Posts Tagged: "FDA"

According to Merriam-Webster, the “Word of the Year for 2019 is “they” when used in the singular, typically to avoid ascribing a gender to the person being referred to. The larger point is this: language matters. Since this is a space dedicated to secrecy, let’s consider how we use language to determine who gets access to our trade secrets. For today, we’ll be looking specifically at how government does this. After all, they write the laws and so should be practiced at defining exceptions to property rights. Why should the government care at all about business secrets? Examples will help us here. Locally, the fire department needs to know what hazardous chemicals you might be storing at your plant, in case they have to come and put out a fire there. For different but equally compelling reasons, the Food and Drug Administration (FDA) insists on knowing exactly how drugs are made, and the Environmental Protection Agency (EPA) requires submission of pesticide ingredients. And then there is the government as consumer: last year the U.S. spent over $550 billion on purchasing goods and services from the private sector, and with all that economic clout comes the right to demand access to a lot of related data.

Drug innovators are providing much needed focus on rare diseases and, at the same time, leveraging early-stage rare disease results to facilitate down-stream market entry in broad-spectrum diseases. This paper provides a data-based demonstration of how early- and mid-stage pharmaceutical companies are using the Orphan Drug Program—in combination with pursuing patent portfolio protection—to secure investment and de-risk their platforms, thus lowering the financial barrier for expanding their product pipeline. The Orphan Drug Program—which is available for drugs that treat diseases affecting fewer than 200,000 patients annually in the United States—provides a number of incentives that can lower the barrier for successfully getting a drug to market. For instance, due in part to the reduced size of clinical trials associated with rare diseases, gaining regulatory approval for treating rare diseases is widely perceived to be simpler and more cost-effective than gaining approval for broad-spectrum diseases. Indeed, the Food and Drug Administration (FDA) allows a number of alternative clinical trial designs to meet approval standards, and orphan drugs are also more likely to qualify for expedited review and approval procedures. On top of this, orphan drugs are eligible for a 25% tax credit for clinical trial expenses (which can be claimed up to 20 years after receipt of the designation, and can in some instances be applied to offset payroll taxes), eligibility for research grants, waiver of FDA user fees, and a seven-year post-approval market exclusivity.

The spectacular failure of blood-testing firm Theranos is the subject of a riveting book, Bad Blood by investigative reporter John Carreyrou, and an engaging documentary, “The Inventor” on HBO, focusing on Elizabeth Holmes, the once-celebrated wunderkind who dropped out of Stanford at age 19 to “change the world” with a device that would perform hundreds of diagnostic tests with a few drops of blood from a finger stick. It’s a story made for Hollywood (Jennifer Lawrence will play Holmes in the forthcoming movie), filled with lies, deception, threats and sex, set in a Silicon Valley startup. But even the Theranos story doesn’t mean that trade secret law is inherently dangerous. Consider Apple, one of the world’s most secretive companies. (Holmes famously modeled her clothing and business habits after Steve Jobs.) Apple has consistently used NDAs and secrecy management to protect products under development, to great effect when they are ultimately unveiled, all without touting non-existent technology. And it’s easy to imagine how Theranos might never have happened if investors and business partners had been less credulous and more insistent to understand the technology.

This week in Other Barks & Bites: the Chinese government announces stricter punitive measures in its IP system; the Federal Circuit says state sovereignty principles do not allow the University of Texas to bring suit in an otherwise improper venue; Congressional leadership asks Google to expand copyright protections under its Content ID tool; Google and Facebook to face antitrust probes from state AGs; George Mason University to create an Innovation Law Clinic; Ariana Grande files a copyright and trademark infringement suit against Forever 21; the Hudson Institute publishes a report on China’s 5G developments; and South Korea’s government has reportedly been collecting copyright payments for use of North Korean TV broadcasts.

The United States is on the brink of making changes to the U.S. patent law that would be modeled on India’s Patent Law. At a Senate Judiciary Committee markup scheduled for tomorrow, June 27, Senator Lindsey Graham (R-SC) plans to offer language as an amendment in the form of the No Combination Drug Patents Act. The language of the bill would prohibit the patenting of new forms, new uses and new methods of administration of new medicines unless the patent applicant can show “a statistically significant increase in efficacy”. This language is oddly similar to India’s Section 3(d), something the Trump Administration’s U.S. Trade Representative has complained “restricts patent eligible subject matter in a way that poses a major obstacle to innovators” (see here, page 49). Other Senators have also weighed in against “a generally deteriorating environment for intellectual property” in India (see here), including Judiciary Committee ranking member Dianne Feinstein (D-CA) and Judiciary Committee members Mike Crapo (R-ID), Amy Klobuchar(D-MN)and Chris Coons (D-CT).

This week in Other Barks & Bites: The United Nations highlights the importance of women in innovation on International Women’s Day; Comments due today on USPTO Section 101 Guidance; FDA Commissioner Scott Gottlieb resigns; a Senate bill with six bipartisan co-sponsors would increase requirements on patent disclosures for biologics; USPTO Director Iancu speaks out on Alice; Apple announces its intention to increase its presence in San Diego while its patent battle with Qualcomm heats up; Chinese copyright registrations increased by double digit percentage points in 2018; Stanley Black & Decker faces off against Sears in a trademark infringement battle over branding for Craftsman tools; Amazon announces that it will close dozens of pop-up stores in the U.S.; and Democrats from both houses of Congress introduce a new net neutrality bill.

Earlier this month, the Federal Circuit dismissed an appeal from the Patent Trial and Appeal Board (Board) where the Board upheld the patentability of a biologics patent. After Momenta Pharmaceuticals petitioned the Board for an inter partes review (IPR) of the patentability of Orencia® (abatacept), the Board sustained patentability and Momenta appealed. During the course of the appeal, Momenta ceased development of an abatacept biosimilar. The Federal Circuit held that the cessation of potential infringement mooted the injury and removed Momenta’s standing to maintain the appeal. Momenta Pharm., Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, 2019 U.S. App. LEXIS 3786 (Fed. Cir. Feb. 7, 2019) (Before Newman, Dyk, and Chen, Circuit Judges) (Opinion for the Court, Newman, Circuit Judge).

Without any explanation, analysis or justification, Chief Judge Prost, and Judges Reyna and Hughes affirmed the decision of colleague Judge Bryson. A patent to a blockbuster drug like Restasis, which has over $1.4 billion in annual sales in the United States, deserves greater consideration than a once sentence disposition that simply says: “Affirmed.”… It is one thing to use Rule 36 to dispose of an appeal that should never have been brought relating to an invention of modest or no commercial success. But there is something fundamentally arrogant about using Rule 36 to finally strike a fatal blow to a patent covering a blockbuster drug responsible for more than $1.4 billion in annual sales in the United States. And given that the district court judge was Judge Bryson, the lack of an opinion only raises further questions.

Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive available to the first generic manufacturer to file a paragraph IV challenge when the Orange Book drug patent is successfully invalidated in a subsequent district court proceeding. Therefore, the IPR process has provided generic manufacturers a dual track option for challenging Orange Book patents by initiating Hatch-Waxman litigation and also pursuing IPRs. Overall, because the rate of settlement in IPRs is much lower than in Hatch-Waxman litigation, both generic manufacturers and patent owners obtain more favorable final decisions in IPRs as compared to their Hatch-Waxman litigation outcomes.

While the changes to the Trial Practice Guide begin to move the rules in the right direction, more is needed before post-grant proceedings will be accepted as neutral to all parties.  The PTAB should endeavor to adopt the time-honored burdens, presumptions and procedures used in the district courts for trying patent cases whenever reasonably possible.  Petitioners should be required to prove that the art upon which they rely is not cumulative to that previously before the USPTO, a patent owner’s Preliminary Response presenting evidence raising genuine issues of material fact should be treated as it would be if presented in opposition to a summary judgment motion brought in the courts, and the presiding panel should determine witness credibility by hearing testimony and cross examination live.

In order to establish that the commercial success factor supports a non-obviousness finding, the patentee must establish that a connection (or nexus) exists between the novel aspects of the patent claim(s) and the alleged commercial success. Id.; WesternGeco LLC v. ION Geophysical Corp., 889 F.3d 1308, 1330 (Fed. Cir. 2018). In other words, the patentee must show that the novel aspects of the claim(s) are driving sales and not aspects of the claim(s) that were known in the prior art. In re Huai-Hung Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011); WesternGeco, 889 F.3d at 1330. In cases brought pursuant to the Hatch-Waxman Act, while there are exceptions, it is most common that patent challengers’ arguments focus predominantly or entirely on an alleged lack of nexus given the substantial sales typically enjoyed by the brand-name drug products that are the subject of such litigation. Though it bears noting that the mere fact that a company is pursuing a generic version of a brand-name drug, by itself, does not support a “commercial success” finding. Galderma Labs., Inc. v. Tolmar, Inc., 737 F.3d 737, 740 (Fed. Cir. 2013).

When relying on scientific guidelines to support an obviousness rationale, practitioners should offer evidence for why contradictory guidelines should be discounted. A claimed constituent is not “necessarily present” if the prior art reference lists several alternative constituents and a skilled artisan could not reasonably deduce that the authors of the prior art reference used the claimed constituent.

The Federal Circuit reviewed whether certain prior art was “publicly accessible,” because Jazz alleged the material was not a “printed publication” under Section 102(b). Jazz argued that the material, meeting minutes, transcripts, and slides pertinent to an FDA advisory meeting scheduled during the review process for a particular “sensitive drug” (Xyrem), failed to meet a “searchability or indexing” requirement and that the Board erred by “equating the constructive notice provided by the Federal Register with the legal standard for prior art.” The Court rejected both arguments, relying on three precedents, MIT, Klopfenstein, and Medtronic, to analogize and proceed on a “case-by-case” analysis of the facts and circumstances surrounding the disclosure to the public – the proper inquiry for determining if a reference is a “printed publication.” The Court looked at three factors: the breadth of the dissemination; the amount of time the materials were available before the critical date; and, the presence or absence of an expectation of confidentiality. Comparing the facts to its three precedents, the Court found that each of the three factors supported the conclusion that the materials were printed publications and thus prior art.

The sole question on appeal was whether it would have been obvious to make zolmitriptan into a nasal spray. The Federal Circuit agreed with the district court that the prior art taught away from formulating zolmitriptan for intranasal administration.

Proving inducement to infringe requires showing that the accused infringer possessed “specific intent” to infringe. In pharmaceutical cases, particularly those arising in the Hatch-Waxman framework, specific intent may be supplied by the wording of a drug label. Vanda sheds light on several issues relevant to inferring inducement to infringe based on a drug’s label. For example, can a label’s clear recommendations on ultimate dosage be negated by how a medical provider arrives at the dosage? Or, does finding specific intent require that every practitioner prescribe an infringing dose? Or, can evidence of substantial non-infringing use negate a finding of inducement when the drug’s label instructs performing the patented method?