The Claim Game

Today I am going to discuss patent claims involved in the case Supreme Court case Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. 

Case Background: Teva sued Sandoz for patent infringement of Copaxone, a drug used to treat the neurological disorder Multiple Sclerosis. In defense, Sandoz claimed that Teva's patent claims were indefinite in that the term "molecular weight" had three possible meanings, and was not defined. The district court ruled that the claims regarding molecular weight were definite, and that Sandoz had infringed on Teva's patents. Sandoz appealed this decision and the appellate court found that Teva's molecular weight claims were indeed indefinite, and therefore the claims were invalid.



Patent at Issue: The patent at hand is U.S. Patent No. 5,800,808: Copolymer-1 Improvements in Compositions of Copolymers.

The claims of the the '808 patent follow as:

1. A method of manufacturing copolymer-1 

1. comprising reacting protected copolymer-1 with hydrobromic acid 
2. to form trifluoroacetyl copolymer-1
3. treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution 
4. to form copolymer-1, 
5. and purifying said copolymer-1, 
6. to result in copolymer-1 
7. having a molecular weight of about 5 to 9 kilodaltons.

1.  of a gene whose transcription is regulated by NF-.kappa.KB
2. the method comprising reducing NF-.kappa.B activity 
3. in the cell such that expression of said gene is inhibited. 

A method inhibiting gene expression of genes regulated by NF-.kappa.B.

2. A method for selectively inhibiting expression

1. in a eukaryotic cell
2. of genes whose transcription is regulated by NF-.kappa.B
3.  the method comprising reducing NF-.kappa.B activity
4. in the cell such that expression of said genes is inhibited

A method selectively inhibiting gene expression of genes regulated by NF-.kappa.B.
3. A method for reducing the level of expression of a viral gene

1. whose transcription is regulated by NF-.kappa.B in a eukaryotic cell
2. the method comprising reducing NF-.kappa.B activity
3.  in the cell such that expression of said viral gene is reduced. 

A method reducing viral gene expression of viral genes regulated by NF-.kappa.B.
4. The method of claim 3, 

1. wherein the viral gene is a cytomegalovirus (CMV), 
2. human immunodeficiency virus (HIV) 
3. or simian virus 40 (SV40) gene. 

A method reducing viral gene expression of a CMV, HIV, SV40 genes regulated by NF-.kappa.B.
5. A method for reducing the level of expression

1. of a cytokine gene 
2. whose transcription is regulated by NF-.kappa.B 
3. in a eukaryotic cell 
4. comprising reducing NF-.kappa.B activity in the cell 
5. such that expression of said cytokine gene is reduced. 

A method reducing gene expression of a cytokine gene regulated by NF-.kappa.B.
6. A method for diminishing induced NF-.kappa.B-mediated intracellular signaling 

1. comprising reducing NF-.kappa.B activity in cells 
2. such that NF-.kappa.B-mediated intracellular signaling is diminished. 

A method for diminishing induced NF-.kappa.B-mediated intracellular signaling.

7. A method for modifying effects of external influences on a eukaryotic cell

1. which external influences induce NF-.kappa.B-mediated intracellular signaling
2.  the method comprising altering NF-.kappa.B activity in the cells 
3. such that NF-.kappa.B-mediated effects of external influences are modified. 

A method for modifying the impact of extracellular influences that induce NF-.kappa.B-mediated intracellular signaling.

8. The method of claim 7

1. wherein NF-.kappa.B activity in the cell is reduced. 

A method for modifying the impact of extracellular influences that induce NF-.kappa.B-mediated intracellular signaling such that NF-.kappa.B activity is reduced.

9. A method for reducing, in eukaryotic cells, the level of expression of genes 

1. which are activated by extracellular influences which induce NF-.kappa.B-mediated intracellular signaling,
2.  the method comprising reducing NF-.kappa.B activity in the cells 
3. such that expression of said genes is reduced. 

A method for reducing gene expression of genes activated by extracellular influences that induce  NF-.kappa.B-mediated intracellular signaling.

10. A method for reducing the effects of bacterial infection on mammalian cells 

1. comprising reducing NF-.kappa.B activity in mammalian cells 
2. so as to reduce bacterial lipopolysaccharide-induced gene expression in the mammalian cells. 

Diamond v. Chakrabarty is a landmark Supreme Court decision in regards to life science patents. In 1971, microbiologist Ananda Chakrabarty genetically engineered Pseudomonas bacteria to metabolize oil by using plasmids to transform bacteria with genes necessary for oil metabolism. Though before his work, oil metabolizing bacteria existed, Chakrabarty discovered a genetic crosslinking method that significantly improved upon the metabolism of oil by two orders of magnitude. Chakrabarty's genetically engineered bacteria could metabolize roughly 66% of the hydrocarbons in an average oil spill. 



Chakrabarty applied for a utility patent on his genetically modified microorganisms, but was denied intellectual property rights on the grounds that U.S. patent law precludes living organisms. Chakrabarty appealed this decision and the U.S. Court of Customs and Patent Appeals overturned the decision, granting Chakrabarty patent rights. This appeals decision was then appealed by the Commissioner of Patents and Trademarks, Sydney Diamond, reaching the Supreme Court in 1980. 

The legal question at hand would set landmark precedent for biotechnology patents: 

Does Section 101 of Title 35 of the United States Code include living organisms as patentable subject matter?

In a 5-4 decision, the court decided that yes, living organisms can be patented under U.S. patent law, affirming the decision of the U.S. Court of Customs and Patent Appeals, and granting Chakrabarty patent rights. The court detailed that though the discovery of naturally occurring phenomena and substances is not patentable, the creation of modified, non-naturally occurring substances is indeed eligible. 

This is an interesting decision in that it points towards the limits of patent law in that the law does not necessarily foresee significant fields of innovation. That said, case law alone may not be sufficient for optimal patent law in biotechnology and pharmaceuticals. There are many challenges unique to innovation in the life sciences, one of them being regulatory hurdles and costs such as clinical trials. This provokes a couple of questions - should the law be tailored towards industry? How can we make make patent law more adaptable to the dynamic nature of innovation and ensure that it continues to facilitate innovation despite being blind to future developments?

Sources:
https://www.oyez.org/cases/1979/79-136
http://davidhuerta.typepad.com/.a/6a01347ff0d110970c0168e508841b970c-500wi

Patenting has shifted from purely and industry practice to one that has become adopted by universities. This comes at no surprise with the passage of the Bayh-Dole Act of 1980 (which allows universities to claim ownership of inventions) as well as the emergence and growth of start-ups, incubators, and university technology transfer offices. However, ownership rights regarding university research can get tricky. There are often various sources of funding that drives university research - from government funding to funding by the private sector. With these multiple stakeholders involved, once an invention is invented, who should receive the intellectual property rights of the invention.

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (Stanford v. Roche) is a Supreme Court case situated in the realm of university licensing and patents. Stanford v. Roche presents the question as to whether patent rights over inventions that result from federally funded research must be awarded to the university at which inventors work at.



This case emerged over a licensing dispute between Stanford University and the pharmaceutical company Roche regarding the patent on Roche's HIV testing kits. The HIV testing kits at hand were developed by Mark Holodniy, a professor at Stanford School of Medicine who had signed a collaborative research contract with Cetus Corp, a company later acquired by Roche. Stanford sued Roche in an attempt to claim intellectual property rights over the HIV testing kit technology.



In 2009, the U.S. Court of Appeals decided this case in favor of Roche, on the grounds that Stanford had no standing to claim patent infringement. In 2011, the Supreme Court decided in favor of Roche in a 7-2 decision. The court argued that

"The Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions" (1).

I personally find this case interesting because there is a lot of research going on at universities that results in inventions, and this research is sometimes funded by the private sector. The decision in Stanford v. Roche shows that as a researcher at a university, the technology transfer may not be a smooth, clear process.

Sources:
(1) https://www.oyez.org/cases/2010/09-1159
(2) http://www.ipwatchdog.com/2011/06/06/supreme-court-affirms-cafc-in-stanford-v-roche-on-bayh-dole/id=17594/
(3) http://static01.nyt.com/images/2011/06/07/business/07bizcourt-inline/07bizcourt-inline-popup.jpg
(4) http://www.ipeg.com/wp-content/uploads/2010/11/University-professor_19287067_M1.jpg

One of the more recent, significant patent litigation cases within biotechnology is the Association for Molecular Pathology v. Myriad Genetics decided by the Supreme Court in 2013.

In this case, the Association for Molecular Pathology challenged Myriad Genetics for its patents relating to BRCA1 and BRCA2 genes and particular mutations in these genes that are strongly associated with the development of breast cancer. As noted by the majority opinion in this case,

"the average American woman has a 12- to 12-percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer (2)."

The specific patents in question regard mutation diagnostic methods that allowed Myriad to exclusively control diagnostic testing and scientific research on the BRCA genes. Myriad received these patents based on its research

The plaintiff, the Association for Molecular Pathology, argued that the patents on the BRCA1/2 genes are patents on products of nature. Since Section 101 of Title 35 of the United States Code defines patentable subject matter as

"any new and useful process, machine, manufacture, or compositions of matter, or any new and useful improvement thereof"

if the genes claimed are merely products of nature, they are not patent eligible. Therefore, the plaintiffs claimed that Myriad Genetics' patents are invalid based on Section 101. Myriad's defense is based on the argument that its patents are valid because once a gene is isolated, it is distinguishable from other genes.

Additionally, the plaintiffs noted that Myriad's exclusivity in regards to BRCA research is an impediment to further scientific research.


This case originated at the district court, which ruled in favor of the Association for Molecular Pathology, invalidating Myriad Genetics BRCA patents. Myriad appealed this case to the U.S. Court of Appeals for the Federal Circuit. The appeal court reversed the district court decision and held Myriad's patents valid on the grounds that isolated genes are chemically and structurally distinct from genes in the body. The Association for Molecular Pathology appealed this decision to the U.S. Supreme Court where in a unanimous 9-0 decision, SCOTUS decided that naturally occurring gene sequences are not patent eligible, however gene sequences that are not occurring in nature are indeed patent eligible. This decision reverses in part and affirms in part the decision of the appeals court.

To understand the two-fold implications of this Supreme Court decision, some molecular biology background is required. Genes are sequences of DNA. This case sets the precedent that naturally occurring sequences of DNA cannot be patented because they are products of nature, and merely isolation does not, on its own, make these sequences of DNA patent eligible. However, there are sequences of DNA that are not occurring naturally in nature. The prime example of these sequences include cDNA. cDNA is DNA that is made in laboratory settings, excluding introns - noncoding regions of DNA.


Therefore, this decision sets precedent for gene patents in that naturally occurring sequences cannot be patented, however cDNA can be patented.

Sources:
(1) https://www.ocf.berkeley.edu/~edy/genomics/cdna.jpg
(2) https://www.oyez.org/cases/2012/12-398 
(3) http://i2.cdn.turner.com/cnnnext/dam/assets/130523190137-sulik-myriad-genetics-protest-horizontal-large-gallery.jpg

The recent lawsuit that VirnetX has brought against Apple in regards to Apple's infringement of VirnetX's patents through the use of Apple's modified VPN On Demand, FaceTime and iMessage technologies. However, this is not the first suit VirnetX has brought against Apple. In 2012, VirnetX won a $384M suit against Apple in regards to Apple's FaceTime and VPN On Demand service. This award was vacated however, after the case was appealed. In doing so, the U.S. Court of Appeals for the Federal Circuit sent the case for retrial on damages at the district court level.

Though the current VirnetX v. Apple lawsuit has awarded VirnetX $625M, Apple has filed to declare papers to U.S. District judge Robert Schroeder for mistrial. Apple claims that VirnetX's attorneys have "misled" the jury during closing arguments. Schroeder's decision has yet to be revealed. The patents contested in this case include: US 7418504: Agile network protocol for secure communications using secure domain names, US 7490151: Establishment of a secure communication link based on a domain name service (DNS) request, and US 6502135: Agile network protocol for secure communications with assured system availability.

As discussed in my previous post, patent trolls have larger deterrent effects on innovation when they target small companies like start ups. Though there is often a call for urgent patent reform to address trolls, patent system reform has had a limited impact on regulating patent trolls. The most recent sweeping patent reform passed is the Leahy Smith America Invents Act (or the AIA for short). The AIA has introduced various provisions to deter patent trolls. For example, the AIA requires the filing of multiple suits and fulfilling multiple fees when suing multiple companies. Additionally, the AIA has created post-grant proceedings in which defendants have an advantage over patent trolls. However, the AIA was enacted in 2012, yet patent trolls have not been altogether deterred. I hope to learn about other policy proposals that may deter patent trolls through the course of this class.

Patent trolls are arguably one of the greatest loopholes of the patent system. Otherwise referred to as Non Practicing Entities (NPEs), patent trolls have patents and enforce patent rights, but they do not innovate. Instead of acquiring patents to protect innovations, patent trolls acquire patent rights for the sake of having these rights and the prospect of profiting off of them. Upon gathering patent rights, patent trolls enforce these rights by suing various companies on the grounds of infringement. These cases, or even the threat of these cases, provide patent trolls with revenue.

The company VirnetX is an example of a patent troll. With over 80 internet security patents, VirnetX has acquired many patent rights over the years and enforced these rights by the means of targeting many companies with lawsuits. Notably, VirnetX has been involved with lawsuits against Apple, Cisco, and Microsoft. Recently, VirnetX has sued Apple in regards to patents that Apple's FaceTime and iMessage technology have violated. The court ordered that Apple pay a fine of $625 million, more than VirnetX's requested $532 million.

Given the size and power of tech giants like Apple, the detriment that this lawsuit will have on Apple as an innovator is questionable at best. However, patent trolls may also target smaller companies. In such scenarios, small companies may be discouraged from even pursuing a lawsuit due to limited funds. As a result, small companies are likely to settle for what trolls request. That said, it is arguable that patent trolls significantly deter innovation that occurs at the level of start-ups and small companies.

Patent trolls illuminate the imperfection that is the patent system. Though there has been patent reform enacted in recent years, such reform has not necessarily addressed the issue of patent trolls. In my next post, I will delve further into the VirnetX v. Apple case and explore policy suggestions that attempt to remediate the issue of patent trolls.