Tagged: Biotech / Biotechnology

Stem Cell Transplant-Related Patent Found Valid Under Alice

Stem Cell Transplant-Related Patent Found Valid Under Alice

In Genzyme Corp. v. Zydus Pharmaceuticals (USA) Inc., a Delaware district court recently found two patents directed to methods of mobilizing progenitor/stem cells from bone marrow to the peripheral blood stream for use in stem cell transplantation valid under 35 U.S.C. § 101 as being directed to patent-eligible subject matter. The district court utilized the framework articulated in Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014), on which we have previously reported here, here, and here, to determine whether the patent claims covered patent-eligible subject matter or were patent-ineligible “[l]aws of nature, natural phenomena, [or] abstract ideas[.]” Under the Alice framework, the court first determines if the patent claims at issue are directed to a patent-ineligible concept, and, if so, then considers whether the claims contain an “inventive concept” which “transform[s] the nature of the claim into a patent-eligible application.” The district court found that the claims at issue were not directed to any patent-ineligible concept under step one of Alice because they were directed to the patent-eligible concept of “using plerixafor, itself a compound that does not naturally exist, to amplify a natural phenomenon – stem cell mobilization – in an unnatural way.” The...

U.S.-Mexico-Canada Trade Agreement to Promote Innovation in Biotechnology

U.S.-Mexico-Canada Trade Agreement to Promote Innovation in Biotechnology

On September 30, 2018, the United States, Mexico, and Canada reached an agreement in principle to replace the North American Free Trade Agreement (NAFTA). The pending United States-Mexico-Canada Agreement (USMCA) includes provisions governing the protection and enforcement of intellectual property rights. This blog post will cover the IP provisions of the USMCA, particularly as applied to pharmaceuticals and biologics. It’s important to note that the provisions of the USMCA prescribe a minimum requirement, some of which is already met or surpassed by the individual countries’ respective patent regimes. 1. Data protection for biologics Under Article 20.F.14, each country must provide, with respect “to the first marketing approval” of a product that “is or contains a biologic,” protection of undisclosed test or other data concerning the safety and efficacy of the product for “a period of at least ten years from the date of first marketing approval of that product.” This ten-year data exclusivity applies “at a minimum” to “a product that is produced using biotechnology processes and that is, or, alternatively, contains, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, for use in human beings for the prevention, treatment, or cure...

Federal Circuit Affirms PTAB Finding That CRISPR-Cas9 Inventions Are Patentably Distinct

Federal Circuit Affirms PTAB Finding That CRISPR-Cas9 Inventions Are Patentably Distinct

The Federal Circuit in Regents of the University of California v. The Broad Institute weighed in on the disputed inventorship of the breakthrough CRISPR-Cas9 technology, holding that the University of California (“UC”)’s invention of the mechanism in vitro did not render obvious Broad’s claims to the mechanism in eukaryotic cells. Gibbons previously reported on the technical background of CRISPR-Cas9. This post will focus on the inventorship issue and the implications of the Federal Circuit decision. In August 2012, UC researchers published an article showing that the CRISPR-Cas9 system, derived from prokaryotic cells like bacteria, could be used in vitro in a non-cellular experimental environment. Several research groups independently applied CRISPR-Cas9 in eukaryotic cells within months of UC’s disclosure. In February 2013, Broad researchers published an article describing the use of CRISPR-Cas9 in a human cell line. Both UC and Broad sought patent protection. UC, the senior party, claims the CRISPR-Cas system without referring to a particular cell type or environment. Broad, the junior party, claims the CRISPR-Cas system limited to use in eukaryotic cells, i.e., plant and animal cells. The Patent Trial and Appeal Board (PTAB) determined there was no interference-in-fact because, given the differences between eukaryotic and prokaryotic systems, a person...

Patent Infringement Defendants’ Attempt to Transfer Venue Thwarted

Patent Infringement Defendants’ Attempt to Transfer Venue Thwarted

In federal cases, venue transfer is permitted pursuant to 28 U.S.C. § 1404(a), “[f]or the convenience of parties and witnesses, in the interest of justice . . . to any other district or division where it might have been brought or to any district or division to which all parties have consented.” The defendants in a patent infringement case venued in the District of New Jersey recently failed in their attempt to transfer venue of their cases to the District of Delaware pursuant to § 1404(a). The cases involve the alleged infringement of a patent that covers Suboxone sublingual film for the treatment of opioid dependence. The defendants argued that venue transfer was appropriate based on their consent to venue in Delaware, the discretionary factors outlined in Jumara v. State Farm Insurance, 55 F.3d 873 (3d Cir. 1995), and the first-filed rule. None of these arguments proved successful, as the magistrate judge issued reports and recommendations denying the motions of defendants Dr. Reddy’s, Teva, and Alvogen Pine Brook. And, the district judge affirmed and adopted the magistrate judge’s opinions. After first concluding that venue for the cases was proper in the District of New Jersey pursuant to the patent venue statue,...

Surveying the CRISPR-Cas9 Patent Landscape in the United States

Surveying the CRISPR-Cas9 Patent Landscape in the United States

This post will discuss the patent landscape of the groundbreaking CRISPR-Cas9 systems in the United States, including pending legal disputes. A CRISPR-Cas9 system is a combination of protein and ribonucleic acid (“RNA”) that can alter the genetic sequence of an organism. CRISPR-Cas systems occur naturally in bacteria and help the bacteria target and cut identified virus deoxyribonucleic acid (“DNA”). The CRISPR-Cas9 system is being developed as a powerful tool to modify specific DNA in the genomes of more complicated organisms, including plant and animal cells. For the purpose of this overview, the mechanism of CRISPR-Cas9 is explained in the Patent Trial and Appeal Board (PTAB)’s Broad Institute v. The Regents of the University of California interference decision. As the decision explains, the CRISPR-Cas9 system comprises three effective parts: a guide-RNA sequence, an activator-RNA sequence, and a protein called Cas9. CRISPR-Cas9 alters a target DNA molecule by first binding the guide-RNA sequence to a specific sequence in the DNA of interest. The activator-RNA sequence then interacts with the Cas9 protein, and the Cas9 protein cuts the target DNA at a specific site. By linking a DNA-cutting protein (Cas9) to a specific site on the target DNA, the CRISPR-Cas9 system achieves specific targeted...

Supreme Court To Review Whether Non-Public Sales Are Invalidating Under Post-AIA Section 102

Supreme Court To Review Whether Non-Public Sales Are Invalidating Under Post-AIA Section 102

The Supreme Court recently agreed to review Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., a case with broad implications for the pharmaceutical industry. In the opinion below, the Federal Circuit held that after the America Invents Act (“AIA”), “if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale” for the sale to be invalidating under Section 102. The Court granted Helsinn’s petition for certiorari to answer “[w]hether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.” Before the AIA, § 102(b) barred the patentability of an invention that was “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent.” By enacting the AIA, Congress amended § 102 to bar the patentability of an “invention [that] was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before...

Stronger Patents Act Introduced in House of Representatives

Stronger Patents Act Introduced in House of Representatives

On April 3, 2018, Representatives Steve Stivers and Bill Foster introduced H.R. 5340, entitled Support Technology and Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patents Act implementation. This legislation parallels legislation introduced by Senators Chris Coons and Tom Cotton last year. This bill was introduced because its sponsors believe that the U.S. has driven innovation away with issues that particularly relate to the America Invents Act (AIA). The bill has the following portions in Section 102: Section A – Requires the Patent Trial and Appeal Board (PTAB) to use the same standard as District Courts when deciding what inventions the patent covers – claim construction. Currently, the PTAB uses the broadest reasonable interpretation standard and does not consider all of the evidence of a valid patent claim. Section B – Requires the PTAB to use the same burden of proof – clear and convincing evidence – that is used by District Courts. Right now, the PTAB uses the preponderance of the evidence standard. Section C – Ensures that a petitioner has a business or financial reason to bring the case before the PTAB. This is in direct response to the stockholder suits that have been brought in the...

The USPTO Under Recently Appointed Director Andrei Iancu Will Promote Innovation and Increase Reliability in Issued Patents

The USPTO Under Recently Appointed Director Andrei Iancu Will Promote Innovation and Increase Reliability in Issued Patents

Speaking to the U.S. Chamber of Commerce on April 11, 2018, recently sworn-in USPTO Director Andrei Iancu gave an impassioned speech about his vision for the patent system. Director Iancu outlined challenges facing the USPTO and goals the agency aspires to achieve, focusing on two main objectives: (1) creating a new pro-innovation, pro-IP dialogue, and (2) increasing the reliability of the USPTO granting patents. Stakeholders should take note of the Director’s objectives and should anticipate policy changes that further strengthen the patent system. Creating a new pro-innovation, pro-IP dialogue One thing is clear from Director Iancu’s remarks: the USPTO under his leadership will strive to help the inventor and incentivize innovation. Consistent with this goal, the USPTO will “create a new narrative that defines the patent system by the brilliance of inventors, the excitement of invention, and the incredible benefits they bring to society.” “And it is these benefits,” Director Iancu continued, “that must drive our patent policies.” Much of the narrative of the patent system in recent memory has focused on curbing abuses of non-practicing entities sometimes referred to as “patent trolls.” And Director Iancu’s remarks suggest that the USPTO will actively try to change that narrative. Iancu explained...

What are “Acts of Infringement” and Where is “A Regular and Established Place of Business” for a Hatch-Waxman Defendant: The District of Delaware Weighs in on the Patent Venue Rule

What are “Acts of Infringement” and Where is “A Regular and Established Place of Business” for a Hatch-Waxman Defendant: The District of Delaware Weighs in on the Patent Venue Rule

We previously reported on the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, in which the Supreme Court created a new patent venue rule. The patent venue statute, 28 U.S.C. § 1400(b), provides that patent infringement suits “may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” In TC Heartland, the Supreme Court held that “[a]s applied to domestic corporations, ‘reside[nce] in § 1400(b) refers only to the State of incorporation.” A Delaware District Court recently considered the provision of the patent venue statute not addressed by TC Heartland – where venue is proper if a “defendant has committed acts of infringement and has a regular and established place of business” in the context of a defendant’s motion to dismiss for improper venue. In Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., a patent infringement matter brought under the Hatch-Waxman statute and filed before the TC Heartland decision, the parties did not dispute that, in light of TC Heartland, the defendant, a West Virginia corporation, could not be said to “reside” in Delaware. Thus, venue would be proper...

Constitutionality of IPRs and PGPs

Constitutionality of IPRs and PGPs

Recently, the Supreme Court granted certiorari in Oil States Energy Services v. Green’s Energy Group, Case 16-712 that may have implications on the constitutionality of America Invents Act (AIA) patent review proceedings such as Inter Partes Review (IPRs) and Post Grant Proceedings (PGPs). The case being reviewed involved a fracking patent granted to Oil States. Green’s Energy petitioned to have the Oil States patent reviewed in an IPR (6,179,053). The IPR resulted in the Oil States patent claims being held unpatentable. But, upon review at the Federal Circuit, Oil States challenged the decision and added that IPRs were not allowed under Article III and the Seventh Amendment of the Constitution. In particular, the Oil States argument advanced that the patents must be tried before a jury because invalidity of patent claims traditionally have been a jury issue before a court of competent jurisdiction. The Oil States argument then indicated that Congress could not delegate that right to an administrative agency. The Federal Circuit affirmed the USPTO’s IPR decision of invalidity, without the issuance of an opinion. Following that decision, Oil States petitioned for certiorari to the Supreme Court regarding three issues. The one issue was whether IPR was in violation...