Posts Tagged: "pharmaceuticals"

Once we go down a path of government price controls and compulsory licensing we will have foregone opportunities for other, more rational policy choices and will soon find ourselves in a race to the bottom. Of course, making prescription drugs more affordable must be an important, shared goal. But the solutions we pursue cannot risk choking off America’s innovative ecosystem that leads the world in discovering new cures and treatments. As Nobel laureate and NIH Director Harold Varmus said in 1995, one must first have a new drug to price before one can worry about how to price it.  Letting our federal government import foreign price controls and expropriate patents is not the way to go about it.

Since Merck & Co. v. Teva Pharmaceuticals, blocking patent arguments have arisen in the Federal Circuit primarily in the pharmaceutical patent context, and until now have largely been limited to undermining evidence of commercial success. But just like gremlins fed after midnight, this doctrine inevitably spawned unwanted offspring that are now wreaking havoc… Assuming that no one would ever develop a product that might infringe a patent is inconsistent with numerous Federal Circuit realities. It’s right up there with the Tooth Fairy (sorry, kids).

As the pharmaceutical industry continues to shift toward biologic-based drugs, including monoclonal antibodies, protecting the underlying technology has been and continues to be a priority for companies. As with any drug, patenting therapeutic monoclonal antibodies as early as possible in the drug development process is crucial to protect the underlying invention. In the early days of antibody discovery for therapeutic development, protection could be obtained with minimal disclosure of the actual antibody. But as the art and case law have evolved, companies now need far more data to obtain the broadest scope of protection. For that reason, it has become more of a challenge to determine the best time to file with the U.S. Patent and Trademark Office (USPTO). After the America Invents Act (AIA), it is a race to the USPTO to be the first to claim your invention, but you may lack the requisite data to enable you to obtain patent protection in the end.

Once composition of matter claims have been obtained for a new compound, or the composition of matter claims for an old compound have expired, what is next? Securing additional patent protection usually entails obtaining claims to methods of treatment, methods of prevention or improvement, methods of maintaining health, and mechanisms of action. These paths diverge depending on whether the compound is being developed as a pharmaceutical (i.e., a drug or biologic) or a dietary supplement.

Rep. Lloyd Doggett (D-TX) recently introduced the Medicare Negotiation and Competitive Licensing Act of 2018. Lest the title confuse you, by “competitive licensing” Rep. Doggett means compulsory licensing anytime a company declines to sell their drug for whatever price the Secretary of Health and Human Services  cares to offer during “Medicare negotiations” where the government holds all the cards. Past attempts to impose artificial “reasonable pricing” requirements on developers of government supported inventions did not result in cheaper drugs. A study titled Compulsory Licensing Often Did Not Produce Lower Prices For Antiretrovirals Compared to International Procurement found that resulting drug prices were often higher than they would have been under a more cooperative approach.

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.

How much is needed to reasonably prove obviousness? In UCB, the majority found UCB, Inc.’s asserted claim nonobvious under non-statutory double patenting.  The dissent, however, found overwhelming evidence in support of obviousness.  The majority determined that prior art teaching was insufficient for a skilled artisan to have a reasonable expectation of success.  To the dissent, however, the majority’s analysis was flawed because it ignored the fact that the law required only a reasonable expectation of success, not a guarantee.  One might say the majority viewed the glass as half full and the dissent half empty. 

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.

The Hatch-Waxman Act and the Biologic Price Competition and Innovation Act are both forged from a noble ideal, grounded in a commitment to a robust and earnest patent system that rewards real innovation… By the power vested in them by specially-reserved patent laws, drug patents are a patent species of their own universe. They can have the economic power of nuclear warheads, in an industry built on an exclusivity model worth hundreds of billions of dollars, per year. We simply cannot afford to fill the silos of those warheads with patent waste that does not innovate or improve upon anything, but which can wreak economic and social havoc, while feeding the general public’s perception that all patents stink.

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?

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same insidious thought process underlying Hatch-Waxman seen underlying the justification for post grant challenges of all patents at the USPTO. How absurd is it that those who question the need for incentive to innovate are so eager to provide incentive to challenge patents?

In Vanda, Chief Judge Prost, one of the judges on the CellzDirect panel, dissented from the majority’s decision that found claims patent eligible for not being directed to a judicial exception in step one of the Mayo/Alice test. What differences between the claims in Vanda and those in CellzDirect led Judge Prost to dissent? Can these differences shed further light on the characteristics necessary for a claim to be found not directed to a patent-ineligible concept in step one?

Critics of drug patents often claim that when initial drug patents expire, drug companies stuff their patent portfolios with “trivial” patents that unjustifiably extend their patent monopoly to keep the prices up.  This argument perpetuates common myths and misunderstandings that fail on several levels… In the last decade, large molecule biological drugs have come to the fore. They provide dramatic new treatments for some conditions but can be very expensive. It is difficult to develop inexpensive generic-type versions for biological drugs.