Orange Book Blog

Research Universities File Amicus Brief In Support of Affirming the Federal Circuit in Bowman v. Monsanto Supreme Court Case

    by Christopher P. Singer

On January 23, 2013, a group of major universities and technology transfer offices filed an amicus brief urging the United States Supreme Court to affirm the Federal Circuit in Monsanto v. Bowman.  The amici argued that reversing the Federal Circuit, which ruled that Bowman infringed Monsanto’s patents for Roundup Ready® soybean seeds, would have a substantial negative impact on university research directed toward artificial, progenitive technologies and the technology transfer function that is vital to bringing such technologies to market for the public benefit.

In their brief, amici noted that "[i]n 2009, academic institutions performed over half (53%) of all basic research in the United States . . . and 14% of total U.S. research and development."  In particular, amici pointed out that research into artificial, progenitive technologies affects a wide range of areas like "stem cells, mutant genes, DNA vectors and molecules, viral vectors, bacterial strains, RNA enzymes, cell lines, and organic computers."  Much of their research is performed under the auspices of the Bayh-Dole Act, which allows universities to obtain patent protection for inventions developed with federal funding and then license those patents to help make the inventions accessible to the public.  Amici argued that reversing the Federal Circuit would harm the value of patents covering artificial, progenitive technologies, making it very difficult for universities and their technology transfer offices to license those patents for the purpose of making them available to the public.

Amici also argued that when Bowman used harvested soybean seeds to grow further generations, he "made" new seeds that infringed Monsanto’s patents because "[e]ven authorized purchasers of a patented article cannot make 'a second creation of the patented entity.'"  Drawing on Supreme Court precedent, amici argued that "[u]nder any definition, Bowman certainly 'made' infringing seeds in this case, even though he grew them rather than genetically engineering them from starting materials."  Moreover, amici argued that this case did not present any unique concerns regarding "innocent infringement" that are not present in any other patent infringement case, and that in any event, Bowman was not an "innocent infringer" owing to his scheme to use illegally-purchased commodity seeds as "a cheap source of seed."

Amici signing on to the brief included the Wisconsin Alumni Research Foundation, Association of University Technology Managers, Association of Public and Land-grant Universities, Association of American Universities, The Regents of the University of California, The Board of Trustees of the University of Illinois, University of Florida, Duke University, Emory University, University of Georgia Research Foundation, Inc., Iowa State University of Science and Technology, NDSU Research Foundation, University of Iowa, University of Missouri-Columbia, South Dakota State University, NUtech Ventures, University of Nebraska-Lincoln, University of Kentucky, University of Kansas, Kansas State University, Montana State University, and University of Delaware. 

The brief was authored by Scott P. McBride, Stephen M. Wurth, and Caroline A. Teichner of McAndrews, Held, and Malloy, Ltd.

OBB News Briefs: First-Inventor-to-File Rules; Myriad oral argument; Lyrica decision

• On Friday morning, the USPTO pre-published its proposed rule changes implementing the provisions of the America Invents Act that convert the U.S. patent system from a "first to invent" to a "first inventor to file" system.  The proposed rules (available here) were scheduled to be published in the Federal Register on Monday, but were withdrawn later Friday.  We understand that the proposed rules were withdrawn because there was not enough space in Monday's Federal Register to accomodate both the proposed rules and a companion "guidance document" that the PTO wants published in the same issue of the Federal Register.  We expect that the proposed rules and guidance document will be published together sometime next week, and further that the published proposed rules will be identical to those that were pre-published today.
• Also Friday morning, the Federal Circuit heard oral argument in AMP v. Myriad following remand from the Supreme Court for further consideration in light of Prometheus.  An .mp3 audio recording of the oral argument is available here and also posted on the Federal Circuit's website.
• On Thursday, Judge Sleet of the U.S. District Court for the District of Delaware issued a 133-page opinion holding Pfizer's patents on Lyrica (pregabilin) valid and infringed by eight generic drug companies who filed ANDAs with paragraph IV certifications to the patents.  The ANDA applicants are now enjoined from marketing their generic versions of Lyrica until at least December 30, 2018, when, according to the Orange Book, the last of the patents-in-suit will expire.  The issues in the case included obviousness, anticipation, priority, written description, inventorship, literal and DOE infringement, and finally whether two patent term extensions, stemming from two separate NDAs for Lyrica that were approved on the same day, were valid.

Federal Circuit Affirms Summary Judgment of No DOE Infringement in CENESTIN Case

Duramed Pharms., Inc. v. Paddock Labs., Inc., No. 2010-1419 (Fed. Cir. 2011)

    by Scott P. McBride

CENESTIN is a conjugated estrogen pharmaceutical composition used to reduce the symptoms of menopause.  In a 3-0 decision last week, the Federal Circuit affirmed that Paddock's generic version of CENESTIN would not infringe U.S. Patent No. 5,908,638, directed to conjugated estrogen compositions, under the Doctrine of Equivalents.

Claim 1 of the '638 patent recites:

A pharmaceutical composition in a solid, unit dosage form capable of oral administration for the hormonal treatment of peri-menopausal, menopausal and post-menopausal disorders in a woman comprising: conjugated estrogens coated onto one or more organic excipients forming a powdered conjugated estrogen composition where said composition is substantially free of inorganic excipients and further comprises about 30-70% gel-forming organic excipient and about 30-70% non-gel forming organic excipient by weight and having less than about 2.5% free water by weight and greater than 2.5% total water wherein said solid unit dosage form is coated with a moisture barrier coating comprising ethylcellulose.

In 2008, Paddock filed an ANDA for a generic version of CENESTIN, after which Duramed filed suit for infringement of the '638 patent.  Duramed asserted infringement of independent claim 1 and dependent claims 4 and 6-8 under the doctrine of equivalents only.

In an opinion last year, District Judge Sand (S.D.N.Y.) concluded on summary judgment that the four asserted claims were not infringed under the doctrine of equivalents due to prosecution history estoppel.  During prosecution, claim 1 originally recited a conjugated estrogen pharmaceutical composition "coated with a moisture barrier coating" (MBC).  Original dependent claim 7 limited "said moisture barrier coating" to one that "comprises ethylcellulose."  After initially rejecting both claims as obvious, the examiner later advised that he would allow the application if Duramed amended claim 1 to include the limitations of claim 7.  In response, Duramed amended claim 1 to recite pharmaceutical compositions with "a moisture barrier coating comprising ethylcellulose."

Judge Sand concluded that the amendment adding the ethylcellulose limitation was substantially related to patentability and narrowed the claim scope, thus triggering the Festo presumption that Duramed had surrendered all territory between the original and amended claim scope (i.e., between "coated with a moisture barrier coating" and coated with a moisture barrier coating "comprising ethylcellulose").  Judge Sand also concluded that Duramed had failed to rebut the Festo presumption based on an argument of the unforeseeability of the use of polyvinyl alcohol (PVA) MBC, used in Paddock's proposed generic product and marketed as Opadry AMB.  Judge Sand concluded that PVA MBCs were foreseeable at the time of Duramed's narrowing amendment (December 1998) because, among other things: (1) a Colorcon PCT application published in January 1996 described PVA as "a moisture barrier coating for pharmaceutical tablets and the like"; (2) pre-September 1996 invoices existed for the sale (by Colorcon) of Opadry AMB; and (3) a 1976 patent to Groppenbächer disclosed the use of PVA in moisture-tight tablets.

In affirming, the Federal Circuit noted that Duramed could rebut the presumption of prosecution history estoppel by showing that the alleged equivalent would have been unforeseeable at the time of the amendment and was thus beyond a fair interpretation of what was surrendered.  Duramed argued that the district court applied the wrong legal test for foreseeability, and that an equivalent is not foreseeable unless it was understood by one of ordinary skill to be suitable for use in the invention as originally claimed.  But the Federal Circuit rejected Duramed's arguments.

Duramed argued that foreseeability requires that PVA must have been known as an MBC for moisture-sensitive pharmaceutical compounds, like the claimed conjugated estrogens.  Relying on Schwarz Pharma, Inc. v. Paddock Labs., Inc., 504 F.3d 1371, 1377 (Fed. Cir. 2007), the Federal Circuit stated that when the language of the original and issued claims begins with the words "[a] pharmaceutical composition," that language (and not merely the specifically-claimed constituent ingredient (here, conjugated estrogens)) defines the field of the invention for purposes of determining foreseeability.  Accordingly, PVA MBCs need only to have been known in the field of pharmaceutical compositions, as of the time of Duramed's narrowing amendment.  Because the Colorcon PCT discloses PVA MBCs, including Opadry AMB, in the field of pharmaceutical compositions, such PVA MBCs were "known in the field of the invention," and thus foreseeable.  Thus, the Federal Circuit held that the Colorcon PCT established foreseeability as a matter of law.

The Federal Circuit also explained that "foreseeability does not require . . . precise evidence of suitability.  . . .  Foreseeability does not require flawless perfection to create an estoppel."  Thus, the Federal Circuit rejected Duramed's arguments that the Colorcon PCT did not establish foreseeability due to its inclusion of (1) technical drawbacks, and (2) conclusory statements, rather than test data showing precise characteristics or precise suitability.

Finally, the Federal Circuit held that no genuine issue of fact precluded a finding that a December 1995 article in the scientific journal "Manufacturing Chemist" was publicly available to assess foreseeability.  In reaching this conclusion, the Federal Circuit emphasized that the amendment date (December 1998), not the application date (July 1995), was the pertinent time for determining foreseeability.