Posts Tagged: "ANDA"

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.

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of the decision compares Vanda’s claims to those found ineligible for patent protection in the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012). While the ultimate patentability conclusions are opposite, the claims in Vanda and Mayo are very similar, highlighting the thin—and often unpredictable—line that divides eligible and ineligible subject matter. Generic drug manufacturers must account for this unpredictability in gauging their litigation risks.

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.

35 U.S.C. § 271(e)(2) provides that it shall be an act of infringement to submit an Abbreviated New Drug Application (“ANDA”) “if the purpose of such submission is to obtain approval … to engage in the commercial manufacture, use, or sale of a drug … claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.” 35 U.S.C. § 271(e)(2). The statute requires that the infringement analysis focus on what is likely to be sold following FDA approval. Bayer AG v. Biovail Corp., 279 F.3d 1340, 1346 (Fed. Cir. 2002). The governing case law holds that this hypothetical inquiry is grounded in the ANDA application itself, the materials submitted in support thereof, as well as any other relevant evidence submitted by the applicant or patent holder. However, as reflected in the below discussion of key Federal Circuit case law examining the appropriate analytical approach, and the sorts of evidence properly considered, when assessing infringement in the ANDA context, these seemingly bedrock legal principles in reality fall by the way side and, therefore, neither patentees nor ANDA applicants should allow themselves to be lulled into a false sense of security through reliance on such verbiage.

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.

Merck appealed the lower court’s finding of non-infringement of U.S. Patent No. 6,127,353 (“the ‘353 patent”), which is directed toward mometasone furoate monohydrate (“MFM”), commercially used in Merck’s Nasonex… Merck further contended that the district court erred by basing its non-infringement ruling on the “Day 1 Batches” rather than the “A Batches” because the focus must be on what will be the final commercial product. However, the Federal Circuit rejected this argument by pointing out Merck’s failure to prove a material difference between the “Day 1 Batches” and the “Day 4 Batches” and “A Batches.”

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.

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including Dr. Reddy’s, Zydus, Cipla, and Lotus Pharmaceutical.  Those ANDAs have triggered corresponding Hatch-Waxman lawsuits from Celgene.  Among the asserted patents, most of them expire by 2022, with the exception of two polymorph patents that could extend Revlimid® monopoly until 2027.  The lawsuits are in their early stages, but an upcoming Markman hearing in the case against Dr. Reddy’s is shaping up to be critical to whether Celgene can protect is Revlimid® monopoly past 2022.

The PTAB subjects all patent owners to double jeopardy, but the situation is particularly bad for pharmaceutical companies which already have to face a Congressionally-mandated validity review process under the Drug Price Competition and Patent Term Restoration Act, colloquially known as Hatch-Waxman. This law creates a regime by which a generic drugmaker can file an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA). The branded pharmaceutical listed in the Orange Book will be covered by patents but the generic drugmaker can include a Paragraph IV certification in the ANDA, a declaration that the patents covering the Orange Book-listed drug are unenforceable and invalid. When a company like Allergan has to face Hatch-Waxman validity trials in federal district court and serial IPRs at the PTAB, it turns Allergan’s Restasis patents into piñatas taking hit after hit at multiple forums before being finally ripped asunder at some point.

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.”

Inherent obviousness cannot be based on what the inventor thought, and, in addition, the results in a particular case may not be inherently obvious depending on what was expected by a person of ordinary skill. The court pointed out “’the mere fact that a certain thing may result from a given set of circumstances is not sufficient’ to render the results inherent.” Millennium Pharmaceuticals, 2017 WL 3013204, at *6 (citations omitted by author). The court also held that it is never appropriate to consider “what the inventor intended when the experiment was performed,” even though Millennium “conceded as a matter of law that the ester is a ‘natural result’ of freeze-drying bortezomib with mannitol.” Id. Thus, hindsight reasoning should never be applied and, obviousness is “measured objectively in light of the prior art, as viewed by a person of ordinary skill in the invention.”

Lex Machina recently released a Hatch-Waxman/ANDA litigation report detailing trends and key findings from pharmaceutical cases filed in U.S. district courts between January 1st, 2009, and March 31st, 2017. More than eight years worth of data shows that patent infringement case filings in response to abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) declined in 2016 for the first time in three years.

In Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., the Federal Circuit reversed the district court and held that Helsinn’s pre-AIA patent claims, “were subject to an invalidating contract for sale prior to the critical date,” and furthermore, “the AIA did not change the statutory meaning of ‘on sale’ in the circumstances involved here.” The asserted claims of the post-AIA patent were also ready for patenting prior to the critical date… The on-sale bar, before and after the AIA, does not require a finding that the offer or sale disclosed the details or claimed features of the invention, so long as the product embodies those features when sold. An invention is reduced to practice, and ready for patenting, when it is reasonably shown to work for its intended purpose, which for a pharmaceutical product is not contingent upon FDA approval.

A claim term can be limited to an embodiment described in the specification, if the claim would otherwise be found invalid and the embodiment was not disclaimed. Thus, a claim term with no ordinary meaning can be defined according to a single example in the specification, if the example provides “a clear objective standard” for that term.