Posts Tagged: "pharmaceuticals"

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 price-tag for non-innovative drug patents, such as these second-wave Restasis patents, is substantial. Indeed, one cannot help but question Allergan’s true motivations for attempting to evade PTAB scrutiny of these patents by reliance on Tribal Immunity based on its deal with the St. Regis Mohawk Tribe. The PTAB, unlike the examiner corps, does have the ability to consider rebuttal expert testimony, and is thus not-so handicapped in its capacity to vet drug patents of questionable validity, with aplomb.

Thanks to a number of new Hepatitis C drugs (Sofosbuvir Ledipasvir, Ladispavir) the disease is curable for many patients. While this is an undeniable victory for patients and payers, the innovators who made this possible have been villainized and undermined. At a time when the public health community should celebrate the tremendous health benefits these breakthrough drugs have brought to patients around the world, they are instead organizing to ensure the destruction of the incentives that made these drugs a reality. A recent study from the Centers for Disease Control and Prevention estimates that 2% – 3% of the world’s population is living with hepatitis C. The World Health Organization states that globally an estimated 71 million people have chronic hepatitis C infection and approximately 399,000 people die each year from the disease.

NCATS is working with industry to de-risk promising therapies by helping to take them further down the development pipeline. But the key ingredient remains finding a private sector partner willing and able to assume the burden of commercial development, which dwarfs the amount of money the government spent on the underlying research. This investment can only be justified if the technology has strong patent protection… There’s a reason it’s called intellectual property. Ownership of inventions in the United States of America isn’t a gift from the king but the right of a free people to securely own what they create. That’s the driver of American entrepreneurs, who with proper support will astound centralized governments run by dictators for life with what they can do when turned loose. Restoring our patent system removes the leash holding them back. After that, watch out if you’re in their way.

AbbVie’s maneuver worked like clockwork to induce regulatory gridlock, which prevented generic competition and kept the company’s profits high at public expense, for years. Fortunately, the FTC would have none of it. The agency filed suit against AbbVie in the Eastern District of Pennsylvania in 2014, accusing the company of illegal monopolization under the antitrust laws. The gravamen of the FTC’s complaint was that AbbVie wrongfully filed objectively-baseless sham litigations, to block generic competition.

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.

Ever since the Supreme Court decided KSR v. Teleflex, it has been appropriate to reject a patent claim because it was obvious to try. If twice the dose intravenously, half as often works, why wouldn’t the highly-educated person of skill in the art – who would hold an M.D. or Ph.D. level education with years of experience – not be tempted to try the same thing subcutaneously? And if they do try it and the results are as expected that should mean, under KSR, that the claimed invention is obvious. Somehow in the pharmaceutical arts KSR does not get applied that way.

Nothing in my own experience leads me to believe that the PTO applies a lower anticipation or obviousness standard to pharmaceuticals, and I expect this would be news to my colleagues in the industry too. I do, however, often get questions from policymakers, journalists, and others who have been misinformed and led to believe that pharmaceutical companies are re-patenting old drugs to keep prices high, and that our industry is spending “too much” effort on trivial modifications to old medicines rather than creating new ones. Be assured – there is no such thing as “re-patenting,” and our industry is spending plenty on true innovation – but Dr. Michelsohn is certainly raising a fashionable complaint. Public debate by and large seems to have accepted that any given smartphone model is covered by hundreds of patents, but when a complex pharmaceutical product is covered by more than one patent there’s immediate scrutiny and concern.

If a drug company plants a more than 100-patent thicket to protect market exclusivity, then it had better be able to justify why it should deserve the cumulative protection of patent term. Yes, the patent on the original formulation will fall into the public domain and may be capable of being made by generics long before the last of the patents expire, but often-times those follow on “innovations” are the kind of trivial advances that ordinarily shouldn’t support a fresh patent.

This article analyzes obviousness issues related to antibody patents at the Patent Trials and Appeal Board (PTAB) and in federal courts. We review several cases categorized by type of claims in search of trends on what types of antibody-related claims are more likely to survive an obviousness challenge… These cases are highly fact-specific, but a few broad observations may be made. To our knowledge, no claims directed to an antibody claimed purely by structure have been challenged, except for those of an ADC (KADCYLA®), where both the antibody part and the drug part of the conjugate were previously known. An antibody broadly claimed by function may be considered obvious “[i]f any one method of achieving any single embodiment [of such claim] would have caused a person of ordinary skill in the art to anticipate success.” Abbott GMBH, 971 F. Supp.2d at 186. Objective indicia of nonobviousness have been helpful, but only where there was a clear nexus between the objective evidence and the claims.

The Federal circuit heard the case on AbbVie Inc. v. MedImmune Ltd. AbbVie and MedImmune entered a development and licensing agreement in 1995. The agreement stemmed from a research collaboration between the parties, resulting in the antibody adalimumab, the active ingredient in Humira… In general, parties may not seek a declaratory judgment to litigate one issue in a dispute that must await adjudication of other issues for complete resolution of the dispute. In limited circumstances, courts may permit this type of action where litigation is pending that would resolve the remaining questions.

Despite the difficulties, the private sector is far and away the best bet for developing the desperately needed medicines of the future. Government is a critical partner and can fund research at our universities and federal laboratories that can’t be done anywhere else. It can also remove some, but not all of the risk inherent in developing treatments for diseases lacking sufficient market size and stability to attract traditional investment. But it still requires a company willing to assume the burden of transforming a discovery into a product that can alleviate suffering.

The European Union suffers from an investment deficit relative to other industrialized nations. A recent report by the European Commission emphasizes this impact, “the EU needs to put in place better incentives and conditions for businesses to innovate” in important areas such as market regulations, intellectual property rights protection, barriers to entrepreneurship, and ease of doing business. Given this, encouraging investment is essential to future growth. Weakening the IP incentives embedded in SPCs would be a step in the wrong direction.

May a court rely on post-priority-date evidence offered to show that a patent lacks written description support even though written description is judged based on the state of the art as of the priority date?  Yes, at least when the evidence relates to whether or not a claimed genus discloses a representative number of species.  Amgen v. Sanofi No. 2017-1480 slip op. Fed. Cir. Oct. 5, 2017 (“Amgen”).   Such evidence, the Federal Circuit observed, is likely to postdate the priority date, because were it to predate, it might be anticipatory.  To consider such evidence is therefore a matter of “common-sense,” the Court added.