Posts Tagged: "pharmaceuticals"

Certainly, patents that read on a potential cure for COVID-19 deserve special treatment. After all, the cure for COVID-19 is not only crucial to save lives all over the world, but also to avoid the collapse of the global economy. Yet, what such special treatment might look like and how special a treatment is necessary is where opinions diverge. In the United States, activists demand that the government should have the rights to the anti-retro viral drug, ‘Remdesivir’. The Open Covid Pledge proposes that all IP related to COVID-19 should be made freely available. Its founding adopters were technology companies such as Facebook, Microsoft, Intel, IBM and Amazon. In contrast, among pharmaceutical companies, the idea of giving up all related IP for free has been viewed critically. With this in mind, the question is therefore not whether patents related to COVID-19  should be given away for free or not, but rather how the profit motive can be managed in public- private partnerships for the benefit of public health.

On Friday, May 29, the World Health Organization (WHO) officially launched the COVID-19 Technology Access Pool (C-TAP), an initiative which is intended to improve access to treatments, vaccines and other medical technologies which are developed in response to the global COVID-19 pandemic. The program, initially proposed by Costa Rica, has highlighted the tension between pharmaceutical developers and advocates for access to medicine, which has been magnified by the economic concerns created during the global shutdown.

If the objective is to beat this virus as fast as possible it simply isn’t helpful to talk about the compulsory licensing of drugs that don’t yet exist and the patents that can’t possibly be issued by the United States Patent and Trademark Office for at least the next two to three years. The COVID-19 crisis will be long since over by the time the first patent issues relating to anything specifically related to COVID-19. Yet somehow it is viewed as productive to demand compulsory licensing of vaccines, treatments and cures for COVID-19 that do not exist?

Since China announced the first fatality caused by a virus about which little was known at the time, coronavirus and the disease it causes, COVID-19, has grown to pandemic proportions. In the less than three months since that first death, this new strain of the severe acute respiratory syndrome-related (SARS) coronavirus has shuttered social gatherings, precipitated a mandatory work-from-home revolution and decimated large parts of the world’s economy. As of the afternoon of March 27, the Coronavirus Resource Center at Johns Hopkins University reports that more than 585,000 cases of COVID-19 infection have been confirmed worldwide, resulting in a total of 26,819 deaths. Those figures have been increasing exponentially each day.

The recent White House meeting with leaders from American pharmaceutical companies sought their help in solving the coronavirus that originated in Wuhan, China and is currently gripping the globe. The meeting was part of the U.S. government marshaling our nation’s private and public medical research and development (R&D) resources in a race to create therapeutics, vaccines, diagnostic tools and cures. The Wall Street Journal has noted that “a core U.S. strength is the breadth of its private medical resources. That’s on display now as the government is calling on private actors to buttress the federal response.” Ironically, the same U.S. government urging the same private industry whose intellectual property rights enable it to develop medical miracles to help is targeting American pharmaceutical firms with a number of IP-killing policy proposals. One such bad idea comes from the Food & Drug Administration in a rulemaking titled “Importation of Prescription Drugs Proposed Rule (Docket No. FDA-2019-N-5711).”

A recent article by Dr. Kristina M. L. Acri née Lybecker highlighted her research about the fiscal workability of state pharmaceutical importation programs from two important aspects. Dr. Acri’s whole paper is very good. I recommend you read it if you’re into policy and not sound bites. I noticed, however, that the comments on the article elicited some common myths about Canadian drug importation that are important to address if we’re going to really understand this issue.

In mid-December, President Trump presented a plan to lower prescription drug prices by allowing states, drug wholesalers and pharmacies to import some cheaper drugs from Canada. While reducing the cost of medicines is a laudable goal, pharmaceutical importation programs – if implemented safely and effectively – would fail to deliver the promised savings. And if implemented without the necessary safeguards, they would endanger the lives of countless patients. The plan essentially relies upon importing price controls from Canada, which will both undermine innovation and prove unsustainable. As with many “simple solutions” the devil is in the details. Not surprisingly, the Trump Administration’s plan contains very few details on implementation. And it is precisely those details that are expensive and complicated.

The pharmaceutical industry presents some of the most important and challenging issues lying at the intersection of the patent and antitrust laws. On the one hand, patents play a crucial role in the industry, which is unique in the cost and duration of reaching the market. But on the other, a complicated regulatory regime and the event of generic entry (which dramatically lowers price and which the brand firm has interest in delaying) opens the door for potentially anticompetitive behavior. One area where this tension has surfaced in recent years has involved the settlement of patent litigation. In 2013, in FTC v. Actavis, the Supreme Court held that agreements by which brand-name drug companies pay generics to settle patent litigation and delay entering the market could have “significant anticompetitive effects” and violate the antitrust laws.

In most respects, the widely reported patent complaint recently filed against Gilead is perfectly ordinary. It was filed in the U.S. District Court for the District of Delaware, the most common venue for patent infringement lawsuits, and alleged that a pharmaceutical company’s drug sales infringed the plaintiff’s patents on uses of the sold drug. The defendant’s response has so far been similarly unexceptional:  Gilead has filed petitions for Inter Partes Review (IPR) of each asserted patent (see links below), arguing that those patents are invalid over the prior art, either as obvious or as entirely anticipated. What is remarkable about this lawsuit, however, is that the plaintiff is the government of the United States.

Petitioners challenging patents covering pharmaceuticals and biologics often use drug product labels as prior art in the Patent Trial and Appeal Board (PTAB). To effectively use a label as prior art, a petitioner must show that it is a “printed publication” under 35 U.S.C. §§ 102 and 311(b). Past PTAB cases demonstrate, however, that proving drug product labels as prior art can be fraught with danger. But practitioners can employ best practices to guard against this. In Celltrion, Inc. v. Biogen, Inc., IPR2016-01614, Paper 65 (Feb. 21, 2018), the Petitioners relied on a copyrighted label for Rituxan that was published on the internet and available on the Food and Drug Administration’s (FDA’s) and on Biogen’s website all before the critical date. The Board held that the Petitioners did not provide sufficient evidence establishing that the drug label was indeed the one disseminated with Rituxan at the time it was proposed to be publicly available or that “persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Similarly, the Board held in Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01563, Paper 16 (Feb. 3, 2017), that a relied-upon Glucophage label had no source identifying information or indicia of when it became publicly available and the declaration attesting to its publication was not based on personal knowledge, but was merely conclusory.

On October 9, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. affirming the U.S. District Court for the District of New Jersey’s findings of invalidity and noninfringement of certain claims of some of the asserted HZNP (Horizon) patents, as well as the district court’s finding of nonobviousness of one claim of another Horizon patent. The finding of nonobviousness means that Actavis, owned by generic drug maker Teva Pharmaceuticals, is enjoined from engaging in the commercial use, offer for sale, or sale of its product covered in its Abbreviated New Drug Application (ANDA) until the expiration of U.S. Patent No. 9,066,913 (the ‘913 patent) in 2027.

The landmark judgment of the Supreme Court of India in Novartis AG & Ors. .v. Union of India & Ors. AIR 2013 SC 1311, a case that dealt with the patenting of a polymorphic form of the anti-cancer drug Imatinib mesylate, created a furor at the international level, particularly within the pharmaceutical and drug discovery communities. This fear and confusion have only been exacerbated by subsequent decisions by Indian courts rejecting patents for a series of pharmaceutical substances. Most of these decisions centered on section 3(d) of the Indian Patent Act, which was introduced in 2005. In the midst of these controversies, it has gone unnoticed that patented drugs are becoming more common at the commercial level in India. The country is slowly moving to an exclusive patent regime for new drug substances similar to that of major markets like the United States and Europe. Recognition of this trend has been obfuscated by the controversy over section 3(d).

Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue,  when Chairman  Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY)  that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee. However, because of two differences in this hearing from its predecessor things didn’t quite go as planned. This time, the Committee invited both sides to appear, not just the critics; and one member dared to challenge its underlying premise, leading to an electrifying exchange with the Chairman. We’ll examine that shortly.

On Thursday, May 9, the Affordable Prescriptions for Patients (APP) Act was introduced into the U.S. Senate by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT). If passed by Congress and signed into law, the bill would modify the Federal Trade Commission (FTC) Act to give the FTC additional antitrust authority to challenge the anticompetitive nature of certain actions by pharmaceutical patent owners in the service of providing more consumer access to generic and biosimilar drugs.

Recently, Knowledge Ecology International sent to Congress a letter objecting to the draft “Green Paper on Unleashing American Innovation” disseminated by the National Institute of Standards and Technology (NIST) in December, 2018. The KEI letter was signed by 10 other organizations* (the Organizations). The letter, unfortunately, is full of misstatements, distortions, falsehoods and disingenuous arguments. It would be easier to focus on the letter’s one accurate statement:  that high drug prices are a serious concern for people everywhere. It is very unfortunate that KEI, in my opinion, utilizes tactics which continually sacrifice fair and constructive dialog in favor of apparently achieving goals “by any means necessary.” The most disturbing element of the letter is KEI’s advocacy of inappropriate and unjustified use of government march-in rights under the Bayh-Dole Act as a purported means of controlling drug prices. In doing so KEI and the Organizations are threatening medical advances and thereby undermining their own missions.