Archive for March, 2010

BIO Press Release

Wednesday, March 31st, 2010

For Immediate Release   www.bio.org  

Contact: Stephanie Fischer     (202) 312-9263 or sfischer@bio.org

BIO Statement on Initial Decision in Myriad Genetics Lawsuit

Washington, D.C. (March 30, 2010) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the decision issued yesterday in the lawsuit brought by the American Civil Liberties Union (ACLU) against Myriad Genetics in the U.S. District Court in the Southern District of New York:  

“As explained in the ruling yesterday, the District Court’s determination is only a preliminary step in the legal process and will not affect how the U.S. Patent and Trademark Office (PTO) evaluates patent applications relating to DNA-based inventions. 

“BIO is pleased that the Court dismissed the far-reaching claims regarding the constitutionality of patenting gene-based inventions. Disputed allegations that patents supposedly stifle research or impede patient access were explicitly excluded from consideration. And the invalidation of the diagnostic method claims was done under a Federal Circuit opinion (In Re Bilski) which will soon be clarified further by the Supreme Court.

“From the mass production of life-saving medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society. Preparations of isolated and purified DNA molecules, which alone can be put to use in these ways, are patentable because they are fundamentally different from anything that occurs in nature.”

BIO’s amicus brief in the Myriad Genetics case is available at [below]and the amicus brief for the Bilski case is available at [below].  Additional background materials on gene patenting are available at http://bio.org/ip/genepat/.

About BIO

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

BIO Amcus Brief Bilski

BIOAmicusBriefACLU-Myriad12-09

Myriad Ruling: DNA Sequences Are Unpatentable “ Products Of Nature”

Tuesday, March 30th, 2010

In a lengthy opinion released yesterday in Assoc. for Molec. Pathology v. USPTO, __F.Supp.2d___(S.D. N.Y.) (PDF below), the court invalidated claims directed to isolated DNA sequences, as well as to cancer screening methods using them, and even to methods of screening potential anti-cancer compounds using them. Although the Judge stated that his opinion was limited to DNA sequences, it is difficult not to extrapolate his reasoning to many heretofore patentable chemical compounds that are obtained by purification from natural sources, including body tissues, fluids, cells and the like. For background on this lawsuit, including representative claims and patents, please refer to my post of May 18, 2009, archived under “Patentable Subject Matter.”

After construing the DNA claims to cover “real and tangible molecules of deoxynucleotides linked by a phosphodiester backbone” that are “substantially separated from cellular components which naturally accompany a gene [including the rest of the chromosomal DNA],” the Judge’s reasoning took an interesting turn. The opinion contains an extensive review of the older case law, such as Funk Bros. Seed Co. v. Kalo, and again and again, the Judge carved off what he viewed as findings of novelty for s. 102 examination and subject matter that might be “new” for s. 101 but was still an unpatentable “product of nature.”

The Judge stated and restated the rationale of the decision: “Considerations of novelty are irrelevant for s. 101 purposes.… Products of nature do not constitute patentable subject matter absent a change that results in creation of a fundamentally new product.” To patent a substance arguably present in “the jungle of nature” – my term, or is it from Bergy? – the claimed composition must be “a product of human ingenuity ‘having a distinctive name, character [and] use.’” [citing Chakrabarty]. Separating absolute novelty from fundamental newness permitted the Judge to distinguish, and ignore, the well-known opinion by Judge Learned Hand in Parke-Davis (189 F.2d 95) which found purified adrenaline to be patentable in view of earlier less-pure adrenal gland extracts that were marginally medically useful. Likewise, In re Bergstrom (PGE3 claim) was ignored as a decision turning on the issue of inherent anticipation, not patentable subject matter. Because he limited his opinion to attempts to claim DNA, the Judge ignored In re Bergy, which permitted applicant to patent cultured pure strain microorganisms useful to make antibiotics.

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Centocor v. Abbott Labs. – “Antibody Exception” To Written Description Requirement Under Fire

Monday, March 29th, 2010

Abbott Laboratories markets a recombinant human antibody, HUMIRA, as a treatment for rheumatoid arthritis. This antibody binds to a receptor on TNF. NYU and Centocor own US Pat No 7070775 which claims an isolated recombinant anti-TNF-a antibody (Ab) comprising a human constant region, where said Ab competitively inhibit binding of the mouse A2 antibody to human TNF-a and binds to a neutralizing epitope of human TNF-a in vivo with the recited affinity. The A2 mouse antibody is the only species disclosed in the specification, and is not the subject of claim 1.

The string of 13 patent applications that yielded this patent began with an application filed in 1991. The ‘775 patent issued in 2006 and Centocor sued Abbott for infringement. The district court denied Abbott’s motion for JMOL that the specification of the ‘775 patent failed to meet the written description requirement of s.112, and Abbott has appealed to the Federal Circuit. Centocor v. Abbott Labs., No. 2:07CV139-TJW, 2009 U.S. Dist. Lexis 102427 (E.D. Tex. Nov. 4, 2009).

A little bit of history. As pointed out by Lilly in its Amicus Brief supporting Abbott (a PDF is provided at the end of this posting), after years of R&D, antibody-based therapies have come of age: “Rapid growth in the field of antibody research has led to the introduction of nineteen monoclonal antibody [MCA] drugs into the U.S. market since 1994, while only one such MCA drug was approved by the FDA prior to 1994.” When I started prosecuting biotech applications in the early 80’s, MCAs were seen primarily as “research tools,” that might have value in diagnostic assays. If a researcher discovered a new polypeptide that might be useful as a disease marker, broad claims were routinely allowed by the PTO, e.g.: “A purified antibody which specifically reacts with protein x [a possible marker for, e.g., prostate cancer], wherein said antibody does not significantly react with prostate specific antigen.” Put simply, if you knew the structure of the antigen, you could get a claim to any antibody that bound to that antigen. In fact, if you could get a claim to the antigen, the antibody claims pretty much got tossed in gratis. Maybe we have the legal death of In re Durden in 1995 to “blame” for this, but that is a story for another day.

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Regulatory Framework For Follow-On Biologics In Health Care Bill

Friday, March 26th, 2010

In the early evening of March 25, 2010, the House voted, finalizing the budget reconciliation package earlier passed by the Senate, that contained some relatively minor amendments to the version of the Senate Bill that the House passed in the historic (and tense) vote on Sunday night, and President Obama signed on Wednesday.

Unremarked upon by most of the press is that this bill, HR. 3590, public law 111-48 contains the entirety of the legal and regulatory approval process for “biosimilars” or generic biological products. This is Title VII, “Improving Access to Innovative Medical Therapies – Subtitle A,” and is to be referred to as the “Biologics Price Competition and Innovation Act of 2009”. It can be most easily accessed by printing (roughly) pages 1827-1869 of the PDF of H.R. 3590 as it can be found at www.thomas.gov with a little searching. (A copy of the PDF is attached at the end of this post.) The Act amends section 351 of 42 U.S.C. 262 and 35 U.S.C. 271(e).

I have read some short blog posts that say that this is nothing like the Hatch-Waxman procedures currently in place for “small molecules”. To the contrary, it is a lot like the Hatch-Waxman procedures, but without the Orange Book (although one may eventually be needed to keep track of approved drugs). Most writers have noted that innovators (who are called “reference product sponsors” — “RPS”) get 12 years of exclusivity from approval (and there is a four year wait before a “subsection (k) applicant” can even file an application for a biosimilar). Additional six month extensions are available for pediatric use approval and for approval for rare diseases.

The biosimilar in fact does not have to be chemically identical to the reference biological, but it must be “highly similar” and there must be no “clinically meaningful differences in terms of the safety, purity and potency” of the biosimilar and that it must be “expected to produce the same clinical result.” The FDA is assigned the task of fleshing out these requirements, which can be established by analytic, animal and /or human studies, as determined by the agency.

The first approved biosimilar gets market exclusivity that seems modeled after Hatch-Waxman exclusivity: 18 months after final decision of Fed. Cir. – not district court, if first (k) applicant is sued, or from dismissal of suit and up to 42 months of exclusivity from approval if litigation continues. First (k) applicant gets 18 months of exclusivity from approval if there is no suit by the RPS.

Instead of the Hatch-Waxman certification, para. IV notification, suit or no suit scheme, the Biologics Price Competition Act contains a complex, short deadline system wherein the FDA notifies the RDS that an ss. (k) application for a biosimilar has been filed, the RDS then must supply the (k) applicant with a list of patents that it believes will be infringed and/or an offer to license. The applicant then provides an answer that sounds a lot like a PIV notification letter. Within 60 days the RDS provides its response, which is a detailed opinion as to why the applicant infringes. Then the Act contains a requirement that the parties negotiate a settlement in good faith, after which there is another exchange of patent lists. Then and only then can the suit commence.

This is only a general summary of small parts of the 46 page Act and I am sure that the most affected organizations will soon be announcing conferences to explain these provisions, so I will quit for now and rest my eyes. This is a full employment act for biotech patent attorneys with opinion experience, so it may be time for us to get that spring break in now.

HR 3590 12_24_09