – a twice daily medication for Alzheimer’s disease – from the market. Allergan also indicated that it would pay $172,000 in legal expenses under a settlement with New York Attorney General Eric Schneiderman.
So ended a legal battle between Allergan, the brand name maker of Namenda IR and Namenda XR, and the State of New York, which began in September 2014. Allergan had sought to discontinue twice-daily Namenda IR in favor of its newer product, once-daily Namenda XR, before Allergan’s patent rights on the twice-daily drug had expired – a practice sometimes referred to as “product hopping.” The move would have inhibited sales of generic versions of the twice-daily medication, which were tentatively set to enter the market in July 2015.
At the district level, and again on appeal, the State of New York successfully argued that withdrawal of Namenda IR from the market would effectively (and improperly) allow Allergan to maintain its monopoly on the medication because patients would first be required to switch from twice-daily Namenda IR to the once-daily Namenda XR before switching back to a twice-daily generic version after the generic version had reached the market (see New York v. Actavis PLC, 787 F.3d 638 (2d Cir. 2015)).
On appeal at the Second Circuit, Allergan argued that its patent rights, i.e., the right to choose whether or not to use or sell its invention, had been improperly limited by the district court’s ruling. Further, after losing on appeal at the Second Circuit, Allergan filed a petition earlier in November for U.S. Supreme Court review of the case (Allergan PLC v. New York, U.S., No. 15-587, review sought 11/4/15). However, with Allergan’s statement that it will not pursue Supreme Court review of the matter, it appears that the question of whether it is a violation of antitrust law for pharmaceutical companies to engage in “product hopping” will remain unanswered by the Supreme Court for now.
Science magazine has named the DNA-editing technology known as “CRISPR” as its Breakthrough of 2015. CRISPR, also known as “CRISPR-Cas” or “CRISPR-Cas9,” was first identified as an unexpected defense mechanism that bacteria use to fend off viruses. CRISPR stands for “clustered regularly interspaced short palindromic repeats.” According to Science, what sets CRISPR apart from previous DNA-editing technology is its easy and inexpensive application.
CRISPR was a runner-up for Breakthrough of the Year in 2012 and 2013, but this year it rose to the top in view of a series of achievements with the technology that include, among other things, creating of a “gene drive” that can quickly spread a desired genetic trait throughout a population, and the first deliberate editing of human embryos (the embryo experiments were performed in China with nonviable embryos from a fertility clinic).
Yet CRISPR’s biological and medical applications are just beginning to emerge. Industrial interest in CRISPR technology spans the food, agriculture, medical/health, and laboratory sectors.
In our July 2015 issue, we reported on a potentially very big battle relating to the intellectual property rights for the DNA-editing technology, which battle may take years to resolve.
Given the DNA-editing technology’s rapid progress and power, there will certainly be ethical, ecological, and legal issues to address going forward – issues which will require equally rapid attention and powerful resources from not just direct stakeholders but the public at large.
Regulatory Science Priorities for Fiscal Year 2016, available at