- Posts by Konstantin M. LinnikPartner
Konstantin Linnik is a partner in Nutter’s Intellectual Property Department. He works with biotechnology and pharmaceutical companies on various matters involving intellectual property, such as IP strategy, building and ...
On December 16, 2014, the United States Patent and Trademark Office (USPTO) published long-awaited guidelines intended to help examiners determine the patent eligibility of a wide range of inventions from isolated genetic materials to computer-implemented methods. The new guidelines revise those published by the office earlier this year (discussed here), which drew heated criticism from some in the patent community as too vague with respect to examination of certain inventions and too onerous with respect to others.
On August 4, 2014, the US Food and Drug Administration (FDA) released Draft Guidance on determining eligibility of a biological drug for regulatory exclusivity.
Under the Public Health Service Act (PHS Act), as amended in 2010, an abbreviated biosimilar application can be accepted by the FDA, but not until 4 years after the first licensure of the original reference product and, once accepted, such an application cannot be fully approved by the FDA for a period of 12 years from the reference’s first licensure. This reference product exclusivity is granted independently of any patent exclusivity, and therefore, by itself, provides a significant incentive to the sponsor of a Biologic License Application (BLA) who obtains the first licensure status. The date of first licensure is also critical to the timing of a follow-on biosimilar entry to the market.
Despite being dismissed by the Federal Circuit before reaching its highly anticipated substantive issues regarding patent eligibility, the ruling in Consumer Watchdog v. Wisconsin Alumni Research Foundation nonetheless significantly alters the patent litigation landscape. Consumer Watchdog (CW), a nonprofit waging a seven-year campaign to invalidate the Wisconsin Alumni Research Foundation (WARF) stem cell patent, saw its battle come to an abrupt end when the Federal Circuit held that it did not have an injury in fact sufficient to confer Article III standing to appeal a United States Patent and Trademark Office (USPTO) decision in federal court. The ruling limits the reach of the statute permitting appeals of USPTO rulings to the constitutional boundaries set by Article III, leaving some third-party challengers stuck with the USPTO as their only available forum.
New draft guidance released by the FDA on May 13, 2014 will assist drug companies in determining whether a proposed therapeutic biological product is “biosimilar” to its reference product. “Biosimilarity” under Section 351(k) of the Public Health Service Act is defined as “highly similar to the reference product notwithstanding minor differences in clinically inactive components” with ”no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” A biosimilar’s applicant must demonstrate to the FDA that the biological product is biosimilar based on analytical studies, animal studies, and clinical studies, including the assessment of immunogenicity and pharmacokinetics (PK)/pharmacodynamics (PD).
In a highly anticipated decision issued today in Association for Molecular Pathology v. Myriad Genetics, the Supreme Court unanimously ruled that isolated DNA sequences are not eligible for patent protection. The Court simultaneously held that cDNA can be patent eligible subject matter – as long as it is distinguishable from natural DNA. Justice Thomas, writing for the Court, clarified that the mixed ruling did not implicate methods, applications of knowledge about genes or alteration of sequences.
While the America Invents Act (AIA) brought many significant changes to the U.S. patent laws, there is arguably no more impactful change than the shift from a “first to invent” system to a “first inventor to file” system that occurred on March 16, 2013. This shift has significant effects on patent applications having an effective filing date on or after March 16, 2013. Under prior U.S. law, a patent applicant could rely on the earliest documented date of the invention, and thus obtain a patent over another’s earlier-filed application. Now, under the AIA, the U.S. Patent and Trademark Office (USPTO) will award a patent to an applicant with the earliest effective filing date. The earliest effective filing date is the actual filing date of the application or the date of the earliest priority application.
On August 16, 2012, biotechnology patent owners breathed a short sigh of relief, as the US Court of Appeals for the Federal Circuit issued the highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, finding that DNA sequences are indeed eligible for patent protection. However, not all biotech innovators will be happy with the Myriad decision since certain diagnostic method claims were again struck down as ineligible for patent protection. Additionally, one of the three judges on the panel dissented on the patentability of isolated DNA, arguing, “extracting a gene is akin to snapping a leaf from a tree.” The final word on this subject may need to come from the Supreme Court.
On July 5, 2012, the United States Patent and Trademark Office issued a memorandum to all patent examiners providing guidelines for examining process claims for patent eligibility in view of the Supreme Court decision Mayo v. Prometheus. Entitled “2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature,” the much-anticipated guidance is intended to apply to process claims focused on a law of nature, natural phenomenon, or naturally occurring relation or correlation (“natural principle”). Although it is expected this guidance will predominantly impact claims examined in Technology Center 1600 (Biotechnology), the guidelines will be applicable to any process claim that refers to a natural principle. Process claims directed to abstract ideas, such as the claims in Bilski will continue to be examined using the previously issued guidance for determining subject matter eligibility under Bilski v. Kappos.
Following close on the heels of last week’s controversial decision in Mayo Collaborative Services v. Prometheus Laboratories, the United States Supreme Court sent another hotly contested biotech case back down for further consideration by a lower federal court. In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court granted certiorari to the parties in the Myriad case, vacated the decision of the Court of Appeals for the Federal Circuit, and then promptly remanded the case to the Federal Circuit for reconsideration in accordance with the Supreme Court’s March 20th decision in the Mayo case, which held that a diagnostic method claim that simply recites a law of nature is unpatentable subject matter under 35 U.S.C. §101.
On March 20, 2012, the United States Supreme Court unanimously reversed the Federal Circuit in a long-awaited decision that may have broad-reaching effects on diagnostic method patents, as well as personalized medicine patents. At issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012) was whether the correlation between blood levels and optimal dosages of a drug was a patentable process or an unpatentable law of nature. The Court held that Prometheus' claim, which had been twice upheld by the Federal Circuit, was an unpatentable law of nature.
Maximizing the protection and value of intellectual property assets is often the cornerstone of a business's success and even survival. In this blog, Nutter's Intellectual Property attorneys provide news updates and practical tips in patent portfolio development, IP litigation, trademarks, copyrights, trade secrets and licensing.