Waiting for November 2012 and the Final Verdict on Brüstle v. Greenpeace e.V.

The German Federal Court of Justice (“BGH”) finally announced that it will decide in the case Brüstle v. Greenpeace e.V. on November 27, 2012.

The case was described and discussed here at PredictER News, December 13, 2012 and June 11, 2012. The court will adjudicate more than two years after it requested preliminary ruling from the European Court of Justice (ECJ) on December 17, 2009 (Case Xa ZR 58/07, now changed to X ZR 58/07), and a year after the ECJ’s decision in Case C-34/10 regarding the interpretation of Art. 6 of the Directive 98/44/EC on October 18, 2011.

The BGH’s decision will not only influence the question of whether or not patents can be gained on inventions which are based on embryonic stem cells, but it will also impact embryonic stem cell research in general. In addition to the German Patent Protection Act, the German Embryonic Protection Act (“ESchG”) is also based on Directive 98/44/EC.

The ESchG prohibits research with embryos, see Paragraph 2 ESchG, but not research with embryonic stem cells. However, Paragraph 2 ESchG has to be interpreted in the terms of the ECJ decision now. As a result, and with ECJ's broad interpretation of the Directive and definition of embryos research with human embryonic stem cells might be prohibited in Germany. In other words, embryonic stem cells would have to be treated as embryos and, as such, research would be prohibited. This prohibition would include even basic research on embryonic stem cells.

Therefore, the German jurisdiction as well as the legislature should examine how the ESchG should be interpreted in future. A change or amendment to the ESchG's definition of embryos should also be deliberated, because under German law, the use of the term "embryo" and its impact on stem cell research needs clarification. Because the ECJ has not directly prohibited embryonic stem cell research, but has persisted in broadly defining "embryo," other than the ECJ the BGH has to take the consequences of its verdict for embryonic stem cell research into consideration.

It still remains to be seen what will happen on November 27, 2012 and what consequences the decision will have on embryonic stem cell research.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

What happened after the European Courts of Justice decision Brüstle v. Greenpeace e.V.?

More than six months after the European Court of Justice (ECJ) decided Brüstle v. Greenpeace e.V. (Case C-34/10) on October 18, 2011 (which was described and discussed here at PredictER News, December 13, 2012), the German Federal Court of Justice (BGH) has still not made its decision. What happened after the October decision?

Only a couple days after the decision had been made, several representatives of the European Parliament filed a request to the EU Commission to stop the funding of embryonic stem cell research in the EU program, Horizon 2020 (EPP Group in the European Parliament). In their point of view, the ECJ decision indicated that embryonic stem cell research shall cease.

Horizon 2020 is the main EU financial instrument to support research and innovation in the Member States. The research funding budget will cover an amount of about 80 Billion Euro to be used from 2014 to 2020. Horizon 2020 was drafted on the basis of Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Program of the European (FP7) Community for research, technological development and demonstration activities (2007-2013). Art. 6 Subsec. 2 of the Decision No 1982/2006/EC regulates that research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member State(s) involved. However, Decision No 1982/2006/EC was made before the European Court of Justice held in Brüstle v. Greenpeace e.V. that human embryonic stem cell lines have to be seen as embryos.

On May 31, 2012 the 3169th Competitiveness Council meeting was held. Inter alia, the Proposal for a Regulation establishing Horizon 2020, as well as the rules for participation and dissemination, were discussed in the form of a Progress Report. It has been announced that the EU Science Minister finally reached an agreement on the overall structure of the Horizon 2020 research funding program. The proposal of the Committee on Industry, Research and Energy to amend the Horizon 2020 proposal (COM(2011) 811) from November 30, 2011 does not suggest any changes to the Horizon 2020 proposal of the European Commission related to stem cell research. Even though, requests have been filed to stop or lower the funding of embryonic stem cell research the proposal for Horizon 2020 did not change the wording of section 2.1, that “Supporting a large set of embryonic, high risk visionary science and technology collaborative research projects is necessary for the successful exploration of new foundations for radically new future technologies” (COM(2011) 811, Sec. 2.1 of the Council Decision).

The Competitiveness Council agreed that stem cell research will be treated under Horizon 2020 the same as under the 7th Framework Program. The following “Triple-Lock-System” which was established under FP7 will be continued for the funding of stem cell research:

1. National Legislation must be respected and EU projects must follow the laws of the Member States in which the research is conducted; and
2. all projects have to be scientifically peer reviewed and must undergo rigorous ethical review; and
3. EU funding cannot be used for derivation of new stem cell lines or for research that destroys embryos (3169th Competitiveness Council meeting).

The German Federal Court of Justice decision is still outstanding. The final decision on Horizon 2020 (“FP8”) has not been made yet either. It still remains to be seen how the German Federal Court of Justice will decide and which influence the decision will have not only on the German legislation but also on Horizon 2020.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

The End of Embryonic Stem Cell Research in Europe? The European Court of Justice Decision, Case C-34/10, October 18, 2011

The European Court of Justice (“ECJ”) ruled in the case Brüstle v. Greenpeace (Case C-34/10) brought up by Greenpeace seeking annulment of the German patent – Patent No. DE19756864C1 – held by Mr. Brüstle concerning isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects. The main focus of the decision is the interpretation of Article 6(2)(c) of Directive 98/44/EC (1998 OJL (L213) 13-18) of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

The German Federal Patent Court (Bundespatentgericht, “BPatG”) ruled on December 5, 2006, Case 3 Ni 42/04, on the basis of Paragraph 22(1) German Patent Protection Act (“PatG”) in conjunction with Paragraph 21 Subsection 1 Point 1 PatG in conjunction with Paragraph 2 Subsection 2 Point 3 PatG, that the patent at issue is invalid in so far as it covers precursor cells obtained from human embryonic stem cells and processes for the production of those precursor cells. The court held that the patent also violates the German Embryonic Protection Act (“ESchG”), which prohibits research with human embryos. Mr. Brüstle appealed against the judgment to the German Federal Court of Justice (Bundesgerichtshof, “BGH”), December 17, 2009, Case Xa ZR 58/07.

In accordance with the guiding principles of European Union Law, the national law of the Member States must be interpreted in terms of the rules and regulations set by the European Union; the court held that the outcome of the application for the annulment of the patent de-pends on the interpretation of Article 6 of the Directive, which is implemented in the PatG as well as the ESchG. Thus, the BGH referred specific questions to the ECJ and requested a preliminary ruling regarding:

1. the interpretation of the term “human embryos” in Article 6(2)(c) of the Directive;
2. the interpretation of the expression “uses of human embryos for industrial or commercial purposes” and the question if this especially includes the use for the purposes of scientific research;
3. and if an invention is unpatentable even if the use of human embryos does not form part of the technical teaching claimed with the patent, but whose production necessi-tates the prior destruction of human embryos. See, in detail: Bundesgerichtshof [BGH] [German Federal Court of Justice], December 17, 2009, Case Xa ZR 58/07; ECJ, October 18, 2011, Case C-34/10, para. 23.

The Concept of Human Embryo

Because the Directive lacks a definition of the term “embryo” and after considering the preamble and the scope of the directive, the court ruled:

"any human ovum after fertilisation, any nonfertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any nonfertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute[s] a human embryo" (Case C-34/10, para. 53);

"stem cells obtained from a human embryo at the blastocyst stage, […] whether they are capable of commencing the process of development of a human being, […] are included within the concept of human embryo” (Case C-34/10, para. 37).

Human Embryos for Scientific Research

The Directive is limited to the patentability of biotechnological inventions; it does not regulate the use of human embryos in the context of scientific research directly. Considering Recital 14 of the Directive, the court ruled:

"[the] use of human embryos for industrial or commercial purposes' within the meaning of Article 6(2)(c) of the Directive also covers use for purposes of scientific research" and are not patentable;

"only use[s] for therapeutic or diagnostic purposes which [are] applied to the human embryo and are useful to it [are] patentable". (Case C-34/10, para. 46)

Inventions Based on the Destruction of Human Embryos

Taking into account that a human embryo is destroyed when a stem cell is removed during the blastocyst stage, for example, in the production of neural precursor cells (Case C-34/10, para. 48), the court held that when the destruction occurs at a stage long before the implementation of the invention it is irrelevant (Case C-34/10, para. 49). Therefore, the court ruled:

"an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos" (Case C-34/10, para. 49);

"the fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is, in that regard, irrelevant" (Case C-34/10, para. 49).

This recent decision may do more to impede the progress of embryonic stem cell research in Europe than any inherent limits in the state of science itself. The court used a very broad definition of the term “embryo” without using any scientific reference points. With its definition of “embryo” the court included nearly all possible stages in the development. Although, the court recognized that non-fertilized ova are incapable of developing into a human being, it nonetheless placed them on the same level as an embryo. The implications of this decision are widespread in Europe; the decision is binding and cannot be appealed. It remains to be seen how the German courts and legislature, as well as those of the other Member States will react and comply.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

Judge Grants Partial Summary Judgment to Plaintiffs: Myriad's Gene Patents Are Invalid

On March 29, Judge Sweet issued a ruling in Association for Molecular Pathology v. United States Patent and Trademark Office. Known as the lawsuit against Myriad Genetics, this case was posed to answer the widely debated question of whether human genes are patentable. In a 152 page opinion, the Court comprehensively addressed whether the defendants’ patents were valid under the standards set forth in 35 USC § 101 and patent law’s subsequent precedent.

For more information on the case, see our previous posting and our Law & Policy Update.

Judge Sweet granted partial summary judgment in favor of the plaintiffs related to both the composition and the method claims, finding as a matter of law defendants’ patents were invalid under 35 USC § 101. (For more on the significance of summary judgment, see Genomic Law Report’s posting.) The Court dismissed the Constitutional claims against the USPTO based on the doctrine of Constitutional Avoidance. This means where it is possible to resolve plaintiffs claims without addressing the Constitutional questions, the Court is precluded from addressing these issues.

Defendants argued that by isolating and purifying DNA, they had sufficiently changed a product of nature into a fundamentally new product that satisfied subject matter patentability requirements. Judge Sweet responded to defendants’ arguments by systematically refuting each point. The Court thoroughly dismantled defendants’ reliance on precedent relating to products of nature in Parke-Davis, explaining that this case’s analysis only related to outdated dicta. Purification of a product of nature without additional handiwork or change to the substance is insufficient to meet the requirements for patentability because isolated DNA is not markedly different from native DNA, according to the Court. By definition, isolated DNA can be used for research tool applications where native DNA is unsuitable because it has an identical sequence.

Notably, Judge Sweet also took issue with defendants’ arguments that USPTO and the Court should treat patents for DNA identically to every other chemical. Unlike other chemicals, genes have a double nature because they are both chemical molecules and physical carriers of information. “DNA, and in particular, the ordering of the nucleotides, therefore serves as the physical embodiment of the laws of nature- those that define the construction of the human body,” wrote Judge Sweet. (124) These distinctions suggest that the Court recognizes the problematic implications of continuing to treat DNA as any other chemical- a frenetic race to patent the rest of the human genome without consideration of research or clinical care consequences.

The Court also invalidated defendants’ claims for analyzing and comparing sequences of the BRCA genes, finding that the claims did not meet the required physically transformative step. Preparatory processes such as isolating and sequencing the DNA only constitutes data gathering and are insufficient to transform an abstract mental process of comparing gene sequences into a transformative process. In addition, the Court invalidated defendants’ claim for comparing the growth rate of cells. In that patent, defendants claim stated that a slower growth of cells indicated a cancer therapeutic. Judge Sweet clarified that the essence of this claim merely recited the scientific method and constituted a patent on a basic scientific principle.

This opinion signals an important pause in frantic pursuit of more and more gene patents. Judge Sweet’s analysis commands us to rethink whether precedent ever actually supported patent eligibility for isolated DNA sequences or sequence comparison claims like Myriad’s.

The impact of this decision alone means that some of Myriad’s patents are invalid and it cannot enforce them in the future. However, defendants will likely appeal this decision to the Federal Circuit, which may choose to stay Judge Sweet’s ruling until it renders a final decision. If the final ruling happens to affirm this Court’s findings, then the USPTO would conform its examination policies to avoid issuing patents on isolated DNA or the comparison or analysis of DNA sequences.

-Katherine Drabiak-Syed

Lawsuit Challenging Myriad’s BRCA1 and BRCA2 Patents Will Go Forward: Judge Rejects Defendants’ Attempts to Preclude Plaintiffs’ Day in Court

Association for Molecular Pathology v. United States Patent and Trademark Office, Civil Action No. 09-4515 RWS ((S.D.N.Y. 2009) known as the lawsuit against Myriad Genetics challenging its gene patents related to BRCA1 and BRCA2 will go forward.

On November 1, 2009 Judge Robert Sweet handed down an order denying the defendants’ motion to dismiss. In the 85 page order, Judge Sweet accepted many of plaintiffs’ arguments set forth in the complaint and accompanying affidavits, finding that the court may properly hear the case and plaintiffs may properly sue each defendant.

The court flatly rejected defendants’ assertion that plaintiffs could not use the court as an arena to challenge questions of patentability.

Judge Sweet declined to adopt defendants’ arguments that the existence of the Patent Act as a comprehensive statutory scheme demonstrates Congressional intent to provide an internal remedy and preclude judicial challenges of the nature in this suit. The court noted that despite the USPTO’s statutory scheme to address patent questions, it does not provide a comparable statutory framework to raise Constitutional concerns and provide remedy accordingly; thus, plaintiffs may still bring an action to enforce the asserted Constitutional rights.

The court’s arrival at this reasoning is closely connected to Judge Sweet’s lengthy description of why the plaintiffs’ allegations of Constitutional violations are adequate and why the Court will not grant defendants’ motions to dismiss. The order described plaintiffs’ assertions that Myriad’s patents in question grant Myriad ownership rights over products of nature, laws of nature, natural phenomena, abstract ideas, basic human knowledge, and thought, which would violate the First Amendment. Additionally, plaintiffs pled that Myriad’s ownership of the patents in question inhibited further research, which would violate of Article I, section 8, clause 8 of the Constitution that directs Congress (and by delegation, the USPTO) to promote the progress of science.

The court also rejected Myriad’s arguments that plaintiffs could not show Myriad acted affirmatively to enforce the patents or that plaintiffs undertook meaningful preparation to potentially infringe the patents.

Judge Sweet adopted facts set forth in plaintiffs’ complaint and affidavits describing how Myriad sent out cease and desist letters to researcher plaintiffs and initiated two actions against infringers, demonstrating Myriad’s affirmative actions and willingness to enforce the patents. Importantly, the court further noted that given the widespread knowledge of the breadth of Myriad’s claims and its willingness to enforce its patents, a court would likely find that infringement of the patents would be considered willful and result in treble damages- meaning a scientist attempting BRCA research could be subject to extraordinary damages above merely compensating Myriad for any monetary losses.

Additionally, Judge Sweet accepted the researcher plaintiffs’ assertions that they are ready, willing, and able to infringe the patent because they are prepared to advance BRCA research, and or offer testing, and could do so within a matter of weeks. The court also noted that the plaintiff women affected by breast or ovarian cancer could take advantage of testing alternatives to find another test covered by their insurance or obtain a second opinion (options currently denied to them because of Myriad’s patents) that would potentially classify them as contributory infringers, meaning they could also properly sue the defendants.

The case moves forward and the court will hear parties’ oral arguments on motions for summary judgment on January 21, 2010. At this hearing, the court will decide whether there are genuine issues of material fact in dispute that would preclude the court from ruling as a matter of law for one party. If Judge Sweet’s order is any indication, a multitude of problems exist that are ripe for a hearing, and in the near future this court could squarely address these contentious issues arising from gene sequence patents. Perhaps finally the judicial system could address both the USPTO's and Congress' failure to re-examine patentability standards for gene sequences and decide whether issuing gene patents run contrary to Constitutional and statutory requirements.

-Katherine Drabiak-Syed

Gene Patents on the Radio

Do you own your genes? Should you have a stake in the profits from gene-related products based on "your" genes? What about the "tens of thousands of patents" issues by the U.S. Patent and Trade Office for gene-related products? If you're interested, Rebecca Roberts discusses Patenting Genes with Joshua D. Sarnoff, Hans Sauer, and Shobita Parthasarathy on The Kojo Nnamdi Show (WAMU 88.5 FM, June 4, 2009.)

Listen to the full show online or read a summary Donald Zuhn's summary, "Gene Patenting Debate Continues" (Patent Docs, June 9, 2009).

Who Owns Your DNA?

Do I own "my" DNA? I'm not sure … I don't own my height or my eye color, so why should I assert a right to possess my genetic information? At the same time, can anyone truly "own" this information? Should I worry that a research institution or a pharmaceutical company might someday tell me that I can not control what I "do" with my genetic information, because they "own" it? These are vexing questions and seldom addressed in blogs on the ethics of genetic research and the future of personalized medicine. Thus, I couldn't resist sharing this comic by Mike Adams, "Biopiracy Patents and the Rise of Intellectual Imperialism (comic)", Sunday, March 1, 2008. www.NaturalNews.com.

In the article that accompanies the comic, Adams gladly veers off into the art of the alarmist rant: "in the near future, couples who wish to reproduce may be forced to pay intellectual property royalties to wealthy corporations in exchange for the 'rights' to copy their own genes through sexual reproduction". If Adams is right about this one, in the future, the individual members of these "wealthy corporations" will have forgotten that they have or want to have children and grandchildren. Like many rants, however, Adams provides plenty of fuel to start a good discussion; thus, if the comic bores you, read the article.